Observational Study to Assess the Effectiveness, Safety Profile and Real-life Prescribing and Utilization Patterns of Tildrakizumab (Ilumetri®) in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice. (SAIL)
Conditions: Plaque Psoriasis
Sponsor: Almirall, S.A.

QPS: AT10112 
Non-Interventional Study Protocol 
Sponsor: NIS M/14745/43 
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Protocol title 
Observational study to assess the effectiveness, safety profile and 
real-life prescribing and utilization patterns of tildrakizumab 
(Ilumetri®) in patients with moderate to severe plaque psoriasis in 
routine clinical practice. 
Protocol ID 
NIS Study M/14745/43 
Medicinal Product: 
Ilumetri®, 100 mg 
Active Substance: 
Tildrakizumab 
 
Study Phase 
Non-Interventional Study 
Document status/Version 
Final, Amendment II 
Date 
13 October 2020 
 
Marketing 
Authorization 
Holder/ Sponsor 
Almirall S.A. 
 
 
 
 
 
 
Confidentiality Statement 
The information contained in this document, especially unpublished data, is the property of the sponsor of this 
study, Almirall S.A. It is therefore provided to you in confidence as an investigator, potential investigator, or 
consultant, for review by you, your staff, and an Ethics Committee or Institutional Review Board. It is understood 
that this information will not be disclosed to others without written authorization from Almirall S.A. except to the 
extent necessary to obtain informed consent from those persons to whom the study drug may be administered. 
 
 

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KEY STUDY PERSONNEL 
 
COORDINATNG STUDY PHYSICIAN:  
 
 
  
Universitätsklinikum 
 
  
Hamburg-Eppendorf 
 
  
Martinistraße 52 
 
  
20246 Hamburg, Germany 
 
  
 
 
CLINICAL RESEARCH ORGANIZATION:  
QPS Austria GmbH 
 
  
Parkring 12 
 
  
8074 Grambach 
 
  
Austria 
 
DATA MANAGEMENT: 
  
QPS Qualitix Taiwan 
 
  
5F. No. 12, Sec. 2  
 
  
Ren-Ai Road 
 
  
Taipei 
 
  
Taiwan 
 
EFFECTIVENESS/STATISTICAL ANALYSIS: QPS Qualitix Taiwan 
 
  
5F. No. 12, Sec. 2  
 
  
Ren-Ai Road 
 
  
Taipei 
 
  
Taiwan 
 
SERIOUS ADVERSE REACTION 
  
 
REPORTING: 
  
QPS Austria GmbH 
 
  
Safety Team 
 
  
Parking 12 
 
  
8074 Grambach 
 
  
Austria 
 
safetySAIL@qps.com 
 
SPONSOR: 
  
Almirall S.A. 
 
  
Ronda General Mitre, 151  
 
  
08022 Barcelona 
 
  
Spain 
PPD
PPD

QPS: AT10112 
Non-Interventional Study Protocol 
Sponsor: NIS M/14745/43 
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2 
 
 
 
 
Study title: 
Observational study to assess the effectiveness, safety 
profile and real-life prescribing and utilization patterns 
of tildrakizumab (Ilumetri®) in patients with moderate to 
severe plaque psoriasis in routine clinical practice 
Medicinal Product: 
 
 
Ilumetri® 
Active Substance: 
 
 
Tildrakizumab 
Protocol number:  
 
 
NIS Study M/14745/43 
Marketing authorization holder: 
Almirall S.A. 
 
I agree to the terms and conditions relating to this non-interventional study (NIS) as defined in 
this Study Protocol, electronic Case Report Form (eCRF), and any other protocol-related 
documents. I fully understand that any changes instituted by the study physician without 
previous agreement with the sponsor would constitute a violation of the study protocol. 
I agree to obtain approval by an Ethics Committee or Institutional Review Board (EC/IRB) 
prior to study start and signed informed consent form (ICF) from all patients included in this 
study. In addition, I will allow direct access to source documents and agree to inspection by 
auditors from the sponsor and Health Authorities. Furthermore, I confirm herewith that the 
sponsor is allowed to enter and utilize my professional contact details and function in an 
electronic database for internal purposes and for submission to the Worldwide Health 
Authorities. 
 
 
 
 
________________________ 
 _________________________  
 
 
Name Study Physician 
Signature 
Date 
(capital letters) 
 
 
 
Name Institution 
 
 
________________________ 
(capital letters) 

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3 
 
1 
Signature Page for the Sponsor / Marketing Authorization holder. .................................. 3 
2 
Signature Page for the Study Physician ............................................................................. 4 
PROTOCOL CHANGES LOG ................................................................................................. 5 
3 
Table of Contents ............................................................................................................... 7 
4 
List of Abbreviations ....................................................................................................... 10 
5 
Protocol Synopsis ............................................................................................................ 12 
6 
Introduction and Rationale ............................................................................................... 23 
6.1 
Introduction ............................................................................................................... 23 
6.1.1 
Psoriasis ............................................................................................................. 23 
6.1.2 
Tildrakizumab (Ilumetri®) ................................................................................. 23 
6.2 
Study Rationale ......................................................................................................... 24 
7 
Study Objectives .............................................................................................................. 26 
7.1 
Primary Objective: .................................................................................................... 26 
7.2 
Secondary Objectives: ............................................................................................... 26 
7.3 
Outcome Parameters ................................................................................................. 26 
7.3.1 
Primary Outcome Parameters ............................................................................ 26 
7.3.2 
Secondary Outcome Parameters ........................................................................ 27 
7.4 
Overall Study Design ................................................................................................ 27 
7.5 
Study Assessments .................................................................................................... 28 
7.5.1 
Informed Consent............................................................................................... 29 
7.5.2 
Baseline Parameters and Concomitant Medications .......................................... 29 
7.5.2.1 
General Medical History ............................................................................ 29 
7.5.2.2 
Psoriasis history .......................................................................................... 29 
7.5.2.3 
Demographics ............................................................................................. 29 
7.5.2.4 
Physical Examination ................................................................................. 29 
7.5.2.5 
Prior and Concomitant Medications ........................................................... 29 
7.5.2.6 
Treatment with tildrakizumab (Ilumetri®) .................................................. 29 
7.5.2.7 
Blood and Urine Analyses - optional ......................................................... 30 
7.5.2.8 
Reasons for prescribing tildrakizumab (Ilumetri®) .................................... 30 
7.5.3 
 ......................................................................... 30 
7.5.3.1 
Psoriasis Area and Severity Index (PASI) .................................................. 30 
7.5.3.2 
Body Surface Area (BSA) .......................................................................... 30 
7.5.3.3 
Study Physic
 ............................................ 31 

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7.5.3.4 
Scalp PGA .................................................................................................. 31 
7.5.3.5 
Nail PGA .................................................................................................... 31 
7.5.3.6 
Reasons for changing tildrakizumab dose .................................................. 31 
7.5.3.7 
Tildrakizumab (Ilumetri®) therapy stop and new therapy, if applicable .... 31 
7.5.3.8 
 ............................................. 31 
7.5.4 
..................................................................................... 31 
7.5.4.1 
Dermatology Life Quality Index (DLQI and DLQI-R) .............................. 32 
7.5.4.2 
Treatment Satisfaction Questionnaire for Medication (TSQM) ................. 32 
7.5.4.3 
Assessment of Itch and Pain ....................................................................... 32 
7.5.4.4 
Patient questionnaires (food intake, physical activity, alcohol and cigarette 
consumption)................................................................................................................ 32 
7.5.5 
Pregnancy Test ................................................................................................... 32 
7.6 
Visit Schedule ........................................................................................................... 33 
7.6.1 
Visit 1  Baseline (Day 0/Week 0), first injection ............................................. 34 
7.6.2 
Induction Visit (only for newly tildrakizumab prescribed patients) .................. 35 
7.6.3 
Visit 2 - 8 ........................................................................................................... 36 
7.6.4 
Visit 9 (End of Study Visit) ............................................................................... 37 
7.6.5 
Early Termination Visit ..................................................................................... 37 
7.6.6 
Extra Visits (unscheduled) ................................................................................. 38 
7.6.7 
Follow-up Evaluation......................................................................................... 39 
7.7 
Study Population ....................................................................................................... 39 
7.7.1 
Inclusion Criteria ............................................................................................... 40 
7.7.2 
Exclusion Criteria .............................................................................................. 40 
7.8 
Study Discontinuation and Study Withdrawal .......................................................... 40 
7.8.1 
Study Discontinuation (Early Termination)....................................................... 40 
7.9 
Investigational Medicinal Product, Dosage and Mode of Administration ................ 41 
8 
Safety Definitions and Reporting Requirements ............................................................. 42 
8.1 
Definition of Adverse Events/Adverse Drug Reactions ........................................... 42 
8.2 
Documentation and Reporting of Adverse Drug Reactions, Events with Fatal 
Outcome and Other Reportable Events ................................................................................ 42 
8.3 
Documentation of other, non-fatal SAEs .................................................................. 43 
9 
Statistical Methodology and Analyses ............................................................................. 44 
9.1 
Statistical Analyses ................................................................................................... 44 
9.1.1 
Statistical Analyses Populations: ....................................................................... 44 
9.1.2 
Interim analyses ................................................................................................. 44 

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9.1.3 
Sample Size ........................................................................................................ 44 
9.2 
Safety and Tolerability Parameters ........................................................................... 44 
9.3 
Baseline Parameters and Concomitant Medications ................................................. 45 
9.4 
Exploratory Analyses ................................................................................................ 46 
9.5 
Effectiveness Parameters........................................................................................... 46 
9.5.1 
Effectiveness Statistical Analysis ...................................................................... 47 
9.6 
Clinical Study Report ................................................................................................ 47 
10 
Procedures ........................................................................................................................ 48 
10.1 Procedures ................................................................................................................. 48 
10.1.1 Protocol Amendments ........................................................................................ 48 
10.1.2 Monitoring ......................................................................................................... 48 
10.1.3 Data Management .............................................................................................. 48 
10.1.3.1 
Data Collection ........................................................................................... 48 
10.1.3.2 
Database Management and Quality Control ............................................... 49 
10.1.4 Audit .................................................................................................................. 49 
10.1.5 Publication of Study Results .............................................................................. 49 
10.2 Confidentiality of Data and Patient Protection ......................................................... 49 
10.2.1 Confidentiality of Data ...................................................................................... 49 
10.2.2 Ethics Committee / Institutional Review Board ................................................ 50 
10.2.3 Informed Consent............................................................................................... 50 
11 
Risk Analysis ................................................................................................................... 51 
12 
References ........................................................................................................................ 52 
 
List of tables 
Table 5-1: Visit and Assessment Schedule based on SmPC.................................................... 18 
Table 5-2: Study Medication Administration Schedule based on SmPC ................................ 22 
 

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4 
 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event 
BMI 
Body Mass Index 
BP 
Blood Pressure 
BSA 
Body Surface Area 
CRO 
Contract Research Organization 
DLQI 
Dermatology Life Quality Index 
DLQI-R 
Dermatology Life Quality Index adjusted for not relevant responses 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EOS 
End of Study 
ET 
Early Termination 
FAS 
Full Analysis Set 
FG 
Fasted Glucose 
GDPR 
General Data Protection Regulation 
HbA1c 
Hemoglobin A1c 
ICF 
Informed Consent Form 
IL 
Interleukine 
IRB 
Institutional Review Board 
MedDRA 
Medical Dictionary for Regulatory Activities 
MetS 
Metabolic Syndrome 
NIS 
Non-Interventional Study 
PASI 
Psoriasis Area and Severity Index 
PGA 
Physician Global Assessment 
PR 
Pulse Rate 
RR 
Respiration rate 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SmPC 
Summary of Product Characteristics 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
TG 
Triglyceride 

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TSQM 
Treatment Satisfaction Questionnaire for Medication 
WHO 
World Health Organization 

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6 
 
6.1 Introduction 
6.1.1 Psoriasis 
Psoriasis is a chronic immune mediated disease affecting the skin and joints. It affects an 
estimated 7.8 million adults in Europe and approximately 125 million people worldwide [3]. It 
is a non-contagious disorder that accelerates the growth cycle of skin cells and results in 
thickening and scaling of skin areas. The most common form of psoriasis, called plaque 
psoriasis, appear as red, raised areas of skin covered with flaky white scales, which may be 
itchy and painful and can crack and bleed. Despite different treatment options existing, many 
people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this 
chronic disease. 
6.1.2 Tildrakizumab (Ilumetri®) 
Tildrakizumab is a humanized IgG1/k monoclonal antibody, which specifically binds to the 
p19 protein subunit of the interleukin-23 (IL-23) cytokine [16] and inhibits its interaction with 
the IL-23 receptor. Ilumetri® an anti-IL-23p19 monoclonal antibody is indicated for the 
treatment of patients with moderate to severe plaque psoriasis plaque psoriasis who are 
candidates for systemic therapy [9].  
IL-23 is a naturally occurring cytokine involved in inflammatory and immune responses. 
Structurally, IL-23 is a heterodimer composed of a unique p19 subunit (IL-23p19) and a p40 
subunit, common for IL-23 and IL-12 [13, 1]. In in vitro models, tildrakizumab was shown to 
disrupt IL-23 mediated signaling and cytokine cascades by disrupting the interaction of IL-23 
binding to its specific receptor, IL-23R without binding to IL-12. 
Identification of key cytokines such as IL-17 and IL-23 as the central axes driving the immune 
pathway in psoriasis has led to immunotherapy that specifically targets these ILs(12) [16]. 
Regarding its biological role, IL-23 is essential in the enhancement of memory T-cells, 
regulation of antibody production, induction of IFN-
IL-17 and IL-22, contributing to immune response against infection, but also is attributed a 
pathogenic role in autoimmune diseases and cancers [21, 2, 18]. In addition, there are studies 
suggesting that alleles around gene regions that encode IL-23 (IL23A, IL12B) and the IL-23R 
increase significantly the risk of psoriasis [5, 12, 1]. In psoriasis skin lesions, Th17 cells and 
IL-23 are abundant, exerting pro-inflammatory effects, and both IL-23 p19 and p40 subunits 
are over-expressed [2]. 
Following completion of the phase III reSURFACE trials, tildrakizumab was approved by the 
EMA on September 2018 for the treatment of adults with moderate-to-severe plaque psoriasis 
who are candidates for systemic therapy [9].
Both studies, reSURFACE 1 and 2, show for both Tildrakizumab 100 mg and 200mg that 
around 61% - 66% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index 
or PASI 75) by week 12 and 73-79% at week 28 after only 3 doses. Moreover, 49 %-57% of 
patients achieved PASI 90 (90% of skin clearance) and 22 %-31 % reached PASI 100 (100% 
of skin clearance) at week 28. More than 50% of patients reported that psoriasis no longer 
affected their lives after only 3 doses [14, 9]. Ninety-two percent (92 %) of patients who had 
achieved a PASI 75 response at 28 weeks maintained their PASI 75 response to tildrakizumab 
after one year of therapy. 

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Moreover, the results of a pooled analysis through 3 years from both studies show the consistent 
maintenance of efficacy and safety over 3 years of tildrakizumab (Ilumetri®) in patients with 
moderate-to-severe chronic plaque psoriasis who were PASI 75 responders at week 28 [17]. A 
PASI 75 response was maintained with continued treatment with tildrakizumab (Ilumetri®) in 
9 out of 10 patients up to week 148. Tildrakizumab (Ilumetri®) was well-tolerated with very 
low drug-related serious adverse events and discontinuation rates. The most common (> 1.0%) 
adverse drug reactions (ADRs) were upper respiratory infections, headache, gastroenteritis, 
nausea, diarrhea, injection site pain and back pain. 
Data from long-term extension studies and real word data are needed to fully explore treatment 
efficacy and maintenance of response as well as safety profile of anti IL-23p19 agents for the 
treatment of moderate to severe psoriasis in routine practice. Tildrakizumab was the first anti 
p19/IL-23 monoclonal antibody to initiate phase 3 clinical development in psoriasis, with long-
term safety studies that have been extended until the product has been commercially available 
[7, 8,]. Therefore, this study will provide the opportunity to continue the follow-up of these 
patients treated for more than 4 years in clinical trials and therefore provide the longest long-
term data available for this new class of monoclonal antibodies. In addition, the study will help 
to confirm the efficacy, maintenance of response and safety profile on new patients under 
routine clinical care.  
It is well understood, that patients with psoriasis have a higher prevalence of cardio-metabolic 
risk factors compared to the overall population [10]. Underlying conditions are high body 
weight, body mass index and altered lipid metabolism in patients with psoriasis. Obesity may 
contribute to an elevated risk of developing immune mediated inflammatory diseases, and vice 
versa 10 to 50 % of patients with immune mediated inflammatory diseases are obese [4]. 
Consequent reduction of lipid intake and/ or lipid-lowering medication are fundamental 
preventative and therapeutic measures to reduce atherosclerosis together with diet, physical 
exercise, and smoking cessation. Hence, together with the onset of a new systemic anti-
inflammatory treatment in patients with plaque psoriasis it is of interest to investigate the 
dynamic profile of lipid serum parameters, together with other known risk factors which are 
measured in daily routine.  
6.2 Study Rationale 
The present study will be conducted to gain further long-term data on effectiveness and 
maintenance of response of tildrakizumab (Ilumetri®) in a study population when treated under 
routine clinical conditions. This study will help to obtain further understanding on real-life 
prescribing and utilization patterns of tildrakizumab (Ilumetri®) in patients with moderate to 
severe plaque psoriasis who completed tildrakizumab studies as well as new tildrakizumab 
patients. Safety data in tildrakizumab treated patients will be collected as well. Moreover, the 
therapy adherence to tildrakizumab (Ilumetri®
ch will allow to 
evaluate 
indicator of treatment success, will be evaluated.  
Changes in physical activity as well as changes in diet will be captured to estimate the effect 
of physical activity on the body weight, BMI and arterial blood pressure. Changes in diet and 
food intake will be generally captured, to rule out that an accompanying new diet or changed 
food intake quantities are responsible for weight loss or gain and BMI changes. 
Additional factors that may be related to obesity, such as accompanying depression are 
captured by co-medication assessment indirectly. 

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In this study, patients will be assigned to one of two cohorts. While Cohort 2 will include newly 
tildrakizumab prescribed patients, Cohort 1 will include patients who completed previous 
Phase 3 tildrakizumab clinical trials and extension studies. In the scope of this NIS a continued 
observation of these patients will allow to collect long term safety data as well as long term 
effectiveness data over several years in total. Additionally, it will be ascertained how real-
world conditions impact the effectiveness of tildrakizumab (Ilumetri®) compared to the 
treatment under defined conditions in the Phase 3 (extension) studies. 

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7 
 
The present study will be conducted to gain further data on effectiveness and safety of 
tildrakizumab (Ilumetri®) in patients treated in routine clinical care including virtual visits and 
assessments, if applicable. Moreover, this study will help to obtain further understanding on 
real-life prescribing and utilization patterns of tildrakizumab (Ilumetri®) in patients with 
moderate to severe plaque psoriasis who completed tildrakizumab clinical trials and extension 
studies as well as newly tildrakizumab prescribed patients. 
The potential effect of tildrakizumab (Ilumetri®) on body weight, waist and hip circumference, 
BMI, and arterial BP will be evaluated as well. An optional evaluation will be performed on 
serum lipids (total cholesterol, HDL-c, LDL-c, VLDL-c, TG, lipoprotein (a)). Furthermore, 
changes in food intake and physical activity will be assessed. 
Additionally, the influence of tildrakizumab (Ilumetri®) on health-related quality of life and 
therapy satisfaction will be evaluated. 
7.1 Primary Objective: 
 
To assess the effectiveness and maintenance of response of tildrakizumab 
(Ilumetri®) treatment in routine clinical practice 
7.2 Secondary Objectives: 
 
To describe the profile of the patients who start treatment with tildrakizumab 
(Ilumetri®) 
 
Correlation between absolute PASI scores and Dermatology Life Quality Index 
(DLQI)-R 
 
To evaluate changes in body weight, waist and hip circumference, BMI and arterial 
blood pressure 
 
To evaluate changes in food intake, physical activity and lipid blood parameters 
 
To evaluate tolerability of tildrakizumab (Ilumetri®) in patients with moderate to 
severe plaque psoriasis 
 
To evaluate prescribing and utilization patterns of 2 doses of tildrakizumab (100 mg 
and 200 mg, if appropriate), understanding factors that influence the study physician 
decision making regarding the tildrakizumab dose 
 
To assess treatment 
and to describe reasons for therapy discontinuation 
 
To assess long term safety profile of tildrakizumab in real life clinical setting 
7.3 Outcome Parameters 
7.3.1 Primary Outcome Parameters 
Cohort 1 (Subgroup of patients continuing treatment with tildrakizumab): 
 
Absolute PASI scores and change from baseline value at Visit 5 and Visit 9 (EOS) 
 
Correlation between absolute PASI scores and DLQI-R at Visit 5 and Visit 9 (EOS) 
 
Percentage of patients maintaining PASI 75, 90, 100 responses at Visit 5 and Visit 9 
(EOS) (re-SURFACE studies (if available) and Week 0/Day 0 of SAIL study) 
 
Absolute BSA and change of BSA from baselines (reSURFACE and SAIL) at Visit 
5 and Visit 9 (EOS) 

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Absolute PGA (general, nail, scalp) and change from baseline values (reSURFACE 
and SAIL) at Visit 5 and Visit 9 (EOS) 
Cohort 2 (Newly prescribed patients):  
 
Absolute PASI scores and change from baseline value at Visit 5 and Visit 9 (EOS) 
 
Correlation between absolute PASI scores and DLQI-R at Visit 5 and Visit 9 (EOS) 
 
Percentage of patients achieving PASI 75, 90, 100 at Visit 5 and Visit 9 (EOS) 
 
Absolute BSA and change from baseline value at Visit 5 and Visit 9 (EOS) 
 
Absolute PGA (general, nail, scalp) and change from baseline value at Visit 5 and 
Visit 9 (EOS) 
7.3.2 Secondary Outcome Parameters 
 
Absolute DLQI and DLQI-R score and change from baseline value at Visit 5 and 
Visit 9 (EOS)(both baselines for continuing patients if data available) 
 
Absolute VAS (patient and physician´s satisfaction with therapy, pain and itch) 
scores and change from baseline (both baselines for continuing patients if data 
available) 
 
Proportion of patients adding concomitant medications from baseline at Visit 5 and 
Visit 9 (EOS) 
 
Changes in weight measurements (body weight, waist and hip circumference, 
waist/hip ratio, BMI) and blood pressure from baseline at Visit 9 (EOS) or Early 
Termination 
 
Changes in food intake: quantitative and qualitative from baseline up to Visit 9 
(EOS) or Early Termination. 
 
Changes in physical activity: quantitative and qualitative from baseline up to Visit 9 
(EOS). 
 
Changes in lipid blood parameters in patients from baseline up to Visit 9 (EOS), if 
routinely available. 
 
Number and proportion of patients withdrawing from the study. 
 
Number of patients changing the dose (if any) and factors that influence the study 
physician  decision  regarding the prescription of a dose of tildrakizumab (100 mg 
or 200 mg, if appropriate) (option based scale) 
 
Drug survival up to Visit 9 (EOS) 
 
Patient adherence up to Visit 9 (EOS) 
7.4 Overall Study Design 
This is an observational, non-interventional, multicenter study according to Directive 
2001/20/EC [11] in the frame of the long-term therapy with tildrakizumab (Ilumetri®) of 
patients with moderate to severe plaque-psoriasis in routine practice, including virtual visits 
and assessments, if applicable. 
The treatment, including diagnosis and monitoring of patients, exclusively follows routine 
medical practice. The study physicians will choose the treatment independently from this NIS. 
In order to be able to assess the study objectives formulated above on a sufficiently large 
number of patients, a multicenter, non-interventional study is best suited, since only this study 
type allows evaluation of the therapy under practice conditions. In particular, it should be noted 

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that the selection of patients to be included in the NIS is made by the study physician only after 
his assessment of the medical utility and necessity. 
All patients will be informed about the purpose and the content of the NIS. Written informed 
consent will be obtained from all participating patients before any data collection. 
The study plan together with the written patient information and informed consent form will 
be submitted to the responsible Ethics Committee before study start. 
Up to 430 patients will be included in this study. These patients will be assigned to one of the 
following cohorts: 
 
Cohort 1: patients who completed tildrakizumab clinical trials 
 
Cohort 2: newly tildrakizumab prescribed patients 
Patients meeting all of inclusion and none of exclusion criteria may be included in the study in 
every participating site. 
Due to the exploratory nature of this study, this maximum number of patients has been 
considered enough to meet the objectives of the study. 
The study will be performed at approximately 76 study sites across seven European countries: 
- 
Austria 
- 
Belgium 
- 
Germany 
- 
Italy 
- 
The Netherlands 
- 
France 
- 
UK 
Each patient will be followed for approximately 2 years. Tildrakizumab will become 
commercially available at different time-points in the participating countries. This will lead to 
variation of the actual time-points of the study start from country to country. Therefore, the 
total study duration from the inclusion of the first patient first visit to the last patient last visit 
will be approximately 4 years. 
Patients will not be compensated for participating in this NIS. 
7.5 Study Assessments 
In this NIS, the visit structure is not defined by the schedule of assessments and the visit 
descriptions, but is driven by routine clinical practice, including virtual visits and assessments, 
if applicable. Diagnostic and therapeutic procedures within the scope of this NIS are not given, 
but stay solely at the discretion of the treating doctor. The following descriptions reflect the 
structure of the eCRF. 
The time windows are proposed in order to provide a systematic assessment of the data. The 
proposed study visit structure is based on the SmPC of tildrakizumab (Ilumetri®) and routine 
clinical practice. 
Data collection stops for each patient at Visit 9 (EOS) or ET visit. (S)AEs, (S)ADRs, and severe 
infections will be evaluated until 12 weeks after last injection. No further data will be collected 
after ICF withdrawal. 

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7.5.1 Informed Consent 
After adequate explanation of the aims and procedures of the study a signed, written informed 
consent regarding collection, evaluation, saving and transfer of the clinical data will be 
obtained from each patient. Patients may withdraw their consent to participate in this NIS at 
any time. 
7.5.2 Baseline Parameters and Concomitant Medications 
The following baseline and patient characteristics will be collected: 
7.5.2.1 General Medical History 
General medical history includes all relevant prior and concomitant diseases other than 
psoriasis. If applicable, all changes during the study should be documented. 
7.5.2.2 Psoriasis history 
Psoriasis history data to be documented at Visit 1 (baseline) include: 
- 
Date of first diagnosis 
- 
Presence of other simultaneous forms of psoriasis (e.g., nail or scalp psoriasis) 
- 
Comorbidities (including info from preceding tildrakizumab clinical trials, if relevant) 
7.5.2.3 Demographics 
Demographic data to be documented at Visit 1 (baseline) include: 
- 
Age 
- 
Gender 
7.5.2.4 Physical Examination 
Routine physical examination will be performed including vital signs (temperature, blood 
pressure (BP), respiration rate (RR), pulse rate (PR)), and height/weight measurements (height, 
weight, BMI, waist and hip circumference (optional), waist/hip ratio (optional)). 
7.5.2.5 Prior and Concomitant Medications 
All concomitant medications for the treatment of concomitant diseases should be documented 
at Visit 1 (baseline). 
Documentation of anti-psoriatic treatment should include all prior (5-year history) and 
concomitant topical, photo- or systemic therapies with start and stop date (if applicable). 
Documentation of any other (not anti-psoriatic) treatments should include all prior (6-months 
history) and concomitant topical, photo- or systemic therapies with start and stop date (if 
applicable). 
If applicable, relevant information from preceding tildrakizumab clinical studies should also 
be documented.  
Documentation of all concomitant medications should be updated at each visit. 
7.5.2.6 Treatment with tildrakizumab (Ilumetri®) 
Dosing of tildrakizumab (Ilumetri®) should follow the guidance provided in the SmPC. 

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Study physicians should document the (planned) dates of all tildrakizumab (Ilumetri®) 
injections. If treatment with tildrakizumab (Ilumetri®) is stopped, the reason for discontinuation 
should be documented and the subsequent therapy be specified. 
7.5.2.7 Blood and Urine Analyses - optional 
If routinely done, the following laboratory assessments should be documented:  
 Blood analysis results: blood lipids (total cholesterol, HDL-c, LDL-c, VLDL-c, TG, 
lipoprotein (a)), MetS  HbA1c and fasted glucose (FG) 
 Urine analysis results 
7.5.2.8 Reasons for prescribing tildrakizumab (Ilumetri®) 
The study physician is asked to document the reason for choosing 100 mg tildrakizumab or 
200 mg tildrakizumab, if applicable. 
7.5.3 Study 
s Assessments 
7.5.3.1 Psoriasis Area and Severity Index (PASI) 
The body is divided into four sections: 
1. Head (H): 10% of a person s skin  
2. Arms (A): 20% of a person`s skin 
3. Trunk (T): 30% of a person`s skin 
4. Legs (L): 40% of a person`s skin 
Each of these areas is scored by itself, and then the four scores are combined into the final 
PASI. For each section, the percent of area of skin involved, is estimated and then transformed 
into a grade from 0 to 6: 
0 = 0% of involved area 
1 = < 10% of involved area 
2 = 10 29% of involved area 
3 = 30 49% of involved area 
4 = 50 69% of involved area 
5 = 70 89% of involved area 
6 = 90 100% of involved area 
Within each area, the severity is estimated by 3 clinical signs: erythema (redness), induration 
(thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, 
from none  to maximum . 
The sum of all 3 severity parameters is then calculated for each section of skin, multiplied by 
the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for 
arms, 0.3 for body and 0.4 for legs). 
The possible range of the PASI is from 0 ( no psoriasis on the body ) to 72 ( the most severe 
case of psoriasis ). PASI should be documented at each visit. 
7.5.3.2 Body Surface Area (BSA) 
The BSA assessment measures the total area of the body affected by psoriasis. Using the 
surface of the hand to equal 1% BSA, the study physician will assess the total BSA affected. 

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7.5.3.3 Study 
 
The PGA is a 5-point measure of psoriasis based on the degree of erythema, induration, and 
scale averaged over the entire body.  
The PGA of psoriasis (of the whole body) will be made on a 5-point scale as follows: 
0 = none (clear) 
1 = minimal 
2 = mild 
3 = moderate 
4 = severe 
The final PGA score is an average of the erythema, induration, and scale 
7.5.3.4 Scalp PGA 
The same scale as for the whole body PGA will be used for scalp PGA. Scalp PGA should be 
made at Visits 1 to 9 or Early Termination Visit. 
7.5.3.5 Nail PGA 
The same scale as for the whole body PGA will be used by the study physician to assess the 
psoriasis of the nails. Nail PGA should be made at Visits 1 to 9 or Early Termination Visit. 
7.5.3.6 Reasons for changing tildrakizumab dose 
The study physician is asked to document his reasons for changing the dosage of tildrakizumab 
(100 mg vs 200 mg), if applicable. The number of patients changing the dose (if any) will be 
documented. The study physician is asked to document the reason(s) for changing the dosage 
of tildrakizumab (100 mg vs 200 mg), if applicable. 
7.5.3.7 Tildrakizumab (Ilumetri®) therapy stop and new therapy, if applicable 
The study physician is asked to document the date and reason for the tildrakizumab (Ilumetri®) 
therapy stop and to provide information regarding new therapy, if applicable. 
7.5.3.8 Study 
Therapy 
Study p
ty of 
tildrakizumab (Ilumetri®) should be documented during the study at Visits 2 - 9 or Early 
Termination Visit. 
Both effectiveness and tolerability of tildrakizumab (Ilumetri®) should be rated on a 4-point 
scale ranging over 
 
eason for this assessment 
 
(ADR form). 
7.5.4 
Questionnaires 
The questionnaires and scales to be completed by the patients for their assessments will be 
provided in their national language. 

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7.5.4.1 Dermatology Life Quality Index (DLQI and DLQI-R) 
The DLQI questionnaire consists of 10 questions, covering the following topics: symptoms, 
embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close 
relationships, sexuality, treatment. 
Each question refers to the impact of the 
week. 
Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact 
of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). 
Patients should be asked to complete this questionnaire at all visits before any examinations or 
assessments. After completion of the questionnaire, the study physician should check the 
questionnaire for completeness and consistency. 
The DLQI-R is a newly introduced variation of the regular DLQI that adjusts the total score 
for the number of not relevant responses and seems to be a valid scoring system for avoiding 
the bias of these not relevant responses of the questionnaire [15]. 
7.5.4.2 Treatment Satisfaction Questionnaire for Medication (TSQM) 
In this NIS, TSQM Version 1.4 [19] will be used to determine patient´s satisfaction with the 
tildrakizumab (Ilumetri®) therapy. This questionnaire is comprised of 14 items which represent 
the following four domains: 
- 
Effectiveness 
- 
Side effects 
- 
Convenience 
- 
Global satisfaction 
TSQM scores range from 0 to 100, higher scores indicating greater satisfaction. 
7.5.4.3 Assessment of Itch and Pain 
Itch and pain of the skin will be assessed by the patients on visual analogue scales (VAS), 
where 0 
 
respectively). 
The VAS for itch and pain should be completed by the patient (and controlled by the study 
physician) at all visits before any examinations or assessments. 
7.5.4.4 Patient questionnaires (food intake, physical activity, alcohol and cigarette 
consumption) 
Patients will be asked to complete a simple questionnaire regarding their food intake and 
physical activities as well as their alcohol and cigarette consumption at every study visit. 
7.5.5 Pregnancy Test 
The administration of tildrakizumab (Ilumetri®) during pregnancy and lactation should be 
avoided as a precautionary measure. According to the SmPC, women of childbearing potential 
must use a reliable method of contraception during the therapy with tildrakizumab (Ilumetri®) 
and for 17 weeks thereafter. 

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7.6 Visit Schedule 
The Visit and Assessment Schedule is presented in Table 5-1. 
In this study, the visit structure is not defined by the study protocol, but is driven by routine 
clinical practice in accordance to the SmPC, including virtual visits and assessments, if 
applicable. Ideally the visit structure will be as follows: 
Visit structure for Cohort 1: 
 Visit 1: Week 0/Day 0 (first injection) 
 Visit 2: ~ Week 12 
 Visit 3: ~ Week 24 
 Visit 4: ~ Week 36 
 Visit 5: ~ Week 48 
 Visit 6: ~ Week 60 
 Visit 7: ~ Week 72 
 Visit 8: ~ Week 84 
 Visit 9: ~ Week 96 (EOS) 
Visit structure for Cohort 2: 
 Visit 1: Week 0/Day 0 (first injection) 
 Induction Visit: Week 4 (second injection) 
 Visit 2: ~ Week 16 
 Visit 3: ~ Week 28 
 Visit 4: ~ Week 40 
 Visit 5: ~ Week 52 
 Visit 6: ~ Week 64 
 Visit 7: ~ Week 76 
 Visit 8: ~ Week 88 
 Visit 9: ~ Week 100 (EOS) 
A follow-up evaluation will be performed 12 weeks after last injection by phone call or during 
patient´s visit at the physician´s office/clinic to evaluate (S)AEs, (S)ADRs and severe 
infections.  
Extra visits may be performed during the study as needed. Relevant data from assessments 
routinely performed in the course of these unscheduled visits will also be recorded. 
Duration of the study per patient will be approximately 2 years. 
Diagnostic and therapeutic procedures within the scope of this NIS are not given, but stay 
solely at the discretion of the treating doctor. The following descriptions reflect the structure 
of the eCRF. 
The visit windows (included in Table 5-1) are proposed in order to provide a systematic 
assessment of the data. The proposed study visit structure is based on the SmPC of 
tildrakizumab (Ilumetri®) and routine clinical practice. 
The Study Medication Administration Schedule based on the SmPC of tildrakizumab 
(Ilumetri®) and is outlined in Table 5-2. 

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Each newly prescribed patient will receive 100 mg of tildrakizumab (Ilumetri®) by 
subcutaneous injections at Week 0/Day 0, Week 4 and every 12 weeks thereafter. For patients 
coming from extension studies with tildrakizumab, no induction period is needed. Thus, 
patients may continue administration of tildrakizumab (Ilumetri®) by subcutaneous injections 
every 12 weeks.  
The decision for the patient treatment by the physician has to be done independently of this 
NIS according to routine care. 
7.6.1 Visit 1  Baseline (Day 0/Week 0), first injection 
 Prior to any documentation within the scope of this study, written informed consent 
must be obtained from the patient 
 Check of the eligibility of the patient (in-/exclusion criteria) 
 Date of visit 
 Demographic data (age, gender) 
 Routine physical examination including vital signs (temperature, BP, RR, PR) and 
height/weight measurements (weight, BMI, waist and hip circumference (optional), 
waist/hip ratio (optional)) 
 General medical history and psoriasis history, including documentation of relevant 
information from preceding tildrakizumab clinical trials, if applicable 
 Existing forms of psoriasis 
 Prior topical, photo- or systemic therapy of psoriasis (within the preceding 5 years) and 
prior topical, photo- or systemic non-psoriasis therapies (within the preceding 6 
months) 
 Concomitant anti-psoriatic and other relevant medication including relevant 
information from preceding tildrakizumab clinical trials, if applicable 
 Only if routinely performed: Laboratory Assessments 
- 
Documentation of Blood analysis: lipid parameters (total cholesterol, HDL-c, 
LDL-c, VLDL-c, TG, lipoprotein (a)), MetS - HbA1c and FG. 
- 
Documentation of Urine analysis 
 Patient s assessments (should be made prior to any other examinations and assessments 
and checked for consistency and completeness by the study physician. 
- 
DLQI 
- 
DLQI-R 
- 
VAS itch 
- 
VAS pain 
- 
Patient questionnaire regarding food intake and physical activity 
 Check for completeness and consistency of patient questionnaires 
 Study physician s assessments:  
- 
PASI 
- 
BSA 
- 
PGA 

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- 
scalp PGA 
- 
nail PGA 
 Reasons for prescribing 100 mg or 200 mg tildrakizumab, if applicable 
 Administration of the first tildrakizumab (Ilumetri®) injection 
 For newly prescribed patients: 
P
 instruction in subcutaneous injection technique (according to package leaflet) 
for self-injection of Ilumetri® at Week 4 and every 12 weeks thereafter (see injection 
schedule in Table 5-2). 
 For patients coming from clinical trials with tildrakizumab no induction period is 
needed. Thus, patients may continue administration of tildrakizumab every 12 weeks 
(see injection schedule in Table 5-2). 
 Documentation of safety and tolerability 
 Documentation of alcohol intake and cigarette consumption 
7.6.2 Induction Visit (only for newly tildrakizumab prescribed patients) 
 Date of Visit 
 Routine physical examination including vital signs (temperature, BP, RR, PR) 
 Concomitant anti-psoriatic and other relevant medication including relevant 
information from preceding tildrakizumab clinical trials, if applicable 
 Only if routinely performed: Laboratory Assessments 
- 
Documentation of blood analysis: lipid parameters (total cholesterol, HDL-c, 
LDL-c, VLDL-c, TG, lipoprotein (a)), MetS - HbA1c and FG. 
- 
Documentation of Urine analysis 
 Patient s assessments (should be made prior to any other examinations and assessments 
and checked for consistency and completeness by the study physician). 
- 
DLQI 
- 
DLQI-R 
- 
VAS itch 
- 
VAS pain 
- 
Patient questionnaire regarding food intake and physical activity 
- 
Patient questionnaire regarding satisfaction with tildrakizumab therapy 
(TSQM) [19] 
 Check for completeness and consistency of patient questionnaires 
 Study physician s assessments:  
- 
PASI 
- 
BSA 
- 
PGA 
- 
scalp PGA 
- 
nail PGA 
 
atisfaction with tildrakizumab (Ilumetri®) therapy 

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 Administration of tildrakizumab (Ilumetri®) injection 
 Documentation of safety and tolerability 
 Reasons for changing dose of tildrakizumab (100 mg vs 200 mg), if applicable 
 Date and reason for the tildrakizumab (Ilumetri®) therapy stop and new therapy, if 
applicable 
7.6.3 Visit 2 - 8 
 Date of visit 
 Update on concomitant anti-psoriatic and other relevant medication 
 Routine physical examination including vital signs (body temperature, BP, RR, PR) 
and weight measurements (weight, BMI, waist and hip circumference (optional), 
waist/hip ratio (optional)) 
 Only if routinely performed: Laboratory Assessments 
- 
Documentation of Blood analysis (if available): lipid parameters (total 
cholesterol, HDL-c, LDL-c, VLDL-c, TG, lipoprotein (a)), MetS - HbA1c and 
FG. 
- 
Documentation of Urine analysis (if available). 
 Patient s assessments (should be made prior to any other examinations and assessments 
and checked for consistency and completeness by the study physician). 
- 
DLQI 
- 
DLQI-R 
- 
VAS itch 
- 
VAS pain 
- 
Patient questionnaire regarding food intake and physical activity 
- 
Patient questionnaire regarding satisfaction with tildrakizumab therapy 
(TSQM) [19] 
 Check for completeness and consistency of patient questionnaires 
 Study physician s assessments:  
- 
PASI 
- 
BSA 
- 
PGA 
- 
scalp PGA 
- 
nail PGA 
 Study p
atisfaction with tildrakizumab (Ilumetri®) therapy 
 Administration of tildrakizumab (Ilumetri®) injection 
 Documentation of safety and tolerability 
 Reasons for changing dose of tildrakizumab (100 mg vs 200 mg), if applicable 
 Date and reason for the tildrakizumab (Ilumetri®) therapy stop and new therapy, if 
applicable 
 Documentation of alcohol intake and cigarette consumption 

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7.6.4 Visit 9 (End of Study Visit) 
 Date of visit 
 Update on concomitant anti-psoriatic and other relevant medication 
 Routine physical examination including vital signs (body temperature, BP, RR, PR) 
and weight measurements (weight, BMI, waist and hip circumference (optional), 
waist/hip ratio (optional)) 
 Only if routinely performed: Laboratory Assessments 
- 
Documentation of Blood analysis: lipid parameters (total cholesterol, HDL-c, 
LDL-c, VLDL-c, TG, lipoprotein (a)), MetS - HbA1c and FG. 
- 
Documentation of Urine analysis 
 Patient s assessments (should be made prior to any other examinations and assessments 
and checked for consistency and completeness by the study physician. 
- 
DLQI 
- 
DLQI-R 
- 
VAS itch 
- 
VAS pain 
- 
Patient questionnaire regarding food intake and physical activity 
- 
Patient questionnaire regarding satisfaction with tildrakizumab therapy 
(TSQM) [19] 
 Check for completeness and consistency of patient questionnaires 
 Study physician s assessments:  
- 
PASI 
- 
BSA 
- 
PGA 
- 
scalp PGA 
- 
nail PGA 
 Study p
atisfaction with tildrakizumab (Ilumetri®) therapy 
 Administration of tildrakizumab (Ilumetri®) injection 
 Documentation of safety and tolerability 
 Reasons for changing dose of tildrakizumab (100 mg vs 200 mg), if applicable 
 Date and reason for the tildrakizumab (Ilumetri®) therapy stop and new therapy, if 
applicable 
 Documentation of alcohol intake and cigarette consumption 
7.6.5 Early Termination Visit 
This visit only applies to patients who discontinue treatment with tildrakizumab (Ilumetri®) 
prior to the regular end of the observation period, i.e., prior to Week 100. It should be performed 
as soon as possible after the decision for treatment discontinuation was made. Thereafter, the 
documentation in context with this NIS will be stopped. 
 Date of visit 

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 Update on concomitant anti-psoriatic and other relevant medication 
 Routine physical examination including vital signs (body temperature, BP, RR, PR) 
and weight measurements (weight, BMI, waist and hip circumference (optional), 
waist/hip ratio (optional)) 
 Only if routinely performed: Laboratory Assessments 
- 
Documentation of Blood analysis: lipid parameters (total cholesterol, HDL-c, 
LDL-c, VLDL-c, TG, lipoprotein (a)), MetS - HbA1c and FG. 
- 
Documentation of Urine analysis. 
 Patient s assessments (should be made prior to any other examinations and assessments 
and checked for consistency and completeness by the study physician. 
- 
DLQI 
- 
DLQI-R 
- 
VAS itch 
- 
VAS pain 
- 
Patient questionnaire regarding food intake and physical activity 
- 
Patient questionnaire regarding satisfaction with tildrakizumab therapy 
(TSQM) [19] 
 Check for completeness and consistency of patient questionnaires 
 Study physician s assessments:  
- 
PASI 
- 
BSA 
- 
PGA 
- 
scalp PGA 
- 
nail PGA 
 Study p
atisfaction with tildrakizumab (Ilumetri®) therapy 
 Documentation of safety and tolerability 
 Date and reason for the tildrakizumab (Ilumetri®) therapy stop and new therapy, if 
applicable 
 Documentation of alcohol intake and cigarette consumption 
7.6.6 Extra Visits (unscheduled) 
This visit only applies to patients who need any extra visits due to any discomforts appearing 
in the course of this study. If routinely performed, data of the following assessments will be 
recorded during these unscheduled visits: 
 Date of Visit 
 Routine physical examination including vital signs (temperature, BP, RR, PR) 
 Concomitant anti-psoriatic and other relevant medication including relevant 
information from preceding tildrakizumab clinical trials, if applicable 
 Only if routinely performed: Laboratory Assessments 
- 
Documentation of blood analysis: lipid parameters (total cholesterol, HDL-c, 
LDL-c, VLDL-c, TG, lipoprotein (a)), MetS - HbA1c and FG. 

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- 
Documentation of Urine analysis 
 Patient s assessments (should be made prior to any other examinations and assessments 
and checked for consistency and completeness by the study physician). 
- 
DLQI 
- 
DLQI-R 
- 
VAS itch 
- 
VAS pain 
- 
Patient questionnaire regarding food intake and physical activity 
- 
Patient questionnaire regarding satisfaction with tildrakizumab therapy 
(TSQM) [19] 
 Check for completeness and consistency of patient questionnaires 
 Study physician s assessments:  
- 
PASI 
- 
BSA 
- 
PGA 
- 
scalp PGA 
- 
nail PGA 
 
atisfaction with tildrakizumab (Ilumetri®) therapy 
 Administration of tildrakizumab (Ilumetri®) injection 
 Documentation of safety and tolerability 
 Reasons for changing dose of tildrakizumab (100 mg vs 200 mg), if applicable 
 Date and reason for the tildrakizumab (Ilumetri®) therapy stop and new therapy, if 
applicable 
 Documentation of alcohol intake and cigarette consumption 
7.6.7 Follow-up Evaluation 
A follow-up evaluation will be performed 12 weeks after last injection by phone call or during 
patient´s visit at the physician´s office/clinic to evaluate (S)AEs, (S)ADRs and severe 
infections. 
7.7 Study Population 
The patient population will include adult male and female patients with moderate-to-severe 
chronic plaque psoriasis.  
Up to 430 patients will be included. These patients will be assigned to one of the following 
cohorts: 
 Cohort 1: patients who completed tildrakizumab clinical trials  
 Cohort 2: newly tildrakizumab prescribed patients 
Patients meeting all of inclusion and none of exclusion criteria may be included in the study in 
every participating site. 

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Due to the exploratory nature of this study, this maximum number of patients has been 
considered enough to meet the objectives of the study. 
7.7.1 Inclusion Criteria 
The following criteria must be met by all subjects considered for study participation: 
1. Written informed consent form. 
2. 
 18years. 
3. Moderate to severe chronic plaque psoriasis diagnosis. 
4. Patients that have participated in tildrakizumab (Ilumetri®) clinical trials OR patients 
tildrakizumab (Ilumetri®). 
7.7.2 Exclusion Criteria 
Patients will be excluded if they meet any of the following criteria: 
1. Unable to comply with the requirements of the study or who in the opinion of the study 
physician should not participate in the study. 
2. Patients meeting any of the exclusion criteria specified in the summary of product 
characteristics (SmPC) of Ilumetri®  
The administration of tildrakizumab (Ilumetri®) during pregnancy and lactation should be 
avoided as a precautionary measure. According to the SmPC, women of childbearing potential 
must use a reliable method of contraception during the therapy with tildrakizumab (Ilumetri®) 
and for 17 weeks thereafter. 
7.8 Study Discontinuation and Study Withdrawal 
7.8.1  Study Discontinuation (Early Termination) 
Patients who discontinue treatment with tildrakizumab (Ilumetri®) prior to the regular end of 
the observation period, i.e., prior to Visit 9 should undergo an Early Termination Visit (see 
Table 5-1) as soon as possible after the decision for treatment discontinuation was made. 
Thereafter, the documentation in context with this NIS will be stopped. 
Patients may withdraw their consent to participate in this NIS at any time at their own request 
and without giving reasons, without this having any adverse effect on their further treatment. 
If a participant withdraws his/her participation, the study physician is obliged to ask the 
participant about the further usability of his/her data (without restriction, anonymization or 
deletion) and to document his/her decision. 
If the study physician decides to withdraw the patient from treatment with tildrakizumab 
(Ilumetri®), he will be asked to document the date and reason for his decision. Additionally, he 
will be asked to indicate the new therapy. 
The patients will be advised that participation in this NIS is voluntary. Patients will not be 
compensated for participating in this NIS. Furthermore, the patients may request that no more 
data will be recorded from the time point of the ICF withdrawal. 
In case of premature discontinuation, the assessments scheduled for the Early Termination Visit 
examination will be performed as soon as possible. 

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7.9 Investigational Medicinal Product, Dosage and Mode of Administration  
Substance 1 code/name: Tildrakizumab (Illumetri®) 
Administration route: subcutaneous 
Unit dose/strength: 100 mg/200 mg 
Dose form: Pre-filled syringe with 1ml injectable solution containing 100 mg of tildrakizumab. 
Frequency: For newly tildrakizumab (Ilumetri®) prescribed patients the recommended dose 
should be administered by subcutaneous injection at Week 0/Day 0, Week 4 and every 12 
weeks thereafter. For patients who completed clinical trials with tildrakizumab (Ilumetri®) no 
induction period is needed. These patients may continue administration of tildrakizumab 
(Ilumetri®) every 12 weeks as indicated in the SmPC. 
Mode of administration: Ilumetri® is administered by subcutaneous injection. Injection sites 
should be alternated. Ilumetri® should not be injected into areas where the skin is affected by 
plaque psoriasis or is tender, bruised, red, hard, thick, or scaly. The pre-filled syringe must not 
be shaken. Each pre-filled syringe is for single use only. 
The full amount of tildrakizumab (Ilumetri®) will have to be injected according to the 
instructions for use provided in the package leaflet. 
After a proper training in subcutaneous injection technique, patients may self-inject Ilumetri® 
if a study physician determines that it is appropriate. However, the study physician should 
ensure appropriate follow-up of patients. Patients should be instructed to inject the full amount 
of Ilumetri® according to the instructions provided in the package leaflet. Comprehensive 
instructions for administration are given in the package leaflet. 

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8 
 
8.1 Definition of Adverse Events/Adverse Drug Reactions 
An AE is any untoward medical occurrence in a patient administered a pharmaceutical product 
which does not necessarily have a causal relationship with this treatment. An AE can therefore 
be any unfavorable and unintended sign, symptom, or disease temporally associated with the 
use of a medicinal product, whether or not related to the medicinal product. 
A Serious Adverse Event (SAE) is any experience that suggests a signification hazard, 
contraindication, side effect or precaution. With respect to human clinical experience, this 
includes any event which: 
 
results in death, 
 
is life-threatening, 
 
requires inpatient hospitalization or prolongation of hospitalization, unless 
hospitalization is for: 
- 
routine treatment or monitoring of the studied indication, not associated with any 
deterioration in condition. 
- 
elective or pre-planned treatment for a pre-existing condition that is unrelated to 
the indication under study and has not worsened since the start of study drug 
- 
treatment on an emergency outpatient basis for an event not fulfilling any of the 
definitions of a SAE given above and not resulting in hospital admission 
- 
general condition 
 
results in persistent of significant disability / incapacity, or 
 
is a congenital anomaly / birth defect, 
 
is a significant or important medical event that, based on appropriate medical judgment, 
may jeopardize the subject or may require intervention to prevent one of the other 
outcomes listed above. 
An ADR is an injury caused by taking medication. ADRs may occur following a single dose 
or prolonged administration of a medicinal product or result from the combination of two or 
more medicinal products. An ADR is a special type of AE in which a causative relationship to 
the medicinal product can be shown. 
8.2 Documentation and Reporting of Adverse Drug Reactions, Events with 
Fatal Outcome and Other Reportable Events 
Each ADR for which a causal relationship to tildrakizumab (Ilumetri®) cannot be excluded, 
within 1 working day (24 hours) of learning of the event and be proactively reported to QPS 
Safety Group: 
Email: safetySAIL@qps.com 
In addition, all events with a fatal outcome and all other reportable events (lack of effectiveness 
of Ilumetri®, pregnancy, overdose, off-label use, misuse, abuse, medication error or 
occupational exposure)  even in the absence of an ADR  must be documented on the 
Drug 
hours) of learning of the event (see above). 

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Early terminated (ET) patients as well as patients who completed EOS visit will be evaluated 
for safety assessments at approximately 12 weeks after the last injection of tildrakizumab. This 
will be documented in the eCRF. 
QPS Austria Safety Group will forward these reports to the Drug Safety Department of 
Almirall S.A. in Spain as defined in an appropriate safety management plan. 
8.3 Documentation of other, non-fatal SAEs 
Non-serious ADRs have to be reported within 3 business days via the ADR report form. Other, 
non-fatal, SAEs will be recorded in the eCRF only. 

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9.1 Statistical Analyses 
Statistical analyses are performed using the SAS program system. 
According to the non-interventional character of the study, the statistical analysis is descriptive 
and explorative. No statistical hypotheses are formulated. A detailed statistical analysis plan 
(SAP) will be written before the analysis. 
Descriptive summary statistics will be provided for all effectiveness endpoints over time based 
on observed data (without imputation for missing data). Multiple Imputation analysis will be 
conducted as a sensitivity analysis. These analyses will be based on FAS population.  
For safety, number and percentage of patients with any Adverse Event will be provided. These 
analyses will be based on Safety Population. 
9.1.1 Statistical Analyses Populations: 
There will be two analyses populations in this trial: 
 Full Analyses Set (FAS), defined as all those patients in safety population that had at 
least some effectiveness data. 
 Safety population, defined as all patients for whom it is known that they had at least 
one tildrakizumab dose during the study duration. 
9.1.2 Interim analyses 
An interim analysis will be performed after 150 patients completed Visit 5. 
9.1.3 Sample Size 
The maximum total number of patients to be included in this study will be 430. The patients 
will be assigned to one of the following cohorts: 
 Cohort 1: patients who completed tildrakizumab clinical trials 
 Cohort 2: newly tildrakizumab prescribed patients 
Patients meeting all of inclusion and none of exclusion criteria may be included in the study in 
every participating site. 
Due to the exploratory nature of this study, this maximum number of patients has been 
considered enough to meet the objectives of the study. 
9.2 Safety and Tolerability Parameters 
An adverse drug reaction (ADR) is defined as: 
al products intended for human use are harmful and 
 
A serious ADR is a reaction, which: 
- 
Results in death, 
- 
Is life-threatening, 
- 
 
- 
Results in persistent or significant disability or incapacity, 

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- 
Results in a congenital anomaly or birth defect 
- 
Is a medically important event. 
A medically important event is defined as an event that endangers the patient and may require 
medical or surgical intervention to prevent a serious adverse event. 
between signing the informed consent and the last scheduled contact with the patient. 
The severity of an ADR, whether serious or not, is assessed according to the following 
definitions: 
- 
Mild: Awareness of sign, symptom, or event, but easily tolerated; 
- 
Moderate: Discomfort enough to cause interference with usual activity and may warrant 
intervention; 
- 
Severe: Incapacitating with inability to do normal daily living activities or significantly 
affects clinical status, and warrants intervention; 
The safety set will be used to perform all safety analyses. 
The medical history will be coded using the MedDRA Version 22.0 or newer and listed. 
The ADRs and AEs are tabulated by system organ class (SOC), and individual preferred terms 
within each SOC by treatment group (100 mg or 200 mg tildrakizumab). The number and 
percentage of patients who experienced AEs coded with the same preferred term and SOC will 
be summarized by treatment group (in descending order according to the incidence in the 
investigational study drug group). ADRs and AEs will also be tabulated by severity and by 
relationship to study drug. Summary tables will be accompanied by individual patient listings 
broken down by treatment group, including pre-dose events. 
SAEs will be listed and summarized similarly to AEs.  
All AEs and SAEs are coded using the MedDRA Version 22.0. 
Reasons for death will only be listed. 
9.3 Baseline Parameters and Concomitant Medications 
Summary statistics (mean, median, standard deviation, min, max, number of available 
observations) will be provided for continuous demographic variables (e.g. age, gender). 
Individual patient listings of demographic data will be provided. 
Qualitative demographic characteristics (gender) will be summarized by counts and 
percentages. Other baseline patient characteristics (medical history, physical examination 
clinical findings, previous medications, inclusion/exclusion checklist) will only be listed.  
Distributions of these parameters will be compared between the treatment groups (100 mg or 
200 mg tildrakizumab) only descriptively. No statistical inference will be performed. 
Previous and concomitant medications will be coded by the sponsor according to the WHO 
drug code and the ATC class code. Previous medications will be summarized by tabulating the 
number and percentages of patients treated. 

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9.4 Exploratory Analyses 
Exploratory data-driven analyses can be performed with the caveat that any statistical inference 
will not have any confirmatory value. 
9.5 Effectiveness Parameters 
Baseline is defined as the last value measured on Day 0 (Week 0) prior to the first tildrakizumab 
(Ilumetri) administration (also if patients participated in tildrakizumab (Ilumetri®) clinical 
trials). 
The following primary effectiveness parameters have been defined for Cohort 1: 
Cohort 1 (Subgroup of patients continuing treatment with tildrakizumab): 
 Absolute PASI scores and change from baseline value at Visit 5 and Visit 9 (EOS) 
 Correlation between absolute PASI scores and DLQI-R at Visit 5 and Visit 9 (EOS) 
 Percentage of patients maintaining PASI 75, 90, 100 responses at Visit 5 and Visit 9 
(EOS) (re-SURFACE studies (if available) and Week 0/Day 0 of SAIL study) 
 Absolute BSA and change of BSA from baselines (reSURFACE and SAIL) at Visit 5 
and Visit 9 (EOS) 
 Absolute PGA (general, nail, scalp) and change from baseline values (reSURFACE and 
SAIL) at Visit 5 and Visit 9 (EOS) 
Cohort 2 (Newly prescribed patients):  
 Absolute PASI scores and change from baseline value at Visit 5 and Visit 9 (EOS) 
 Correlation between absolute PASI scores and DLQI-R at Visit 5 and Visit 9 (EOS) 
 Percentage of patients achieving PASI 75, 90, 100 at Visit 5 and Visit 9 (EOS) 
 Absolute BSA and change from baseline value at Visit 5 and Visit 9 (EOS) 
 Absolute PGA (general, nail, scalp) and change from baseline value at Visit 5 and Visit 
9 (EOS) 
The following secondary effectiveness parameters have been defined: 
 Absolute DLQI and DLQI-R score and change from baseline value at Visit 5 and Visit 
9 (EOS) (both baselines for continuing patients if data available) 
 Absolute VAS (patient and physician´s satisfaction with therapy, pain and itch) scores 
and change from baseline (both baselines for continuing patients if data available) 
 Proportion of patients adding concomitant medications from baseline at Visit 5 and 
Visit 9 (EOS) 
 Changes in weight measurements (body weight, BMI, waist and hip circumference 
(optional), waist/hip ratio (optional)) and blood pressure from baseline at Visit 9 (EOS) 
or Early Termination 
 Changes in food intake: quantitative and qualitative from baseline up to Visit 9 (EOS) 
or Early Termination. 
 Changes in physical activity: quantitative and qualitative from baseline up Visit 9 
(EOS). 
 Changes in lipid blood parameters in patients from baseline up to Visit 9 (EOS), if 
routinely available. 
 Number and proportion of patients withdrawing from the study. 

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 Number of patients changing the dose (if any) and factors that influence the study 
physician  decision  regarding the prescription of a dose of tildrakizumab (100 mg or 
200 mg, if appropriate) (option based scale) 
 Drug survival up to Visit 9 (EOS) 
 Patient adherence up to Visit 9 (EOS) 
9.5.1 Effectiveness Statistical Analysis 
Descriptive summary statistics will be provided for all effectiveness endpoints over time based 
on observed data (without imputation for missing data). Multiple Imputation analysis will be 
conducted as a sensitivity analysis. These analyses will be based on FAS population.  
9.6 Clinical Study Report 
Study results will be included the study report that will be submitted to the Competent 
Authorities and ECs, if applicable, for publication according to national law and regulations. 

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10.1 Procedures 
10.1.1 Protocol Amendments 
Any substantial change to a protocol has to be considered as an amendment as soon as these 
documents have been submitted to ECs/IRBs or Health Authorities. Therefore, an amendment 
could occur before or after the approval of these documents by ECs/IRBs or Health Authorities. 
Each amendment must be documented in writing and approved by Almirall. 
Adaptations of the core Patient Information and Informed Consent requested by ECs/IRBs are 
not considered as amendments, as long as they do not significantly change the core document 
or affect the protocol. 
10.1.2 Monitoring 
The study Clinical Research Organization (CRO) QPS Austria GmbH has been designated by 
the sponsor to monitor the study progression. An initiation visit will be performed before the 
first patient is included to explain the study and instruct on the completion of the eCRF. 
During the study, the monitor will be the primary contact person in case of questions regarding 
documentation of data, query resolution, etc. To improve data quality, remote monitoring is 
planned as a risk-based approach. 
At the end of the study, each participating site will be remotely closed by the monitor. 
The study physician must ensure that patients' anonymity will be maintained. On eCRFs or 
other documents submitted to Almirall, patients should not be identified by their names, but by 
the patient number. The study physician must keep a patient identification code list showing 
the identification number, the patient's name, date of birth and address or any other locally 
accepted identifiers. Documents identifying the patients (e.g., patients' signed informed consent 
forms) should not be sent to Almirall and must be kept by the study physician in strict 
confidence. 
The study physician and his/her deputy agree to cooperate with the monitor(s) to ensure that 
any issue detected is resolved. If the patient is hospitalized or dies in a hospital other than the 
study center, the study physician is in charge of contacting this hospital in order to document 
this SAE. 
The study physician will supply Almirall on request with any required background data from 
the study documentation or clinic records. This is particularly important when eCRFs are 
illegible or when errors in data transcription are suspected. In case of special problems and/or 
governmental queries, it is also necessary to have access to the complete study records, 
provided that subject confidentiality is protected. 
10.1.3 Data Management 
10.1.3.1 Data Collection 
The data will be captured on an electronic CRF (eCRF). The data management will be 
conducted by QPS with relevant standards and procedures to ensure data integrity, e.g., 
eliminating errors and inconsistencies in the data, as well as data authenticity and 
confidentiality. All quality control activities will be described in the data validation plan. 

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All medications will be coded using the drug dictionary of the World Health Organization 
(WHO-DD). All ADRs/deaths/other reportable events and medical histories will be coded 
according to the Medical Dictionary for Regulatory Activities (MedDRA). 
If a patient withdraws from the study, the reason must be noted on the eCRF. Case report forms 
are to be completed on an ongoing basis. 
Designated study physician staff will enter the data required by the protocol into the electronic 
Case Report Forms. Designated study physician site staff will not be given access to the EDC 
system until they have been trained. The study Physician must certify that the data entered into 
the eCRFs are complete and accurate. 
10.1.3.2 Database Management and Quality Control 
All data from the source documents will be entered into the eCRF. After completion of the 
eCRF, each patient will be electronically approved (signed) by the physician. 
The CRA will use the eCRF system to track the monitoring queries and their resolution by the 
site.  
The entered data is systematically checked by Data Management according to the data 
validation plan and the applicable SOPs. 
After the eCRF has been declared complete and accurate, the eCRF will be locked, after written 
approval of the sponsor. Any changes to the eCRF after that time can only be made after receipt 
of written approval of the sponsor. 
10.1.4 Audit 
The Almirall Quality Management Department may conduct audits of clinical research 
activities in accordance with internal standard operating procedures (SOPs) to ensure that the 
clinical study is performed and data are generated, documented (recorded) and reported in 
compliance with the applicable regulatory requirements.. 
Health Authorities may also wish to conduct an inspection (during the study or after its 
completion). Should an inspection be requested by Health Authorities, the study physician must 
inform Almirall immediately that such request has been made. 
The study physician will permit such audits by Almirall or Health Authorities and facilitate 
them by providing access to the relevant source documents. 
10.1.5 Publication of Study Results 
In accordance with standard editorial and ethical practice, Almirall will support publication of 
the data. This will be done under the responsibility of Almirall. 
10.2 Confidentiality of Data and Patient Protection 
10.2.1 Confidentiality of Data  
Personal data will be collected, stored and processed exclusively in pseudonymized form. The 
data will be processed in accordance with the European GDPR EU 2016/679 and national 
regulations. 
The study physician's file will contain the signed protocol/amendments, site staff curriculum 
vitae and authorization forms, signed conflict of Interest forms, eCRFs and data clarification 
and query forms, Health Authority and EC approval, if applicable, and signed informed consent 

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forms. The study physician file will be updated by the site accordingly. The study physician 
will ensure that this study is conducted in full conformance with the laws and regulations of 
the country in which the NIS is conducted. 
10.2.2 Ethics Committee / Institutional Review Board 
The study physician will submit this protocol and any related document provided to the patient 
(such as patient information used to obtain informed consent) to an Ethics Committee (EC) or 
Institutional Review Board (IRB). Approval from the committee must be obtained before 
starting the study, and should be documented in a dated letter to the study physician, clearly 
identifying the study, the documents reviewed and the date of approval. The advice of the ethics 
committee is intended to ensure that the rights of the patients participating in this study are not 
impaired and that the NIS is designed to gain knowledge. 
10.2.3 Informed Consent 
The Informed Consent and Patient Information will be provided in the local language. 
With regard to therapy decisions, the patient does not need to be informed beyond the usual 
professional duty of the study physician to provide information. 
The patients will be informed about the collection and evaluation of data within the framework 
of the NIS as well as about their rights regarding the processing of their personal data according 
to the General Data Protection Regulation (GDPR) prior to participation and must give their 
written consent to participation.  
The patient will receive a written version of the patient information and one of two originals of 
the dated and signed consent form. The study physician documents the patient s information 
and consent in the medical records. 

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The Monitoring Plan will include a risk-based approach. 

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2018 Nov; 179(5):1102-1108. doi: 10.1111/bjd.16927. Epub 2018 Sep 19. 

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