Taltz

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  



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1. NAME OF THE MEDICINAL PRODUCT 
 
Taltz 80 mg solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe contains 80 mg ixekizumab in 1 ml. 
 
Ixekizumab is produced in CHO cells by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
 
The solution is clear and colourless to slightly yellow. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Plaque psoriasis 
 
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates 
for systemic therapy. 
 
Paediatric plaque psoriasis 
 
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age 
of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for 
systemic therapy. 
 
Psoriatic arthritis 
 
Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic 
arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more 
disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1). 
 
Axial spondyloarthritis 
 
Ankylosing spondylitis (radiographic axial spondyloarthritis) 
Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have 
responded inadequately to conventional therapy. 
 
Non-radiographic axial spondyloarthritis 
Taltz is indicated for the treatment of adult patients with active non-radiographic axial 
spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein 
(CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal 
anti-inflammatory drugs (NSAIDs). 
 



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4.2 Posology and method of administration 
 
This medicinal product is intended for use under the guidance and supervision of a physician 
experienced in the diagnosis and treatment of conditions for which it is indicated. 
 
Posology 
 
Plaque psoriasis in adults 
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, 
followed by 80 mg (one injection) at weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg 
(one injection) every 4 weeks (Q4W).  
 
Paediatric plaque psoriasis (age 6 years and above) 
Efficacy and safety data is not available in children below the age of 6 years (see section 5.1). 
Available data do not support a posology below a body weight of 25 kg. 
The recommended dose given by subcutaneous injection in children is based on the following weight 
categories: 
 

Children’s body 
weight 

Recommended starting 
dose (week 0) 

Recommended dose every 
4 weeks (Q4W) thereafter 

Greater than 50 kg  160 mg (two 80 mg injections) 80 mg 
25 to 50 kg 80 mg 40 mg 

 
For children prescribed 80 mg, Taltz can be used directly from the pre-filled syringe. 
For instructions on preparation of Taltz 40 mg, see section 6.6. Doses less than 80 mg must be 
prepared by a healthcare professional. 
Taltz is not recommended for use in children with a body weight below 25 kg. Paediatric body weights 
must be recorded and regularly re-checked prior to dosing. 
  
Psoriatic arthritis 
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, 
followed by 80 mg (one injection) every 4 weeks thereafter. For psoriatic arthritis patients with 
concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for 
plaque psoriasis. 
 
Axial spondyloarthritis (radiographic and non-radiographic) 
The recommended dose is 160 mg (two 80 mg injections) by subcutaneous injection at week 0, 
followed by 80 mg every 4 weeks (see section 5.1 for further information). 
 
For all indications (plaque psoriasis in adults and children, psoriatic arthritis, axial spondyloarthritis) 
consideration should be given to discontinuing treatment in patients who have shown no response after 
16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve 
with continued treatment beyond 20 weeks. 
 
Special populations 
 
Elderly (≥ 65 years) 
No dose adjustment is required (see section 5.2). 
There is limited information in subjects aged ≥ 75 years. 
 
Renal or hepatic impairment 
Taltz has not been studied in these patient populations. No dose recommendations can be made. 
 



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Paediatric population 
 
Paediatric plaque psoriasis (below a body weight of 25 kg and below the age of 6 years) 
There is no relevant use of Taltz in children below a body weight of 25 kg and below the age of 
6 years in the treatment of moderate to severe plaque psoriasis.  
 
Paediatric psoriatic arthritis 
The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the 
treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been 
established. No data are available.  
There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis. 
 
Method of administration  
 
Subcutaneous use. 
 
Taltz is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that 
show psoriasis should be avoided as injection sites. The solution/the syringe must not be shaken. 
 
After proper training in subcutaneous injection technique, patients may self-inject Taltz if a healthcare 
professional determines that it is appropriate. However, the physician should ensure appropriate 
follow-up of patients. Comprehensive instructions for administration are given in the package leaflet 
and the user manual.  
 
Doses less than 80 mg which require dose preparation should only be administered by a healthcare 
professional. 
 
For instructions on preparation of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Clinically important active infections (e.g. active tuberculosis, see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Infections 
 
Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract 
infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8). 
 
Taltz should be used with caution in patients with clinically important chronic infection or a history of 
recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms 
suggestive of an infection occur. If an infection develops, patients should be carefully monitored and 
Taltz discontinued if the patient is not responding to standard therapy or if the infection becomes 
serious. Taltz should not be resumed until the infection resolves. 
 
Taltz must not be given to patients with active tuberculosis (TB). Anti-TB therapy prior to initiation of 
Taltz in patients with latent TB should be considered. 
 



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Hypersensitivity 
 
Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, 
rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread 
urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction 
occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated. 
 
Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) 
 
Cases of new or exacerbations of inflammatory bowel disease have been reported with ixekizumab 
(see section 4.8). Ixekizumab is not recommended in patients with inflammatory bowel disease. If a 
patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of 
pre-existing inflammatory bowel disease, ixekizumab should be discontinued and appropriate medical 
management should be initiated. 
 
Immunisations 
 
Taltz should not be used with live vaccines. No data are available on the response to live vaccines; 
there are insufficient data on response to inactive vaccines (see section 5.1). 
 
Excipients  
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say 
essentially “sodium-free”.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or 
phototherapy has not been evaluated. 
In population pharmacokinetic analyses, clearance of ixekizumab was not affected by concomitant 
administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate. 
 
Cytochrome P450 substrates 
 
Results from an interaction study in patients with moderate-to-severe psoriasis determined that 
12 weeks of administration of ixekizumab with substances metabolised by CYP3A4 (i.e., midazolam), 
CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., 
dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these 
substances. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
 
Women of childbearing potential should use an effective method of contraception during treatment 
and for at least 10 weeks after treatment. 
 
Pregnancy 
 
There is a limited amount of data from the use of ixekizumab in pregnant women. Animal studies do 
not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal 
development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is 
preferable to avoid the use of Taltz during pregnancy. 
 



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Breast-feeding 
 
It is not known whether ixekizumab is excreted in human milk or absorbed systemically after 
ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys. A 
decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into 
account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate 
direct or indirect harmful effects with respect to fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Taltz has no or negligible influence on the ability to drive and use machines.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were injection site reactions (15.5 %) and upper 
respiratory tract infections (16.4 %) (most frequently nasopharyngitis). 
 
Tabulated list of adverse reactions 
 
Adverse reactions from clinical studies and postmarketing reports (Table 1) are listed by MedDRA 
system organ class. Within each system organ class, the adverse reactions are ranked by frequency, 
with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented 
in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse 
reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); 
uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 
 
A total of 8,956 patients have been treated with Taltz in blinded and open-label clinical studies in 
plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and other autoimmune conditions. Of these, 
6,385 patients were exposed to Taltz for at least one year, cumulatively representing 
19,833 adult patient years of exposure and 196 children cumulatively representing 207 patient years of 
exposure. 



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Table 1.  List of adverse reactions in clinical studies and postmarketing reports 
 

System organ class Frequency Adverse reaction 
Infections and infestations  
 

Very common Upper respiratory tract 
infection 

Common Tinea infection, 
Herpes simplex 
(mucocutaneous) 

Uncommon Influenza, 
Rhinitis, 
Oral candidiasis, 
Conjunctivitis, 
Cellulitis 

Blood and lymphatic system 
disorders  

Uncommon Neutropenia, 
Thrombocytopenia 

Immune system disorders  Uncommon  Angioedema 
Rare Anaphylaxis 

Respiratory, thoracic and 
mediastinal disorders  

Common Oropharyngeal pain 

Gastrointestinal disorders  Common Nausea 
Uncommon  Inflammatory bowel disease 

Skin and subcutaneous 
disorders  

Uncommon Urticaria, 
Rash, 
Eczema 

General disorders and 
administration site conditions 

Very common Injection site reactionsa 

a See section description of selected adverse reactions 
 
Description of selected adverse reactions 
 
Injection site reactions 
The most frequent injection site reactions observed were erythema and pain. These reactions were 
predominantly mild to moderate in severity and did not lead to discontinuation of Taltz. 
In the adult plaque psoriasis studies, injection site reactions were more common in subjects with a 
body weight < 60 kg compared with the group with a body weight ≥ 60 kg (25 % vs. 14 % for the 
combined Q2W and Q4W groups). In the psoriatic arthritis studies, injection site reactions were more 
common in subjects with a body weight < 100 kg compared with the group with a body weight 
≥ 100 kg (24 % vs. 13 % for the combined Q2W and Q4W groups). In the axial spondyloarthritis 
studies, injection site reactions were similar in subjects with a body weight < 100 kg compared with 
the group with a body weight ≥ 100 kg (14 % vs. 9 % for the combined Q2W and Q4W groups). The 
increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in 
an increase in discontinuations in either the plaque psoriasis, the psoriatic arthritis or the axial 
spondyloarthritis studies. 
 
Infections 
In the placebo-controlled period of the phase III clinical studies in plaque psoriasis in adults, infections 
were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of 
patients treated with placebo.  
 
The majority of infections were non-serious and mild to moderate in severity, most of which did not 
necessitate treatment discontinuation. Serious infections occurred in 13 (0.6 %) of patients treated with 
Taltz and in 3 (0.4 %) of patients treated with placebo (see section 4.4). Over the entire treatment 
period infections were reported in 52.8 % of patients treated with Taltz (46.9 per 100 patient years). 
Serious infections were reported in 1.6 % of patients treated with Taltz (1.5 per 100 patient years). 
 



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Infection rates observed in psoriatic arthritis and axial spondyloarthritis clinical studies were similar to 
those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse 
reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis. 
 
Laboratory assessment of neutropenia and thrombocytopenia 
In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia. In most cases, the 
blood neutrophil count was ≥1,000 cells/mm3. Such levels of neutropenia may persist, fluctuate or be 
transient. 0.1% of patients receiving Taltz developed a neutrophil count <1,000 cells/mm3. In general, 
neutropenia did not require discontinuation of Taltz. 3% of patients exposed to Taltz had a shift from a 
normal baseline platelet value to <150,000 platelet cells/mm3 to ≥75,000 cells/mm3. 
Thrombocytopenia may persist, fluctuate or be transient. 
 
The frequency of neutropenia and thrombocytopenia in psoriatic arthritis and axial spondyloarthritis 
clinical studies is similar to that observed in the plaque psoriasis studies. 
 
Immunogenicity 
Approximately 9-17% of adult plaque psoriasis patients treated with Taltz at the recommended dosing 
regimen developed anti-drug antibodies, the majority of which were low titres and not associated with 
reduced clinical response up to 60 weeks of treatment. However, approximately 1% of patients treated 
with Taltz had confirmed neutralising antibodies associated with low drug concentrations and reduced 
clinical response.  
 
In psoriatic arthritis patients treated with Taltz at the recommended dosing regimen up to 52 weeks, 
approximately 11% developed anti-drug antibodies, the majority of which were low titre, and 
approximately 8% had confirmed neutralising antibodies. No apparent association between the 
presence of neutralising antibodies and impact on drug concentration or efficacy was observed. 
 
In paediatric psoriasis patients treated with Taltz at the recommended dosing regimen up to 12 weeks, 
21 patients (18%) developed anti-drug antibodies, approximately half were low titer and 5 patients 
(4%) had confirmed neutralizing antibodies associated with low drug concentrations. There was no 
association with clinical response or adverse events. 
 
In radiographic axial spondyloarthritis patients treated with Taltz at the recommended dosing regimen 
up to 16 weeks, 5.2% developed anti-drug antibodies, the majority of which were low titer, and 1.5% 
(3 patients) had neutralising antibodies (NAb). In these 3 patients, NAb-positive samples had low 
ixekizumab concentrations and none of these patients achieved an ASAS40 response. In 
non-radiographic axial spondyloarthritis patients treated with Taltz at the recommended dosing 
regimen for up to 52 weeks, 8.9% developed anti-drug antibodies, all of which were low titer; no 
patient had neutralising antibodies; and no apparent association between the presence of anti-drug 
antibodies and drug concentration, efficacy, or safety was observed. 
 
Across all indications, an association between immunogenicity and treatment emergent adverse events 
has not been clearly established. 
 
Paediatric population 
 
The safety profile observed in children with plaque psoriasis treated with Taltz every 4 weeks is 
consistent with the safety profile in adult patients with plaque psoriasis with the exception of the 
frequencies of conjunctivitis, influenza, and urticaria which were common. Inflammatory bowel 
disease was also more frequent in paediatric patients, although it was still uncommon. In the paediatric 
clinical study, Crohn’s disease occurred in 0.9% of patients in the Taltz group and 0% of patients in 
the placebo group during the 12-week, placebo-controlled period. Crohn’s disease occurred in a total 
of 4 Taltz treated subjects (2.0%) during the combined placebo-controlled and maintenance periods of 
the paediatric clinical study. 
 



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Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting 
toxicity. Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have 
been reported without any serious adverse events.  
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms 
of adverse reactions and appropriate symptomatic treatment be instituted immediately. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC13 
 
Mechanism of action 
 
Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (< 3 pM) and specificity to 
interleukin 17A (both IL-17A and IL-17A/F). Elevated concentrations of IL-17A have been implicated 
in the pathogenesis of psoriasis by promoting keratinocyte proliferation and activation, as well as in 
the pathogenesis of psoriatic arthritis and axial spondyloarthritis by driving inflammation leading to 
erosive bone damage and pathological new bone formation. Neutralisation of IL-17A by ixekizumab 
inhibits these actions. Ixekizumab does not bind to ligands IL-17B, IL-17C, IL-17D, IL-17E or 
IL-17F. 
In vitro binding assays confirmed that ixekizumab does not bind to human Fcγ receptors I, IIa, and IIIa 
or to complement component C1q. 
 
Pharmacodynamic effects 
 
Ixekizumab modulates biological responses that are induced or regulated by IL-17A. Based on 
psoriatic skin biopsy data from a phase I study, there was a dose-related trend towards decreased 
epidermal thickness, number of proliferating keratinocytes, T cells, and dendritic cells, as well as 
reductions in local inflammatory markers from baseline to day 43. As a direct consequence treatment 
with ixekizumab reduces erythema, induration and desquamation present in plaque psoriasis lesions. 
 
Taltz has been shown to lower (within 1 week of treatment) levels of C-reactive protein, which is a 
marker of inflammation.  
 
Clinical efficacy and safety 
 
Adult plaque psoriasis 
 
The efficacy and safety of Taltz were assessed in three randomised, double-blind, placebo-controlled 
phase III studies in adult patients (N=3,866) with moderate to severe plaque psoriasis who were 
candidates for phototherapy or systemic therapy (UNCOVER-1, UNCOVER-2, and UNCOVER-3). 
The efficacy and safety of Taltz were also evaluated versus etanercept (UNCOVER-2 and 
UNCOVER-3). Patients randomised to Taltz who were sPGA (0,1) responders (static Physicians 
Global Assessment) at week 12 were re-randomised to receive placebo or Taltz for an additional 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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48 weeks (UNCOVER-1 and UNCOVER-2); patients randomised to placebo, etanercept or Taltz who 
were sPGA (0,1) non-responders received Taltz for up to 48 weeks. 
 
64 % of patients had received prior systemic therapy (biologic, conventional systemic or psoralen and 
ultraviolet A (PUVA)), 43.5 % prior phototherapy, 49.3 % prior conventional systemic therapy, and 
26.4 % prior biologic therapy. 14.9 % had received at least one anti-TNF alpha agent, and 8.7 % an 
anti-IL-12/IL-23. 23.4 % of patients had a history of psoriatic arthritis at baseline.  
 
In all three studies, the co-primary endpoints were the proportion of patients who achieved a PASI 75 
response (Psoriasis Area and Severity Index) and an sPGA of 0 (“clear”) or 1 (“minimal”) response at 
week 12 versus placebo. The median baseline PASI score ranged from 17.4 to 18.3; 48.3 % to 51.2 % 
of patients had a baseline sPGA score of severe or very severe, and mean baseline itch Numeric Rating 
Scale (itch NRS) ranged from 6.3 to 7.1. 
 
Clinical response at 12 weeks 
UNCOVER-1 randomised 1,296 patients (1:1:1) to receive either placebo or Taltz (80 mg every two 
or four weeks [Q2W or Q4W] following a 160 mg starting dose) for 12 weeks.  
 
Table 2. Efficacy results at week 12 in UNCOVER-1 
 

Endpoints 

Number of patients (%) Difference from placebo in 
response rate (95% CI) 

Placebo 
(N = 431) 

Taltz 
80 mg Q4W 
(N = 432) 

Taltz  
80 mg Q2W 
(N = 433) 

Taltz 
80 mg Q4W 

 

Taltz  
80 mg Q2W 

 
sPGA of “0” 
(clear) or “1” 
(minimal) 

14 (3.2) 330 (76.4)a 354 (81.8)a 73.1 (68.8, 77.5) 78.5 (74.5, 82.5) 

sPGA of “0” 
(clear) 

0 149 (34.5)a 160 (37.0)a 34.5 (30.0, 39.0) 37.0 (32.4, 41.5) 

PASI 75  17 (3.9) 357 (82.6)a 386 (89.1)a 78.7 (74.7, 82.7) 85.2 (81.7, 88.7) 
PASI 90  2 (0.5) 279 (64.6)a 307 (70.9)a 64.1 (59.6, 68.7) 70.4 (66.1, 74.8) 
PASI 100 0 145 (33.6)a 153 (35.3)a 33.6 (29.1, 38.0) 35.3 (30.8, 39.8) 
Itch NRS 
reduction ≥ 4b 

58 (15.5) 305 (80.5)a 336 (85.9)a 65.0 (59.5, 70.4) 70.4 (65.4, 75.5) 

Abbreviations: N = number of patients in the intent-to-treat population 
Note: patients with missing data were counted as non-responders 
a p < 0.001 compared with placebo 
b Patients with Itch NRS ≥ 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 
80 mg Q2W N = 391 
 
UNCOVER-2 randomised 1,224 patients (1:2:2:2) to receive either placebo, or Taltz (80 mg every two 
or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 
12 weeks. 
 



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Table 3. Efficacy results at week 12 in UNCOVER-2  
 

Endpoints 

Number of patients (%) Difference from placebo in 
response rate (95% CI) 

Placebo 
(N = 168) 

Taltz 
80 mg Q4W 
(N = 347) 

Taltz  
80 mg Q2W 
(N = 351) 

Etanercept 

50 mg twice 
weekly 

(N = 358) 

Taltz 
80 mg Q4W 

 

Taltz  
80 mg Q2W 

 

sPGA of “0” 
(clear) or “1” 
(minimal) 

4 (2.4) 253 (72.9)a,b 292 (83.2)a,b 129 (36.0)a 70.5 (65.3, 
75.7) 

80.8 (76.3, 
85.4) 

sPGA of “0” 
(clear) 1 (0.6) 112 (32.3)a,b 147 (41.9)a,b 21 (5.9)c 31.7 (26.6, 

36.7) 
41.3 (36.0, 

46.6) 

PASI 75 4 (2.4) 269 (77.5)a,b 315 (89.7)a,b 149 (41.6)a 75.1 (70.2, 
80.1) 

87.4 (83.4, 
91.3) 

PASI 90 1 (0.6) 207 (59.7)a,b 248 (70.7)a,b 67 (18.7)a 59.1 (53.8, 
64.4) 

70.1 (65.2, 
75.0) 

PASI 100 1 (0.6) 107 (30.8)a,b 142 (40.5)a,b 19 (5.3)c 30.2 (25.2, 
35.2) 

39.9 (34.6, 
45.1) 

Itch NRS 
reduction ≥ 4d 19 (14.1) 225 (76.8)a,b 258 (85.1)a,b 177 (57.8)a 62.7 (55.1, 

70.3) 
71.1 (64.0, 

78.2) 
Abbreviations: N = number of patients in the intent-to-treat population 
Note: patients with missing data were counted as non-responders. 
a p < 0.001 compared with placebo; b p < 0.001 compared with etanercept;  
c p < 0.01 compared with placebo 
d Patients with Itch NRS ≥ 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 
80 mg Q2W N = 303, etanercept N = 306 
 
UNCOVER-3 randomised 1,346 patients (1:2:2:2) to receive either placebo, or Taltz (80 mg every two 
or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 
12 weeks. 
 



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Table 4. Efficacy results at week 12 in UNCOVER-3 
 

Endpoints 

Number of patients (%)  
Difference from placebo in 

response rate (95% CI) 
 

Placebo 
(N = 193) 

Taltz 
80 mg Q4W 
(N = 386) 

Taltz  
80 mg Q2W 
(N = 385) 

Etanercept 
50 mg twice 

weekly  
(N = 382) 

Taltz 
80 mg Q4W 

Taltz 
80 mg Q2W 

sPGA of “0” 
(clear) or “1” 
(minimal)  

13 (6.7) 291 (75.4)a,b 310 (80.5)a,b 159 (41.6)a 68.7 (63.1, 
74.2) 

73.8 (68.5, 
79.1) 

sPGA of “0” 
(clear)  0 139 (36.0)a,b 155 (40.3)a,b 33 (8.6)a 36.0 (31.2, 

40.8) 
40.3 (35.4, 

45.2) 

PASI 75  14 (7.3) 325 (84.2)a,b 336 (87.3)a,b 204 (53.4)a 76.9 (71.8, 
82.1) 

80.0 (75.1, 
85.0) 

PASI 90  6 (3.1) 252 (65.3)a,b 262 (68.1)a,b 98 (25.7)a 62.2 (56.8, 
67.5) 

64.9 (59.7, 
70.2) 

PASI 100  0 135 (35.0)a,b 145 (37.7)a,b 28 (7.3)a 35 (30.2, 39.7) 37.7 (32.8, 
42.5) 

Itch NRS 
reduction 
≥ 4c 

33 (20.9) 250 (79.9)a,b 264 (82.5)a,b 200 (64.1)a 59.0 (51.2, 
66.7) 

61.6 (54.0, 
69.2) 

Abbreviations: N = number of patients in the intent-to-treat population 
Note: patients with missing data were counted as non-responders 
a p < 0.001 compared with placebo 
b p < 0.001 compared with etanercept 
c Patients with Itch NRS ≥ 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 
80 mg Q2W N = 320, etanercept N = 312 
 
Taltz was associated with a fast onset of efficacy with > 50 % reduction in mean PASI by week 2 
(Figure 1). The percentage of patients achieving PASI 75 was significantly greater for Taltz compared 
with placebo and etanercept as early as week 1. Approximately 25 % of patients treated with Taltz 
achieved a PASI score < 5 by week 2, more than 55 % achieved the PASI score < 5 by week 4, and 
increased to 85 % by week 12 (compared to 3 %, 14 % and 50 % for etanercept). Significant 
improvements in itch severity were seen at week 1 in patients treated with Taltz.  
 



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Figure 1.  PASI score, percent improvement at each post baseline visit (mBOCF)) in the 
intent-to-treat population during the induction dosing period - UNCOVER-2 and UNCOVER-3 
 

 
 
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI 
baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a 
biologic. Taltz was efficacious in systemic treatment-naive, biologic-naive, 
biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients. 
 
For patients identified as an sPGA (0,1) non-responder to etanercept at week 12 in UNCOVER-2 
(N = 200) and who were switched to Taltz 80 mg Q4W after a 4 week washout period, 73 % and 
83.5 % of patients achieved sPGA (0,1) and PASI 75, respectively, after 12 weeks of treatment with 
Taltz. 
 
In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate 
of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation 
due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz. The rate of infections was 21.5 % 
for etanercept and 26.0 % for Taltz, with 0.4 % being serious for etanercept and 0.5 % for Taltz. 
 
Maintenance of response at week 60 
Patients originally randomised to Taltz and who were responders at week 12 (i.e., sPGA score of 0,1) 
in UNCOVER-1 and UNCOVER-2 were re-randomised to an additional 48 weeks of treatment with 
placebo or Taltz (80 mg every four or twelve weeks [Q4W or Q12W]).  
For sPGA (0,1) responders at week 12 re-randomised to treatment withdrawal (i.e., placebo), the 
median time to relapse (sPGA ≥ 3) was 164 days in integrated UNCOVER-1 and UNCOVER-2 
studies. Among these patients, 71.5 % regained at least an sPGA (0,1) response within 12 weeks of 
restarting treatment with Taltz 80 mg Q4W. 
 



14 

 

Table 5. Maintenance of response and efficacy at week 60  
(Studies UNCOVER-1 and UNCOVER-2)  

 

Endpoints 

Number of patients (%)  

Difference from placebo in 
response rate (95% CI) 

80 mg Q4W 
(induction) / 

Placebo 
(maintenance) 

(N = 191) 

80 mg Q2W 
(induction) / 

Placebo 
(maintenance) 

(N = 211) 

80 mg Q4W 
(induction) / 
80 mg Q4W 

(maintenance) 
(N = 195) 

80 mg Q2W 
(induction) / 
80 mg Q4W 

(maintenance) 
(N = 221) 

80 mg Q4W 
(induction) / 
80 mg Q4W 

(maintenance) 

80 mg Q2W 
(induction) / 
80 mg Q4W 

(maintenance) 

Maintained 
sPGA of “0” 
(clear) or “1” 
(minimal) 

12 (6.3) 16 (7.6) 134 (68.7)a  173 (78.3)a  

62.4 (55.1, 
69.8) 

70.7 (64.2, 
77.2) 

Maintained or 
achieved 
sPGA 0 
(clear) 

3 (1.6) 6 (2.8) 96 (49.2)a  130 (58.8)a  

47.7 (40.4, 
54.9) 

56.0 (49.1, 
62.8) 

Maintained or 
achieved 
PASI 75 

15 (7.9) 19 (9.0) 145 (74.4)a  184 (83.3)a  
66.5 (59.3, 

73.7) 
74.3 (68.0, 

80.5) 

Maintained or 
achieved 
PASI 90 

9 (4.7) 10 (4.7) 130 (66.7)a  169 (76.5)a  
62.0 (54.7, 

69.2) 
71.7 (65.4, 

78.0) 

Maintained or 
achieved 
PASI 100 

3 (1.6) 6 (2.8) 97 (49.7)a  127 (57.5)a  
48.2 (40.9, 

55.4) 
54.6 (47.7, 

61.5) 

Abbreviations: N = number of patients in the analysis population 
Note: patients with missing data were counted as non-responders 
a p < 0.001 compared with placebo 
 
Taltz was efficacious in the maintenance of response in systemic treatment-naive, biologic-naive, 
biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.  
 
Significantly greater improvements at week 12 from baseline compared to placebo and etanercept 
were demonstrated in nail psoriasis (as measured by the Nail Psoriasis Severity Index [NAPSI]), in 
scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI]) and in palmoplantar psoriasis 
(as measured by Psoriasis Palmoplantar Severity Index [PPASI]) and were maintained at week 60 in 
patients treated with Taltz who were sPGA (0,1) responders at week 12. 
 
Quality of life/patient-reported outcomes 
At week 12 and across studies, Taltz was associated with statistically significant improvement in 
Health-related Quality of Life as assessed by mean decrease ranges from baseline in the Dermatology 
Life Quality Index (DLQI) (Taltz 80 mg Q2W from -10.2 to -11.1, Taltz 80 mg Q4W from -9.4 
to -10.7, etanercept from -7.7 to -8.0 and placebo -1.0 to -2.0). A significantly greater proportion of 
patients treated with Taltz achieved a DLQI 0 or 1. Across studies a significantly greater proportion of 
patients treated with Taltz achieved a reduction of Itch NRS ≥ 4 points at week 12 (84.6% for Taltz 
Q2W, 79.2% for Taltz Q4W and 16.5% for placebo) and the benefit was sustained over time up to 
week 60 in patients treated with Taltz who were sPGA (0 or 1) responders at week 12. There was not 
any evidence of worsening of depression up to 60 weeks treatment with Taltz as assessed by the Quick 
Inventory of Depressive Symptomatology Self Report. 
 
Postmarketing phase 3b, direct comparative study 
In a double-blind study ixekizumab was superior against ustekinumab on the primary study objective 
PASI 90 response at week 12 (Table 6). Onset of response was superior on PASI 75 as early as week 2 
(p < 0.001) and on PASI 90 and PASI 100 by week 4 (p < 0.001). Superiority of ixekizumab versus 
ustekinumab was also demonstrated in the subgroups stratified by weight. 



15 

 

 
Table 6. PASI-response rates from comparative study ixekizumab versus ustekinumab 
 

 week 12 week 24 week 52 
 Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** 
Patients (n) 136 166 136 166 136 166 
PASI 75, n (%) 120 (88.2 %) 114 (68.7 %) 124 (91.2 %) 136 (81.9%) 120 (88.2%) 126 (75.9 %) 
PASI 90, n (%) 99 (72.8%)§ 70 (42.2 %) 113 (83.1 %) 98 (59.0 %) 104 (76.5%) 98 (59.0 %) 
PASI 100, n (%) 49 (36.0 %) 24 (14.5 %) 67 (49.3%) 39 (23.5 %) 71 (52.2%) 59 (35.5 %) 

* Ixekizumab 160 mg given as a loading dose followed by 80 mg at week 2,4,6,8,10 and 12, and 
80 mg Q4W thereafter 
** Weight based dosing: Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, 
then every 12 weeks until week 52 (dosed by weight as per approved posology) 
§p < 0.001 versus ustekinumab (p value only provided for primary endpoint) 
 
Efficacy in genital psoriasis 
A randomised, double-blind, placebo-controlled study (IXORA-Q) was conducted in 149 adult 
subjects (24% females) with moderate to severe genital psoriasis (sPGA of Genitalia score of ≥3), a 
minimum body surface area (BSA) involvement of 1% (60.4% had a BSA ≥ 10%) and previous failure 
of or intolerance to at least one topical therapy for genital psoriasis. Patients had at least moderate 
plaque psoriasis (defined as sPGA score of ≥ 3 and being candidates for phototherapy and/or systemic 
therapy) for at least 6 months.  
 
Subjects randomised to Taltz received an initial dose of 160 mg followed by 80 mg every 2 weeks for 
12 weeks. The primary endpoint was the proportion of patients who achieved at least a "0" (clear) or 
"1" (minimal) response on the sPGA of Genitalia (sPGA of Genitalia 0/1). At week 12, significantly 
more subjects in the Taltz group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 
independent of baseline BSA (baseline BSA 1% - <10% resp. ≥10%: sPGA of Genitalia ‘’0” or “1”: 
Taltz 71%, resp. 75%; placebo: 0%, resp. 13%). A significantly greater proportion of patients treated 
with Taltz achieved a reduction in the PROs of severity of genital pain, genital itch, impact of genital 
psoriasis on sexual activity, and Dermatology Quality of Life Index (DLQI). 
 
Table 7.  Efficacy results at week 12 in Adults with genital psoriasis in trial IXORA-Q; NRI a 
 

Endpoints Taltz Placebo Difference from 
placebo (95% CI) 

Number of patients (N) randomised N=75 N=74  
sPGA of Genitalia “0” or “1”  73% 8% 65% (53%, 77%) 
sPGA “0” or “1”  73% 3% 71% (60%, 81%) 
DLQI 0,1b 45% 3% 43% (31%, 55%) 
N with baseline GPSS Itch NRS Score ≥3 N=62 N=60  
GPSS Genital Itch (≥3 point improvement) 60% 8% 51% (37%, 65%) 
N with baseline SFQ Item 2 Score ≥2 N=37 N=42  
SFQ-item 2 score, “0” (never limited) or 
“1” (rarely limited) 

78% 21% 57% (39%, 75%) 

a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; 
GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = 
Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no effect at 
all on patient’s life. sPGA of “0” or “1” is equivalent to “clear” or “minimal”; NRS = Numeric 
Rating Scale 
 
Paediatric plaque psoriasis 
 
A randomised, double-blind, multicenter, placebo-controlled trial (IXORA-Peds) enrolled 
201 children 6 to less than 18 years of age, with moderate to severe plaque psoriasis (as defined by a 



16 

 

sPGA score ≥3, involving ≥10% of the body surface area, and a PASI score ≥12) who were candidates 
for phototherapy or systemic therapy, or were inadequately controlled on topical therapy. 
Patients were randomised to placebo (n=56), etanercept (n=30) or Taltz (n=115) with dosing stratified 
by weight: 

<25 kg: 40 mg at week 0 followed by 20 mg Q4W (n=4) 
25 kg to 50 kg: 80 mg at week 0 followed by 40 mg Q4W (n=50) 
>50 kg: 160 mg at week 0 followed by 80 mg Q4W (n=147) 

Patients randomised to etanercept (patients with severe psoriasis) received 0.8 mg/kg, not exceeding 
50 mg per dose, every week from week 0 through week 11.  
Response to treatment was assessed after 12 weeks and defined by the proportion of patients who 
achieved the co-primary endpoint of an sPGA score of “0” (clear) or “1” (almost clear) with at least a 
2 point improvement from baseline and the proportion of patients that achieved a reduction in PASI 
score of at least 75% (PASI 75) from baseline. 
Other evaluated outcomes at week 12 included the proportion of patients who achieved PASI 90, 
PASI 100, sPGA of “0” and an improvement of itch severity as measured by a reduction of at least 
4 points on an 11-point itch Numeric Rating Scale. 
Patients had a median baseline PASI of 17 score ranging from 12-49. Baseline sPGA score was 
severe or very severe in 49%. Of all patients, 22% had received prior phototherapy and 32% had 
received prior conventional systemic therapy for the treatment of psoriasis. 
25% of patients (n=43) were below 12 years (14% of patients [n=24] were 6-9 years and 11% of 
patients [n=19] were 10-11 years); 75% (n=128) were 12 years or above. 
 
The clinical response data are presented in Table 8. 
 
Table 8. Efficacy results in pediatric patients with plaque psoriasis, NRI 
 
Endpoints Taltza 

(N=115) 
n (%) 

Placebo 
(N=56) 
n (%) 

Difference vs 
placebo (95% 

CI) 

Etanerceptb  
(N=30) 
n (%) 

Difference vs 
etanercept (95% 

CI)b 
sPGA “0” (clear) or 
“1” (almost clear)c 

     

week 4 55 (48) 4 (7) 40.7 (29.3, 52.0)f 0(0) 36.8 (21.5, 52.2)  
week 12c 93 (81) 6 (11) 70.2 (59.3, 81.0)f 16 (53) 23.0 (0.6, 45.4) 

sPGA “0” (clear) d 60 (52) 1 (2) 50.4 (40.6, 60.2)f 5 (17) 46.5 (26.2, 66.8) 
PASI 75c      

week 4 62 (54) 5 (9) 45.0 (33.2, 56.8)f 3 (10) 34.7 (15.6, 53.8) 
week 12 102 (89) 14 (25) 63.7 (51.0, 76.4)f 19 (63) 20.9 (0.1, 41.7) 

PASI 90d 90 (78) 3 (5) 72.9 (63.3, 82.5)f 12 (40) 36.3 (14.2, 58.5) 
PASI 100d 57 (50) 1 (2) 47.8 (38.0, 57.6)f 5 (17) 43.9 (23.4, 64.3) 
Itch NRS (≥4 point 
improvement) d, e 

59 (71) 8 (20) 51.1 (35.3, 66.9)f Not evaluated --- 

Abbreviations: N = Number of patients in the intent-to-treat population; NRI = Non-Responder 
Imputation. 

a At week 0, subjects received 160 mg, 80 mg, or 40 mg of Taltz, followed by 80 mg, 40 mg, or 
20 mg every 4 weeks, depending on weight category, for 12 weeks. 

b Comparisons to etanercept were performed within the sub-population of patients outside of US and 
Canada with severe Ps (N for Taltz = 38). 

c Co-primary endpoints. 
d Results at week 12. 
e Itch NRS (≥4 improvement) in patients with baseline Itch NRS ≥4. The number of ITT patients 

with baseline Itch NRS Score ≥4 are as follows: Taltz, n = 83; PBO, n = 40. 
f  p<0.001  
 



17 

 

Figure 2.  Percent of patients achieving PASI 75 in pediatric psoriasis through week 12 

 
 
Patients in the ixekizumab treatment group had clinically meaningful higher CDLQI/DLQI (0,1) 
responses at week 12 (NRI) compared with placebo. The difference between treatment groups was 
apparent from as early as week 4. 
 
There were greater improvements at week 12 from baseline compared to placebo in nail psoriasis (as 
measured by the Nail Psoriasis Severity Index [NAPSI=0: Taltz 18% (6/34), placebo 0% (0/12)]), in 
scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI=0: Taltz 69% (70/102), placebo 
16% (8/50)]) and in palmoplantar psoriasis (as measured by Psoriasis Palmoplantar Severity Index 
[PPASI 75: Taltz 53% (9/17), placebo 11% (1/9)]). 
 
Psoriatic arthritis 
 
Taltz was assessed in two randomised, double-blind, placebo-controlled phase III studies in 
780 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints). Patients had a diagnosis 
of psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 
5.33 years and had current plaque psoriasis skin lesions (94.0%) or a documented history of plaque 
psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline. Over 58.9% 
and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively. 
Primary endpoint of both studies was American College of Rheumatology (ACR) 20 response at 
week 24. 
 
In Psoriatic Arthritis Study 1 (SPIRIT-P1), patients naive to biologic therapy with active psoriatic 
arthritis were randomised to placebo, adalimumab 40 mg once every 2 weeks (active control reference 
arm), Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W). Both Taltz 
regimens included a 160 mg starting dose. 85.3% of patients in this study had received prior treatment 
with ≥1 cDMARD. 53% of patients had concomitant use of MTX at a mean weekly dose of 15.8 mg. 
67% of patients who had concomitant use of MTX had a dose of 15 mg or greater. Patients with an 
inadequate response at week 16 received rescue therapy (modification to background therapy). 
Patients on Taltz Q2W or Q4W remained on their originally assigned dose of Taltz. Patients receiving 
adalimumab or placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on 
responder status. 
 
Psoriatic Arthritis Study 2 (SPIRIT-P2) enrolled patients who were previously treated with an 
anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance 
(anti-TNF-IR patients). Patients were randomised to placebo, Taltz 80 mg once every 2 weeks (Q2W), 
or 80 mg once every 4 weeks (Q4W). Both Taltz regimens included a 160 mg starting dose. 56% and 
35% of patients were inadequate responders to 1 anti-TNF or 2 anti-TNF, respectively. SPIRIT-P2 



18 

 

evaluated 363 patients, of whom 41% had concomitant use of MTX at a mean weekly dose of 16.1 mg. 
73.2% of patients who had concomitant use of MTX had a dose of 15 mg or greater. Patients with an 
inadequate response at week 16 received rescue therapy (modification to background therapy). 
Patients in Taltz Q2W or Q4W remained on their originally assigned dose of Taltz. Patients receiving 
placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status. 

Signs and symptoms 
Treatment with Taltz resulted in significant improvement in measures of disease activity compared to 
placebo at week 24 (see Table 9). 
 
Table 9. Efficacy results in SPIRIT-P1 and SPIRIT-P2 at week 24 
 
 SPIRIT-P1 SPIRIT-P2 
Endpoints     Difference from 

placebo in 
response rate 

(95% CI) 

   Difference from 
placebo in 

response rate 
(95% CI) 

 PBO 
(N = 106) 

 

Taltz 
Q4W 

(N = 107) 

Taltz 
Q2W 

(N = 103) 

ADA 
(N = 101) 

Taltz 
Q4W 

Taltz 
Q2W 

PBO 
(N = 118) 

Taltz 
Q4W 

(N = 122) 

Taltz 
Q2W 

(N = 123) 

Taltz 
Q4W 

Taltz 
Q2W 

ACR 20 response, n (%)  
week 24 

32 (30.2) 62 (57.9) 64 (62.1) 58 (57.4) 
27.8 

(15.0, 
40.6)c 

31.9 
(19.1, 
44.8)c 

23 (19.5) 65 (53.3) 59 (48.0) 
33.8 

(22.4, 
45.2)c 

28.5 
(17.1, 
39.8)c 

ACR 50 response, n (%)  
week 24 

16 (15.1) 43 (40.2) 48 (46.6) 39 (38.6) 
25.1 

(13.6, 
36.6)c 

31.5 
(19.7, 
43.3)c 

6 (5.1) 43 (35.2) 41 (33.3) 
30.2 

(20.8, 
39.5)c 

28.3 
(19.0, 
37.5)c 

ACR 70 response, n (%)  
week 24 

6 (5.7) 25 (23.4) 35 (34.0) 26 (25.7) 
17.7 
(8.6, 

26.8)c 

28.3 
(18.2, 
38.5)c 

0 27 (22.1) 15 (12.2) 
22.1 

(14.8, 
29.5)c 

12.2 
(6.4, 

18.0)c 
Minimal disease activity (MDA) n (%) 
week 24 

16 (15.1) 32 (29.9) 42 (40.8) 32 (31.7) 
14.8 
(3.8, 

25.8)a 

25.7 
(14.0, 
37.4)c 

4 (3.4) 34 (27.9) 29 (23.6) 
24.5 

(15.9, 
33.1)c 

20.2 
(12.0, 
28.4)c 

ACR 50 and PASI 100 in patients with ≥3% BSA psoriasis skin involvement at baseline, n (%) 
week 24 

1 (1.5) 21 (28.8) 19 (32.2) 9 (13.2) 
27.3 

(16.5, 
38.1)c 

30.7 
(18.4, 
43.0)b 

0 (0.0) 12 (17.6) 10 (14.7) 
17.6 
(8.6, 

26.7)c 

14.7 
(6.3, 

23.1)c 
Abbreviations: ACR 20/50/70 = American College of Rheumatology 20%/50%/70% response rate; 
ADA = adalimumab; BSA = body surface area; CI = confidence interval; Q4W = Taltz 80 mg every 
4 weeks; Q2W = Taltz 80 mg every 2 weeks; N = number of patients in the analysis population; 
n = number of patients in the specified category; NRI = non-responder imputation; PASI 
100 = psoriasis area and severity index 100% improvement; PBO = placebo.  
Note: patients who were rescued at week 16 or discontinued or with missing data were imputed as 
non-responders for week 24 analyses. 
Concomitant cDMARDs included MTX, leflunomide and sulfasalazine. 
a p<0.05; b p<0.01; c p<0.001 compared with placebo. 
 
In patients with pre-existing dactylitis or enthesitis, treatment with Taltz Q4W resulted in 
improvement in dactylitis and enthesitis at week 24 compared to placebo (resolution: 78% vs. 24%; 
p<0.001, and 39% vs. 21%; p<0.01, respectively). 
 

In patients with ≥3% BSA, the improvement in skin clearance at week 12 as measured by 75% 
improvement in Psoriasis Area Severity Index (PASI 75), was 67% (94/141) for those treated with the 



19 

 

Q4W dosing regimen, and 9% (12/134) for those treated with placebo (p<0.001). The proportion of 
patients achieving a PASI 75, PASI 90, and PASI 100 response at week 24 was greater with Taltz 
Q4W compared to placebo (p<0.001). In patients with concomitant moderate to severe psoriasis and 
psoriatic arthritis, Taltz Q2W dose regimen showed significantly higher response rate for PASI75, 
PASI 90 and PASI 100 compared to placebo (p<0.001) and demonstrated clinically meaningful benefit 
over the Q4W dose regimen. 
 
Treatment responses on Taltz were significantly greater than those on placebo as early as week 1 for 
ACR 20, week 4 for ACR 50 and week 8 for ACR 70 and persisted through week 24. 
 
Figure 3. ACR 20 response in SPIRIT-P1 over time up to week 24 

 
For both Taltz Q2W and Q4W: b p<0.01 and c p<0.001 compared with placebo. 
 
In SPIRIT-P1 and SPIRIT-P2, similar responses for ACR 20/50/70 were seen in patients with psoriatic 
arthritis regardless of whether they were on concomitant cDMARDs, including MTX treatment, or 
not. 
 
In SPIRIT-P1and SPIRIT-P2, improvements were shown in all components of the ACR scores 
including patient assessment of pain. At week 24 the proportion of patients achieving a modified 
Psoriatic Arthritis Response Criteria (PsARC) response was greater in the Taltz-treated patients 
compared to placebo. 
 
In SPIRIT-P1, efficacy was maintained up to week 52 as assessed by ACR 20/50/70, MDA, enthesitis 
resolution, dactylitis resolution, and PASI 75/90/100 response rates.  
 
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, disease duration, 
baseline body weight, baseline psoriasis involvement, baseline CRP, baseline DAS28-CRP, 
concomitant corticosteroid use, and previous treatment with a biologic. Taltz was efficacious in 
biologic-naive, biologic-exposed and biologic-failure patients.  

Radiographic response 
In SPIRIT-P1, inhibition of progression of structural damage was assessed radiographically and 
expressed as the change in modified total Sharp Score (mTSS) and its components, the Erosion 

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12 14 16 18 20 22 24

AC
R2

0 
Re

sp
on

de
rs

, %

Treatment Week

PBO (N=106) ADA (N=101) IXE Q4 (N=107) IXE Q2 (N=103)

b

c
c

c c c c c



20 

 

Score (ES) and the Joint Space Narrowing score (JSN) at weeks 24 and 52, compared to baseline. 
week 24 data are presented in Table 10. 
 
Table 10. Change in modified Total Sharp Score in SPIRIT-P1 
 
  Difference from placebo 

(95% CI) 
PBO 

(N = 106) 
Taltz Q4W 
(N = 107) 

Taltz Q2W 
(N = 103) 

ADA 
(N = 101) 

Taltz Q4W Taltz Q2W 

Baseline score, mean (SD) 17.6 (28.62) 19.2 (32.68) 15.2 (28.86) 15.9 (27.37) NA NA 
Change from baseline at 
week 24, LSM (SE) 0.51 (0.092) 0.18 (0.090) 0.09 (0.091) 0.13 (0.093) -0.33 

(-0.57,-0.09)b 
-0.42 

(-0.66,-0.19)c 
Abbreviations: ADA = adalimumab; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; 
Q2W = Taltz 80 mg every 2 weeks; LSM = least squares mean; N = number of patients in the analysis 
population; PBO = placebo; SE = standard error; SD = standard deviation. 
b p<0.01; c p<0.001 compared with placebo. 
 
Radiographic joint damage progression was inhibited by Taltz (Table 10) at week 24, and the 
percentage of patients with no radiographic joint damage progression (defined as a change from 
baseline in mTSS of ≤0.5) from randomisation to week 24 was 94.8% for Taltz Q2W (p<0.001), 
89.0% for Taltz Q4W (p=0.026), 95.8% for adalimumab (p<0.001), all compared to 77.4% for 
placebo. At week 52, the mean change from baseline in mTSS was 0.27 for placebo/Taltz Q4W, 
0.54 for Taltz Q4W/Taltz Q4W, and 0.32 for adalimumab/Taltz Q4W. The percentage of patients with 
no radiographic joint damage progression from randomisation to week 52 was 90.9% for placebo/Taltz 
Q4W, 85.6% for Taltz Q4W/Taltz Q4W, and 89.4% for adalimumab/Taltz Q4W.  
 
Physical function and health-related quality of life 
In both SPIRIT-P1 and SPIRIT-P2, patients treated with Taltz Q2W (p<0.001) and Q4W (p<0.001) 
showed significant improvement in physical function compared to patients treated with placebo as 
assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24, and 
maintained at week 52 in SPIRIT-P1. 
 
Taltz-treated patients reported improvements in health-related quality of life as measured by the 
Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p<0.001). 
There were also improvements demonstrated in fatigue as assessed by Fatigue severity NRS scores 
(p<0.001).  
 
Postmarketing phase 4, direct comparative study 
Efficacy and safety of Taltz was investigated in a multicenter, randomised, open-label, rater-blinded, 
parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who 
were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD). Patients were stratified at 
baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12, 
BSA≥10 and sPGA≥3). 
Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and 
PASI 100 response at week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 
15.8%]). Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT 
analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [-4.3%; 
12.1%]; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and 
superiority on PASI 100 at week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were 
the major secondary endpoints in the study. 
 



21 

 

Figure 4.  Primary endpoint (simultaneous ACR 50 & PASI 100) and major secondary 
endpoints (ACR 50; PASI 100) response rates week 0 – 24 [ITT population, NRI]**  

  
** Taltz 160 mg week 0, then 80 mg every 2 weeks to week 12 and every 4 weeks thereafter for 
patients with moderate to severe plaque psoriasis or 160 mg week 0, then 80 mg every 4 week for 
other patients, ADA 80 mg week 0, then 40 mg every 2 weeks from week 1 for patients with moderate 
to severe plaque psoriasis or 40 mg week 0, then 40 mg every 2 weeks for other patients. 
Significance level only provided for endpoint that was pre-defined and multiplicity tested. 
 
Axial spondyloarthritis 
 
Taltz was assessed in a total of 960 adult patients with axial spondyloarthritis in three randomised 
placebo-controlled studies (two in radiographic and one in non-radiographic axial spondyloarthritis). 
 
Radiographic axial spondyloarthritis 
Taltz was assessed in a total of 657 patients in two randomised, double-blind, placebo-controlled 
studies (COAST-V and COAST-W) in adult patients who had active disease as defined by the Bath 
Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and total back pain ≥4 on a numeric 
rating scale despite non-steroidal anti-inflammatory drug (NSAID) therapy. Across both studies at 
baseline, patients had symptoms for a mean of 17 years (median of 16 years). At baseline, 
approximately 32% of the patients were on a concomitant cDMARD. 
COAST-V evaluated 341 biologic-naive patients treated with either Taltz 80 mg or 160 mg at week 0 
followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or 
with placebo. Patients receiving placebo were re-randomised at week 16 to receive Taltz (160 mg 
starting dose, followed by 80 mg Q2W or Q4W). Patients receiving adalimumab were re-randomised 
at week 16 to receive Taltz (80 mg Q2W or Q4W). 
COAST-W evaluated 316 patients who had prior experience with 1 or 2 TNF-inhibitors (90% were 
inadequate responders and 10% were intolerant to TNF inhibitors). All patients were treated with 
Taltz 80 or 160 mg at week 0 followed by 80 mg Q2W or Q4W, or with placebo. Patients receiving 
placebo were re-randomised at week 16 to receive Taltz (160 mg initial dose, followed by 80 mg Q2W 
or Q4W).  
The primary endpoint in both studies was the percentage of patients achieving an Assessment of 
Spondyloarthritis International Society 40 (ASAS40) response at week 16. 
 
Clinical response 
In both studies, patients treated with Taltz 80 mg Q2W or 80 mg Q4W demonstrated greater 
improvements in ASAS40 and ASAS20 responses compared to placebo at week 16 (Table 11). 



22 

 

Responses were similar in patients regardless of concomitant therapies. In COAST-W, responses were 
seen regardless of the number of prior TNF inhibitors. 

 
Table 11. Efficacy results in COAST-V and COAST-W at week 16 
 

 COAST-V, biologic-naive COAST-W, TNF-inhibitor experienced 
Taltz 
80 mg 
Q4Wa 
(N=81) 

  

Placebo 
(N=87) 

  

Difference 
from placebo g 

Adalimumab 
40 mg 
Q2W 

(N=90) 
  

Taltz 
80 mg 
Q4Wc 

(N=114) 
  

Placebo 
(N=104) 

  

Difference 
from placebo g 

ASAS20 responseb, n (%), 
NRI 

52 
(64.2%) 

35 
(40.2%) 

24.0 (9.3,  
38.6) ** 

53 (58.9%) 55 
(48.2%) 

31 
(29.8%) 

18.4 (5.7, 31.1) 

** 
ASAS40 responseb,c, n (%), 
NRI 

39 
(48.1%) 

16 
(18.4%) 

29.8 (16.2, 
43.3) *** 

32 (35.6%) 29 
(25.4%) 

13 
(12.5%) 

12.9 (2.7, 23.2) 

* 
ASDAS 
Change from baseline 
Baseline  

-1.4 
3.7 

-0.5 
3.9 

-1.0 (-1.3, -0.7) 
*** 

-1.3*** 
3.7 

-1.2 
4.2 

-0.1 
4.1 

-1.1 (-1.3, -0.8) 
*** 

BASDAI Score 
Change from baseline 
Baseline 

-2.9 
6.8 i 

-1.4 
6.8 i 

-1.5 (-2.1, -0.9) 
*** 

-2.5*** 
6.7 i 

-2.2 
7.5 

-0.9 
7.3 

-1.2 (-1.8, -0.7) 
*** 

MRI Spine SPARCCd 
Change from baseline 
Baseline 

-11.0 
14.5 

-1.5 
15.8 

-9.5 (-12.6, 
-6.4) *** 

-11.6*** 
20.0 

-3.0 
8.3 

3.3 
6.4 

-6.3 (-10.0, 
-2.5) ** 

BASDAI50e n (%), NRI 34 
(42.0%) 

15 
(17.2%) 

24.7 (11.4, 
38.1) *** 

29 (32.2%)* 25 
(21.9%)i 

10 
(9.6%)i 

12.3 (2.8, 
21.8)* 

ASDAS <2.1, n (%) (low 
disease activity), NRI 

35 
(43.2%)h 

11 
(12.6%)h 

30.6 (17.7, 
43.4) *** 

34 
(37.8%)*** h 

20 
(17.5%) 

5 (4.8%) 12.7 ( 4.6, 
20.8) ** 

ASDAS <1.3, n (%) 
(inactive disease), NRI 

13 
(16.0%) 

2 (2.3%) 13.8 (5.2, 22.3) 
** 

14 (15.6%)** 4 (3.5%)i 1 (1.0%)i 2.5 (-1.3, 6.4)  

ASAS HIf   

Change from baseline 
Baseline 

 
-2.4 
7.5 

 
-1.3 
8.1 

 
-1.1 (-2.0, -0.3) 

* 

 
-2.3* 
8.2 

 
-1.9 
10.0 

 
-0.9 
9.0 

 
-1.0 (-1.9, -0.1) 

* 
SF-36 PCS 
Change from baseline 
Baseline 

 
7.7 

34.0 

 
3.6 

32.0 

 
4.1 (1.9, 6.2) 

*** 

 
6.9** 
33.5 

 
6.6 

27.5 

 
1.4 
30.6 

 
5.2 (3.0, 7.4) 

*** 
Abbreviations: N = number of patients in the intent-to-treat population; NRI = Non-responder 
Imputation; patients with missing data were counted as non-responders. 
ASAS HI = Assessment of SpondyloArthritis International Society Health Index; ASDAS = Ankylosing 
Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; 
CFB = least square mean change from baseline at week 16; MRI Spine SPARCC = Spondyloarthritis 
Research Consortium of Canada Magnetic Resonance Imaging Scoring of the Spine 
(23 discovertebral unit scale) 
 
a At week 0, patients received 80 mg or 160 mg of Taltz. 
b An ASAS20 response is defined as a ≥20% improvement and an absolute improvement from 

baseline of ≥1 unit (range 0 to 10) in ≥3 of 4 domains (Patient Global, Spinal Pain, Function, 
and Inflammation), and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining 
domain. An ASAS40 response is defined as a ≥40% improvement and an absolute improvement 
from baseline of ≥2 units in ≥3 of 4 domains without any worsening in the remaining domain. 

c Primary endpoint. 
d The numbers of ITT patients with MRI data at baseline are as follows: COAST-V: Taltz, n = 81; 

PBO, n = 82; ADA, n=85. COAST-W: Taltz, n = 58; PBO, n = 51. 
e BASDAI50 response defined as an improvement of ≥50% of the BASDAI score from baseline. 
f ASAS HI: Assessment of SpondyloArthritis International Society Health Index (ASAS HI) across 

all domains. 
g The reported values are difference in %( 95% CI) for categorical variables, and difference in 

LSM (95% CI) for continuous variables. 
h  post hoc analysis, not multiplicity corrected. 
i  prespecified, but not multiplicity gated. 
* p<0.05; ** p<0.01; *** p<0.001 compared with placebo. 
 



23 

 

There were improvements in the main components of the ASAS40 response criteria (spinal pain, 
BASFI, patient global assessment, stiffness) and other measures of disease activity, including CRP, at 
week 16. 

Figure 5. Percent of patients achieving ASAS40 responses in COAST-V and COAST-W 
through week 16, NRIa 

 

 

 

a Patients with missing data were counted as non-responders. 
* p<0.05; ** p<0.01; *** p<0.001 compared with placebo. 
 
Similar response in ASAS40 was seen in patients regardless of baseline CRP levels, baseline ASDAS 
scores and MRI spine SPARCC scores. The ASAS40 response was demonstrated regardless of age, 
gender, race, disease duration, baseline body weight, baseline BASDAI score and prior biologic 
treatment.  
In COAST-V and COAST-W efficacy was maintained up to week 52 as assessed by the endpoints 
presented in Table 11, including ASAS20, ASAS40, ASDAS, BASDAI, and ASAS HI response rates.  
 
Health-related outcomes 
Spinal pain showed improvements versus placebo as early as week 1, maintained through week 16 
[Taltz vs placebo: COAST-V -3.2 vs -1.7; COAST-W -2.4 vs -1.0]; fatigue and spinal mobility 
showed improvements versus placebo at week 16. Improvements in spinal pain, fatigue and spinal 
mobility were maintained through week 52. 
 
Non-radiographic axial spondyloarthritis 
Taltz was assessed in a randomised, double-blind study with a 52-week placebo-controlled period 
(COAST-X) in 303 adult patients with active axial spondyloarthritis for at least 3 months. Patients 
must have had objective signs of inflammation indicated by elevated C-reactive protein (CRP) and/or 
sacroiliitis on magnetic resonance imaging (MRI), and no definitive radiographic evidence of 
structural damage on sacroiliac joints. Patients had active disease as defined by the Bath Ankylosing 
Spondylitis Disease Activity Index (BASDAI) ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating 
Scale (NRS), despite non-steroidal anti-inflammatory drug (NSAID) therapy. Patients were treated 
with either Taltz 80 mg or 160 mg at week 0, followed by 80 mg every 2 weeks (Q2W) or 80 mg 
every 4 weeks (Q4W) or with placebo. Dose adjustment and/or initiation of concomitant medications 
(NSAIDs, cDMARDs, corticosteroids, analgesics) were permitted starting at week 16.  
 
At baseline, patients had symptoms of non-radiographic axSpA for an average of 11 years. 
Approximately 39% of the patients were on a concomitant cDMARD. 
 
The primary endpoint was the percentage of patients achieving an Assessment of Spondyloarthritis 
International Society 40 (ASAS40) response at week 16. 
 



24 

 

Clinical response 
Higher proportions of patients treated with Taltz 80 mg Q4W achieved ASAS40 response compared to 
placebo at week 16 (Table 12). Responses were similar regardless of concomitant therapies. 

 
Table 12. Efficacy results at week 16 in COAST-X, NRI a,b 

 
 Taltz 80 mg Q4Wc 

(N=96) 
 

Placebo 
(N=105) 

 

Difference from 
placebo h 

ASAS20 responsed, n (%), NRI 52 (54.2%) 41 (39.0%) 15.1 (1.5, 28.8)* 
ASAS40 responsed,e, n (%), NRI 34 (35.4%) 20 (19.0%) 16.4 (4.2, 28.5)** 
ASDAS 
Change from baseline 
Baseline  

-1.1 
3.8 

-0.6 
3.8 

-0.5 (-0.8, -0.3) *** 

BASDAI Score 
Change from baseline 
Baseline 

-2.2 
7.0  

-1.5 
7.2 

-0.7 (-1.3, -0.1) * 

MRI SIJ SPARCCf 
Change from baseline 
Baseline 

-3.4 
5.1 

-0.3 
6.3 

-3.1 (-4.6, -1.6) *** 

ASDAS <2.1, n (%)  
(low disease activity), NRIg 

26 (27.7%) 13 (12.4%) 15.3 (4.3, 26.3) ** 

SF-36 PCS 
Change from baseline 
Baseline 

8.1 
33.5 

5.2 
32.6 

2.9 (0.6, 5.1) * 

a Abbreviations: N = number of patients in the intent-to-treat population; NRI = Non-responder 
Imputation. ASDAS = Ankylosing Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing 
Spondylitis Disease Activity Index; Change from baseline = least square mean change from baseline 
at week 16; MRI SIJ SPARCC = Spondyloarthritis Research Consortium of Canada Magnetic 
Resonance Imaging Scoring of the sacroiliac joint. 

b Patients with missing data were counted as non-responders. 
c At week 0, patients received 80 mg or 160 mg of Taltz. 
d An ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline 

of ≥1 units (range 0 to 10) in ≥3 of 4 domains (Patient Global, Spinal Pain, Function, and 
Inflammation), and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. An 
ASAS40 response is defined as a ≥40% improvement and an absolute improvement from baseline of 
≥2 units in ≥3 of 4 domains without any worsening in the remaining domain. 

e Primary endpoint at week 16. 
f The numbers of ITT patients with MRI data at baseline and week 16 are as follows: Taltz, n = 85; 

PBO, n = 90.  
g Patients with missing data were counted as non-responders. Percentages are based on the number of 

patients in the ITT population with baseline ASDAS ≥2.1. 
h The reported values are difference in %( 95% CI) for categorical variables, and difference in 

LSM (95% CI) for continuous variables. 
* p<0.05; ** p<0.01; *** p<0.001 compared with placebo. 
 
The improvement in the main components of the ASAS40 response criteria (spinal pain, BASFI, 
patient global assessment, stiffness) and other measures of disease activity demonstrated significant 
clinical improvement at week 16. 
 



25 

 

Figure 6. Percent of patients achieving ASAS40 response through week 16 in COAST-X, NRIa 

 

a Patients with missing data were counted as non-responders. 
** p<0.01 compared with placebo. 
 
Efficacy was maintained up to week 52 as assessed by the endpoints presented in Table 12.  
 
Health-related outcomes 
Spinal pain showed improvements versus placebo as early as week 1 and was maintained through 
week 16 [Taltz vs placebo: COAST-X: -2.4 vs -1.5]. In addition, more patients on Taltz compared 
with placebo achieved good health status (ASAS HI ≤5) at week 16 and week 52. 
 
Immunisations  
In a study in healthy subjects, no safety concerns were identified of two inactivated vaccines (tetanus 
and pneumococcal), received after two doses of ixekizumab (160 mg followed by a second dose of 
80 mg two weeks later). However, the data concerning immunisation were insufficient to conclude on 
an adequate immune response to these vaccines following administration of Taltz. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with Taltz 
in one or more subsets of the paediatric population in the treatment of plaque psoriasis and psoriatic 
arthritis/axial spondyloarthritis (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following a single subcutaneous dose of ixekizumab in patients with psoriasis, mean peak 
concentrations were achieved within 4 to 7 days, across a dose range of 5 to 160 mg. The mean (SD) 
maximum plasma concentration (Cmax) of ixekizumab, after the 160 mg starting dose, was 
19.9 (8.15) µg/ml. 
 
After the 160 mg starting dose, steady state was achieved by week 8 with the 80 mg Q2W dosing 
regimen. Mean (SD) Cmax,ss, and C trough,ss estimates are 21.5 (9.16) µg/ml, and 5.23 (3.19) µg/ml. 
 



26 

 

After switching from the 80 mg Q2W dosing regimen to the 80 mg Q4W dosing regimen at week 12, 
steady state would be achieved after approximately 10 weeks. Mean (SD) Cmax,ss, and Ctrough,ss estimates 
are 14.6 (6.04) µg/ml, and 1.87 (1.30) µg/ml. 
 
The average bioavailability of ixekizumab after subcutaneous administration was 54 % to 90 % across 
analyses. 
 
Distribution 
 
From population pharmacokinetic analyses, the mean total volume of distribution at steady state was 
7.11 L. 
 
Biotransformation 
 
Ixekizumab is a monoclonal antibody and is expected to be degraded into small peptides and amino 
acids via catabolic pathways in the same manner as endogenous immunoglobulins. 
 
Elimination 
 
In the population PK analysis, mean serum clearance was 0.0161 L/hr. Clearance is independent of 
dose. The mean elimination half-life, as estimated from population pharmacokinetic analysis, is 
13 days in patients with plaque psoriasis. 
 
Linearity/non-linearity 
 
Exposure (AUC) increased proportionally over a dose range of 5 to 160 mg given as a subcutaneous 
injection. 
 
Pharmacokinetic properties across indications 
 
The pharmacokinetic properties of Taltz were similar across the plaque psoriasis, psoriatic arthritis, 
radiographic axial spondyloarthritis and non-radiographic axial spondyloarthritis indications. 
 
Elderly 
 
Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years 
of age or older and 36 patients were 75 years of age or older. Of the 1,118 psoriatic arthritis patients 
exposed to Taltz in clinical studies, a total of 122 patients were 65 years of age or older and 6 patients 
were 75 years of age or older. 
Based on population pharmacokinetic analysis with a limited number of elderly patients (n = 94 for 
age ≥ 65 years and n = 12 for age ≥ 75 years), clearance in elderly patients and patients less than 
65 years of age was similar. 
 
Renal or hepatic impairment 
 
Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic 
impairment on the PK of ixekizumab have not been conducted. Renal elimination of intact 
ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are 
mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence 
clearance of ixekizumab. 
 
Paediatric population 
 
Paediatric psoriasis patients (age 6 to less than 18 years) were administered ixekizumab at the 
recommended paediatric dosing regimen for 12 weeks. Patients weighing >50 kg and 25 to 50 kg had 



27 

 

a mean ±SD steady-state trough concentration of 3.8 ±2.2 µg/ml and 3.9 ±2.4 µg/ml, respectively, at 
week 12. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on repeat-dose toxicity studies, safety 
pharmacology evaluations, and reproductive and developmental toxicity studies.  
 
Ixekizumab administration to cynomolgus monkeys for 39 weeks at subcutaneous doses up to 
50 mg/kg weekly produced no organ toxicity or undesirable effects on immune function (e.g. T-cell 
dependent antibody response and NK cell activity). A weekly subcutaneous dose of 50 mg/kg to 
monkeys is approximately 19 times the 160 mg starting dose of Taltz and in monkeys results in 
exposure (AUC) that is at least 61-fold higher than the predicted mean steady-state exposure in 
humans administered the recommended dose regimen.  
 
Non-clinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of 
ixekizumab.  
 
No effects on reproductive organs, menstrual cycles or sperm were observed in sexually mature 
cynomolgus monkeys that received ixekizumab for 13 weeks at a weekly subcutaneous dose of 
50 mg/kg. 
 
In developmental toxicity studies, ixekizumab was shown to cross the placenta and was present in the 
blood of offspring for up to 6 months of age. A higher incidence of postnatal mortality occurred in the 
offspring of monkeys given ixekizumab compared to concurrent controls. This was related primarily 
to early delivery or maternal neglect of offspring, common findings in nonhuman primate studies, and 
considered clinically irrelevant. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium citrate  
Citric acid, anhydrous 
Sodium chloride 
Polysorbate 80 
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 ºC to 8 ºC). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30 ºC. 
 



28 

 

6.5 Nature and contents of container  
 
1 ml solution in a type I clear glass syringe. 
Pack sizes of 1, 2, or 3 pre-filled syringes. 
Not all pack sizes may be marketed. 
 
 
6.6 Special precautions for disposal and other handling 
 
The instructions for using the syringe, included with the package leaflet, must be followed carefully. 
The pre-filled syringe is for single use only. 
 
Taltz should not be used if particles appear or if the solution is cloudy and/or distinctly brown. 
 
Taltz that has been frozen must not be used. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
40 mg preparation of ixekizumab for children 25-50 kg body weight 
 
Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional. 
Use only Taltz 80 mg solution for injection in pre-filled syringe when preparing the prescribed 40 mg 
paediatric doses. 
 

1. Expel the entire contents of the pre-filled syringe into a sterile, clear glass vial. DO NOT 
shake or swirl the vial. 

2. Use a 0.5 mL or 1 mL disposable syringe and sterile needle to withdraw the prescribed 
dose (0.5 ml for 40 mg) from the vial. 

3. Change the needle and use a 27-gauge, sterile needle to inject the patient. Discard any 
unused ixekizumab in the vial. 

 
The prepared ixekizumab must be administered within 4 hours of puncturing the sterile vial at 
room temperature. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.  
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1085/004 
EU/1/15/1085/005 
EU/1/15/1085/006 

 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 25 April 2016 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT  
 
 



29 

 

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


30 

 

1. NAME OF THE MEDICINAL PRODUCT 
 
Taltz 80 mg solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled pen contains 80 mg ixekizumab in 1 ml. 
 
Ixekizumab is produced in CHO cells by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
The solution is clear and colourless to slightly yellow. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Plaque psoriasis 
 
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates 
for systemic therapy. 
 
Paediatric plaque psoriasis 
 
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age 
of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for 
systemic therapy. 
 
Psoriatic arthritis 
 
Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic 
arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more 
disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1). 
 
Axial spondyloarthritis 
 
Ankylosing spondylitis (radiographic axial spondyloarthritis) 
Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have 
responded inadequately to conventional therapy. 
 
Non-radiographic axial spondyloarthritis 
Taltz is indicated for the treatment of adult patients with active non-radiographic axial 
spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein 
(CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal 
anti-inflammatory drugs (NSAIDs). 
 



31 

 

4.2 Posology and method of administration 
 
This medicinal product is intended for use under the guidance and supervision of a physician 
experienced in the diagnosis and treatment of conditions for which it is indicated. 
 
Posology 
 
Plaque psoriasis in adults 
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, 
followed by 80 mg (one injection) at weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg 
(one injection) every 4 weeks (Q4W). 
 
Paediatric plaque psoriasis (age 6 years and above) 
Efficacy and safety data is not available in children below the age of 6 years (see section 5.1). 
Available data do not support a posology below a body weight of 25 kg. 
The recommended dose given by subcutaneous injection in children is based on the following weight 
categories: 
 

Children’s body 
weight 

Recommended starting 
dose (week 0) 

Recommended dose every 
4 weeks (Q4W) thereafter 

Greater than 50 kg  160 mg (two 80 mg injections) 80 mg 
25 to 50 kg 80 mg 40 mg 

 
Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional 
using the commercial Taltz 80 mg/1 ml pre-filled syringe. 
Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg and do not 
require dose preparation. 
Taltz is not recommended for use in children with a body weight below 25 kg. Paediatric body weights 
must be recorded and regularly re-checked prior to dosing. 
  
Psoriatic arthritis 
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, 
followed by 80 mg (one injection) every 4 weeks thereafter. For psoriatic arthritis patients with 
concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for 
plaque psoriasis. 
 
Axial spondyloarthritis (radiographic and non-radiographic) 
The recommended dose is 160 mg (two 80 mg injections) by subcutaneous injection at week 0, 
followed by 80 mg every 4 weeks (see section 5.1 for further information). 
 
For all indications (plaque psoriasis in adults and children, psoriatic arthritis, axial spondyloarthritis) 
consideration should be given to discontinuing treatment in patients who have shown no response after 
16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve 
with continued treatment beyond 20 weeks. 
 
Special populations 
 
Elderly (≥ 65 years) 
No dose adjustment is required (see section 5.2). 
 
There is limited information in subjects aged ≥ 75 years. 
 
Renal or hepatic impairment 
Taltz has not been studied in these patient populations. No dose recommendations can be made. 
 



32 

 

Paediatric population 
 
Paediatric plaque psoriasis (below a body weight of 25 kg and below the age of 6 years) 
There is no relevant use of Taltz in children below a body weight of 25 kg and below the age of 
6 years in the treatment of moderate to severe plaque psoriasis. 
 
Paediatric psoriatic arthritis 
The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the 
treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been 
established. No data are available. There is no relevant use of Taltz in children below 2 years for the 
indication of psoriatic arthritis. 
 
Method of administration  
 
Subcutaneous use. 
 
Taltz is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that 
show psoriasis should be avoided as injection sites. The solution/the pen must not be shaken. 
 
After proper training in subcutaneous injection technique, patients may self-inject Taltz if a healthcare 
professional determines that it is appropriate. However, the physician should ensure appropriate 
follow-up of patients. Comprehensive instructions for administration are given in the package leaflet 
and the user manual.  
 
4.3 Contraindications 
 
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Clinically important active infections (e.g. active tuberculosis, see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Infections 
 
Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract 
infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8). 
 
Taltz should be used with caution in patients with clinically important chronic infection or a history of 
recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms 
suggestive of an infection occur. If an infection develops, patients should be carefully monitored and 
Taltz discontinued if the patient is not responding to standard therapy or if the infection becomes 
serious. Taltz should not be resumed until the infection resolves. 
 
Taltz must not be given to patients with active tuberculosis (TB). Anti-TB therapy prior to initiation of 
Taltz in patients with latent TB should be considered.  
 
Hypersensitivity 
 
Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, 
rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread 



33 

 

urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction 
occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated. 
 
Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) 
 
Cases of new or exacerbations of inflammatory bowel disease have been reported with ixekizumab 
(see section 4.8). Ixekizumab is not recommended in patients with inflammatory bowel disease. If a 
patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of 
pre-existing inflammatory bowel disease, ixekizumab should be discontinued and appropriate medical 
management should be initiated. 
 
Immunisations 
 
Taltz should not be used with live vaccines. No data are available on the response to live vaccines; 
there are insufficient data on response to inactive vaccines (see section 5.1). 
 
Excipients  
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say 
essentially “sodium-free”.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or 
phototherapy has not been evaluated. 
In population pharmacokinetic analyses, clearance of ixekizumab was not affected by concomitant 
administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate. 
 
Cytochrome P450 substrates 
 
Results from an interaction study in patients with moderate-to-severe psoriasis determined that 
12 weeks of administration of ixekizumab with substances metabolised by CYP3A4 (i.e., midazolam), 
CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., 
dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these 
substances. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
 
Women of childbearing potential should use an effective method of contraception during treatment 
and for at least 10 weeks after treatment. 
 
Pregnancy 
 
There is a limited amount of data from the use of ixekizumab in pregnant women. Animal studies do 
not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal 
development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is 
preferable to avoid the use of Taltz during pregnancy. 
 
Breast-feeding 
 
It is not known whether ixekizumab is excreted in human milk or absorbed systemically after 
ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys. A 
decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into 
account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
 



34 

 

Fertility 
 
The effect of ixekizumab on human fertility has not been evaluated. Animal studies do not indicate 
direct or indirect harmful effects with respect to fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Taltz has no or negligible influence on the ability to drive and use machines.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were injection site reactions (15.5 %) and upper 
respiratory tract infections (16.4 %) (most frequently nasopharyngitis).  
 
Tabulated list of adverse reactions 
 
Adverse reactions from clinical studies and postmarketing reports (Table 1) are listed by MedDRA 
system organ class. Within each system organ class, the adverse reactions are ranked by frequency, 
with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented 
in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse 
reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); 
uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 
 
A total of 8,956 patients have been treated with Taltz in blinded and open-label clinical studies in 
plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and other autoimmune conditions. Of these, 
6,385 patients were exposed to Taltz for at least one year, cumulatively representing 
19,833 adult patient years of exposure and 196 children cumulatively representing 207 patient years of 
exposure.  
 



35 

 

Table 1.  List of adverse reactions in clinical studies and postmarketing reports 
 

System organ class Frequency Adverse reaction 
Infections and infestations  
 

Very common Upper respiratory tract 
infection 

Common Tinea infection, 
Herpes simplex 
(mucocutaneous) 

Uncommon Influenza, 
Rhinitis, 
Oral candidiasis, 
Conjunctivitis, 
Cellulitis 

Blood and lymphatic system 
disorders  

Uncommon Neutropenia, 
Thrombocytopenia 

Immune system disorders  Uncommon  Angioedema 
Rare Anaphylaxis 

Respiratory, thoracic and 
mediastinal disorders  

Common Oropharyngeal pain 

Gastrointestinal disorders  Common Nausea 
Uncommon  Inflammatory bowel disease 

Skin and subcutaneous 
disorders  

Uncommon Urticaria, 
Rash, 
Eczema 

General disorders and 
administration site conditions 

Very common Injection site reactionsa 

a See section description of selected adverse reactions 
 
Description of selected adverse reactions 
 
Injection site reactions 
The most frequent injection site reactions observed were erythema and pain. These reactions were 
predominantly mild to moderate in severity and did not lead to discontinuation of Taltz. 
In the adult plaque psoriasis studies, injection site reactions were more common in subjects with a 
body weight < 60 kg compared with the group with a body weight ≥ 60 kg (25 % vs. 14 % for the 
combined Q2W and Q4W groups). In the psoriatic arthritis studies, injection site reactions were more 
common in subjects with a body weight < 100 kg compared with the group with a body weight 
≥ 100 kg (24 % vs. 13 % for the combined Q2W and Q4W groups). In the axial spondyloarthritis 
studies, injection site reactions were similar in subjects with a body weight < 100 kg compared with 
the group with a body weight ≥ 100 kg (14 % vs. 9 % for the combined Q2W and Q4W groups). The 
increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in 
an increase in discontinuations in either the plaque psoriasis, the psoriatic arthritis or the axial 
spondyloarthritis studies. 
 
Infections 
In the placebo-controlled period of the phase III clinical studies in plaque psoriasis in adults, infections 
were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of 
patients treated with placebo.  
 
The majority of infections were non-serious and mild to moderate in severity, most of which did not 
necessitate treatment discontinuation. Serious infections occurred in 13 (0.6 %) of patients treated with 
Taltz and in 3 (0.4 %) of patients treated with placebo (see section 4.4). Over the entire treatment 
period infections were reported in 52.8 % of patients treated with Taltz (46.9 per 100 patient years). 
Serious infections were reported in 1.6 % of patients treated with Taltz (1.5 per 100 patient years). 
 



36 

 

Infection rates observed in psoriatic arthritis and axial spondyloarthritis clinical studies were similar to 
those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse 
reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis. 
 
Laboratory assessment of neutropenia and thrombocytopenia 
In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia. In most cases, the 
blood neutrophil count was ≥1,000 cells/mm3. Such levels of neutropenia may persist, fluctuate or be 
transient. 0.1% of patients receiving Taltz developed a neutrophil count <1,000 cells/mm3. In general, 
neutropenia did not require discontinuation of Taltz. 3% of patients exposed to Taltz had a shift from a 
normal baseline platelet value to <150,000 platelet cells/mm3 to ≥75,000 cells/mm3. 
Thrombocytopenia may persist, fluctuate or be transient. 
 
The frequency of neutropenia and thrombocytopenia in psoriatic arthritis and axial spondyloarthritis 
clinical studies is similar to that observed in the plaque psoriasis studies. 
 
Immunogenicity 
Approximately 9–17% of adult plaque psoriasis patients treated with Taltz at the recommended dosing 
regimen developed anti-drug antibodies, the majority of which were low titres and not associated with 
reduced clinical response up to 60 weeks of treatment. However, approximately 1% of patients treated 
with Taltz had confirmed neutralising antibodies associated with low drug concentrations and reduced 
clinical response.  
 
In psoriatic arthritis patients treated with Taltz at the recommended dosing regimen up to 52 weeks, 
approximately 11% developed anti-drug antibodies, the majority of which were low titre, and 
approximately 8% had confirmed neutralising antibodies. No apparent association between the 
presence of neutralising antibodies and impact on drug concentration or efficacy was observed. 
 
In paediatric psoriasis patients treated with Taltz at the recommended dosing regimen up to 12 weeks, 
21 patients (18%) developed anti-drug antibodies, approximately half were low titer and 5 patients 
(4%) had confirmed neutralizing antibodies associated with low drug concentrations. There was no 
association with clinical response or adverse events. 
 
In radiographic axial spondyloarthritis patients treated with Taltz at the recommended dosing regimen 
up to 16 weeks, 5.2% developed anti-drug antibodies, the majority of which were low titer, and 1.5% 
(3 patients) had neutralising antibodies (NAb). In these 3 patients, NAb-positive samples had low 
ixekizumab concentrations and none of these patients achieved an ASAS40 response. In 
non-radiographic axial spondyloarthritis patients treated with Taltz at the recommended dosing 
regimen for up to 52 weeks, 8.9% developed anti-drug antibodies, all of which were low titer; no 
patient had neutralising antibodies; and no apparent association between the presence of anti-drug 
antibodies and drug concentration, efficacy, or safety was observed. 
 
Across all indications, an association between immunogenicity and treatment emergent adverse events 
has not been clearly established. 
 
Paediatric population 
 
The safety profile observed in children with plaque psoriasis treated with Taltz every 4 weeks is 
consistent with the safety profile in adult patients with plaque psoriasis with the exception of the 
frequencies of conjunctivitis, influenza, and urticaria which were common. Inflammatory bowel 
disease was also more frequent in paediatric patients, although it was still uncommon. In the paediatric 
clinical study, Crohn’s disease occurred in 0.9% of patients in the Taltz group and 0% of patients in 
the placebo group during the 12-week, placebo-controlled period. Crohn’s disease occurred in a total 
of 4 Taltz treated subjects (2.0%) during the combined placebo-controlled and maintenance periods of 
the paediatric clinical study. 



37 

 

 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting 
toxicity. Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have 
been reported without any serious adverse events. In the event of overdose, it is recommended that the 
patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic 
treatment be instituted immediately. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC13 
 
Mechanism of action 
 
Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (< 3 pM) and specificity to 
interleukin 17A (both IL-17A and IL-17A/F). Elevated concentrations of IL-17A have been implicated 
in the pathogenesis of psoriasis by promoting keratinocyte proliferation and activation, as well as in 
the pathogenesis of psoriatic arthritis and axial spondyloarthritis by driving inflammation leading to 
erosive bone damage and pathological new bone formation. Neutralisation of IL-17A by ixekizumab 
inhibits these actions. Ixekizumab does not bind to ligands IL-17B, IL-17C, IL-17D, IL-17E or 
IL-17F. 
 
In vitro binding assays confirmed that ixekizumab does not bind to human Fcγ receptors I, IIa, and IIIa 
or to complement component C1q. 
 
Pharmacodynamic effects 
 
Ixekizumab modulates biological responses that are induced or regulated by IL-17A. Based on 
psoriatic skin biopsy data from a phase I study, there was a dose-related trend towards decreased 
epidermal thickness, number of proliferating keratinocytes, T cells, and dendritic cells, as well as 
reductions in local inflammatory markers from baseline to day 43. As a direct consequence treatment 
with ixekizumab reduces erythema, induration and desquamation present in plaque psoriasis lesions. 
 
Taltz has been shown to lower (within 1 week of treatment) levels of C-reactive protein, which is a 
marker of inflammation.  
 
Clinical efficacy and safety 
 
Adult plaque psoriasis 
 
The efficacy and safety of Taltz were assessed in three randomised, double-blind, placebo-controlled 
phase III studies in adult patients (N=3,866) with moderate to severe plaque psoriasis who were 
candidates for phototherapy or systemic therapy (UNCOVER-1, UNCOVER-2, and UNCOVER-3). 
The efficacy and safety of Taltz were also evaluated versus etanercept (UNCOVER-2 and 
UNCOVER-3). Patients randomised to Taltz who were sPGA (0,1) responders (static Physicians 
Global Assessment) at week 12 were re-randomised to receive placebo or Taltz for an additional 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38 

 

48 weeks (UNCOVER-1 and UNCOVER-2); patients randomised to placebo, etanercept or Taltz who 
were sPGA (0,1) non-responders received Taltz for up to 48 weeks. 
 
64 % of patients had received prior systemic therapy (biologic, conventional systemic or psoralen and 
ultraviolet A (PUVA)), 43.5 % prior phototherapy, 49.3 % prior conventional systemic therapy, and 
26.4 % prior biologic therapy. 14.9 % had received at least one anti-TNF alpha agent, and 8.7 % an 
anti-IL-12/IL-23. 23.4 % of patients had a history of psoriatic arthritis at baseline.  
 
In all three studies, the co-primary endpoints were the proportion of patients who achieved a PASI 75 
response (Psoriasis Area and Severity Index) and an sPGA of 0 (“clear”) or 1 (“minimal”) response at 
week 12 versus placebo. The median baseline PASI score ranged from 17.4 to 18.3; 48.3 % to 51.2 % 
of patients had a baseline sPGA score of severe or very severe, and mean baseline itch Numeric Rating 
Scale (itch NRS) ranged from 6.3 to 7.1. 
 
Clinical response at 12 weeks 
UNCOVER-1 randomised 1,296 patients (1:1:1) to receive either placebo or Taltz (80 mg every two 
or four weeks [Q2W or Q4W] following a 160 mg starting dose) for 12 weeks.  
 
Table 2. Efficacy results at week 12 in UNCOVER-1 
 

Endpoints 

Number of patients (%) Difference from placebo in 
response rate (95% CI) 

Placebo 
(N = 431) 

Taltz 
80 mg Q4W 
(N = 432) 

Taltz  
80 mg Q2W 
(N = 433) 

Taltz 
80 mg Q4W 

 

Taltz  
80 mg Q2W 

 
sPGA of “0” 
(clear) or “1” 
(minimal) 

14 (3.2) 330 (76.4)a 354 (81.8)a 73.1 (68.8, 77.5) 78.5 (74.5, 82.5) 

sPGA of “0” 
(clear) 0 149 (34.5)a 160 (37.0)a 34.5 (30.0, 39.0) 37.0 (32.4, 41.5) 

PASI 75  17 (3.9) 357 (82.6)a 386 (89.1)a 78.7 (74.7, 82.7) 85.2 (81.7, 88.7) 

PASI 90  2 (0.5) 279 (64.6)a 307 (70.9)a 64.1 (59.6, 68.7) 70.4 (66.1, 74.8) 

PASI 100 0 145 (33.6)a 153 (35.3)a 33.6 (29.1, 38.0) 35.3 (30.8, 39.8) 

Itch NRS 
reduction ≥ 4b 58 (15.5) 305 (80.5)a 336 (85.9)a 65.0 (59.5, 70.4) 70.4 (65.4, 75.5) 

Abbreviations: N = number of patients in the intent-to-treat population 
Note: patients with missing data were counted as non-responders 
a p < 0.001 compared with placebo 
b Patients with Itch NRS ≥ 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 
80 mg Q2W N = 391 
 
UNCOVER-2 randomised 1,224 patients (1:2:2:2) to receive either placebo, or Taltz (80 mg every two 
or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 
12 weeks. 
 



39 

 

Table 3. Efficacy results at week 12 in UNCOVER-2  
 

Endpoints 

Number of patients (%) Difference from placebo in 
response rate (95% CI) 

Placebo 
(N = 168) 

Taltz 
80 mg Q4W 
(N = 347) 

Taltz  
80 mg Q2W 
(N = 351) 

Etanercept 

50 mg twice 
weekly 

(N = 358) 

Taltz 
80 mg Q4W 

 

Taltz  
80 mg Q2W 

 

sPGA of “0” 
(clear) or 
“1” 
(minimal) 

4 (2.4) 253 (72.9)a,b 292 (83.2)a,b 129 (36.0)a 70.5 (65.3, 
75.7) 

80.8 (76.3, 
85.4) 

sPGA of “0” 
(clear) 1 (0.6) 112 (32.3)a,b 147 (41.9)a,b 21 (5.9)c 31.7 (26.6, 

36.7) 
41.3 (36.0, 

46.6) 

PASI 75 4 (2.4) 269 (77.5)a,b 315 (89.7)a,b 149 (41.6)a 75.1 (70.2, 
80.1) 

87.4 (83.4, 
91.3) 

PASI 90 1 (0.6) 207 (59.7)a,b 248 (70.7)a,b 67 (18.7)a 59.1 (53.8, 
64.4) 

70.1 (65.2, 
75.0) 

PASI 100 1 (0.6) 107 (30.8)a,b 142 (40.5)a,b 19 (5.3)c 30.2 (25.2, 
35.2) 

39.9 (34.6, 
45.1) 

Itch NRS 
reduction 
≥ 4d 19 (14.1) 225 (76.8)a,b 258 (85.1)a,b 177 (57.8)a 62.7 (55.1, 

70.3) 
71.1 (64.0, 

78.2) 

Abbreviations: N = number of patients in the intent-to-treat population 
Note: patients with missing data were counted as non-responders. 
a p < 0.001 compared with placebo; b p < 0.001 compared with etanercept 
c p < 0.01 compared with placebo 
d Patients with Itch NRS ≥ 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 
80 mg Q2W N = 303, etanercept N = 306 
 
UNCOVER-3 randomised 1,346 patients (1:2:2:2) to receive either placebo, or Taltz (80 mg every two 
or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 
12 weeks. 
 



40 

 

Table 4. Efficacy results at week 12 in UNCOVER-3 
 

Endpoints 

Number of patients (%)  
Difference from placebo in 

response rate (95% CI) 
 

Placebo 
(N = 193) 

Taltz 
80 mg Q4W 
(N = 386) 

Taltz  
80 mg Q2W 
(N = 385) 

Etanercept 
50 mg twice 

weekly  
(N = 382) 

Taltz 
80 mg Q4W 

Taltz 
80 mg Q2W 

sPGA of “0” 
(clear) or 
“1” 
(minimal)  

13 (6.7) 291 (75.4)a,b 310 (80.5)a,b 159 (41.6)a 68.7 (63.1, 
74.2) 

73.8 (68.5, 
79.1) 

sPGA of “0” 
(clear)  0 139 (36.0)a,b 155 (40.3)a,b 33 (8.6)a 36.0 (31.2, 

40.8) 
40.3 (35.4, 

45.2) 

PASI 75  14 (7.3) 325 (84.2)a,b 336 (87.3)a,b 204 (53.4)a 76.9 (71.8, 
82.1) 

80.0 (75.1, 
85.0) 

PASI 90  6 (3.1) 252 (65.3)a,b 262 (68.1)a,b 98 (25.7)a 62.2 (56.8, 
67.5) 

64.9 (59.7, 
70.2) 

PASI 100  0 135 (35.0)a,b 145 (37.7)a,b 28 (7.3)a 35 (30.2, 39.7) 37.7 (32.8, 
42.5) 

Itch NRS 
reduction 
≥ 4c 

33 (20.9) 250 (79.9)a,b 264 (82.5)a,b 200 (64.1)a 59.0 (51.2, 
66.7) 

61.6 (54.0, 
69.2) 

Abbreviations: N = number of patients in the intent-to-treat population 
Note: patients with missing data were counted as non-responders 
a p < 0.001 compared with placebo 
b p < 0.001 compared with etanercept 
c Patients with Itch NRS ≥ 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 
80 mg Q2W N = 320, etanercept N = 312 
 
Taltz was associated with a fast onset of efficacy with > 50 % reduction in mean PASI by week 2 
(Figure 1). The percentage of patients achieving PASI 75 was significantly greater for Taltz compared 
with placebo and etanercept as early as week 1. Approximately 25 % of patients treated with Taltz 
achieved a PASI score < 5 by week 2, more than 55 % achieved the PASI score < 5 by week 4, and 
increased to 85 % by week 12 (compared to 3 %, 14 % and 50 % for etanercept). Significant 
improvements in itch severity were seen at week 1 in patients treated with Taltz.  
 



41 

 

Figure 1.  PASI score, percent improvement at each post baseline visit (mBOCF)) in the 
intent-to-treat population during the induction dosing period – UNCOVER-2 and UNCOVER-3
  
 

 
 

The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI 
baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a 
biologic. Taltz was efficacious in systemic treatment-naive, biologic-naive, 
biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.  
 
For patients identified as an sPGA (0,1) non-responder to etanercept at week 12 in UNCOVER-2 
(N = 200) and who were switched to Taltz 80 mg Q4W after a 4 week washout period, 73 % and 
83.5 % of patients achieved sPGA (0,1) and PASI 75, respectively, after 12 weeks of treatment with 
Taltz.  
 
In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate 
of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation 
due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz. The rate of infections was 21.5 % 
for etanercept and 26.0 % for Taltz, with 0.4 % being serious for etanercept and 0.5 % for Taltz. 
 
Maintenance of response at week 60 
Patients originally randomised to Taltz and who were responders at week 12 (i.e., sPGA score of 0,1) 
in UNCOVER-1 and UNCOVER-2 were re-randomised to an additional 48 weeks of treatment with 
placebo or Taltz (80 mg every four or twelve weeks [Q4W or Q12W]).  
For sPGA (0,1) responders at week 12 re-randomised to treatment withdrawal (i.e., placebo), the 
median time to relapse (sPGA ≥ 3) was 164 days in integrated UNCOVER-1 and UNCOVER-2 
studies. Among these patients, 71.5 % regained at least an sPGA (0,1) response within 12 weeks of 
restarting treatment with Taltz 80 mg Q4W. 
 



42 

 

Table 5. Maintenance of response and efficacy at week 60  
(Studies UNCOVER-1 and UNCOVER-2)  

 

Endpoints 

Number of patients (%)  

Difference from placebo in 
response rate (95% CI) 

80 mg Q4W 
(induction) / 

Placebo 
(maintenance) 

(N = 191) 

80 mg Q2W 
(induction) / 

Placebo 
(maintenance) 

(N = 211) 

80 mg Q4W 
(induction) / 
80 mg Q4W 

(maintenance) 
(N = 195) 

80 mg Q2W 
(induction) / 
80 mg Q4W 

(maintenance) 
(N = 221) 

80 mg Q4W 
(induction) / 
80 mg Q4W 

(maintenance) 

80 mg Q2W 
(induction) / 
80 mg Q4W 

(maintenance) 

Maintained 
sPGA of “0” 
(clear) or “1” 
(minimal) 

12 (6.3) 16 (7.6) 134 (68.7)a  173 (78.3)a  

62.4 (55.1, 
69.8) 

70.7 (64.2, 
77.2) 

Maintained or 
achieved 
sPGA 0 
(clear) 

3 (1.6) 6 (2.8) 96 (49.2)a  130 (58.8)a  

47.7 (40.4, 
54.9) 

56.0 (49.1, 
62.8) 

Maintained or 
achieved 
PASI 75 

15 (7.9) 19 (9.0) 145 (74.4)a  184 (83.3)a  
66.5 (59.3, 

73.7) 
74.3 (68.0, 

80.5) 

Maintained or 
achieved 
PASI 90 

9 (4.7) 10 (4.7) 130 (66.7)a  169 (76.5)a  
62.0 (54.7, 

69.2) 
71.7 (65.4, 

78.0) 

Maintained or 
achieved 
PASI 100 

3 (1.6) 6 (2.8) 97 (49.7)a  127 (57.5)a  
48.2 (40.9, 

55.4) 
54.6 (47.7, 

61.5) 

Abbreviations: N = number of patients in the analysis population 
Note: patients with missing data were counted as non-responders 
a p < 0.001 compared with placebo 
 
Taltz was efficacious in the maintenance of response in systemic treatment-naive, biologic-naive, 
biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.  
 
 
Significantly greater improvements at week 12 from baseline compared to placebo and etanercept 
were demonstrated in nail psoriasis (as measured by the Nail Psoriasis Severity Index [NAPSI]), in 
scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI]) and in palmoplantar psoriasis 
(as measured by Psoriasis Palmoplantar Severity Index [PPASI]) and were maintained at week 60 in 
patients treated with Taltz who were sPGA (0,1) responders at week 12. 
 
Quality of life/patient-reported outcomes 
At week 12 and across studies, Taltz was associated with statistically significant improvement in 
Health-related Quality of Life as assessed by mean decrease ranges from baseline in the Dermatology 
Life Quality Index (DLQI) (Taltz 80 mg Q2W from -10.2 to -11.1, Taltz 80 mg Q4W from -9.4 
to -10.7, etanercept from -7.7 to -8.0 and placebo -1.0 to -2.0). A significantly greater proportion of 
patients treated with Taltz achieved a DLQI 0 or 1. Across studies a significantly greater proportion of 
patients treated with Taltz achieved a reduction of Itch NRS ≥ 4 points at week 12 (84.6% for Taltz 
Q2W, 79.2% for Taltz Q4W and 16.5% for placebo) and the benefit was sustained over time up to 
week 60 in patients treated with Taltz who were sPGA (0 or 1) responders at week 12. There was not 
any evidence of worsening of depression up to 60 weeks treatment with Taltz as assessed by the Quick 
Inventory of Depressive Symptomatology Self Report. 
 
Postmarketing phase 3b, direct comparative study 
In a double-blind study ixekizumab was superior against ustekinumab on the primary study objective 
PASI 90 response at week 12 (Table 6). Onset of response was superior on PASI 75 as early as week 2 



43 

 

(p < 0.001) and on PASI 90 and PASI 100 by week 4 (p < 0.001). Superiority of ixekizumab versus 
ustekinumab was also demonstrated in the subgroups stratified by weight. 
 
Table 6. PASI-response rates from comparative study ixekizumab versus ustekinumab 
 

 week 12 week 24 week 52 
 Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** 
Patients (n) 136 166 136 166 136 166 
PASI 75, n (%) 120 (88.2 %) 114 (68.7 %) 124 (91.2 %) 136 (81.9%) 120 (88.2%) 126 (75.9 %) 
PASI 90, n (%) 99 (72.8%)§ 70 (42.2 %) 113 (83.1 %) 98 (59.0 %) 104 (76.5%) 98 (59.0 %) 
PASI 100, n (%) 49 (36.0 %) 24 (14.5 %) 67 (49.3%) 39 (23.5 %) 71 (52.2%) 59 (35.5 %) 

* Ixekizumab 160 mg given as a loading dose followed by 80 mg at week 2,4,6,8,10 and 12, and 
80 mg Q4W thereafter 
** Weight based dosing: Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, 
then every 12 weeks until week 52 (dosed by weight as per approved posology) 
§p < 0.001 versus ustekinumab (p value only provided for primary endpoint) 
 
Efficacy in genital psoriasis 
A randomised, double-blind, placebo-controlled study (IXORA-Q) was conducted in 149 adult 
subjects (24% females) with moderate to severe genital psoriasis (sPGA of Genitalia score of ≥3), a 
minimum body surface area (BSA) involvement of 1% (60.4% had a BSA ≥ 10%) and previous failure 
of or intolerance to at least one topical therapy for genital psoriasis. Patients had at least moderate 
plaque psoriasis (defined as sPGA score of ≥ 3 and being candidates for phototherapy and/or systemic 
therapy) for at least 6 months.  
 
Subjects randomised to Taltz received an initial dose of 160 mg followed by 80 mg every 2 weeks for 
12 weeks. The primary endpoint was the proportion of patients who achieved at least a "0" (clear) or 
"1" (minimal) response on the sPGA of Genitalia (sPGA of Genitalia 0/1). At week 12, significantly 
more subjects in the Taltz group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 
independent of baseline BSA (baseline BSA 1% - <10% resp. ≥10%: sPGA of Genitalia ‘’0” or “1”: 
Taltz 71%, resp. 75%; placebo: 0%, resp. 13%). A significantly greater proportion of patients treated 
with Taltz achieved a reduction in the PROs of severity of genital pain, genital itch, impact of genital 
psoriasis on sexual activity, and Dermatology Quality of Life Index (DLQI). 
 
Table 7. Efficacy results at week 12 in Adults with genital psoriasis in trial IXORA-Q; NRI a 

 
Endpoints Taltz Placebo Difference from 

placebo (95% CI) 
Number of patients (N) randomised N=75 N=74  
sPGA of Genitalia “0” or “1”  73% 8% 65% (53%, 77%) 
sPGA “0” or “1”  73% 3% 71% (60%, 81%) 
DLQI 0,1b 45% 3% 43% (31%, 55%) 
N with baseline GPSS Itch NRS Score ≥3 N=62 N=60  
GPSS Genital Itch (≥3 point improvement) 60% 8% 51% (37%, 65%) 
N with baseline SFQ Item 2 Score ≥2 N=37 N=42  
SFQ-item 2 score, “0” (never limited) or 
“1” (rarely limited) 

78% 21% 57% (39%, 75%) 

a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; 
GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; 
DLQI = Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no 
effect at all on patient’s life. sPGA of “0” or “1” is equivalent to “clear” or “minimal”; 
NRS = Numeric Rating Scale 
 



44 

 

Paediatric plaque psoriasis 
 
A randomised, double-blind, multicenter, placebo-controlled trial (IXORA-Peds) enrolled 
201 children 6 to less than 18 years of age, with moderate to severe plaque psoriasis (as defined by a 
sPGA score ≥3, involving ≥10% of the body surface area, and a PASI score ≥12) who were candidates 
for phototherapy or systemic therapy, or were inadequately controlled on topical therapy. 
Patients were randomised to placebo (n=56), etanercept (n=30) or Taltz (n=115) with dosing stratified 
by weight: 

<25 kg: 40 mg at week 0 followed by 20 mg Q4W (n=4) 
25 kg to 50 kg: 80 mg at week 0 followed by 40 mg Q4W (n=50) 
>50 kg: 160 mg at week 0 followed by 80 mg Q4W (n=147) 

Patients randomised to etanercept (patients with severe psoriasis) received 0.8 mg/kg, not exceeding 
50 mg per dose, every week from week 0 through week 11.  
Response to treatment was assessed after 12 weeks and defined by the proportion of patients who 
achieved the co-primary endpoint of an sPGA score of “0” (clear) or “1” (almost clear) with at least a 
2 point improvement from baseline and the proportion of patients that achieved a reduction in PASI 
score of at least 75% (PASI 75) from baseline. 
Other evaluated outcomes at week 12 included the proportion of patients who achieved PASI 90, 
PASI 100, sPGA of “0” and an improvement of itch severity as measured by a reduction of at least 
4 points on an 11-point itch Numeric Rating Scale. 
Patients had a median baseline PASI of 17 score ranging from 12-49. Baseline sPGA score was 
severe or very severe in 49%. Of all patients, 22% had received prior phototherapy and 32% had 
received prior conventional systemic therapy for the treatment of psoriasis. 
25% of patients (n=43) were below 12 years (14% of patients [n=24] were 6-9 years and 11% of 
patients [n=19] were 10-11 years); 75% (n=128) were 12 years or above. 
 
The clinical response data are presented in Table 8. 
 
Table 8. Efficacy results in pediatric patients with plaque psoriasis, NRI 
 
Endpoints Taltza 

(N=115) 
n (%) 

Placebo 
(N=56) 
n (%) 

Difference vs 
placebo (95% 

CI) 

Etanercept b  
(N=30) 
n (%) 

Difference vs 
etanercept (95% 

CI)b 
sPGA “0” (clear) or 
“1” (almost clear)c 

     

week 4 55 (48) 4 (7) 40.7 (29.3, 52.0)f 0(0) 36.8 (21.5, 52.2)  
week 12 c 93 (81) 6 (11) 70.2 (59.3, 81.0)f 16 (53) 23.0 (0.6, 45.4) 

sPGA “0” (clear) d 60 (52) 1 (2) 50.4 (40.6, 60.2)f 5 (17) 46.5 (26.2, 66.8) 
PASI 75c      

week 4 62 (54) 5 (9) 45.0 (33.2, 56.8)f 3 (10) 34.7 (15.6, 53.8) 
week 12 102 (89) 14 (25) 63.7 (51.0, 76.4)f 19 (63) 20.9 (0.1, 41.7) 

PASI 90d 90 (78) 3 (5) 72.9 (63.3, 82.5)f 12 (40) 36.3 (14.2, 58.5) 
PASI 100d 57 (50) 1 (2) 47.8 (38.0, 57.6)f 5 (17) 43.9 (23.4, 64.3) 
Itch NRS (≥4 point 
improvement) d, e 

59 (71) 8 (20) 51.1 (35.3, 66.9)f Not evaluated --- 

Abbreviations: N = Number of patients in the intent-to-treat population; NRI =Non-Responder 
Imputation. 

a At week 0, subjects received 160 mg, 80 mg, or 40 mg of Taltz, followed by 80 mg, 40 mg, or 
20 mg every 4 weeks, depending on weight category, for 12 weeks. 

b Comparisons to etanercept were performed within the sub-population of patients outside of US and 
Canada with severe Ps (N for Taltz = 38). 

c Co-primary endpoints. 
d Results at week 12. 
e Itch NRS (≥4 improvement) in patients with baseline Itch NRS ≥4. The number of ITT patients 

with baseline Itch NRS Score ≥4 are as follows: Taltz, n = 83; PBO, n = 40. 
f p<0.001  
 



45 

 

Figure 2.  Percent of patients achieving PASI 75 in pediatric psoriasis through week 12 

 
 
Patients in the ixekizumab treatment group had clinically meaningful higher CDLQI/DLQI (0,1) 
responses at week 12 (NRI) compared with placebo. The difference between treatment groups was 
apparent from as early as week 4. 
 
There were greater improvements at week 12 from baseline compared to placebo in nail psoriasis (as 
measured by the Nail Psoriasis Severity Index [NAPSI=0: Taltz 18% (6/34), placebo 0% (0/12)]), in 
scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI=0: Taltz 69% (70/102), placebo 
16% (8/50)]) and in palmoplantar psoriasis (as measured by Psoriasis Palmoplantar Severity Index 
[PPASI 75: Taltz 53% (9/17), placebo 11% (1/9)]). 
 
Psoriatic arthritis 
 
Taltz was assessed in two randomised, double-blind, placebo-controlled phase III studies in 780 
patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints). Patients had a diagnosis of 
psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 
5.33 years and had current plaque psoriasis skin lesions (94.0%) or a documented history of plaque 
psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline. Over 58.9% 
and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively. 
Primary endpoint of both studies was American College of Rheumatology (ACR) 20 response at 
week 24. 
 
In Psoriatic Arthritis Study 1 (SPIRIT-P1), patients naive to biologic therapy with active psoriatic 
arthritis were randomised to placebo, adalimumab 40 mg once every 2 weeks (active control reference 
arm), Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W). Both Taltz 
regimens included a 160 mg starting dose. 85.3% of patients in this study had received prior treatment 
with ≥1 cDMARD. 53% of patients had concomitant use of MTX at a mean weekly dose of 15.8 mg. 
67% of patients who had concomitant use of MTX had a dose of 15 mg or greater. Patients with an 
inadequate response at week 16 received rescue therapy (modification to background therapy). 
Patients on Taltz Q2W or Q4W remained on their originally assigned dose of Taltz. Patients receiving 
adalimumab or placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on 
responder status.  
 
Psoriatic Arthritis Study 2 (SPIRIT-P2) enrolled patients who were previously treated with an 
anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance 
(anti-TNF-IR patients). Patients were randomised to placebo, Taltz 80 mg once every 2 weeks (Q2W), 



46 

 

or 80 mg once every 4 weeks (Q4W). Both Taltz regimens included a 160 mg starting dose. 56% and 
35% of patients were inadequate responders to 1 anti-TNF or 2 anti-TNF, respectively. SPIRIT-P2 
evaluated 363 patients, of whom 41% had concomitant use of MTX at a mean weekly dose of 16.1 mg. 
73.2% of patients who had concomitant use of MTX had a dose of 15 mg or greater. Patients with an 
inadequate response at week 16 received rescue therapy (modification to background therapy). 
Patients in Taltz Q2W or Q4W remained on their originally assigned dose of Taltz. Patients receiving 
placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status. 

Signs and symptoms 
Treatment with Taltz resulted in significant improvement in measures of disease activity compared to 
placebo at week 24 (see Table 9). 
 
Table 9. Efficacy results in SPIRIT-P1 and SPIRIT-P2 at week 24 
 
 SPIRIT-P1 SPIRIT-P2 
Endpoints     Difference from 

placebo in 
response rate 

(95% CI) 

   Difference from 
placebo in 

response rate 
(95% CI) 

 PBO 
(N = 106) 

 

Taltz 
Q4W 

(N = 107) 

Taltz 
Q2W 

(N = 103) 

ADA 
(N = 101) 

Taltz 
Q4W 

Taltz 
Q2W 

PBO 
(N = 118) 

Taltz 
Q4W 

(N = 122) 

Taltz 
Q2W 

(N = 123) 

Taltz 
Q4W 

Taltz 
Q2W 

ACR 20 response, n (%)  
week 24 

32 (30.2) 62 (57.9) 64 (62.1) 58 (57.4) 
27.8 

(15.0, 
40.6)c 

31.9 
(19.1, 
44.8)c 

23 (19.5) 65 (53.3) 59 (48.0) 
33.8 

(22.4, 
45.2)c 

28.5 
(17.1, 
39.8)c 

ACR 50 response, n (%)  
week 24 

16 (15.1) 43 (40.2) 48 (46.6) 39 (38.6) 
25.1 

(13.6, 
36.6)c 

31.5 
(19.7, 
43.3)c 

6 (5.1) 43 (35.2) 41 (33.3) 
30.2 

(20.8, 
39.5)c 

28.3 
(19.0, 
37.5)c 

ACR 70 response, n (%)  
week 24 

6 (5.7) 25 (23.4) 35 (34.0) 26 (25.7) 
17.7 
(8.6, 

26.8)c 

28.3 
(18.2, 
38.5)c 

0 27 (22.1) 15 (12.2) 
22.1 

(14.8, 
29.5)c 

12.2 
(6.4, 

18.0)c 
Minimal disease activity (MDA) n (%) 
week 24 

16 (15.1) 32 (29.9) 42 (40.8) 32 (31.7) 
14.8 
(3.8, 

25.8)a 

25.7 
(14.0, 
37.4)c 

4 (3.4) 34 (27.9) 29 (23.6) 
24.5 

(15.9, 
33.1)c 

20.2 
(12.0, 
28.4)c 

ACR 50 and PASI 100 in patients with ≥3% BSA psoriasis skin involvement at baseline, n (%) 
week 24 

1 (1.5) 21 (28.8) 19 (32.2) 9 (13.2) 
27.3 

(16.5, 
38.1)c 

30.7 
(18.4, 
43.0)b 

0 (0.0) 12 (17.6) 10 (14.7) 
17.6 
(8.6, 

26.7)c 

14.7 
(6.3, 

23.1)c 
Abbreviations: ACR 20/50/70 = American College of Rheumatology 20%/50%/70% response rate; 
ADA = adalimumab; BSA = body surface area; CI = confidence interval; Q4W = Taltz 80 mg every 
4 weeks; Q2W = Taltz 80 mg every 2 weeks; N = number of patients in the analysis population; 
n = number of patients in the specified category; NRI = non-responder imputation; PASI 
100 = psoriasis area and severity index 100% improvement; PBO = placebo.  
Note: patients who were rescued at week 16 or discontinued or with missing data were imputed as 
non-responders for week 24 analyses. 
Concomitant cDMARDs included MTX, leflunomide and sulfasalazine. 
a p<0.05; b p<0.01; c p<0.001 compared with placebo. 
 
In patients with pre-existing dactylitis or enthesitis, treatment with Taltz Q4W resulted in 
improvement in dactylitis and enthesitis at week 24 compared to placebo (resolution: 78% vs. 24%; 
p<0.001, and 39% vs. 21%; p<0.01, respectively). 
 



47 

 

In patients with ≥3% BSA, the improvement in skin clearance at week 12 as measured by 75% 
improvement in Psoriasis Area Severity Index (PASI 75), was 67% (94/141) for those treated with the 
Q4W dosing regimen, and 9% (12/134) for those treated with placebo (p<0.001). The proportion of 
patients achieving a PASI 75, PASI 90, and PASI 100 response at week 24 was greater with Taltz 
Q4W compared to placebo (p<0.001). In patients with concomitant moderate to severe psoriasis and 
psoriatic arthritis, Taltz Q2W dose regimen showed significantly higher response rate for PASI75, 
PASI 90 and PASI 100 compared to placebo (p<0.001) and demonstrated clinically meaningful benefit 
over the Q4W dose regimen. 
 
Treatment responses on Taltz were significantly greater than those on placebo as early as week 1 for 
ACR 20, week 4 for ACR 50 and week 8 for ACR 70 and persisted through week 24.  
 
Figure 3. ACR 20 response in SPIRIT-P1 over time up to week 24

 
For both Taltz Q2W and Q4W: b p<0.01 and c p<0.001 compared with placebo. 
 
In SPIRIT-P1 and SPIRIT-P2, similar responses for ACR 20/50/70 were seen in patients with psoriatic 
arthritis regardless of whether they were on concomitant cDMARDs, including MTX treatment, or 
not.  
 
In SPIRIT-P1and SPIRIT-P2, improvements were shown in all components of the ACR scores 
including patient assessment of pain. At week 24 the proportion of patients achieving a modified 
Psoriatic Arthritis Response Criteria (PsARC) response was greater in the Taltz-treated patients 
compared to placebo.  
 
In SPIRIT-P1, efficacy was maintained up to week 52 as assessed by ACR 20/50/70, MDA, enthesitis 
resolution, dactylitis resolution, and PASI 75/90/100 response rates.  
 
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, disease duration, 
baseline body weight, baseline psoriasis involvement, baseline CRP, baseline DAS28-CRP, 
concomitant corticosteroid use, and previous treatment with a biologic. Taltz was efficacious in 
biologic-naive, biologic-exposed and biologic-failure patients.  

0

10

20

30

40

50

60

70

80

90

100

0 2 4 6 8 10 12 14 16 18 20 22 24

AC
R2

0 
Re

sp
on

de
rs

, %

Treatment Week

PBO (N=106) ADA (N=101) IXE Q4 (N=107) IXE Q2 (N=103)

b

c
c

c c c c c



48 

 

Radiographic response 
In SPIRIT-P1, inhibition of progression of structural damage was assessed radiographically and 
expressed as the change in modified total Sharp Score (mTSS) and its components, the Erosion 
Score (ES) and the Joint Space Narrowing score (JSN) at weeks 24 and 52, compared to baseline. 
week 24 data are presented in Table 10. 
 
Table 10. Change in modified Total Sharp Score in SPIRIT-P1 
 
  Difference from placebo 

(95% CI) 
PBO 

(N = 106) 
Taltz Q4W 
(N = 107) 

Taltz Q2W 
(N = 103) 

ADA 
(N = 101) 

Taltz Q4W Taltz Q2W 

Baseline score, mean (SD) 17.6 (28.62) 19.2 (32.68) 15.2 (28.86) 15.9 (27.37) NA NA 
Change from baseline at 
week 24, LSM (SE) 0.51 (0.092) 0.18 (0.090) 0.09 (0.091) 0.13 (0.093) -0.33 

(-0.57,-0.09)b 
-0.42 

(-0.66,-0.19)c 
Abbreviations: ADA = adalimumab; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; 
Q2W = Taltz 80 mg every 2 weeks; LSM = least squares mean; N = number of patients in the analysis 
population; PBO = placebo; SE = standard error; SD = standard deviation. 
b p<0.01; c p<0.001 compared with placebo. 
 
Radiographic joint damage progression was inhibited by Taltz (Table 10) at week 24, and the 
percentage of patients with no radiographic joint damage progression (defined as a change from 
baseline in mTSS of ≤0.5) from randomisation to week 24 was 94.8% for Taltz Q2W(p<0.001), 89.0% 
for Taltz Q4W(p=0.026), 95.8% for adalimumab (p<0.001), all compared to 77.4% for placebo. At 
week 52, the mean change from baseline in mTSS was 0.27 for placebo/Taltz Q4W, 0.54 for Taltz 
Q4W/Taltz Q4W, and 0.32 for adalimumab/Taltz Q4W. The percentage of patients with no 
radiographic joint damage progression from randomisation to week 52 was 90.9% for placebo/Taltz 
Q4W, 85.6% for Taltz Q4W/Taltz Q4W, and 89.4% for adalimumab/Taltz Q4W.  
 
Physical function and health-related quality of life 
In both SPIRIT-P1 and SPIRIT-P2, patients treated with Taltz Q2W (p<0.001) and Q4W (p<0.001) 
showed significant improvement in physical function compared to patients treated with placebo as 
assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24, and 
maintained at week 52 in SPIRIT-P1. 
 
Taltz-treated patients reported improvements in health-related quality of life as measured by the 
Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p<0.001). 
There were also improvements demonstrated in fatigue as assessed by Fatigue severity NRS scores 
(p<0.001).  
 
Postmarketing phase 4, direct comparative study 
Efficacy and safety of Taltz was investigated in a multicenter, randomised, open-label, rater-blinded, 
parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who 
were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD). Patients were stratified at 
baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12, 
BSA≥10 and sPGA≥3). 
Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and 
PASI 100 response at week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 
15.8%]). Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT 
analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [-4.3%; 
12.1%]; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and 
superiority on PASI 100 at week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were 
the major secondary endpoints in the study.  
 



49 

 

Figure 4. Primary endpoint (simultaneous ACR 50 & PASI 100) and major secondary 
endpoints (ACR 50; PASI 100) response rates week 0 – 24 [ITT population, NRI]** 

 
** Taltz 160 mg week 0, then 80 mg every 2 weeks to week 12 and every 4 weeks thereafter for 
patients with moderate to severe plaque psoriasis or 160 mg week 0, then 80 mg every 4 week for 
other patients, ADA 80 mg week 0, then 40 mg every 2 weeks from week 1 for patients with moderate 
to severe plaque psoriasis or 40 mg week 0, then 40 mg every 2 weeks for other patients. 
Significance level only provided for endpoint that was pre-defined and multiplicity tested. 
 
Axial spondyloarthritis 
 
Taltz was assessed in a total of 960 adult patients with axial spondyloarthritis in three randomised 
placebo-controlled studies (two in radiographic and one in non-radiographic axial spondyloarthritis). 
 
Radiographic axial spondyloarthritis 
Taltz was assessed in a total of 657 patients in two randomised, double-blind, placebo-controlled 
studies (COAST-V and COAST-W) in adult patients who had active disease as defined by the Bath 
Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and total back pain ≥4 on a numeric 
rating scale despite non-steroidal anti-inflammatory drug (NSAID) therapy. Across both studies at 
baseline, patients had symptoms for a mean of 17 years (median of 16 years). At baseline, 
approximately 32% of the patients were on a concomitant cDMARD.  
COAST-V evaluated 341 biologic-naive patients treated with either Taltz 80 mg or 160 mg at week 0 
followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or 
with placebo. Patients receiving placebo were re-randomised at week 16 to receive Taltz (160 mg 
starting dose, followed by 80 mg Q2W or Q4W). Patients receiving adalimumab were re-randomised 
at week 16 to receive Taltz (80 mg Q2W or Q4W). 
COAST-W evaluated 316 patients who had prior experience with 1 or 2 TNF-inhibitors (90% were 
inadequate responders and 10% were intolerant to TNF inhibitors). All patients were treated with 
Taltz 80 or 160 mg at week 0 followed by 80 mg Q2W or Q4W, or with placebo. Patients receiving 
placebo were re-randomised at week 16 to receive Taltz (160 mg initial dose, followed by 80 mg Q2W 
or Q4W).  
The primary endpoint in both studies was the percentage of patients achieving an Assessment of 
Spondyloarthritis International Society 40 (ASAS40) response at week 16. 
 
Clinical response 
In both studies, patients treated with Taltz 80 mg Q2W or 80 mg Q4W demonstrated greater 
improvements in ASAS40 and ASAS20 responses compared to placebo at week 16 (Table 11). 



50 

 

Responses were similar in patients regardless of concomitant therapies. In COAST-W, responses were 
seen regardless of the number of prior TNF inhibitors. 

 
Table 11. Efficacy results in COAST-V and COAST-W at week 16 
 

 COAST-V, biologic-naive COAST-W, TNF-inhibitor experienced 
Taltz 
80 mg 
Q4Wa 
(N=81) 

  

Placebo 
(N=87) 

  

Difference 
from placebo g 

Adalimumab 
40 mg 
Q2W 

(N=90) 
  

Taltz 
80 mg 
Q4Wc 

(N=114) 
  

Placebo 
(N=104) 

  

Difference 
from placebo g 

ASAS20 responseb, n (%), 
NRI 

52 
(64.2%) 

35 
(40.2%) 

24.0 (9.3,  
38.6) ** 

53 (58.9%) 55 
(48.2%) 

31 
(29.8%) 

18.4 (5.7, 31.1) 

** 
ASAS40 responseb,c, n (%), 
NRI 

39 
(48.1%) 

16 
(18.4%) 

29.8 (16.2, 
43.3) *** 

32 (35.6%) 29 
(25.4%) 

13 
(12.5%) 

12.9 (2.7, 23.2) 

* 
ASDAS 
Change from baseline 
Baseline  

-1.4 
3.7 

-0.5 
3.9 

-1.0 (-1.3, -0.7) 
*** 

-1.3*** 
3.7 

-1.2 
4.2 

-0.1 
4.1 

-1.1 (-1.3, -0.8) 
*** 

BASDAI Score 
Change from baseline 
Baseline 

-2.9 
6.8 i 

-1.4 
6.8 i 

-1.5 (-2.1, -0.9) 
*** 

-2.5*** 
6.7 i 

-2.2 
7.5 

-0.9 
7.3 

-1.2 (-1.8, -0.7) 
*** 

MRI Spine SPARCCd 
Change from baseline 
Baseline 

-11.0 
14.5 

-1.5 
15.8 

-9.5 (-12.6, -
6.4) *** 

-11.6*** 
20.0 

-3.0 
8.3 

3.3 
6.4 

-6.3 (-10.0, -
2.5) ** 

BASDAI50e n (%), NRI 34 
(42.0%) 

15 
(17.2%) 

24.7 (11.4, 
38.1) *** 

29 (32.2%)* 25 
(21.9%)i 

10 
(9.6%)i 

12.3 (2.8, 
21.8)* 

ASDAS <2.1, n (%) (low 
disease activity), NRI 

35 
(43.2%)h 

11 
(12.6%)h 

30.6 
(17.7,43.4) *** 

34 
(37.8%)*** h 

20 
(17.5%) 

5 (4.8%) 12.7 ( 4.6, 
20.8) ** 

ASDAS <1.3, n (%) 
(inactive disease), NRI 

13 
(16.0%) 

2 (2.3%) 13.8 (5.2, 22.3) 
** 

14 (15.6%)** 4 (3.5%)i 1 (1.0%)i 2.5 (-1.3, 6.4)  

ASAS HIf   

Change from baseline 
Baseline 

 
-2.4 
7.5 

 
-1.3 
8.1 

 
-1.1 (-2.0, -0.3) 

* 

 
-2.3* 
8.2 

 
-1.9 
10.0 

 
-0.9 
9.0 

 
-1.0 (-1.9, -0.1) 

* 
SF-36 PCS 
Change from baseline 
Baseline 

 
7.7 

34.0 

 
3.6 
32.0 

 
4.1 (1.9, 6.2) 

*** 

 
6.9** 
33.5 

 
6.6 

27.5 

 
1.4 
30.6 

 
5.2 (3.0, 7.4) 

*** 
Abbreviations: N = number of patients in the intent-to-treat population; NRI = Non-responder 
Imputation; patients with missing data were counted as non-responders. 
ASAS HI = Assessment of SpondyloArthritis International Society Health Index; ASDAS = Ankylosing 
Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; 
CFB = least square mean change from baseline at week 16; MRI Spine SPARCC = Spondyloarthritis 
Research Consortium of Canada Magnetic Resonance Imaging Scoring of the Spine 
(23 discovertebral unit scale) 
 
a At week 0, patients received 80 mg or 160 mg of Taltz. 
b An ASAS20 response is defined as a ≥20% improvement and an absolute improvement from 

baseline of ≥1 unit (range 0 to 10) in ≥3 of 4 domains (Patient Global, Spinal Pain, Function, and 
Inflammation), and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. An 
ASAS40 response is defined as a ≥40% improvement and an absolute improvement from baseline 
of ≥2 units in ≥3 of 4 domains without any worsening in the remaining domain. 

c Primary endpoint. 
d The numbers of ITT patients with MRI data at baseline are as follows: COAST-V: Taltz, n = 81; 

PBO, n = 82; ADA, n=85. COAST-W: Taltz, n = 58; PBO, n = 51. 
e BASDAI50 response defined as an improvement of ≥50% of the BASDAI score from baseline. 
f ASAS HI: Assessment of SpondyloArthritis International Society Health Index (ASAS HI) across all 

domains. 
g The reported values are difference in %( 95% CI) for categorical variables, and difference in 

LSM (95% CI) for continuous variables. 
h post hoc analysis, not multiplicity corrected. 
i prespecified, but not multiplicity gated. 
* p<0.05; ** p<0.01; *** p<0.001 compared with placebo. 
 



51 

 

There were improvements in the main components of the ASAS40 response criteria (spinal pain, 
BASFI, patient global assessment, stiffness) and other measures of disease activity, including CRP, at 
week 16. 
 

Figure 5. Percent of patients achieving ASAS40 responses in COAST-V and COAST-W 
through week 16, NRIa 

 

 

 

a Patients with missing data were counted as non-responders. 
* p<0.05; ** p<0.01; *** p<0.001 compared with placebo. 
 
Similar response in ASAS40 was seen in patients regardless of baseline CRP levels, baseline ASDAS 
scores and MRI spine SPARCC scores. The ASAS40 response was demonstrated regardless of age, 
gender, race, disease duration, baseline body weight, baseline BASDAI score and prior biologic 
treatment.  
In COAST-V and COAST-W efficacy was maintained up to week 52 as assessed by the endpoints 
presented in Table 11, including ASAS20, ASAS40, ASDAS, BASDAI, and ASAS HI response rates.  
 
Health-related outcomes 
Spinal pain showed improvements versus placebo as early as week 1, maintained through week 16 
[Taltz vs placebo: COAST-V -3.2 vs -1.7; COAST-W -2.4 vs -1.0]; fatigue and spinal mobility 
showed improvements versus placebo at week 16. Improvements in spinal pain, fatigue and spinal 
mobility were maintained through week 52. 
 
Non-radiographic axial spondyloarthritis 
Taltz was assessed in a randomised, double-blind study with a 52-week placebo-controlled period 
(COAST-X) in 303 adult patients with active axial spondyloarthritis for at least 3 months. Patients 
must have had objective signs of inflammation indicated by elevated C-reactive protein (CRP) and/or 
sacroiliitis on magnetic resonance imaging (MRI), and no definitive radiographic evidence of 
structural damage on sacroiliac joints. Patients had active disease as defined by the Bath Ankylosing 
Spondylitis Disease Activity Index (BASDAI) ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating 
Scale (NRS), despite non-steroidal anti-inflammatory drug (NSAID) therapy. Patients were treated 
with either Taltz 80 mg or 160 mg at week 0, followed by 80 mg every 2 weeks (Q2W) or 80 mg 
every 4 weeks (Q4W) or with placebo. Dose adjustment and/or initiation of concomitant medications 
(NSAIDs, cDMARDs, corticosteroids, analgesics) were permitted starting at week 16.  
 
At baseline, patients had symptoms of non-radiographic axSpA for an average of 11 years. 
Approximately 39% of the patients were on a concomitant cDMARD. 
 
The primary endpoint was the percentage of patients achieving an Assessment of Spondyloarthritis 
International Society 40 (ASAS40) response at week 16. 
 



52 

 

Clinical response 
Higher proportions of patients treated with Taltz 80 mg Q4W achieved ASAS40 response compared to 
placebo at week 16 (Table 12). Responses were similar regardless of concomitant therapies. 

 
Table 12. Efficacy results at week 16 in COAST-X, NRI a,b 

 
 Taltz 80 mg Q4Wc 

(N=96) 
 

Placebo 
(N=105) 

 

Difference from 
placebo h 

ASAS20 responsed, n (%), NRI 52 (54.2%) 41 (39.0%) 15.1 (1.5, 28.8)* 
ASAS40 responsed,e, n (%), NRI 34 (35.4%) 20 (19.0%) 16.4 (4.2, 28.5)** 
ASDAS 
Change from baseline 
Baseline  

-1.1 
3.8 

-0.6 
3.8 

-0.5 (-0.8, -0.3) *** 

BASDAI Score 
Change from baseline 
Baseline 

-2.2 
7.0  

-1.5 
7.2 

-0.7 (-1.3, -0.1) * 

MRI SIJ SPARCCf 
Change from baseline 
Baseline 

-3.4 
5.1 

-0.3 
6.3 

-3.1 (-4.6, -1.6) *** 

ASDAS <2.1, n (%)  
(low disease activity), NRIg 

26 (27.7%) 13 (12.4%) 15.3 (4.3, 26.3) ** 

SF-36 PCS 
Change from baseline 
Baseline 

8.1 
33.5 

5.2 
32.6 

2.9 (0.6, 5.1) * 

a Abbreviations: N = number of patients in the intent-to-treat population; NRI = Non-responder 
Imputation. ASDAS = Ankylosing Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing 
Spondylitis Disease Activity Index; Change from baseline = least square mean change from baseline 
at week 16; MRI SIJ SPARCC = Spondyloarthritis Research Consortium of Canada Magnetic 
Resonance Imaging Scoring of the sacroiliac joint. 

b Patients with missing data were counted as non-responders. 
c At week 0, patients received 80 mg or 160 mg of Taltz. 
d An ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline 

of ≥1 units (range 0 to 10) in ≥3 of 4 domains (Patient Global, Spinal Pain, Function, and 
Inflammation), and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. An 
ASAS40 response is defined as a ≥40% improvement and an absolute improvement from baseline of 
≥2 units in ≥3 of 4 domains without any worsening in the remaining domain. 

e Primary endpoint at week 16. 
f The numbers of ITT patients with MRI data at baseline and week 16 are as follows: Taltz, n = 85; 

PBO, n = 90.  
g Patients with missing data were counted as non-responders. Percentages are based on the number of 

patients in the ITT population with baseline ASDAS ≥2.1. 
h The reported values are difference in %( 95% CI) for categorical variables, and difference in 

LSM (95% CI) for continuous variables. 
* p<0.05; ** p<0.01; *** p<0.001 compared with placebo. 
 
The improvement in the main components of the ASAS40 response criteria (spinal pain, BASFI, 
patient global assessment, stiffness) and other measures of disease activity demonstrated significant 
clinical improvement at week 16. 
 



53 

 

Figure 6. Percent of patients achieving ASAS40 response through week 16 in COAST-X, NRIa 

 

a Patients with missing data were counted as non-responders. 
** p<0.01 compared with placebo. 
 
Efficacy was maintained up to week 52 as assessed by the endpoints presented in Table 12.  
 
Health-related outcomes 
Spinal pain showed improvements versus placebo as early as week 1 and was maintained through 
week 16 [Taltz vs placebo: COAST-X: -2.4 vs -1.5]. In addition, more patients on Taltz compared 
with placebo achieved good health status (ASAS HI ≤5) at week 16 and week 52. 
 
Immunisations 
In a study in healthy subjects, no safety concerns were identified of two inactivated vaccines (tetanus 
and pneumococcal), received after two doses of ixekizumab (160 mg followed by a second dose of 
80 mg two weeks later). However, the data concerning immunisation were insufficient to conclude on 
an adequate immune response to these vaccines following administration of Taltz. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with Taltz 
in one or more subsets of the paediatric population in the treatment of plaque psoriasis and psoriatic 
arthritis/axial spondyloarthritis (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following a single subcutaneous dose of ixekizumab in patients with psoriasis, mean peak 
concentrations were achieved within 4 to 7 days, across a dose range of 5 to 160 mg. The mean (SD) 
maximum plasma concentration (Cmax) of ixekizumab, after the 160 mg starting dose, was 
19.9 (8.15) µg/ml. 
 
After the 160 mg starting dose, steady state was achieved by week 8 with the 80 mg Q2W dosing 
regimen. Mean (SD) Cmax,ss, and C trough,ss estimates are 21.5 (9.16) µg/ml, and 5.23 (3.19) µg/ml. 
 



54 

 

After switching from the 80 mg Q2W dosing regimen to the 80 mg Q4W dosing regimen at week 12, 
steady state would be achieved after approximately 10 weeks. Mean (SD) Cmax,ss, and Ctrough,ss estimates 
are 14.6 (6.04) µg/ml, and 1.87 (1.30) µg/ml. 
 
The average bioavailability of ixekizumab after subcutaneous administration was 54 % to 90 % across 
analyses. 
 
Distribution 
 
From population pharmacokinetic analyses, the mean total volume of distribution at steady state was 
7.11 L. 
 
Biotransformation 
 
Ixekizumab is a monoclonal antibody and is expected to be degraded into small peptides and amino 
acids via catabolic pathways in the same manner as endogenous immunoglobulins. 
 
Elimination 
 
In the population PK analysis, mean serum clearance was 0.0161 L/hr. Clearance is independent of 
dose. The mean elimination half-life, as estimated from population pharmacokinetic analysis, is 
13 days in patients with plaque psoriasis. 
 
Linearity/non-linearity 
 
Exposure (AUC) increased proportionally over a dose range of 5 to 160 mg given as a subcutaneous 
injection. 
 
Pharmacokinetic properties across indications 
 
The pharmacokinetic properties of Taltz were similar across the plaque psoriasis, psoriatic arthritis, 
radiographic axial spondyloarthritis and non-radiographic axial spondyloarthritis indications. 
 
Elderly 
 
Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years 
of age or older and 36 patients were 75 years of age or older. Of the 1,118 psoriatic arthritis patients 
exposed to Taltz in clinical studies, a total of 122 patients were 65 years of age or older and 6 patients 
were 75 years of age or older.  
Based on population pharmacokinetic analysis with a limited number of elderly patients (n = 94 for 
age ≥ 65 years and n = 12 for age ≥ 75 years), clearance in elderly patients and patients less than 
65 years of age was similar. 
 
Renal or hepatic impairment 
 
Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic 
impairment on the PK of ixekizumab have not been conducted. Renal elimination of intact 
ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are 
mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence 
clearance of ixekizumab. 
 
Paediatric population 
 
Paediatric psoriasis patients (age 6 to less than 18 years) were administered ixekizumab at the 
recommended paediatric dosing regimen for 12 weeks. Patients weighing >50 kg and 25 to 50 kg had 



55 

 

a mean ±SD steady-state trough concentration of 3.8 ±2.2 µg/ml and 3.9 ±2.4 µg/ml, respectively, at 
week 12. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on repeat-dose toxicity studies, safety 
pharmacology evaluations, and reproductive and developmental toxicity studies.  
 
Ixekizumab administration to cynomolgus monkeys for 39 weeks at subcutaneous doses up to 
50 mg/kg weekly produced no organ toxicity or undesirable effects on immune function (e.g. T-cell 
dependent antibody response and NK cell activity). A weekly subcutaneous dose of 50 mg/kg to 
monkeys is approximately 19 times the 160 mg starting dose of Taltz and in monkeys results in 
exposure (AUC) that is at least 61-fold higher than the predicted mean steady-state exposure in 
humans administered the recommended dose regimen.  
 
Non-clinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of 
ixekizumab.  
 
No effects on reproductive organs, menstrual cycles or sperm were observed in sexually mature 
cynomolgus monkeys that received ixekizumab for 13 weeks at a weekly subcutaneous dose of 
50 mg/kg. 
 
In developmental toxicity studies, ixekizumab was shown to cross the placenta and was present in the 
blood of offspring for up to 6 months of age. A higher incidence of postnatal mortality occurred in the 
offspring of monkeys given ixekizumab compared to concurrent controls. This was related primarily 
to early delivery or maternal neglect of offspring, common findings in nonhuman primate studies, and 
considered clinically irrelevant. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium citrate  
Citric acid, anhydrous 
Sodium chloride 
Polysorbate 80 
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 ºC to 8 ºC). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30 ºC. 
 



56 

 

6.5 Nature and contents of container  
 
1 ml solution in a type I clear glass syringe. 
The syringe is encased in a disposable, single-dose pen. 
Packs of 1, 2, or 3 pre-filled pens. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The instructions for using the pen, included with the package leaflet, must be followed carefully. 
 
The pre-filled pen is for single use only. 
 
Taltz should not be used if particles appear or if the solution is cloudy and/or distinctly brown. 
 
Taltz that has been frozen must not be used. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.  
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1085/001 
EU/1/15/1085/002 
EU/1/15/1085/003 

 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 25 April 2016 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT  
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


57 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



58 

 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Eli Lilly Kinsale Limited 
Dunderrow 
Kinsale  
Co. Cork 
Ireland 
 
Name and address of the manufacturer responsible for batch release 
 
Eli Lilly Italia S.p.A. 
Via Gramsci 731/733 
50019 Sesto Fiorentino (FI) 
Italy. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 
any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

  



59 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



60 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A. LABELLING 



61 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Taltz 80 mg solution for injection in pre-filled syringe 
ixekizumab 
 
 
2. STATEMENT OF ACTIVE SUBTANCE(S) 
 
Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for 
injections. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 pre-filled syringe of 1 ml solution  
2 pre-filled syringes of 1 ml solution 
3 pre-filled syringes of 1 ml solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken, do not use. 
Do not shake. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



62 

 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1085/004 1 pre-filled syringe 
EU/1/15/1085/005 2 pre-filled syringes 
EU/1/15/1085/006 3 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Taltz 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN  



63 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Taltz 80 mg injection 
ixekizumab 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 



64 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON - PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Taltz 80 mg solution for injection in pre-filled pen 
ixekizumab 
 
 
2. STATEMENT OF ACTIVE SUBTANCE(S) 
 
Each pre-filled pen contains 80 mg of ixekizumab in 1 ml solution. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for 
injections. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 pre-filled pen of 1 ml solution 
2 pre-filled pens of 1 ml solution 
3 pre-filled pens of 1 ml solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken, do not use. 
Do not shake. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



65 

 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1085/001 1 pre-filled pen 
EU/1/15/1085/002 2 pre-filled pens 
EU/1/15/1085/003 3 pre-filled pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Taltz 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



66 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Taltz 80 mg solution for injection 
ixekizumab 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 

 
  



67 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



68 

 

Package leaflet: Information for the patient 
 

Taltz 80 mg solution for injection in pre-filled syringe  
ixekizumab 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Taltz is and what it is used for 
2. What you need to know before you use Taltz 
3. How to use Taltz 
4. Possible side effects 
5. How to store Taltz 
6. Contents of the pack and other information 
 
 
1. What Taltz is and what it is used for 
 
Taltz contains the active substance ixekizumab.  
 
Taltz is intended for the treatment of the inflammatory diseases described below: 
• Plaque psoriasis in adults 
• Plaque psoriasis in children from the age of 6 and with a body weight of at least 25 kg and in 

adolescents 
• Psoriatic arthritis in adults 
• Radiographic Axial Spondyloarthritis in adults 
• Non-radiographic Axial Spondyloarthritis in adults 
 
Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine 
works by blocking the activity of a protein called IL-17A, which promotes psoriasis and 
inflammatory disease of the joints and the spine. 
 
Plaque psoriasis 
Taltz is used to treat a skin condition called “plaque psoriasis” in adults and in children from the age 
of 6 years and with a body weight of at least 25 kg and in adolescents with moderate to severe 
disease. Taltz reduces the signs and symptoms of the disease.  
 
Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms 
such as scaling, itching and pain. 
 
Psoriatic arthritis  
Taltz is used to treat a condition called “psoriatic arthritis” in adults, an inflammatory disease of the 
joints, often accompanied by psoriasis. If you have psoriatic arthritis you will first be given other 
medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be 
given Taltz to reduce the signs and symptoms of the disease. Taltz can be used alone or with another 
medicine named methotrexate. 
 
Using Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical 
function (ability to do normal daily activities), and slowing down the damage to the joints. 



69 

 

 
Axial spondyloarthritis 
Taltz is used to treat adults with an inflammatory disease primarily affecting the spine which causes 
inflammation of the spinal joints, called axial spondyloarthritis. If the condition is visible using 
X-rays, it is referred to as “radiographic axial spondyloarthritis”; if it occurs in patients with no visible 
signs on X-rays, it is referred to as “non-radiographic axial spondyloarthritis”. If you have axial 
spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 
medicines, you will be given Taltz to reduce the signs and symptoms of the disease, reduce 
inflammation and improve your physical function. 
 
 
2. What you need to know before you use Taltz 
 
Do not use Taltz 
- if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in 

section 6). If you think you may be allergic, ask your doctor for advice before using Taltz. 
- if you have an infection which your doctor thinks is important (for example, active 

tuberculosis). 
 

Warnings and precautions 
Talk to your doctor before using Taltz:  
 
- if you currently have an infection or if you have long-term or repeated infections. 
- if you have an inflammatory disease affecting the gut named Crohn’s disease. 
- if you have an inflammation of the large intestine named ulcerative colitis. 
- if you are receiving any other treatment for psoriasis (such as immunosuppressant or 

phototherapy with ultraviolet light) or for psoriatic arthritis. 
 
Inflammatory bowel disease (Crohn's disease or ulcerative colitis) 
Stop using Taltz and tell your doctor or seek medical help immediately if you notice abdominal 
cramps and pain, diarrhoea, weight loss or blood in the stool (any signs of bowel problems). 
 
If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Taltz. 
 
Look out for infections and allergic reactions 
Taltz can potentially cause serious side effects, including infections and allergic reactions. You must 
look out for signs of these conditions while you are using Taltz. 
 
Stop using Taltz and tell your doctor or seek medical help immediately if you notice any signs of a 
serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in 
section 4. 
 
Children and adolescents 
Do not use this medicine for the treatment of plaque psoriasis in children under 6 years of age because 
it has not been studied in this age group. 
 
Do not use this medicine for the treatment of psoriatic arthritis in children and adolescents under 
18 years of age because it has not been studied in this age group. 
 
Other medicines and Taltz 
Tell your doctor, pharmacist or nurse  
- if you are using, have recently used or might use any other medicines. 
- if you have recently had or are due to have a vaccination. You should not be given certain 

types of vaccines while using Taltz. 
 



70 

 

Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for 
advice before using this medicine.  
It is preferable to avoid the use of Taltz in pregnancy. The effects of this medicine in pregnant 
women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming 
pregnant and must use adequate contraception while using Taltz and for at least 10 weeks after the last 
Taltz dose.  
 
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. 
You and your doctor should decide if you can breast-feed or use Taltz. You should not do both.  
 
Driving and using machines 
Taltz is unlikely to influence your ability to drive and use machines. 
 
Taltz contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially 
“sodium-free”.  
 
 
3. How to use Taltz 
 
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, 
nurse or pharmacist if you are not sure. 
 
Taltz is given by injection under your skin (subcutaneous injection). You and your doctor or nurse 
should decide if you should inject Taltz yourself. 
 
For use in children with a body weight of 25-50 kg ixekizumab doses of 40 mg must be prepared and 
administered by a qualified healthcare professional. 
 
It is important not to try to inject yourself until you have been trained by your doctor or 
nurse. A caregiver may also give you your Taltz injection after proper training. 
 
Use a reminder method such as notes in a calendar or diary to help you remember your next dose so 
that you avoid missing or repeating doses. 
 
Taltz is for long-term treatment. Your doctor or nurse will regularly monitor your condition to check 
that the treatment is having the desired effect. 
 
Each syringe contains one dose of Taltz (80 mg). Each syringe delivers only one dose. The syringe 
must not be shaken. 
 
Read the “Instructions for use” for the syringe carefully before using Taltz. 
 
How much Taltz is given and for how long 
Your doctor will explain to you how much Taltz you need and for how long.  
 
Plaque psoriasis in adults 
- The first dose is 160 mg (2 syringes with 80 mg each) by subcutaneous injection. This may be 

given by your doctor or nurse. 
- After the first dose, you will use an 80 mg dose (1 syringe) at weeks 2, 4, 6, 8, 10, and 12. From 

week 12, you will use an 80 mg dose (1 syringe) every 4 weeks.  
 



71 

 

Plaque psoriasis in children (age 6 years and above and at least 25 kg body weight) and in adolescents. 
The recommended dose given by subcutaneous injection in children is based on the following 
weight categories: 
 

Children’s body 
weight 

Recommended starting 
dose (week 0) 

Recommended dose every 
4 weeks (Q4W) thereafter 

Greater than 50 kg  160 mg (2 syringes) 80 mg (1 syringe) 
25 to 50 kg 80 mg (1 syringe) 40 mg (dose preparation required) 

 
40 mg preparation of ixekizumab in children 
Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional. 
Taltz is not recommended for use in children with a body weight below 25 kg. 
 
Psoriatic arthritis  
For psoriatic arthritis patients who also have moderate to severe plaque psoriasis:  
- The first dose is 160 mg (2 syringes with 80 mg each) by subcutaneous injection. This may be 

given by your doctor or nurse. 
- After the first dose, you will use an 80 mg dose (1 syringe) at weeks 2, 4, 6, 8, 10, and 12. From 

week 12, you will use an 80 mg dose (1 syringe) every 4 weeks. 
 
For other psoriatic arthritis patients 
- The first dose is 160 mg (2 syringes with 80 mg each) by subcutaneous injection. This may be 

given by your doctor or nurse. 
- After the first dose you will use an 80 mg dose (1 syringe) every 4 weeks. 
 
Axial spondyloarthritis  
The recommended dose is 160 mg (2 syringes with 80 mg each) by subcutaneous injection at week 0, 
followed by 80 mg (1 syringe) every 4 weeks. 
 
If you use more Taltz than you should 
If you have received more Taltz than you should or the dose has been given sooner than prescribed, 
inform your doctor. 
 
If you forget to use Taltz 
If you have forgotten to inject a dose of Taltz, talk to your doctor. 
 
If you stop using Taltz  
You should not stop using Taltz without speaking to your doctor first. If you stop treatment, symptoms 
of psoriasis or psoriatic arthritis may come back. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects  
Stop using Taltz and tell your doctor or seek medical help immediately if you get any of the following 
side effects. Your doctor will decide if and when you may restart the treatment:  
 
Possible serious infection (may affect up to 1 in 100 people) - the signs may include:  
- fever, flu-like symptoms, night sweats 
- feeling tired or short of breath, cough which will not go away 
- warm, red and painful skin, or a painful skin rash with blisters 
  



72 

 

Serious allergic reaction (may affect up to 1 in 1,000 people) - the signs may include:  
- difficulty breathing or swallowing 
- low blood pressure, which can cause dizziness or light-headedness 
- swelling of the face, lips, tongue or throat 
- severe itching of the skin, with a red rash or raised bumps 
 
Other side effects that have been reported: 
 
Very common (may affect more than 1 in 10 people) 
- upper respiratory tract infections with symptoms such as sore throat and stuffy nose. 
- injection site reactions (e.g. red skin, pain). 

 
Common (may affect up to 1 in 10 people) 
- nausea. 
- fungal infections such as athlete’s foot. 
- pain in the back of the throat. 
- cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous) 
 
Uncommon (may affect up to 1 in 100 people) 
- oral thrush (oral candidiasis). 
- influenza.  
- runny nose. 
- bacterial skin infection. 
- hives. 
- discharge from the eye with itching, redness and swelling (conjunctivitis). 
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections 

(neutropenia). 
- low blood platelet count (thrombocytopenia). 
- eczema 
- rash 
- rapid swelling of the tissues of the neck, face, mouth or throat (angioedema) 
- abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 

problems). 
 

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects, you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Taltz 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the syringe label and on the outer 
carton after “EXP”. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Do not push to the back panel of the fridge. 
 
Store in the original packaging in order to protect from light. 
 
Taltz can be left out of the fridge for up to 5 days at a temperature not above 30 ºC. 
 
Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, 
distinctly brown, or has particles in it.  
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


73 

 

This medicine is for single use only.  
 
Do not throw away any medicines via wastewater. Ask your doctor, nurse or pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Taltz contains 
- The active substance is ixekizumab. 
 Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution. 
- The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; 

polysorbate 80; water for injections.  
 

What Taltz looks like and contents of the pack 
Taltz is a solution in a clear glass syringe. Its colour may vary from colourless to slightly yellow.  
 
Pack sizes of 1, 2, 3 pre-filled syringes. Not all pack sizes may be available in your country. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer 
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 
 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 



74 

 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā 
Tel: +371 67364000 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu.  
-------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for medical or healthcare professionals only: 
 
40 mg preparation of ixekizumab for children 25-50 kg body weight 
 
Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional. 
Use only the Taltz 80 mg solution for injection in pre-filled syringe when preparing the prescribed 
40 mg paediatric doses. 
 
1. Expel the entire contents of the pre-filled syringe into a sterile, clear glass vial. DO NOT shake 

or swirl the vial. 
2. Use a 0.5 ml or 1 ml disposable syringe and sterile needle to withdraw the prescribed dose 

(0.5 ml for 40 mg) from the vial. 
3. Change the needle and use a 27-gauge, sterile needle to inject the patient. Discard any unused 

ixekizumab in the vial. 
 
The prepared ixekizumab must be administered within 4 hours of puncturing the sterile vial at room 
temperature. 

http://www.ema.europa.eu/


76 

 

Instructions for use 
 

Taltz 80 mg solution for injection in pre-filled syringe 
 

ixekizumab 
 

 

 

 

 

 

 
 
 
Before using your pre-filled syringe:  
 
Important points to know 
 
• Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step 

instructions. Keep the Instructions for use and refer to them as needed. 
• The pre-filled syringe contains 1 dose of Taltz. The syringe is for ONE-TIME USE ONLY. 
• The syringe must not be shaken. 
• Your doctor, pharmacist or nurse may help you decide where on your body to inject your 

dose.  
• Read the Taltz Package Leaflet inside this box to learn more about your medicine. 
 
 
INSTRUCTIONS FOR USE 
 
Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step 
instructions. 

  



77 

 

Guide to the parts 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1 GET READY 
 
1a Take the syringe from the refrigerator. Leave the needle cap on the 

syringe until you are ready to inject. Wait 30 minutes to let the syringe 
warm to room temperature before you use it.  
 
DO NOT use any heat sources to warm the medicine, for example: a 
microwave, hot water, or direct sunlight. 

 

 
1b Gather the supplies for your injection: 

 
• 1 alcohol wipe 
• 1 cotton ball or piece of gauze 
• 1 sharps container for disposal of syringes 

 
 
 
 
 
 
 
 
 
 
 

Finger grips 

30
 minutes 

Thumb pad 

Green 
plunger rod 

Syringe body 
with medicine 

Needle 

Needle cap 

Grey syringe 
plunger 



78 

 

 
1c  

 
 
 
 

Inspect the pre-filled syringe for damage to the 
outside. Leave the needle cap on the syringe until you 
are ready to inject. Check the label. Make sure the 
name Taltz appears on the label.  
 
The medicine inside should be clear. Its colour may 
vary from colourless to slightly yellow. 
 
If you see any of the following, DO NOT USE the 
syringe, and dispose of it as directed: 
 

• It is past the expiry date. 
• It looks damaged. 
• The medicine is cloudy, is distinctly brown, or 

has small particles. 
 

 
1d Wash your hands before you inject your medicine. 

 
 
 

 
1e  

 
 
 
 
 
 
 
 
 
 
 
 
 
 

Choose your injection site. 
 
You may inject in your abdomen (stomach area), in 
your thigh, or in the back of your arm. To inject in 
your arm, you will need someone to help you. 
 
DO NOT inject into areas where the skin is tender, 
bruised, red, or hard or where you have scars or stretch 
marks. DO NOT inject within 2.5 centimetres of the 
navel (belly button). 
 
Alternate your injection sites. DO NOT inject in the 
exact same spot every time. For example, if your last 
injection was in your left thigh, your next injection 
should be in your right thigh, your abdomen, or the 
back of either arm.  

 
 
1f Prepare your skin. Clean your skin with an alcohol wipe. Let the injection site dry naturally 

before you inject your medicine. 
 

  

Back of 
arm 

Abdomen 

Thigh 

Expiration date 



79 

 

2 INJECT 
 
2a  Pull the needle cap off and throw it away. 

 
DO NOT put the needle cap back on—you could 
damage the needle or injure yourself by accident. 
 
DO NOT touch the needle. 
 
 
 
 
 
 
 
 
 

 
2b  Gently pinch and hold a fold of skin where you 

will inject. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2c  

 
 
 
 
 
 
 
 
 
 
 

Insert the needle at a 45-degree angle. Then gently 
let go of your skin. Make sure to keep the needle in 
place. 
 
  

 
 
 
 
 
 
 
 
 



80 

 

2d  Push in the plunger. 
 
Slowly push the plunger all the way in until all the 
medicine is injected. The grey syringe plunger should 
be pushed all the way to the end of the syringe. 
Gently remove the needle from your skin. 
 
Press a cotton ball or gauze over the injection site. 
DO NOT rub the injection site, as this may cause 
bruising. You may have slight bleeding. This is 
normal. 
 
You should see the green plunger rod showing 
through the syringe body when the injection is 
complete. 
 
 
 
 
 
 
 
 
 

 
3 FINISH 

 
 
3a  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Dispose of the pre-filled syringe. 
 
DO NOT put the needle cap back on. Dispose of the 
syringe in a sharps container or as directed by your 
doctor, pharmacist or nurse. 
 
 
 
 
 
 
 
 
 
 
 
 
 

When you dispose of syringes and the sharps container: 
 
• Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or 

nurse.  
• Do not recycle the filled sharps container. 
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use. 
 

Green 
plunger rod 

Grey syringe 
plunger Grey syringe 

plunger 

Green 
plunger rod 



81 

 

Safety tips 
 
• If you have questions or need help with your pre-filled syringe, call your doctor, pharmacist 

or nurse. 
• If you have vision problems, DO NOT use the pre-filled syringe without help from a person 

trained to use it. 
• DO NOT share or reuse your Taltz pre-filled syringe. You may give or get an infection 
• Keep the syringe out of the reach and sight of children. 
• If you do not have a sharps container, ask your doctor, pharmacist or nurse about where you 

can get one. 
 
 
Commonly asked questions 
 
Q. What if I see air bubbles in my syringe? 

 
A. It is normal to sometimes have air bubbles in the syringe. Taltz is injected under your skin 

(subcutaneous injection). Air bubbles are not a problem in this type of injection. They will not 
harm you or affect your dose. 

 
Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap? 

 
A. It is okay to see a drop of liquid on the tip of the needle. This will not harm you or affect your 

dose. 
 
Q. What if I cannot push in the plunger? 

 
A. If the plunger is stuck or damaged: 

 
 • DO NOT continue to use the syringe. 
 • Remove the needle from your skin. 
 
Q. How can I tell if my injection is complete? 

 
A. When your injection is complete: 

 
 • The green plunger rod should show through the body of the syringe. 
 • The grey syringe plunger should be pushed all the way to the end of the syringe. 
 
Read the full Instructions for use and the package leaflet inside this box to learn more about 
your medicine. 
 
 
 
 

 



82 

 

Package leaflet: Information for the patient 
 

Taltz 80 mg solution for injection in pre-filled pen 
ixekizumab 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Taltz is and what it is used for 
2. What you need to know before you use Taltz 
3. How to use Taltz 
4. Possible side effects 
5. How to store Taltz 
6. Contents of the pack and other information 
 
 
1. What Taltz is and what it is used for 
 
Taltz contains the active substance ixekizumab.  
 
Taltz is intended for the treatment of the inflammatory diseases described below: 
• Plaque psoriasis in adults 
• Plaque psoriasis in children from the age of 6 and with a body weight of at least 25 kg and in 

adolescents 
• Psoriatic arthritis in adults 
• Radiographic Axial Spondyloarthritis in adults 
• Non-radiographic Axial Spondyloarthritis in adults 
 
Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine 
works by blocking the activity of a protein called IL-17A, which promotes psoriasis and 
inflammatory disease of the joints and the spine. 
 
Plaque psoriasis 
Taltz is used to treat a skin condition called “plaque psoriasis” in adults and in children from the age 
of 6 years and with a body weight of at least 25 kg and in adolescents with moderate to severe 
disease. Taltz reduces the signs and symptoms of the disease.  
 
Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms 
such as scaling, itching and pain. 
 
Psoriatic arthritis  
Taltz is used to treat a condition called “psoriatic arthritis” in adults, an inflammatory disease of the 
joints, often accompanied by psoriasis. If you have psoriatic arthritis you will first be given other 
medicines. If you do not respond well enough to these medicines or in case of intolerance, you will be 
given Taltz to reduce the signs and symptoms of the disease. Taltz can be used alone or with another 
medicine named methotrexate. 
 
Using Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical 
function (ability to do normal daily activities), and slowing down the damage to the joints. 



83 

 

 
Axial spondyloarthritis 
Taltz is used to treat adults with an inflammatory disease primarily affecting the spine which causes 
inflammation of the spinal joints, called axial spondyloarthritis. If the condition is visible using 
X-rays, it is referred to as “radiographic axial spondyloarthritis”; if it occurs in patients with no visible 
signs on X-rays, it is referred to as “non-radiographic axial spondyloarthritis”. If you have axial 
spondyloarthritis you will first be given other medicines. If you do not respond well enough to these 
medicines, you will be given Taltz to reduce the signs and symptoms of the disease, reduce 
inflammation and improve your physical function. 
 
2. What you need to know before you use Taltz 
 
Do not use Taltz 
- if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in 

section 6). If you think you may be allergic, ask your doctor for advice before using Taltz. 
- if you have an infection which your doctor thinks is important (for example, active 

tuberculosis). 
 

Warnings and precautions 
Talk to your doctor before using Taltz:  
 
- if you currently have an infection or if you have long-term or repeated infections. 
- if you have an inflammatory disease affecting the gut named Crohn’s disease. 
- if you have an inflammation of the large intestine named ulcerative colitis. 
- if you are receiving any other treatment for psoriasis (such as immunosuppressant or 

phototherapy with ultraviolet light) or for psoriatic arthritis. 
 
Inflammatory bowel disease (Crohn's disease or ulcerative colitis) 
Stop using Taltz and tell your doctor or seek medical help immediately if you notice abdominal 
cramps and pain, diarrhoea, weight loss or blood in the stool (any signs of bowel problems). 
 
If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Taltz. 
 
Look out for infections and allergic reactions 
Taltz can potentially cause serious side effects, including infections and allergic reactions. You must 
look out for signs of these conditions while you are using Taltz. 
 
Stop using Taltz and tell your doctor or seek medical help immediately if you notice any signs of a 
serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in 
section 4. 
 
Children and adolescents 
Do not use this medicine for the treatment of plaque psoriasis in children under 6 years of age because 
it has not been studied in this age group. 
 
Do not use this medicine for the treatment of psoriatic arthritis in children and adolescents under 
18 years of age because it has not been studied in this age group. 
 
Other medicines and Taltz 
Tell your doctor, pharmacist or nurse  
- if you are using, have recently used or might use any other medicines. 
- if you have recently had or are due to have a vaccination. You should not be given certain 

types of vaccines while using Taltz. 
 
Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for 
advice before using this medicine. It is preferable to avoid the use of Taltz in pregnancy. The effects 



84 

 

of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you 
are advised to avoid becoming pregnant and must use adequate contraception while using Taltz and for at 
least 10 weeks after the last Taltz dose.  
 
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. 
You and your doctor should decide if you can breast-feed or use Taltz. You should not do both.  
 
Driving and using machines 
Taltz is unlikely to influence your ability to drive and use machines. 
 
Taltz contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially 
“sodium-free”.  
 
 
3. How to use Taltz 
 
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, 
nurse or pharmacist if you are not sure. 
 
Taltz is given by injection under your skin (subcutaneous injection). You and your doctor or nurse 
should decide if you should inject Taltz yourself. 
 
For use in children with a body weight of 25-50 kg ixekizumab doses of 40 mg must be prepared and 
administered by a qualified healthcare professional. 
Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg and do not 
require dose preparation. 
 
It is important not to try to inject yourself until you have been trained by your doctor or 
nurse. A caregiver may also give you your Taltz injection after proper training. 
 
Use a reminder method such as notes in a calendar or diary to help you remember your next dose so 
that you avoid missing or repeating doses. 
 
Taltz is for long-term treatment. Your doctor or nurse will regularly monitor your condition to check 
that the treatment is having the desired effect. 
 
Each pen contains one dose of Taltz (80 mg). Each pen delivers only one dose. The pen must not be 
shaken. 
  
Read the “Instructions for use” for the pen carefully before using Taltz. 
 
How much Taltz is given and for how long 
Your doctor will explain to you how much Taltz you need and for how long. 
 
Plaque psoriasis in adults 
- The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given 

by your doctor or nurse. 
- After the first dose, you will use an 80 mg dose (1 pen) at weeks 2, 4, 6, 8, 10, and 12. From 

week 12, you will use an 80 mg dose (1 pen) every 4 weeks.  
 



85 

 

Plaque psoriasis in children (age 6 years and above and at least 25 kg body weight) and in adolescents. 
The recommended dose given by subcutaneous injection in children is based on the following 
weight categories: 
 

Children’s body 
weight 

Recommended starting 
dose (week 0) 

Recommended dose every 
4 weeks (Q4W) thereafter 

Greater than 50 kg  160 mg (2 pens) 80 mg (1 pen) 
25 to 50 kg 80 mg (1 pen) 40 mg (dose preparation required) 

 
Ixekizumab doses of 40 mg must be prepared and administered by a qualified healthcare professional 
using the commercial Taltz 80 mg/1 ml pre-filled syringe. 
Use the Taltz 80 mg pre-filled pen only in those children that require a dose of 80 mg. Do not use the 
Taltz 80 mg pre-filled pen for the preparation of the 40 mg dose. 
Taltz is not recommended for use in children with a body weight below 25 kg. 
 
Psoriatic arthritis  
For psoriatic arthritis patients who also have moderate to severe plaque psoriasis:  
- The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given 

by your doctor or nurse. 
- After the first dose, you will use an 80 mg dose (1 pen) at weeks 2, 4, 6, 8, 10, and 12. From 

week 12, you will use an 80 mg dose (1 pen) every 4 weeks. 
 
For other psoriatic arthritis patients 
- The first dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection. This may be given 

by your doctor or nurse. 
- After the first dose you will use an 80 mg dose (1 pen) every 4 weeks. 
 
Axial spondyloarthritis  
The recommended dose is 160 mg (2 pens with 80 mg each) by subcutaneous injection at week 0, 
followed by 80 mg (1 pen) every 4 weeks. 
 
If you use more Taltz than you should 
If you have received more Taltz than you should or the dose has been given sooner than prescribed, 
inform your doctor. 
 
If you forget to use Taltz 
If you have forgotten to inject a dose of Taltz, talk to your doctor. 
 
If you stop using Taltz  
You should not stop using Taltz without speaking to your doctor first. If you stop treatment, symptoms 
of psoriasis or psoriatic arthritis may come back. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects  
Stop using Taltz and tell your doctor or seek medical help immediately if you get any of the following 
side effects. Your doctor will decide if and when you may restart the treatment:  
 
Possible serious infection (may affect up to 1 in 100 people) - the signs may include:  
- fever, flu-like symptoms, night sweats 
- feeling tired or short of breath, cough which will not go away 
- warm, red and painful skin, or a painful skin rash with blisters 



86 

 

  
Serious allergic reaction (may affect up to 1 in 1,000 people) - the signs may include:  
- difficulty breathing or swallowing 
- low blood pressure, which can cause dizziness or light-headedness 
- swelling of the face, lips, tongue or throat 
- severe itching of the skin, with a red rash or raised bumps 
 
Other side effects that have been reported: 
 
Very common (may affect more than 1 in 10 people) 
- upper respiratory tract infections with symptoms such as sore throat and stuffy nose. 
- injection site reactions (e.g. red skin, pain). 

 
Common (may affect up to 1 in 10 people) 
- nausea. 
- fungal infections such as athlete’s foot. 
- pain in the back of the throat. 
- cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous) 
 
Uncommon (may affect up to 1 in 100 people) 
- oral thrush (oral candidiasis). 
- influenza.  
- runny nose. 
- bacterial skin infection. 
- hives. 
- discharge from the eye with itching, redness and swelling (conjunctivitis). 
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections 

(neutropenia). 
- low blood platelet count (thrombocytopenia). 
- eczema 
- rash 
- rapid swelling of the tissues of the neck, face, mouth or throat (angioedema) 
- abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel 

problems). 
 

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects, you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Taltz 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen label and on the outer carton 
after “EXP”. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Do not push to the back panel of the fridge. 
 
Store in the original packaging in order to protect from light. 
 
Taltz can be left out of the fridge for up to 5 days at a temperature not above 30 ºC. 
 
Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, distinctly 
brown, or has particles in it. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


87 

 

 
This medicine is for single use only.  
 
Do not throw away any medicines via wastewater. Ask your doctor, nurse or pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Taltz contains 
- The active substance is ixekizumab. 
 Each pre-filled pen contains 80 mg of ixekizumab in 1 ml solution. 
- The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; 

polysorbate 80; water for injections.  
 

What Taltz looks like and contents of the pack 
Taltz is a solution in a clear glass syringe. Its colour may vary from colourless to slightly yellow.  
 
The syringe is encased in a disposable, single-dose pen. 
 
Pack sizes of 1, 2, 3 pre-filled pens. Not all pack sizes may be available in your country. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer 
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 
 



88 

 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā 
Tel: +371 67364000 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu.  
-------------------------------------------------------------------------------------------------------------------------- 
  

http://www.ema.europa.eu/


89 

 

 
 

Instructions for use 
 

Taltz 80 mg solution for injection in pre-filled pen 
 

ixekizumab 
 
 
 
 
 
 

 
 

 
 
 
Before using your pre-filled pen:  
 
Important points to know 
 
• Before you use the Taltz pre-filled pen, read and carefully follow all the step-by-step 

instructions. Keep the Instructions for use and refer to them as needed. 
• The pre-filled pen contains 1 dose of Taltz. The pre-filled pen is for ONE-TIME USE ONLY. 
• The pre-filled pen must not be shaken. 
• The pre-filled pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do 

not use it. Use a new pre-filled pen for your injection. 
• Your doctor, pharmacist or nurse may help you decide where on your body to inject your 

dose.  
• Read the Taltz Package Leaflet inside this box to learn more about your medicine. 

 
 

INSTRUCTIONS FOR USE 
 
Before you use the Taltz pre-filled pen, read and carefully follow all the step-by-step 
instructions. 

  



90 

 

Guide to the parts 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1 GET READY 
 

1a Take the pre-filled pen from the refrigerator. Leave the base cap on until 
you are ready to inject. Wait 30 minutes to let the pre-filled pen warm to 
room temperature before you use it.  
 
DO NOT use any heat sources to warm the medicine, for example: a 
microwave, hot water, or direct sunlight. 

 

 
1b Gather the supplies for your injection: 

 
• 1 alcohol wipe 
• 1 cotton ball or piece of gauze 
• 1 sharps container for disposal of pre-filled pen 

 
  

Top 
Injection 
button 

Lock ring 

Lock/unlock 
symbols 

Medicine 

Clear base 

Twist-off 
base cap 

 

Bottom/ 
End Needle 

30 
minutes 



91 

 

 
1c  

 
 
 
 
 
 
 
 
 
 

 
 

Inspect the pre-filled pen. Check the label. Make sure 
the name Taltz appears on the label.  
 
The medicine inside should be clear. Its colour may vary 
from colourless to slightly yellow. 
 
If you see any of the following, DO NOT USE the 
pre-filled pen, and dispose of it as directed: 
 

• It is past the expiry date. 
• It looks damaged. 
• The medicine is cloudy, is distinctly brown, or has 

small particles. 
 
 

 

 

 
1d Wash your hands before you inject your medicine. 

 
 
 

 
1e  

 
 
 
 
 
 
 
 
 
 
 
 
 
 

Choose your injection site. 
 
You may inject in your abdomen (stomach area), in your 
thigh, or in the back of your arm. To inject in your arm, 
you will need someone to help you. 
 
DO NOT inject into areas where the skin is tender, 
bruised, red, or hard or where you have scars or stretch 
marks. DO NOT inject within 2.5 centimetres of the 
navel (belly button). 
 
Alternate your injection sites. DO NOT inject in the 
exact same spot every time. For example, if your last 
injection was in your left thigh, your next injection 
should be in your right thigh, your abdomen, or the back 
of either arm.  

 
1f Prepare your skin. Clean your skin with an alcohol wipe. Let the injection site dry naturally 

before you inject your medicine. 
 

  

Back of 
arm 

Abdomen 

Thigh 

Expiration date 



92 

 

2 INJECT 
 
2a  Make sure the lock ring is in the lock position. 

 
Leave the base cap on until you are ready to inject. DO 
NOT touch the needle. 
 
Twist off the base cap. 
 
Throw the base cap in the bin. You will not need to put 
the base cap back on—doing so could damage the 
needle or cause you to injure yourself by accident. 
 
 
 
 
 
 
 

 
2b  

 
 
 
 
 
 
 
 

Place the clear base flat and firmly against your 
skin. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 
2c  

 
 
 
 
 
 
 
 
 
 
 
 

Keep the base on your skin, and then turn the lock 
ring to the unlock position. You are now ready to 
inject. 

 
 
 
 
 
 



93 

 

 
2d  

 
 
 
 

Press the green injection button. There will be a loud 
click. 
 
Keep holding the clear base firmly against your 
skin. You will hear a second loud click in about 5 to 
10 seconds after the first one. The second loud click 
tells you that your injection is complete. 
  
You will also see the grey plunger at the top of the 
clear base. 
 
Remove the pre-filled pen from your skin. 
 
Press a cotton ball or gauze over the injection site. DO 
NOT rub the injection site, as this may cause bruising. 
You may have slight bleeding. This is normal. 
 
 
 

 
3 FINISH 

 
 
3a  

 
 
 
 
 
 
 
 
 
 
 
 
 

Dispose of the pre-filled pen. 
 
DO NOT put the base cap back on. Dispose of the 
pre-filled pen in a sharps container or as directed by 
your doctor, pharmacist or nurse. 
 
 
 
 
 
 
 
 
 
 
 

When you dispose of the pre-filled pen and the sharps container: 
 
• Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.  
• Do not recycle the filled sharps container. 
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use. 
 
Safety tips 
 
• If you have questions or need help with your pre-filled pen, call your doctor, pharmacist or 

nurse. 
• If you have vision problems, DO NOT use the pre-filled pen without help from a person trained 

to use it. 
• Keep the pre-filled pen out of the reach and sight of children. 
• If you do not have a sharps container, ask your doctor, pharmacist or nurse where you can get 

one. 

Grey 
plunger 

5-10 

seconds 

Click 



94 

 

 

Commonly asked questions 
 
Q. What if I see air bubbles in the pre-filled pen? 
A. It is normal to have air bubbles in the pre-filled pen. Taltz is injected under the skin 

(subcutaneous injection). Air bubbles are not a problem in this type of injection. They will not 
harm you or affect your dose. 

 
Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap? 
A. It is okay to see a drop of liquid on the tip of the needle. This will not harm you or affect your 

dose. 
 
Q. What if I unlocked the pre-filled pen and pressed the green injection button before I twisted 

off the base cap? 
A. Do not remove the base cap. Contact your doctor, pharmacist or nurse. 
 
Q. Do I need to hold the injection button down until the injection is complete? 
A. This is not necessary, but it may help you keep the pre-filled pen steady and firm against your 

skin. 
 
Q. What if the needle did not retract after my injection? 
A. Do not touch the needle or replace the base cap. Dispose of the pre-filled pen in a closable, 

puncture-resistant sharps container. Contact your doctor, pharmacist or nurse. 
 
Q. What if I heard more than 2 clicks during my injection—2 loud clicks and a soft one. Did I 

get my complete injection? 
A. Some patients may hear a soft click right before the second loud click. That is normal. Do not 

remove the pre-filled pen from your skin until you hear the second loud click. 
 
Q. How can I tell if my injection is complete? 
A. After you press the green injection button, you will hear 2 loud clicks. The second click tells you 

that your injection is complete. You will also see the grey plunger at the top of the clear base. 
 
 
Read the full Instructions for use and the package leaflet inside this box to learn more about 
your medicine. 
 
 

 
 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET