Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice
Conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Crohn´s Disease, Ulcerative Colitis, Plaque Psoriasis
Sponsor: AbbVie

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1.0 
Title Page 
AbbVie 
STUDY PROTOCOL Amendment 
HUMIRA P13-562 
Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing 
Spondylitis, Plaque Psoriasis, Crohn’s Disease and Ulcerative Colitis 
patients` 
adherence attitudes to maintenance therapy with a scheduled  
Adalimumab treatment in routine clinical practice
Product Name: 
HUMIRA®
Type of Study: 
Non Interventional - Post-Marketing Observational Study 
Original Protocol Date: 
26 July 2011 
Protocol Amendment Date: 
27. October 2016
Biometrics/Datamanagement: 
Sponsor: 
Primary AbbVie Contact Person 
/ Affiliated Scientific Lead 
This study will be conducted in compliance with this protocol including country specific amendment(s) 
NCT01768858 

 
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2.0 
Table of Contents 
1.0 
 Title Page ......................................................................................................................................... 1 
2.0 
Table of Contents .............................................................................................................................. 2 
3.0 
Introduction ....................................................................................................................................... 3 
4.0 
Rationale ........................................................................................................................................... 4 
5.0 
Study Objectives ............................................................................................................................... 7 
5.1 
 Main objectives ............................................................................................................................... 7 
5.2 
Secondary objectives ....................................................................................................................... 7 
6.0 
Investigational Plan ........................................................................................................................... 7 
6.1 
 Selection of Study Population ......................................................................................................... 8 
6.1.1 
 Inclusion Criteria ............................................................................................................................. 8 
6.1.2 
 Exclusion Criteria ............................................................................................................................ 9 
6.2 
 Number of patients to be enrolled ................................................................................................... 9 
6.3 
 Investigator Selection Criteria ......................................................................................................... 9 
6.4 
 Study Duration ................................................................................................................................ 9 
6.5 
 Study Conduct and Schedule of Activities: ................................................................................... 10 
6.5.1 
Description of Activities .................................................................................................................. 12 
6.5.2 
 Description of the Visits................................................................................................................. 18 
6.5.2.1 Inclusion visit .................................................................................................................................. 18 
6.5.2.2 Follow-up visits ............................................................................................................................... 19 
6.6 
Product Supply ............................................................................................................................... 20 
7.0 
 Management and Reporting of Complaints ................................................................................... 21 
7.1 Medical Complaints ............................................................................................................................... 22 
7.1.1 
Adverse event and serious adverse event definition, serious adverse event categories .............. 22 
7.1.2  
 Severity ......................................................................................................................................... 24 
7.1.3 
  Relationship to Pharmaceutical Product ...................................................................................... 24 
7.1.4 
Spontaneously Serious Adverse Event - collection period ............................................................ 25 
7.1.5 
Spontaneously reported Serious Adverse Event - reporting .......................................................... 25 
7.1.6 
Pregnancy Reporting ..................................................................................................................... 26 
8.0 
Product Complaint ........................................................................................................................... 27 
8.1 
Definition ........................................................................................................................................ 27 
8.2 
 Reporting ....................................................................................................................................... 27 
9.0 
 Ethics and Quality .......................................................................................................................... 28 
10.0 
Data Report Forms .......................................................................................................................... 29 
11.0 
Data Analysis Plans ........................................................................................................................ 29 
11.1 
 End points ..................................................................................................................................... 29 
11.1.1  Primary end point .......................................................................................................................... 29 
11.1.2.  Secondary end points ................................................................................................................... 29 
11.2 
 Plan of Analysis ............................................................................................................................. 30 
12.0 
 Final Reports and Publications ...................................................................................................... 30 
13.0 
 Conduct of the PMOS .................................................................................................................... 31 
14.0 
 References ..................................................................................................................................... 31 
15.  
Appendix ......................................................................................................................................... 32 
16. Research Plan Signature Page ............................................................................................................ 110 

 
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3.0 
Introduction 
The Adherence to biological medication in Rheumatoid Arthritis (RA), Psoriatic Arthritis 
(PsA), Ankylosing Spondylitis (AS), plaque psoriasis (PsO), Crohn’s disease (CD) and 
ulcerative colitis (UC):  
As there exist a lot of variations in the definitions and methodologies of measurement used to 
characterize adherence - compliance and persistence - first of all it is important to provide a 
definition for these terms. Compliance or more precisely medication compliance refers to the 
extent a patient is passively following the physician`s orders as acting in accordance with the 
prescribed timing, frequency and dosage. It is typically measured as a percentage of total number 
of doses taken in relation to the time period of observation, during which medication compliance 
is measured 1,2. In the literature an arbitrary cut-off value of 80% is used to distinguish between 
compliance and non-compliance although it is not clear what the clinically relevant cut-off point 
is. It is also understandable that the required drugs which are necessary to achieve an optimal 
treatment goal may be different for each patient and each drug. Therefore some patients may be 
well controlled with a standard dosage scheme while other patients may require a more frequent 
administration. Persistence or more precisely medication persistence is the duration of time from 
the beginning to the discontinuation of the prescribed therapy and is measured in units of time 1,2. 
Adherence can be considered as an umbrella term for medication compliance and medication 
persistence as this term involves both perceptions of taking a medication, namely regularity and 
consistency 1,2. Poor or non-adherence to a drug is a very important aspect in contributing to 
inadequate response to or failure of treatment and worsening of the disease. In consequence of an 
insufficient adherence clinical outcomes will deteriorate and may prompt a physician to further 
diagnostic procedures and eventually to an unnecessary change in medication 3. Clearly this may 
lead to a longer patient recovery period and increased healthcare costs. This raises the question: 
how can we improve adherence in those patients who are afflicted with chronic inflammatory 
diseases like RA, AS, PsA, PsO, CD or UC? The answer is not easy because adherence is a 
complex phenomenon and it can both be difficult to identify factors associated with non-
adherence and applying help in an effective manner. In clinical studies about tight control such 
factors can be easier identified and patients can therefore be more intensively motivated to be 

 
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compliant and continue their treatment (persistence). Although on the contrary in routine clinical 
practice such a tight control is hardly possible, medical aid for the optimization of treatment 
adherence should as far as possible be tailored to individual´s primary reasons and concerns (e.g. 
worries of potential adverse events of biological treatment) for not taking a drug. In this context, 
patients’ attitudes to treatment play an important role for adherence – mainly due to the fact that 
attitudes are varying. 
 
4.0 
Rationale 
The aim of this non-interventional post-marketing observational study (PMOS) is to assess RA, 
PsA, AS, PsO, CD and UC patients` adherence attitudes (beliefs), currently being managed in a 
specialist rheumatology, dermatology or gastroenterology practice or respective hospital 
department, to maintenance therapy with a scheduled Adalimumab monotherapy or a 
combination therapy with methotrexate and to investigate whether there are correlations between 
such beliefs and adherence to maintenance treatment. For the assessment of RA, PsA, AS, PsO, 
CD or UC patients attitudes/beliefs to their scheduled maintenance treatment and medicine in 
general we are going to use the Beliefs about Medicines Questionnaire (BMQ) 4 at the 
beginning of this study. In order to identify RA, PsA, AS, PsO, CD or UC patients at risk for 
non-adherence in due time in the course of this study the Morisky Medication Adherence Scale 
(MMAS) 5 shall be used. In this context it is also of interest to evaluate patients` treatment 
satisfaction during Adalimumab monotherapy or combination therapy with methotrexate for 
which reason the Treatment Satisfaction Questionaire for Medication (TSQM) 6,7 is used. As 
part of clinical practice the laboratory parameters ESR and/or CRP will be measured as an 
indication for disease activity. Furthermore the degree of disease activity has certainly a 
significant impact of treatment adherence for which reason the Rheumatoid Arthritis Disease 
Acitivity Index (RADAI) for RA and if reasonable for PsA patients,the Bath Ankylosing 
Activity Index (BASDAI) for AS patients, the Psoriasis Area and Severity Index (PASI)10,11 
for plaque psoriasis, Harvey-Bradshaw Index (HBI)12 for CD patients and the Partial Mayo 
score (PMS)13 for UC patients shall be used. 

 
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Remark: A patient support program is not offered or scheduled by the sponsor. As this is a non- 
interventional study all decisions are up to a participating physician. A physician may offer a 
patient support program to a patient anyhow. As this might affect study results a respective 
question is incorporated in the eCRF. 
 
o Adalimumab 
The fully human (100% human peptide sequences) recombinant monoclonal IgG1 antibody 
adalimumab has been approved in combination with methotrexate for the treatment of moderate 
to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying 
anti-rheumatic drugs including methotrexate has been inadequate and for the treatment of severe 
active and progressive rheumatoid arthritis in adults not previously treated with methotrexate 8. 
In case of incompatibility against methotrexate or continuing treatment with methotrexate is 
considered as not appropriate, adalimumab can also be administered as a monotherapy. 
Adalimumab in combination with methotrexate is also indicated for the treatment of active 
polyarticular juvenile idiopathic arthritis, in children and adolescents aged 13 to 17 years who 
have had an inadequate response to one or more disease-modifying anti-rheumatic drugs 
(DMARDs). Adalimumab can be given as monotherapy in case of intolerance to methotrexate or 
when continued treatment with methotrexate is inappropriate. Adalimumab is also indicated for 
the treatment of adults with severe active ankylosing spondylitis who have had an inadequate 
response to conventional therapy and for the treatment of active and progressive psoriatic 
arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy 
has been inadequate. Moreover, adaliumumab is indicated for the treatment of moderate to 
severe chronic plaque psoriasis in adult patients who failed to respond to or who have a 
contraindication to, or are intolerant to other systemic therapy including cyclosporine, 
methotrexate or PUVA8.  
In gastroenterology, adalimumab is indicated for treatment of moderately to severely active 
Crohn’s disease, in adult patients who have not responded despite a full and adequate course of 
therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have 

 
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medical contraindications for such therapies, as well as for treatment of moderately to severely 
active ulcerative colitis in adult patients who have had an inadequate response to conventional 
therapy including corticosteroids and 6- mercaptopurine (6-MP) or azathioprine (AZA), or who 
are intolerant to or have medical contraindications for such therapies8. 
The recommended dose for adults in patients with rheumatoid arthritis is 40 mg Adalimumab 
administered every two weeks as single dose via subcutaneous injection. Methotrexate should be 
continued during treatment with adalimumab. The recommended dose of Adalimumab for 
patients with ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab 
administered every other week as a single dose via subcutaneous injection.  
The recommended dose of Adalimumab for adult patients with plaque psoriasis is an initial dose 
of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other 
week starting one week after the initial dose.  
For adult patients with moderately to severely active Crohn’s disease an induction dose regimen 
is 80 mg at Week 0 followed by 40 mg at Week 2. In case there is a need for a more rapid 
response to therapy, the regimen 160 mg at Week 0, 80 mg at Week 2, can be used. After 
induction treatment, the recommended dose is 40 mg every other week via subcutaneous 
injection. Some patients who experience decrease in their response may benefit from an increase 
in dosing frequency to 40 mg Adalimumab every week. The recommended Adalimumab 
induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at 
Week 0 and 80 mg at Week 2. After induction treatment, the recommended dose is 40 mg every 
other week via subcutaneous injection. Some patients who experience decrease in their response 
may benefit from an increase in dosing frequency to 40 mg Adalimumab every week8. 
Indistinguishable in structure and function from naturally occurring human immunoglobulin G1 
(IgG1) Adalimumab has been estimated to have a terminal half-life of 10 –14 days 9. Because of 
the linear pharmacokinetic of Adalimumab it allows to be self-administered by either a pre-filled 
syringe or an autoinjection pen. 
 

 
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5.0 
Study Objectives 
 
5.1 
 
Main objectives 
 
The main purpose of this study is to assess patients` adherence attitudes (beliefs) to the 
maintenance therapy with a scheduled Adalimumab monotherapy or a combination therapy with 
methotrexate and to investigate whether there are correlations between such beliefs and 
adherence to maintenance treatment. In order to measure such beliefs the following questionnaire 
is used: 
 Changes in the Beliefs about Medicines Questionnaire (BMQ) at 12 months compared to 
baseline. In addition, the correlations between beliefs and adherence to treatment will be 
done at baseline and at 12 months 
 
5.2 
Secondary objectives 
 Changes in the Morisky Medication Adherence Scale (MMAS) at 12 months compared 
to month 3,  
 Changes of the Treatment Satisfaction Questionaire for Medication (TSQM) over time, 
 Changes in Rheumatoid Arthritis Disease Activity Index (RADAI) in patients with RA 
and if reasonable in patients with PsA, 
 Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients 
with AS, 
 Changes in Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis, 
 Changes in Harvey-Bradshaw Index (HBI) for patients with CD, 
 Changes in Partial Mayo Score (PMS) for patients with UC, 
 Changes of the C-reactive protein (CRP) over time 
 Changes of the Erythrocyte sedimentation rate (ESR) over time 
6.0 
Investigational Plan 
 

 
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6.1 
 
Selection of Study Population 
The study P13-562 is a non-interventional, observational study in which HUMIRA® is prescribed 
in the usual manner in accordance with the terms of the local marketing authorization with 
regards to dose, population and indication. The assignment of the patient to a HUMIRA® -
containing regimen has to be decided in advance and has to be current practice. The prescription 
of HUMIRA® is clearly separated from the decision to include the patient in this study! No 
additional procedures (other than standard of care) shall be applied to the patients. 
It is planned to enroll approximately 140 patients in total. All patient data entered in the patient's 
data report form (CRF) will be forwarded - without naming the patient - for evaluation to 
AbbVie. In order to maintain patient confidentiality, the patient’s age in year, gender and race 
will be documented in the CRF. The patients must provide written authorization to the 
investigator to use and/or disclose personal and/or health data before entry into study P13-562. .  
 
6.1.1  
Inclusion Criteria 
 
Patients aged ≥ 18 years with RA, PsA, AS, PsO, CD, or UC that have been prescribed 
adalimumab in accordance to physician’s clinical decision and according to local guidelines, 
up to 30 days prior to screening. 
 Patients must fulfil international and national guidelines for the use of a BDMARD in RA, 
PsA, AS, PsO, CD, or UC (Chest X-ray and IGRA* interferon gamma release assay or 
PPD-skin test negative for tuberculosis). *Please see also APPENDIX-C! 
In addition one of the following criteria must be fulfilled: 
 Unsatisfactory DMARD response defined as failure to treatment with at least two 
DMARDs including Methotrexate in patients with RA or PsA 
 Unsatisfactory NSAID response in patients with AS or unsatisfactory response to prior  
BDMARDs in patients with RA or PsA or AS. 
 Unsatisfactory response to or contraindication to, or intolerance to other systemic therapy 
including cyclosporine, methotrexate or PUVA in patients with PsO.Unsatisfactory response 

 
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despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or 
intolerance or medical contraindications for such therapies in CD. 
 Unsatisfactory response to conventional therapy including corticosteroids and 6-
mercaptopurine (6-MP) or azathioprine (AZA), or intolerance to or medical 
contraindications for such therapies in UC. 
 
6.1.2  
Exclusion Criteria 
The following patients will not be included in this observational study: 
x Patients who are not covered in the latest version of the HUMIRA syringe® SPC and 
HUMIRA Pen® SPC; 
x Patients participating in another study program or clinical trial. 
x Patients who have been treated with Adalimumab before.- 
 
6.2 
 
Number of patients to be enrolled 
It is planned to enroll approximately 140 patients in total (80 RA, PsA and AS / 30 PsO /30 
MCeor UC). The study will be conducted at 28 sites in Austria. Each site shall enroll 
approximately 5 patients. 
 
6.3 
 
Investigator Selection Criteria 
The investigational sites will be centers with experience in the treatment of RA, PsA, AS, PsO, 
CD and UC patients. For the investigators it is not mandatory to have any clinical research (i.e. 
PMOS) experience but it may be beneficial.  
 
6.4 
 
Study Duration 
This PMOS has started In RA, PsA and AS in Feb 2013. The study start for PsO, CD and UC 
was in November 2014. The estimated end of the patient inclusion is September 2016. Each 
patient will be observed for a period of max.12 months. Follow-up of patients should enable 
approximately 5 patient visits (including screening = visit 1) during 12 months. For these 
reasons, the most likely visits are defined as “V1”,“V2”,“V3”,“V4” and “V5” although numbers 

 
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and dates will depend only on the decision of the physician. A schedule of activities can be found 
in the next section. According to the standard of care the approximate frequency of the visits will 
be 3 months. As a result, failure to meet these suggested dates will not constitute a breach of the 
protocol.  
 
6.5 
 
Study Conduct and Schedule of Activities: 
The study will be conducted in a prospective, single-country, multicenter format. The 
participating investigator will provide the patient with a prescription for HUMIRA®40mg 
syringe or HUMIRA®40mg pen, as the patient can select between two available application 
devices. Depending on a patient´s selection, the investigator will also provide him/her the 
instructions for appropriate use of the HUMIRA®40mg pen (please see Appendix-A) or 
HUMIRA®40mg syringe (please see Appendix-B). Patient safety data and information about co-
medications other medications or supplements taken for RA, PsA, AS, PsO, CD or UC will be 
recorded on electronic data report forms (eCRFs) at study enrollment and during their regularly 
scheduled visits. If treatment with Adalimumab is interrupted, standard practice is to review the 
patient after a period of 3 months. If the physician decides to permanently discontinue 
Adalimumabbefore the end of the planned observational period of 12 months, the reason for 
discontinuation and the new RA, PsA,AS, PsO, CD or UC treatment regimen prescribed, if 
applicable, will be documented. The next routine follow-up visit will be the termination visit for 
this patient in the post-marketing observational study. 
There is no recommendation regarding an appropriate amount of time for wash out of previous 
BDMARDs prior to initiating Adalimumab therapy. The determination of an appropriate time to 
initiate Adalimumab following discontinuation of another BDMARD is at the discretion of the 
physician. While individual patient variability can affect drug elimination, it is generally felt that 
a majority of a drug is eliminated after 4 to 5 drug half-lives. The health care professional may 
wish to consider this in determining the appropriate time to initiate Adalimumab therapy. Health 
care providers should use their knowledge of TNFα biology and best clinical judgment when 
determining an appropriate washout period of previous BDMARD therapy. AbbVie Austria’s 
recommended wash out periods are: Etanercept received > 3 weeks (21 days) before 1st 

 
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h. 
Final statement shall also include a statement about pain-management with respect to a potential influence of 
adalimumab 
i. 
According to the recommendations of the German central committee for the fight against tuberculosis all patients who are 
about to be treated with a TNF-inhibitor should be screened for a latent tuberculosis infection by the use of a highly  
specific interferon-γ-test (IGRA interferon gamma release assay) in addition to chest X-ray and an accurate careful  
anamnesis.  
Please see also APPENDIX C ! 
AUSTRIAN CONSENSUS STATEMENT ABOUT TUBERCULOSIS & BIOLOGICALS  
 
RECOMMENDATIONS FOR TUBERCULOSIS SCREENING BEFORE INITIATION OF TNFα-INHIBITOR TREATMENT  
IN RHEUMATIC DISEASES 
 
As by the use of the PPD skin test (Mendel Mantoux) false positive or false negative test results are expected in patients 
with latent tuberculosis, the PPD skin test shall be used in exceptional  cases only. 
 
The PPD-skin test as a supplementary test is useful only in the following cases, if: 
 
o 
in spite of a negative IGRA test an earlier tight exposure to a patient with infectious lung TB is anamnestic 
plausible 
o 
a BCG (Bacille Calmette-Guérin) vaccination in due consideration of the immunisation policy of the respective 
country of origin of a patient is implausible and/or 
o 
a IGRA-test is indeterminable in the repetition 
In such cases a positive PPD test defines the further course of action. 
 
If a patient has had a PPD test placed within 3 months prior to the first Adalimumab-application, a repetition of the PPD  
test  
will not be required provided the following conditions are met: 
1. There is documentation signed by a licensed health care professional that the PPD test was read within 48-72 hours of 
placement and a precise assessment of induration in millimetres is included. 
2. The chest x-ray before first Adalimumab-application does not indicate any evidence of TB (no evidence of calcified 
granulomas, no evidence of pleural scarring and no evidence of latent TB) 
3. Nothing in the patient’s history has changed since the time of the PPD tests to warrant a repeat test. 
Please see also APPENDIX C!  CDC Treatment Recommendations for Positive PPD; CDC CENTERS FOR DISEASE 
CONTROL AND PREVENTION 
 
 
6.5.1 
Description of Activities 
 
Beliefs about Medicines Questionnaire (BMQ) 
The BMQ is a method for assessing cognitive representations of medication. The questionnaire 
comprises two sections: the BMQ-Specific which assesses representations of medication 
prescribed for personal use and the BMQ-General which assesses beliefs about medicines in 
general. The BMQ-Specific comprises two 5-item factors assessing beliefs about the necessity of 
prescribed medication (Specific-Necessity) and concerns about prescribed medication based on 
beliefs about the danger of dependence and long-term toxicity and the disruptive effects of 
medication (Specific-Concern). The BMQ-General comprises two 4-item factors assessing 
beliefs that medicines are harmful, addictive, poisons which should not be taken continuously 
(General-Harm) and that medicines are overused by doctors (General-Overcure).  The total 

 
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score, the sum of all the points from the Specific AND General questions range from 17 (lowest 
score) to 85 (highest score). Patients who have positive beliefs about medicine have a score < 47 
and patients who have negative beliefs have a score > 47.  
 
Morisky Medication Adherence Scale (MMAS) 
The MMAS is a 4-item Self-Report Measure of Medication-Taking Behavior. It measures both 
intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping 
medication when feeling better, or stopping medication when feeling worse). The 4-item 
MMAS-4-item consists of 4 questions which can be answered with yes (=0 point) and no (=1 
point). The MMAS score is the sum of all four question and range from 0 (=non-adherent) to 4 
(=adherent).  
 
Treatment Satisfaction Questionaire for Medication (TSQM) 
The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an 
instrument to assess patients' satisfaction with medication, providing scores on four scales – side 
effects, effectiveness, convenience and global satisfaction. The 11 questions can be answered 
either with yes/no or by means of a five or seven stage scale (e.g. ranging from very unsatisfied 
to satisfied). SCALE SCORING ALGORITHM: TSQM Scale scores range from 0 to 100 and no 
computed score should be lower or higher than these limits. Higher scores represent higher 
satisfaction. EFFECTIVENESS: ([(Item 1 + Item 2) − 2] divided by (12) × 100 SIDE EFFECTS: 
([Sum of Item 4 to Item 6) − 3] divided by 12) × 100 If one item is missing: ([(Sum of the two 
completed items) − 2] divided by (8) × 100 CONVENIENCE: ([Sum of Item 7 to Item 9) − 3] 
divided by 18) × 100 If one item is missing: ([(Sum of the two completed items) − 2] divided by 
(12) × 100 GLOBAL SATISFACTION: ([Sum of Item 10 to Item 11) − 2] divided by 12) × 100. 
 
Rheumatoid Arthritis Disease Activity Index (RADAI): 
The RADAI is a questionnaire for patients used for measuring disease activity. The index 
consists of 6 questions. The items ask the patient about (1) global disease activity in the last 6 
months , (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) 
the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a 

 
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joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, 
hips, knees, ankles and toes. The first four items are all rated on a numeric rating scale from 0 to 
10, where higher scores indicate more disease activity. The scores on the last two items range 
from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. 
 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): 
The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis. 
This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal 
pain, joint pain/swelling, areas of localized tenderness (=enthesitis – inflammation of tendons 
and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue 
scale ranging from 0 to 10 is used to answer the questions (zero being no problem and 10 being 
the worst problem). 
 
Psorasis Area and Severity Index (PASI): 
The PASI has been developed to provide quantitative assessment of psoriasis lesional burden 
based on the amount of BSA involved and degree of severity of erythema, induration, and scale, 
weighted by body part. The head, upper extremities, lower extremities, and trunk are assessed 
separately and then combined using weighting based on the surface area represented by each area 
(head 0.1, upper extremities 0.2, trunk 0.3, and lower extremities 0.4). The degree of erythema, 
induration, and scale in each area is judged on a 0–4 scale, the sum of which represents disease 
severity. The area of involvement of each area is graded from 0–6, depending on the estimated 
percentage of lesion area (0: 0 %, 1: 0-10%, 2: 10-29%, 3: 30-49%, 4: 50-69%, 5: 70-89%, and 
6: 90-100%). These body scores are multiplied by the disease severity score and the weighting 
for each body area, yielding a score between 0 and 7210.  
 
Harvey-Bradshaw Index (HBI): 
The Harvey-Bradshaw index is a score for quantification of symptoms in patients with CD. It 
consists of only clinical parameters: 
general well-being (0 = very well, 1 = slightly below average, 2 = poor, 3 = very poor, 4 = 
terrible) 

 
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abdominal pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) 
number of liquid stools per day 
abdominal mass (0 = none, 1 = dubious, 2 = definite, 3 = tender) 
complications, as above, with one point for each. 
The values can range from 0 (in healthy subjects) to 30 points, whereas moderate to severe 
patients have Harvey-Bradshaw index t 7. A score of less than 5 is generally considered to 
represent clinical remission12. 
 
Partial Mayo score (PMS) 
For the evaluation of the patient’s disease activity the partial Mayo score will be documented at 
each visit. In this study, an average score of five measurements (see subscore sections) shall be 
used for analysis. The partial Mayo Score has been proven to be a valid and reliable noninvasive 
measure to evaluate disease activity in adults with UC13. If endoscopy is routinely performed 
during the visit the full mayo score can be documented14. (Please see definition of Mayo Score 
below) 
The Mayo Score is a composite of the following subscores:  Stool Frequency subscore, Rectal 
Bleeding subscore, Endoscopy subscore, and Physician's Global Assessment subscore13. 
The Partial Mayo Score is a composite of the following subscores:  Stool Frequency subscore, 
Rectal Bleeding subscore, and Physician's Global Assessment subscore14. 
Stool Frequency Subscore 
The stool frequency subscore is calculated by comparing the stool frequency to a reference 
number.  The reference number is the number of stools per day (24 hours) that is typical for the 
subject when having active UC but not experiencing a flare and needs to be designated once 
prior to enrollment.  The reference number should represent a full number of at least 1. 
Subjects will record the daily number of stools throughout the trial.  Using these numbers, the 
Stool Frequency subscore will be assessed for each study day as follows:  
A number of bowel movements lower than or equal to the reference number of bowel 
movements should be scored as 0 = Normal. 

 
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One or 2 bowel movements more than the reference number of bowel movements should 
be scored as 1. 
Three or 4 bowel movements more than the reference number of bowel movements 
should be scored as 2. 
Five or more bowel movements more than the reference number of bowel movements 
should be scored as 3. 
The Stool Frequency subscores from the 5 days prior to each study visit will be averaged and 
used for the Stool Frequency subscore for each study visit.   
The Stool Frequency subscore during days which the subject received anti-diarrheal medication 
will be scored as a 3. 
Diary entries for stool frequency should not be included in the 5 days prior to the visit that are 
evaluated for the Stool Frequency subscore for the following days:  (1) the day the subject 
received medication for bowel preparation prior to endoscopy, (2) the day the subject underwent 
an endoscopy, and (3) 2 days following the endoscopy.  Earlier diary entries will be used 
accordingly in order to provide the most recent data for 5 days prior to the respective study visit. 
 
Rectal Bleeding Subscore 
Subjects should record a daily rectal bleeding subscore value as follows: 
No visible blood with stool during the respective day should be scored as 0. 
Visible blood with stool less than half the time during the respective day should be scored 
as 1. 
Visible blood with stool at least half the time during the respective day should be scored 
as 2. 
A score of 3 for bleeding requires subjects to have at least 50% of bowel movements 
accompanied by visible blood and at least one bowel movement with blood alone. 

 
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The score entries into subject's diary from the 5 days prior to each study visit will be averaged 
and used for the Rectal Bleeding subscore for each study visit.   
Diary entries for rectal bleeding should not be included in the 5 days prior to the visit that are 
evaluated for the Rectal Bleeding  subscore for the following days:  (1) the day the subject 
received medication for bowel preparation prior to endoscopy, (2) the day the subject underwent 
an endoscopy, and (3) 2 days following the endoscopy .  Earlier diary entries will be used 
accordingly in order to provide the most recent data for 5 days prior to the respective study visit. 
Physician's Global Assessment Subscore 
The physician's global assessment acknowledges the 2 subject-reported subscores, the endoscopy 
subscore as applicable, the subject's daily record of abdominal discomfort (pain/cramps) and 
general well-being during the 5 days prior to the visit, and other observations such as physical 
findings, and the subject's performance status in order to assess disease activity as follows: 
0 = Normal 
1 = Mild disease 
2 = Moderate disease 
3 = Severe disease 
Endoscopy Subscore 
The endoscopist should evaluate each observed segment of the colon (rectum, sigmoid, 
descending colon, transverse colon, ascending colon/cecum) by using the classification as 
follows: 
0 = Normal or inactive disease 
1 = Mild disease (erythema, decreased vascular pattern, mild friability) 
2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 
3 = Severe disease (spontaneous bleeding, ulceration) 

 
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The endoscopic subscore for the subject will be the worst score of the observed segments. 
The local endoscopist should also separately assess presence or absence of friability (yes/no). 
The endoscopy will be recorded on a videotape and will undergo a central review process for 
endoscopy subscore assessment. 
 
C-reactive protein CRP: 
The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is 
commonly used as an indirect measure of the extent and activity of an inflammation. Synthesis 
of this protein increases rapidly in response to inflammatory stimuli in both acute and chronic 
settings. After the inflammation is over the CRP level is rapidly decreased again. The normal 
reference range in the blood is as a rule from 0 to 1,0 mg/dl CRP. The CRP is increased in a 
variety of disorders like rheumatic diseases. 
 
 
 
Erythrocyte sedimentation rate (ESR): 
The ESR is based on the sedimentation and aggregation of erythrocytes. It is influenced due to 
the large and asymmetric plasmaproteins as immunoglobulins, fibrinogen and α2-macro-
globulin. These plasmaproteins favour the production of erythrocyte aggregates which sediment 
faster than every single erythrocyte. The ESR is a practicable and sensitive but not specific 
parameter for measuring disease progression. By means of the ESR it can be generally 
distinguished between an active and non-active rheumatic disease. The normal reference range is 
as a rule for men 0 – 10 mm/h and for women 0-15 mm/h.   
 
6.5.2  
Description of the Visits 
6.5.2.1 
Inclusion visit  
 

 
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Patients will be documented according to the following procedure: demographics (year of birth, 
gender, disease and disease duration, results of Chest X-ray and a highly specific interferon-γ-
release assay [IGRA] or PPD-test for Tb-screening and RA, PsA, AS, PsO, CD or UC treatment 
in the past), ESR, CRP; Beliefs about Medicines Questionnaire (BMQ), concomitant treatment 
other medication or supplement, start of Adalimumab application will be documented in the 
appropriate eCRF.  
6.5.2.2 
Follow-up visits 
The total treatment period is max. 12 months for each patient.  
Approximately 4 follow-up visits are expected over the 12 months period. These visits should 
occur at an interval of 3 months - “V2”,“V3”,“V4”,“V5”. 
The visit schedule is to be decided by the investigator according to the routine clinical practice. 
Intercurrent visits will be documented using the CRF module with the next following visit 
number, Visits V2,V3,V4,V5. 
Follow up visits shall comprise the following: 
V2:  ESR,CRP, MMAS, TSQM, RADAI, BASDAI, PASI, HBI, PMS concomitant treatment, 
Adalimumab-application 
V3: ESR,CRP, MMAS, TSQM, RADAI, BASDAI, PASI, HBI, PMS concomitant treatment, 
Adalimumab application 
V4:  ESR,CRP, MMAS, TSQM, RADAI, BASDAI, PASI, HBI, PMS concomitant treatment, 
Adalimumab application 
V5: ESR,CRP, BMQ, MMAS, TSQM, RADAI, BASDAI, PASI, HBI, PMS concomitant 
treatment, Adalimumab-application, final statement 
 
Evaluation of the tolerability of the Adalimumab treatment 
Any serious adverse events (SAEs) of the Adalimumab regimen will be collected throughout this 
study and 70-days following the last dose of Adalimumab.  
 

 
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Evaluation of the durability of the Adalimumab treatment 
Any changes to RA, PsA, AS, PsO, CD or UC treatment and the type of change (dose 
modification or discontinuation) will be recorded in the data report form, whether the 
modifications relate to the use of Adalimumab or to the use of concomitant RA, PsA, AS, PsO, 
CD or UC treatments. If Adalimumab is temporarily interrupted or permanently discontinued 
before the end of the planned observational period of 12 months, the reason for 
interruption/discontinuation and the details on the subsequent RA, PsA, AS, PsO, CD or UC 
treatment, if applicable, will be recorded.  
The next routine follow-up visit will be the post interruption/discontinuation visit (see 6.5.1.3).  
 
 
6.5.2.3  
Follow-up visit after temporary interruption or early permanent 
discontinuation of the Adalimumab treatment (Post interruption / 
discontinuation visit) 
 
Follow-up visits after temporary interruption or early permanent discontinuation shall comprise 
the following: 
ESR,CRP, Beliefs about Medicines Questionnaire (BMQ), Morisky Medication Adherence Scale 
(MMAS), Treatment Satisfaction Questionnaire for Medication (TSQM), concomitant treatment, 
Adalimumab application, final statement. 
Evaluation of the tolerability since the interruption/discontinuation of the Adalimumab 
treatment 
All serious adverse events (SAEs) will be reported to AbbVie until 70 days following intake of 
the last dose of physician-prescribed Adalimumab treatment. 
If the physician decides to permanently discontinue Adalimumab this visit will be the 
termination visit for the patient in the post-marketing observational study.  
 
 
6.6 
Product Supply 
 
Since this is a post-marketing observational study, Adalimumab is not supplied by AbbVie. All 
treatments must be prescribed in accordance with the authorization and local reimbursement 
guidelines. 

 
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Study treatment: 
All regimens will be prescribed according to international and national guidelines for treating 
RA, PsA, AS, PsO, CD or UC. Adalimumab will be prescribed according to the standard dosing 
regimen as detailed in the released SPC. 
Permitted treatments: 
In the context of an observational non-interventional study, the physician is free to initiate any 
co-prescriptions according to his or her own judgment, although he or she will pay attention to 
treatments interacting with Adalimumab. 
 
Prohibited treatments: 
In the context of an observational study the physician may prescribe according to his or her own 
judgment although he or she is reminded that Adalimumab must be associated with neither IL-1-
antagonists (Anakinra) nor abatacept. 
 
7.0 
 
Management and Reporting of Complaints 
A Complaint is any written, electronic, or oral communication that alleges deficiencies related to 
the physical characteristics, identity, quality, purity, potency, durability, reliability, safety, 
effectiveness, or performance of a product/device after it is released for distribution. 
The investigational product in this trial contains both:  
x Biologic compound(s) and 
x Device component(s) (pre-filled syringe, pen). 
 
Complaints associated with any component of this investigational product must be reported to 
the Sponsor. For adverse events, please refer to Sections 7.1.1 through 7.1.6. For product 
complaints, please refer to Section 8. 
 

 
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7.1 Medical Complaints 
7.1.1 
Adverse event and serious adverse event definition, serious adverse 
event categories 
An “adverse event” (AE) is defined as any untoward medical occurrence in a subject or clinical 
investigation subject administered a pharmaceutical product and which does not necessarily have 
a causal relationship with this treatment.  An adverse event can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a medicinal (investigational) product, whether or not the event is 
considered causally related to the use of the product. 
Such an event can result from use of the drug as stipulated in the protocol or labeling, as well as 
from accidental or intentional overdose, drug abuse, or drug withdrawal.  Any worsening of a 
pre-existing condition or illness is considered an adverse event.  Laboratory abnormalities and 
changes in vital signs are considered to be adverse events only if they result in discontinuation 
from the study, necessitate therapeutic medical intervention, and/or if the investigator considers 
them to be adverse events. 
An elective surgery/procedure scheduled to occur during a study will not be considered an 
adverse event if the surgery/procedure is being performed for a pre-existing condition and the 
surgery/procedure has been documented as pre-planned prior to study entry.  However, if the 
pre-existing condition deteriorates unexpectedly during the study (e.g., surgery performed earlier 
than planned), then the deterioration of the condition for which the elective surgery/procedure is 
being done, will be considered an adverse event. 
A “serious adverse event” (SAE) is an adverse event, which results in death, is life-threatening, 
requires inpatient hospitalization or prolongation of an existing hospitalization, leads to 
persistent or significant disability or invalidity, or is a congenital anomaly/birth defect. 
If an adverse event meets any of the following criteria, it is considered a serious adverse event 
(SAE) and has to be reported within 24 hours of the site being made aware of the SAE: 
 
Death of Subject 
An event that results in the death of a subject.  

 
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Life-Threatening 
An event that, in the opinion of the investigator, would have 
resulted in immediate fatality if medical intervention had not 
been taken. This does not include  an event that would have been 
fatal if it had occurred in a more severe form. 
Hospitalization 
An event that results in an admission to the hospital for any 
length of time. This does not include an emergency room visit or 
admission to an outpatient facility. 
Prolongation of 
Hospitalization 
An event that occurs while the study subject is hospitalized and 
prolongs the subject's hospital stay. 
Congenital Anomaly 
An anomaly detected at or after birth, or any anomaly that 
results in fetal loss. 
Persistent or Significant 
Disability/Invalidity 
An event that results in a condition that substantially interferes 
with the activities of daily living of a study subject. Disability is 
not intended to include experiences of relatively minor medical 
significance such as headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (e.g., sprained ankle). 
Important Medical Event 
Requiring Medical or 
Surgical Intervention to 
Prevent Serious Outcome 
An important medical reaction that may not be immediately life-
threatening or result in death or hospitalization, but based on 
medical judgment may jeopardize the subject and may require 
medical or surgical intervention to prevent any of the outcomes 
listed 
above 
(i.e., 
death 
of 
subject, 
life-threatening, 
hospitalization, prolongation of hospitalization, congenital 
anomaly, or persistent or significant disability/invalidity).  
Examples of such reaction include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, 
blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug 
abuse. 
Spontaneous Abortion 
Miscarriage experienced by study subject. 

 
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Elective Abortion 
 
Elective abortion performed on study subject. 
 
7.1.2   
Severity 
The physician will use the following definitions to rate the severity of any adverse reaction being 
collected as an endpoint/datapoint in the study and for all serious adverse reactions: 
Mild 
The adverse event is transient and easily tolerated by the subject. 
Moderate 
The adverse event causes the subject discomfort and interrupts the 
subject's usual activities. 
Severe 
The adverse event causes considerable interference with the subject's 
usual activities and may be incapacitating or life-threatening. 
 
7.1.3  
 Relationship to Pharmaceutical Product 
This is any report of an adverse event or the absence of an effect or the contamination of an 
AbbVie product, which may jeopardize the patient, as well as frequently observed inappropriate 
use or serious abuse. A SAE, that occurs after the therapy has been terminated, has to be reported 
if it occurs within 5 half-lives of the AbbVie product. 
An SAE must meet the following criteria for consideration: 
x An identifiable patient 
x An e suspected product 
x An AE, in utero exposure to AbbVie pharmaceutical or fatal outcome 
x An identifiable reporter 
 
The physician will use the following definitions for all serious adverse events, to assess the 
relationship of the serious adverse event to the use of the pharmaceutical product: 
 
 

 
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Not Related 
An adverse event is due to an underlying or concurrent illness or effect 
of another drug and is not related to the study drug (e.g., has no 
temporal relationship to study drug or has a much more likely 
alternative etiology). This is per definition not a serious adverse 
reaction. 
Probably Not Related An adverse event has little or no temporal relationship to the study drug 
and/or a more likely alternative etiology exists. 
Possibly Related 
An adverse event has a strong temporal relationship to the study drug 
and an alternative etiology is equally or less likely compared to the 
potential relationship to study drug. 
Probably Related 
An adverse event has a strong temporal relationship to study drug or 
recurs on re-challenge and another etiology is unlikely or significantly 
less likely. 
Definitely Related 
An adverse event has a strong temporal relationship to study drug, is 
known AR, another etiology is unlikely, it disappears respectively 
reappears with dechallenge respectively rechallenge. 
 
If an investigator's opinion of possibly, probably not, or not related to pharmaceutical product is 
given, an alternate etiology must be provided by the investigator for the serious adverse event. 
 
7.1.4 
Spontaneously Serious Adverse Event - collection period 
All serious adverse events (SAEs) related or not related to Adalimumab will be reported to 
AbbVie from the time the physician obtains the patient’s authorization to use and disclose 
information (or the patient’s informed consent) until 70 days following the intake of the last dose 
of physician-prescribed treatment.  
 
7.1.5 
Spontaneously reported Serious Adverse Event - reporting 
In the event of a serious adverse event (SAE), and additionally, any non-serious event of 
malignancy in patients 30 years of age and younger, related or not related to Adalimumab, the 

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physician will notify the AbbVie contact person identified below within 24 hours of the 
physician becoming aware of the even. The physician has to complete the SAE section of the 
electronic Data Report Form (eCRF). The designated AbbVie pharmacovigilance contact person 
identified below, will be automatically informed via e-mail in case a SAE occurred, including an 
attachment containing the entire SAE-form. The local project manager will - in case a SAE 
occurred - receive this e-mail including the SAE -form for his / her information only.  
Aggregate safety data will be integrated into the final study report as well as into periodic safety 
update reports for the marketed product. Local AbbVie pharmacovigilance contact persons are:
7.1.6 
Pregnancy Reporting 
Pregnancies in patients will be collected from the date of the first dose through 150 days 
following the last dose of adalimumab taken during the study. In the event of pregnancy, the 
physician will notify the AbbVie contact person identified in Section 7.1.5 within 24 hours of the 
physician becoming aware of the pregnancy. 
Information regarding a pregnancy occurrence in a study subject and the outcome of the 
pregnancy will be collected. 
Pregnancy in a study subject is not considered an adverse event. However the medical outcome 
of an elective or spontaneous abortion, stillbirth or congenital anomaly is considered a serious 
adverse event and must be reported to AbbVie within 24 hours of the site becoming aware of 
the event! 

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8.0 
Product Complaint 
8.1 
Definition 
A Product Complaint is any Complaint (see Section 0 for the definition) related to the biologic or 
drug component of the product or to the medical device component(s). 
For a product this may include, but is not limited to, damaged/broken product or packaging, 
product appearance whose color/markings do not match the labeling, labeling 
discrepancies/inadequacies in the labeling/instructions (example:  printing illegible), missing 
components/product, device not working properly, or packaging issues. 
For medical devices, a product complaint also includes all deaths of a patient using the device, 
any illness, injury, or adverse event in the proximity of the device, an adverse event that could be 
a result of using the device, any event needing medical or surgical intervention including 
hospitalization while using the device and use errors. 
Any information available to help in the determination of causality by the device to the events 
outlined directly above should be captured. 
8.2 
 
Reporting 
The relevant AbbVie Product Complaint contact details are specified below:  
In the event of a product complaint related to concerning the investigational product and/or 
device, the physician has to retrieve the form for product complaints from the InterTrial page 
(see miscellaneous documents), complete the form and will notify AbbVie, by faxing (fax-no.: 
) this form within 24 hours of the physician becoming aware of the event. In 
instances where a return is requested, every effort should be made by the investigator to return 

 
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the product within 30 days. If returns cannot be accommodated within 30 days, the site will need 
to provide justification and an estimated date of return. 
Please return the concerned product to the pharmacy where the patient did purchase it along with 
the specified description of the complaint. The pharmacy will return it via wholesaler to AbbVie 
for investigation.  
The description of the complaint is important for AbbVie in order to enable AbbVie to 
investigate and determine if any corrective actions are required. 
 
 
 
9.0 
 
Ethics and Quality 
All patient data entered in the patient's electronic data report form (eCRF) will be forwarded - 
without naming the patient - for evaluation to AbbVie. In order to maintain patient 
confidentiality, instead of date of birth, the patient’s age will be documented in the eCRF. 
The patients must provide written authorization to the investigator to use and/or disclose 
personal and/or health data before entry into this PMOS. The investigator will document this 
authorization in the patient’s chart. There are no local law requirements for monitoring, 
notification /submission of a post-marketing observational study to an ethics committee and/or 
regulatory body. However, a written confirmation from one of the Lead–ECs will be obtained. In 
this the following statement should be documented: “According to §2 paragraph 3 of the 
Austrian Pharmaceutical Act it is an observational study and therefore an evaluation by the ethics 
committee (EC) is not required”. The protocol and the IC/ADU should be provided to the EC for 
review. It will be submitted to a regulatory body. The study will not be monitored. However in 
order to assure professional site data-management a qualified Clinical Research Organisation 
(CRO) as well as a statistician is assigned. Concretely this means that data entered in the eCRFs 
by the sites will be checked for consistency of data. Inconsistent data will be queried.   
 

 
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10.0 
Data Report Forms 
Examinations, diagnostic measures, findings and observations routinely performed in patients 
included in this postmarketing observational study will be entered by the investigator or staff 
according to the protocol in the data report forms provided by AbbVie. AbbVie Austria will 
document data in electronic data report forms (eCRF). Completed eCRF visit modules will be 
sent electronically immediately after completion to the contracted statistician and CRO. 
 
11.0 
Data Analysis Plans 
11.1  
End points  
 
 
 
 
 
 
 
 
 
11.1.1  
Primary end point 
Patients` adherence attitudes (beliefs) to maintenance therapy with a scheduled Adalimumab 
monotherapy or a combination therapy with methotrexate will be assessed at baseline (visit 1 
=screening) and at the end of the study at visit 5. Furthermore it shall be investigated whether 
there are correlations between such beliefs and adherence to maintenance treatment.  
11.1.2.  
Secondary end points 
As secondary endpoints the following parameters will be evaluated: changes in the Morisky 
Medication Adherence Scale (MMAS) at visit 2, 3, 4 and 5, changes in the Treatment 
Satisfaction Questionnaire for Medication (TSQM) at visit 2, 3, 4 and 5, changes at the 
laboratory parameters such as C-reactive protein (CRP) and Erythrocyte sedimentation rate 
(ESR). 
Changes in the Rheumatoid Arthritis Disease Activity Index (RADAI), Bath Ankylosing 
Activity Index (BASDAI), Psoriasis Area and Severity Index (PASI), Harvey-Bradshaw Index 
(HBI) and the Partial Mayo score (PMS)  at visit 2, 3, 4 and 5. The quality of the analyses will 
depend on the fact that laboratory measurements are not stringent in the context of a non-
interventional observational study. Tolerability and safety will be assessed by collection and 
classification of serious adverse events. Serious adverse reactions observed on treatment with 
Adalimumab will be described. The duration on treatment with Adalimumab until development 

 
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of a serious adverse reaction leading to  Adalimumab discontinuation or until escape from 
treatment will be measured. 
11.2  
Plan of Analysis 
The statistical analysis shall describe the characteristics of patients included in the survey 
together with outcomes and clinical tolerability of Adalimumab.  
Subject to the level of measurement of the respective variables appropriate descriptive statistics 
is used: e.g. frequency absolute and/or percental; nonmissing, missing data respectively; mean, 
standard deviation, where applicable: median, 25th percentile (first quartile) and 75th percentile 
(third quartile), minimum and maximum, range, calculation of confidence intervals (if 
applicable). Appropriate graphs are used (e.g. scatterplot, boxplot, histogram, etc.). As the study 
is an open label non-interventional post marketing observational study there is no working 
hypothesis allowed!  
Compliance with treatments, outcomes and clinical tolerability of treatments will be compared as 
a function of patient characteristics.  
A data analysis plan will be available prior to the conduct of the statistical analysis for the study. 
12.0  
Final Reports and Publications 
At the end of the data collection of Plaque Psoriasis patients the final report for all indications 
will be written at the end of the study. A publication (e.g. an abstract and/or poster) based on the 
final report will be published. The report will contain a description of the objectives of the 
survey, the methodology of the survey, its results, conclusions and a list of all involved 
physicians/hospitals. The information contained in the data report forms, the statistical analysis 
report and the clinical report must be treated as the confidential property of AbbVie. It may not 
be released to unauthorized people in any form (publications or presentations) without explicit 
written approval from AbbVie. The results of this survey may be published or presented by the 
sponsor and author of the present protocol alone or under participation by one of the 
investigators after agreement with the sponsor or by one of the investigators alone after 
agreement with the sponsor. 
 

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13.0  
Conduct of the PMOS 
This PMOS will be supervised by AbbVie 
 If there is any 
question regarding the conduct of this PMOS, please call 
14.0  
References 
1.
Osterberg L, Blaschke T, Adherence to Medication. N Engl J Med 2005;353:487-97
2.
Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK, 
Medication Compliance and Persistence: Terminology and Definitions. Value In Health 
2008;11(1), pp.:44-47 
3.
Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L, Adherence to biologic 
DMARD therapies in rheumatoid arthritis. Expert Opin. Biol. Ther. 2010;10(9):1367-1378 
4.
Horne R, Weinman J, Hankins M, The beliefs about medicines questionnaire: the 
development and evaluation of a new method for assessing the cognitive representation of 
medication. Psychology and Health. 1999;14,pp.:1-24
5.
Morisky DE, Green LW, Levine DM, Concurrent and Predictive Validity of a Self-reported 
Measure of Medication Adherence. Medical Care, 1986,24(1),pp.:67-74 
6.
Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR, Validation 
of a general measure of treatment stisfaction, the Treatment Satisfaction Questionnaire for 
Medication (TSQM), using a national panel study of chronic disease 
7.
Hierachical Construct Validity of the Treatment Satisfaction Questionnaire for Medication 
(TSQM Version II) among Outpatient Pharmacy Consumers. Value In Health 2005,8(Suppl 
I) S9-S24 
8.
HUMIRA EPAR/SPC as downloaded from EMEA homepage on 22 October 2013. Link: 
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000481/WC500050870.pdf
9.
Scallon B, Cai A, Solowski N, Rosenberg A, Song XY, Shealy D, Wagner C. Binding and 
Functional Comparisons of Tumor Necrosis Factor Antagonists. J Pharmacol Exp Ther  
2002; 301; pp.:418-2610.

 
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10. 
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. 
Dermatologica. 1978;157(4):238-44. 
11. 
Mease, P. J. Measures of Psoriatic Arthritis. Arthritis Care Res, 2011,63(Suppl 11): S64–
S85. 
12. 
Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980; 
1(8167):514. 
13. 
Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the 
noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. 
Inflamm Bowel Dis 200814(12):1660-6. 
14. 
Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for 
mildly to moderatly active ulcerative colitis. A randomized study. N Engl J Med 1987; 
317(26):1625-9. 
 
15.  Appendix 
Appendix A: HUMIRA® PEN-Instruction (EMA) 
 
Humira 40 mg solution for injection in pre-filled pen 
Adalimumab 
 
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. 
Your doctor will also give you a Patient Alert Card, which contains important safety information 
that you need to be aware of before you are given Humira and during treatment with 
Humira. Keep this Patient Alert Card with you. 
If you have any further questions, ask your doctor or pharmacist. 
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 or pharmacist. This includes any possible side 
effects not listed in this leaflet (see section 4). 
 
What is in this leaflet:  
1. 
What Humira is and what it is used for 
2. 
What you need to know before you use Humira 
3. 
How to use Humira 
4. 
Possible side effects 

 
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5 
How to store Humira 
6. 
Contents of the pack and other information 
1. 
WHAT HUMIRA IS AND WHAT IT IS USED FOR 
Humira contains the active substance adalimumab, a selective immunosuppressive agent.Humira 
is intended for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, 
ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing 
spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. It is a medicine 
that decreases the inflammation process of these diseases. The active ingredient, adalimumab, is 
a human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins 
that recognise and bind to other unique proteins. Adalimumab binds to a specific protein (tumour 
necrosis factor or TNFD), which is present at increased levels in inflammatory diseases such as 
rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, axial 
spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, 
psoriasis, Crohn’s disease and ulcerative colitis. 
Rheumatoid arthritis 
Humira is used to treat rheumatoid arthritis in adults. Rheumatoid arthritis is an inflammatory 
disease of the joints.  If you have moderate to severe active rheumatoid arthritis, you may first be 
given other disease-modifying medicines, such as methotrexate.  If you do not respond well 
enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.   
 
Humira can also be used to treat severe, active and progressive rheumatoid arthritis without 
previous methotrexate treatment. 
 
Humira has been shown to slow down the damage to the cartilage and bone of the joints caused 
by the disease and to improve physical function.  
Usually, Humira is used with methotrexate. If your doctor determines that methotrexate is 
inappropriate, Humira can be given alone.  
Polyarticular juvenile idiopathic arthritis 
 
Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 
2 to 17 years. Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one 
or more joints, with diagnosis typically occurring in children under the age of 16 years. You may 
first be given other disease-modifying medicines, such as methotrexate.  If you do not respond 
well enough to these medicines, you will be given Humira to treat your polyarticular juvenile 
idiopathic arthritis. 
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing 
spondylitis 

 
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Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic 
evidence of ankylosing spondylitis in adults. Ankylosing spondylitis and axial spondyloarthritis 
without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine. 
If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of 
ankylosing spondylitis, you will first be given other medicines. If you do not respond well 
enough to these medicines, you will be given Humira to reduce the signs and symptoms of your 
disease. 
 
Psoriatic arthritis 
 
Humira is used to treat psoriatic arthritis in adults. Psoriatic arthritis is an inflammation of the 
joints associated with psoriasis. Humira has been shown to slow down the damage to the 
cartilage and bone of the joints caused by the disease and to improve physical function. 
 
Psoriasis  
 
Humira is used to treat psoriasis in adults. Psoriasis is an inflammatory disease of the skin. If you 
have moderate to severe plaque psoriasis, you will first be given other medicines or e.g. 
phototherapy. If you do not respond well enough to these treatments, you will be given Humira 
to reduce the signs and symptoms of your psoriasis. 
 
Crohn’s disease in Aults and Children 
 
Humira is used to treat Crohn’s disease in adults and children aged 6 to 17 years of of age. 
Crohn’s disease is an inflammatory disease of the digestive tract. Humira is indicated for the 
treatment of Crohn's disease in adults and in children aged 6 to 17 years. If you have Crohn’s 
disease you will first be given other medicines. If you do not respond well enough to these 
medicines, you will be given Humira to reduce the signs and symptoms of your Crohn’s disease. 
 
Ulcerative Colitis 
 
Humira is used to treat ulcerative colitis in adults. Ulcerative colitis is an inflammatory disease 
of the bowel.  If you have ulcerative colitis you will first be given other medicines.  If you do not 
respond well enough to these medicines, you will be given Humira to reduce the signs and 
symptoms of your disease. 
 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMIRA 
Do not use Humira 
If you are allergic to adalimumab or any of the other ingredients ofthis medicine (listed in section 
6).  

 
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If you have a severe infection, including active tuberculosis (see “Warnings and precautions”). It 
is important that you tell your doctor if you have symptoms of infections, e.g. fever, 
wounds, feeling tired, dental problems. 
 
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or 
have a serious heart condition (see “Warnings and precautions”). 
 
Warnings and precautions 
 
Talk to your doctor or pharmacist before using Humira 
 
If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, 
swelling or rash do not inject more Humira and contact your doctor immediately. 
 
If you have an infection, including long-term or localized infection (for example, leg ulcer) 
consult your doctor before starting Humira. If you are unsure, please contact your doctor.  
 
You might get infections more easily while you are receiving Humira treatment. This risk may 
increase if your lung function is impaired. These infections may be serious and include 
tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other 
opportunistic infections and sepsis that may, in rare cases, be life-threatening. It is 
important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or 
dental problems. Your doctor may recommend temporary discontinuation of Humira. 
 
As cases of tuberculosis have been reported in patients treated with Humira, your doctor will 
check you for signs and symptoms of tuberculosis before starting Humira. This will include 
a thorough medical evaluation including your medical history and appropriate screening 
tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests 
should be recorded on your Patient Alert Card.  It is very important that you tell your 
doctor if you have ever had tuberculosis, or if you have been in close contact with someone 
who has had tuberculosis.  Tuberculosis can develop during therapy even if you have 
received preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent 
cough, weight loss, listlessness, mild fever), or any other infection appear during or after 
therapy tell your doctor immediately. 
 
Advise your doctor if you reside or travel in regions where fungal infections such as 
histoplasmosis coccidioidomycosis or blastomycosis are endemic. 
 
Advise your doctor if you have a history of recurrent infections or other conditions that increase 
the risk of infections. 
 
Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or 
if you think you might be at risk of contracting HBV. Your doctor should test you for 

 
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HBV. Humira can cause reactivation of HBV in people who carry this virus. In some rare 
cases, especially if you are taking other medicines that suppress the immune system, 
reactivation of HBV can be life-threatening.   
 
If you are over 65 years you may be more susceptible to infections while taking Humira. 
 You and your doctor should pay special attention to signs of infection while you are 
being  
treated with Humira. It is important to tell your doctor if you get symptoms of 
infections, such as fever, wounds, feeling tired or dental problems. 
 
If you are about to undergo surgery or dental procedures please inform your doctor that you are 
taking Humira. Your doctor may recommend temporary discontinuation of Humira.  
 
If you have demyelinating disease such as multiple sclerosis, your doctor will decide if you 
should receive Humira. 
 
Certain vaccines may cause infections and should not be given while receiving Humira. Please 
check with your doctor before you receive any vaccines. It is recommended that children, if 
possible, be brought up to date with all immunisations in agreement with current 
immunisation guidelines prior to initiating Humira therapy. If you received Humira while 
you were pregnant, your baby may be at higher risk for getting such an infection for up to 
approximately five months after the last dose you received during pregnancy.  It is 
important that you tell your baby's doctors and other health care professionals about your 
Humira use during your pregnancy so they can decide when your baby should receive any 
vaccine. 
 
x 
If you have mild heart failure and you are being treated with Humira, your heart failure 
status must be closely monitored by your doctor.  It is important to tell your doctor if you 
have had or have a serious heart condition.  If you develop new or worsening symptoms of 
heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your 
doctor immediately.  Your doctor will decide if you should receive Humira. 
 
In some patients the body may fail to produce enough of the blood cells that help your body fight 
infections or help you to stop bleeding.  If you develop a fever that does not go away, 
bruise or bleed very easily or look very pale, call your doctor right away.  Your doctor may 
decide to stop treatment. 
 
There have been very rare cases of certain kinds of cancer in children and adult patients taking 
Humira or other TNF blockers.  People with more serious rheumatoid arthritis that have 
had the disease for a long time may have a higher than average risk of getting lymphoma (a 
kind of cancer that affects the lymph system), and leukemia (a kind of cancer that affects 
the blood and bone marrow). If you take Humira the risk of getting lymphoma, leukemia, 
or other cancers may increase. On rare occasions, a specific and severe type of lymphoma, 
has been observed in patients taking Humira. Some of those patients were also treated with 
azathioprine or 6- mercaptopurine. Tell your doctor if you are taking azathioprine or 6-

 
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mercaptopurine with Humira. In addition cases of non-melanoma skin cancer have been 
observed in patients taking Humira. If new skin lesions appear during or after therapy or if 
existing lesions change appearance, tell your doctor. 
 
There have been cases of cancers, other than lymphoma in patients with a specific type of lung 
disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF 
blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor 
whether treatment with a TNF blocker is appropriate for you. 
Children and adolescents 
x 
Vaccinations: if possible children should be up to date with all vaccinations before using 
Humira. 
x 
Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the 
age of 2 years. 
Other medicines and Humira 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic 
agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), 
steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs). 
 
You should not take Humira with medicines containing the active substance, anakinra or 
abatacept.  If you have questions, please ask your doctor. 
 
Humira with food and drink 
 
Since Humira is injected under the skin (subcutaneously), food and drink should not affect 
Humira. 
Pregnancy and breast-feeding 
The effects of Humira in pregnant women are not known and so the use of Humira in pregnant 
women is not recommended.  You are advised to avoid becoming pregnant and must use 
adequate contraception while using Humira and for at least 5 months after the last Humira 
treatment. If you become pregnant, you should consult your doctor. 
 
It is not known whether adalimumab passes into breast milk. 
 
If you are a breast-feeding mother, you should stop breast-feeding during Humira treatment and 
for at least 5 months after the last Humira treatment. If you received Humira during your 

 
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pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell 
your baby’s doctors and other health care professionals about your Humira use during your 
pregnancy before the baby receives any vaccine (for more information see section on 
vaccination). 
 
If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 
for advice before taking this medicine. 
 
Driving and using machines 
 
 Humira may have a minor influence on your ability to drive, cycle or use machines.  Room 
spinning sensation and vision disturbances may occur after taking Humira. 
3. 
HOW TO USE HUMIRA 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure.  
 
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial 
spondyloarthritis without radiographic evidence of ankylosing spondylitis 
 
Humira is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid 
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of 
ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every 
other week as a single dose.   
 
In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor determines 
that methotrexate is inappropriate, Humira can be given alone.  
 
If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, 
your doctor may decide to give 40 mg adalimumab every week. 
 
Children with polyarticular juvenile idiopathic arthritis 
 
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, 
aged 2 to 12 years depends on the height and weight of the child. .  
 
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, 
aged 13 to 17 years, is 40mg every other week. 
 
Adults with Psoriasis 
 

 
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The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given 
every other week starting one week after the initial dose. You should continue to inject Humira 
for as long as your doctor has told you. 
 
Adults with Crohn’s disease 
 
The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other 
week two weeks later. If a faster response is required your doctor may prescribe an initial dose of 
160 mg (as 4 injections in one day or 2 injections per day for two consecutive days), followed by 
80 mg two weeks later, and thereafter as 40 mg every other week.  Depending on your response, 
your doctor may increase the dose frequency to 40 mg every week. 
 
Children or adolescents with Crohn's Disease 
 
Children or adolescents weighing less than 40 kg:   
 
The usual dose regimen is 40 mg initially followed by 20 mg two weeks later.  If a faster 
response is required, your doctor may prescribe an initial dose of 80 mg (as 2 injections in 1 day) 
followed by 40 mg two weeks later. 
 
Thereafter, the usual dose is 20 mg every other week.  Depending on your response, your doctor 
may increase the dose frequency to 20 mg every week.   
 
Children or adolescents weighing 40 kg or more:  
 
The usual dose regimen is 80 mg initially followed by 40 mg two weeks later.  If a faster 
response is required, your doctor may prescribe an initial dose of 160 mg (as 4 injections in 1 
day or as 2 injections per day for 2 consecutive days) followed by 80 mg two weeks later. 
 
Thereafter, the usual dose is 40mg every other week.  Depending on your response, your doctor 
may increase the dose frequency to 40 mg every week. 
 
For patients who do not require a full 40 mg dose of Humira, a 40mg vial is also available. 
 
Adults with ulcerative colitis 
 
The usual Humira dose for adults with ulcerative colitis is 160 mg at Week 0 (dose can be 
administered as four injections in one day or as two injections per day for two consecutive days) 
and 80 mg at Week 2, and thereafter 40 mg every other week.  Depending on your response, 
your doctor may increase the dose to 40 mg every week.     
Method and route of administration 
Humira is administered by injection under the skin (by subcutaneous injection). 

 
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Injecting Humira yourself 
The following instructions explain how to give yourself an injection of Humira using the pre-
filled pen.  Please read the instructions carefully and follow them step by step. You will be 
instructed by your doctor or his/her assistant on the technique of self-injection. Do not attempt to 
self-inject until you are sure that you understand how to prepare and give the injection. After 
proper training, the injection can be self-administered or given by another person, for example a 
family member or friend. 
What should I do before I give myself a subcutaneous injection of Humira? 
1. 
Wash your hands thoroughly.  
2.  
Take one dose tray containing a pre-filled pen of Humira from the refrigerator.  
3.  
Do not shake or drop the pre-filled pen. 
4.  
Set up the following items on a clean surface. 
 
One pre-filled pen of Humira  
One alcohol pad 
 
 
 
 
Pad 
 
 
Window 
 
5.  
Check the expiry date on the pre-filled pen label (EXP:) Do not use the product if the date 
has passed the month and year shown. 
 
6.  
Hold the pre-filled pen with the grey cap (labelled ‘1’) pointing up. Check the appearance 
of the Humira solution through the windows on the sides of the pre-filled pen. It must be 
clear and colourless.  If it is cloudy or discoloured or has flakes or particles in it, you must 
not use it. Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight. 
Only remove both the grey cap and the plum cap immediately before injection 
 

 
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Window 
 
Clear Liquid in Syringe 
 
Where should I give my injection?   
1.  
Choose a site on the top of your thigh or stomach (except the area around 
the navel). 
 
 
2.  
Change the place that you inject each time so that you do not become sore in one area. 
Each new injection should be given at least 3 cm from the last injection site.  
 
3.  
Do not inject in an area where the skin is reddened, bruised, or hard.  This may mean there 
is an infection.   
 
How do I give my injection? 
 
1.  
Wipe your skin by using the enclosed alcohol pad, using a circular motion. Do not touch 
the area again before injecting.   
  
 
2. 
Only remove both the grey cap and the plum cap immediately before injection.  Hold the 
grey body of the pre-filled pen with one hand.  Place hand on the middle of the pen so that 
neither the grey cap (1) nor the plum cap (2) is covered.  Hold the pre-filled pen with the 
grey cap (1) pointing up. With your other hand, pull the grey cap (1) straight off and 
discard cap.  Check that the small grey needle cover of the syringe has been removed with 

 
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the cap.  .  If a few small drops of liquid come out of the needle, that is okay.  The white 
needle sleeve will now be exposed.  Do not try to touch the needle housed in the barrel. 
DO NOT RECAP as you may damage the needle inside.  
 
 
 
3.  
Pull the plum safety cap (labelled ‘2’) straight off to expose the plum coloured activation 
button.  The pre-filled pen is now ready to use.  Do not press the plum activation button 
until properly positioned as this will result in discharge of medication. DO NOT RECAP 
as this could cause the unit to discharge. 
 
Giving the injection 
 
1.  
With your free hand, gently grasp a sizable area of the cleaned skin at the injection site and 
hold firmly (see below).   
2.   Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that 
you can see the window. The presence of one or more bubbles in the window is normal. 
3.  
Holding the barrel of the pre-filled pen, press down slightly onto the injection site (holding 
in place without moving).  
4.  
With your index finger or your thumb, press the plum coloured button on top once you are 
ready to begin the injection (see below).  You will then hear a loud ‘click’ as the needle is 
released, and you will feel a small prick as the needle advances.  
5.  
Keep pressing and continue to hold the pre-filled pen with steady pressure in place for 
about 10 seconds to ensure a complete injection.  Do not remove the pre-filled pen while 
the injection is being given.  

 
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6.  
You will see a yellow indicator move into the windows during the injection.  The injection 
is complete when the yellow indicator stops moving.   
7.  
Lift the pre-filled pen straight up from the injection site. The white needle sleeve will move 
down over the needle and lock into place over the needle tip. Do not try to touch the 
needle.  The white needle sleeve is there to protect you from touching the needle.    
 
 
 
White Needle 
Sleeve 
 
 
 
 
Window 
 
Yellow Indicator 
Visible 
 
 
8.  
You may notice a spot of blood at the injection site.  You can press a cotton ball or a piece 
of gauze over the injection site for 10 seconds. Do not rub the injection site. Use a plaster if 
you want to. 
Throwing away supplies 
Only use each pre-filled pen for one injection.  Do not put either of the caps back on the pre-
filled pen 
After injecting Humira, immediately throw away the used pre-filled pen in a special container 
as instructed by your doctor, nurse or pharmacist 
Keep this container out of the reach and sight of children 
If you use more Humira than you should: 
If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, you 
should call your doctor or pharmacist and tell him/her that you have taken more. Always take the 
outer carton of medicine with you, even if it is empty.  

 
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If you forget to use Humira: 
If you forget to give yourself an injection, you should inject the next dose of Humira as soon as 
you remember.  Then take your next dose as you would have on your originally scheduled day, 
had you not forgotten a dose.  
 
If you stop using Humira: 
 
The decision to stop using Humira should be discussed with your doctor. Your symptoms may 
return upon discontinuation. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
4. 
POSSIBLE SIDE EFFECTS 
Like all medicines, this medicine can  cause side effects, although not everybody gets them. 
Most side effects are mild to moderate.  However, some may be serious and require treatment. 
Side effects may occur at least up to 4 months after the last Humira injection.   
 
Tell your doctor immediately if you notice any of the following:  
Severe rash, hives or other signs of allergic reaction;  
Swollen face, hands, feet; 
Trouble breathing, swallowing; 
Shortness of breath with exertion or upon lying down or swelling of the feet; 
 
Tell your doctor as soon as possible if you notice any of the following:  
Signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination; 
Feeling weak or tired; 
Coughing; 
Tingling; 
Numbness; 
Double vision; 
Arm or leg weakness 
A bump or open sore that doesn't heal 
x 
e 
 
The symptoms described above can be signs of the below listed side effects, which have been 
observed with Humira: 
 
Very common (may affect more than 1 in 10 people):   
 

 
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x 
injection site reactions (including pain, swelling, redness or itching; 
x 
respiratory tract infections (including cold, runny 
nose, sinus infection, pneumonia); 
x 
headache; 
x 
abdominal pain; 
x 
nausea and vomiting; 
x 
rash; 
x 
musculoskeletal pain. 
 
Common (may affect up to 1 in 10 people):   
 
x 
serious infections (including blood poisoning and influenza); 
x 
skin infections (including cellulitis and shingles); 
x 
ear infections; 
x 
oral infections (including tooth infections and cold sores); 
x 
reproductive tract infections; 
x 
urinary tract infection); 
x 
fungal infections; 
x 
joint infections; 
x 
benign tumours; 
x 
skin cancer; 
x 
allergic reactions (including seasonal allergy); 
x 
dehydration; 
x 
mood swings (including depression); 
x 
anxiety; 
x 
difficulty sleeping; 
x 
sensation disorders such as tingling, prickling or 
numbness; 
x 
migraine; 
x 
nerve root compression (including low back pain 
and leg pain); 
x 
vision disturbances;  
x 
eye inflammation; 
x 
inflammation of the eye lid and eye swelling; 
x 
vertigo; 
x 
sensation of heart beating rapidly; 
x 
high blood pressure; 
x 
flushing; 
x 
haematoma; 
x 
cough; 
x 
asthma; 
x 
shortness of breath; 
x 
gastrointestinal bleeding; 

 
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x 
dyspepsia (indigestion, bloating, heart burn); 
x 
acid reflux disease; 
x 
sicca syndrome (including dry eyes and dry mouth); 
x 
itching; 
x 
itchy rash; 
x 
bruising; 
x 
inflammation of the skin  (such as eczema); 
x 
breaking of finger nails and toe nails; 
x 
increased sweating; 
x 
hair loss; 
x 
new onset or worsening of psoriasis; 
x 
muscle spasms; 
x 
blood in urine; 
x 
kidney problems; 
x 
chest pain; 
x 
oedema; 
x 
fever; 
x 
reduction in blood platelets which increases risk of bleeding or bruising; 
x 
impaired healing. 
 
Uncommon (may affect up to 1 in 100 people):   
 
x 
opportunistic infections (which include tuberculosis and other infections that occur when 
resistance to disease is lowered); 
x 
neurological infections (including viral meningitis); 
x 
eye infections; 
x 
bacterial infections; 
x 
diverticulitis (inflammation and infection of the 
large intestine); 
x 
cancer; 
x 
cancer that affects the lymph system; 
x 
melanoma; 
x 
immune disorders that could affect the lungs, skin 
and lymph nodes (most commonly presenting as sarcoidosis); 
x 
tremor; 
x 
neuropathy; 
x 
stroke; 
x 
double vision; 
x 
hearing loss, buzzing; 
x 
sensation of heart beating irregularly such as 
skipped beats; 
x 
heart problems that can cause shortness of breath or 
ankle swelling; 

 
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x 
heart attack; 
x 
a sac in the wall of a major artery, inflammation and 
clot of a vein, blockage of a blood vessel; 
x 
lung diseases causing shortness of breath (including 
inflammation); 
x 
pulmonary embolism (blockage in an artery of the 
lung); 
x 
pleural effusion (abnormal collection of fluid in the 
pleural space); 
x 
inflammation of the pancreas which causes severe 
pain in the abdomen and back; 
x 
difficulty in swallowing; 
x 
 facial oedema; 
x 
gallbladder inflammation, gallbladder stones; 
x 
fatty liver; 
x 
night sweats; 
x 
scar; 
x 
abnormal muscle breakdown; 
x 
systemic lupus erythematosus (including 
inflammation of skin, heart, lung, joints and other organ systems); 
x 
sleep interruptions; 
x 
impotence; 
x 
inflammations. 
 
Rare (may affect up to 1 in 1000 people) 
 
x 
leukemia (cancer affecting the blood and bone marrow); 
x 
severe allergic reaction with shock; 
x 
multiple sclerosis; 
x 
nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may 
cause muscle weakness, abnormal sensations, tingling in the arms and upper body); 
heart stops pumping; 
pulmonary fibrosis (scarring of the lung); 
intestinal perforation; 
hepatitis; 
reactivation of hepatitis B; 
autoimmune hepatitis (inflammation of the liver caused by the body's own immune system) 
cutaneous vasculitis (inflammation of blood vessels in the skin); 
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash); 
facial oedema associated with allergic reactions; 
erythema multiforme (inflammatory skin rash); 
lupus-like syndrome. 
 

 
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Not known (frequency cannot be estimated from available data): 
 
x 
hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal); 
x 
Merkel cell carcinoma (a type of skin cancer); 
x 
liver failure; 
x 
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle         
weakness). 
 
Some adverse experiences observed with Humira may not have symptoms and may only be 
discovered through blood tests.  These include: 
 
Very common (may affect more than 1 in 10 people) 
 
x 
low blood measurements for white blood cells; 
x 
low blood measurements for red blood cells; 
x 
increased lipids in the blood; 
x 
elevated liver enzymes. 
 
Common (may affect up to 1 in 10 people): 
 
x 
high blood measurements for white blood cells;   
x 
low blood measurements for platelets; 
x 
increased uric acid in the blood; 
x 
abnormal blood measurements for sodium; 
x 
low blood measurements for calcium; 
x 
low blood measurements for phosphate; 
x 
high blood sugar; 
x 
high blood measurements for lactate dehydrogenase; 
x 
autoantibodies present in the blood. 
 
Rare (may affect up to in 1 in 1,000 people): 
 
x 
low blood measurements for white blood cells, red blood cells and platelet count. 
 
Not known (frequency cannot be estimated from the available data): 
 
• 
liver failure. 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist . This includes any possible side 
effects not listed in this leaflet.   

 
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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 HUMIRA 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date stated on the label/blister/carton after EXP:. The 
expiry date refers to the last day of that month. 
 
Store in a refrigerator (2qC – 8qC).  Do not freeze.  
 
Keep the pre-filled pen in the outer carton in order to protect from light.   
 
Alternative Storage: 
 
When needed (for example when you are travelling), a single Humira pre-filled pen may be 
stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it 
from light.  Once removed from the refrigerator for room temperature storage, the pen must be 
used within 14 days or discarded, even if it is returned to the refrigerator.   
 
You should record the date when the pen is first removed from refrigerator, and the date after 
which it should be discarded. 
DO NOT THROW AWAY ANY MEDICINES VIA WASTEWATER OR HOUSEHOLD 
WASTE. ASK YOUR DOCTOR OR PHARMACIST HOW TO THROW AWAY 
MEDICINES YOU NO LONGER USE. THESE MEASURES WILL HELP PROTECT 
THE ENVIRONMENT. ANY UNUSED PRODUCT OR WASTE MATERIAL SHOULD 
BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS. 
6. 
CONTENTS OF THE PACK AND OTHER INFORMATION 
 
What Humira contains 
 
The active substance is adalimumab. 
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen 
phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium 
hydroxide and water for injections. 
 

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This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. 
essentially ‘sodium-free’ and does not contain preservatives.
What the Humira pre-filled pen looks like and contents of the pack 
Humira 40 mg solution for injection in pre-filled pen is supplied as a sterile solution of 40 mg 
adalimumab dissolved in 0.8 ml solution. 
The Humira pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass 
syringe with Humira.  There are two caps – one is grey and labelled ‘1’ and the other is plum and 
labelled ‘2’.  There is a window on each side of the pen through which you can see the Humira 
solution inside the syringe.   
The Humira pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens.  Each 
pre-filled pen comes with 1 alcohol pad.  Not all pack sizes may be marketed.   
Humira is available as a vial, a pre-filled syringe and a pre-filled pen. 
Marketing Authorisation Holder 
AbbVie Ltd 
Maidenhead 
SL6 4XE 
United Kingdom  
Manufacturer  
For any information about thismedicine, please contact the local representative of the Marketing 
Authorisation Holder. 

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This leaflet was last revised in 09/2013. 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.
Appendix B: HUMIRA® -Pre-Filled Syringe-Instruction (EMA) 
Humira 40 mg solution for injection in pre-filled syringe 
Adalimumab
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. 

Your doctor will also give you a Patient Alert Card, which contains important safety 
information that you need to be aware of before you are given Humira and during 
treatment with Humira.  Keep this Patient Alert Card with you.  

If you have any further questions, please ask your doctor or pharmacist. 

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 or pharmacist. This includes any possible 
side effects not listed in this leaflet (see section 4).
What is in this leaflet:
1. 
What Humira is and what it is used for 
2. 
What you need to know before you use Humira 
3. 
How to use Humira 
4. 
Possible side effects 
5 
How to store Humira 
6. 
Contents of the pack and other information 

 
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1. 
WHAT HUMIRA IS AND WHAT IT IS USED FOR 
Humira contains the active substance adalimumab, a selective immuno suppressive agent. 
Humira is intended for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic 
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of 
ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. It is a 
medicine that decreases the inflammation process of these diseases. The active ingredient, 
adalimumab, is a human monoclonal antibody produced by cultured cells. Monoclonal 
antibodies are proteins that recognise and bind to other unique proteins. Adalimumab binds to a 
specific protein (tumour necrosis factor or TNFD), which is present at increased levels in 
inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, 
ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing 
spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. 
 
Rheumatoid arthritis 
 
Humira is used to treat rheumatoid arthritis in adults. Rheumatoid arthritis is an inflammatory 
disease of the joints.  If you have moderate to severe active rheumatoid arthritis, you may first be 
given other disease-modifying medicines, such as methotrexate.  If you do not respond well 
enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.   
 
Humira can also be used to treat severe, active and progressive rheumatoid arthritis without 
previous methotrexate treatment. 
 
Humira has been shown to slow down the damage to the cartilage and bone of the joints caused 
by the disease and to improve physical function. 
 
Usually, Humira is used with methotrexate. If your doctor determines that methotrexate is 
inappropriate, Humira can be given alone. 
 
Polyarticular juvenile idiopathic arthritis 
 
Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 
2 to 17 years. Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one 
or more joints, with diagnosis typically occurring in children under the age of 16 years. You may 
first be given other disease-modifying medicines, such as methotrexate.  If you do not respond 
well enough to these medicines, you will be given Humira to treat your polyarticular juvenile 
idiopathic arthritis. 
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing 
spondylitis 
Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic 
evidence of ankylosing spondylitis in adults. Ankylosing spondylitis and axial spondyloarthritis 

 
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without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine. 
If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of 
ankylosing spondylitis, you will first be given other medicines. If you do not respond well 
enough to these medicines, you will be given Humira to reduce the signs and symptoms of your 
disease. 
Psoriatic arthritis 
Humira is used to treat psoriatic arthritis in adults. Psoriatic arthritis is an inflammation of the 
joints associated with psoriasis. Humira has been shown to slow down the damage to the 
cartilage and bone of the joints caused by the disease and to improve physical function. 
 
Psoriasis  
 
Humira is used to treat psoriasis in adults. Psoriasis is an inflammatory disease of the skin. If you 
have moderate to severe plaque psoriasis, you will first be given other medicines or e.g. 
phototherapy. If you do not respond well enough to these treatments, you will be given Humira 
to reduce the signs and symptoms of your psoriasis. 
 
Crohn’s disease in Adults and Children 
 
Humira is used to treat Crohn’s disease in adults and children aged 6 to 17 years of age. Crohn’s 
disease is an inflammatory disease of the digestive tract. Humira is indicated for the treatment of 
Crohn's disease in adults and in children aged 6 to 17 years. If you have Crohn’s disease you will 
first be given other medicines.  If you do not respond well enough to these medicines, you will 
be given Humira to reduce the signs and symptoms of your Crohn’s disease. 
 
Ulcerative Colitis 
 
Humira is used to treat ulcerative colitis in adults. Ulcerative colitis is an inflammatory disease 
of the bowel.  If you have ulcerative colitis you will first be given other medicines.  If you do not 
respond well enough to these medicines, you will be given Humira to reduce the signs and 
symptoms of your disease. 
 
 
 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE HUMIRA 
Do not use Humira 
 
x If you are allergic to adalimumab or any of the other ingredients ofthis medicine (listed in 
section 6). 

 
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x If you have a severe infection, including active tuberculosis (seeWarnings and precautions”).  
It is important that you tell your doctor if you have symptoms of infections, e.g. fever, 
wounds, feeling tired, dental problems. 
 
x If you have moderate or severe heart failure. It is important to tell your doctor if you have 
had or have a serious heart condition (see “Warnings and precautions”). 
 
Warnings and precautions 
 
Talk to your doctor or pharmacist before using Humira 
 
x 
If you experience allergic reactions with symptoms such as chest tightness, wheezing, 
dizziness, swelling or rash do not inject more Humira and contact your doctor immediately.  
 
x 
If you have an infection, including long-term or localized infection (for example, leg ulcer) 
consult your doctor before starting Humira. If you are unsure, please contact your doctor.  
 
x 
You might get infections more easily while you are receiving Humira treatment. This risk 
may increase if your lung function is impaired. These infections may be serious and 
include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other 
opportunistic infections and sepsis that may, in rare cases, be life-threatening. It is 
important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or 
dental problems. Your doctor may recommend temporary discontinuation of Humira. 
 
x 
As cases of tuberculosis have been reported in patients treated with Humira, your doctor 
will check you for signs and symptoms of tuberculosis before starting Humira. This will 
include a thorough medical evaluation including your medical history and appropriate 
screening tests (for example chest X-ray and a tuberculin test). The conduct and results of 
these tests should be recorded on your Patient Alert Card.  It is very important that you tell 
your doctor if you have ever had tuberculosis, or if you have been in close contact with 
someone who has had tuberculosis.  Tuberculosis can develop during therapy even if you 
have received preventative treatment for tuberculosis. If symptoms of tuberculosis 
(persistent cough, weight loss, listlessness, mild fever), or any other infection appear 
during or after therapy tell your doctor immediately.  
 
x 
Advise your doctor if you reside or travel in regions where fungal infections such as 
histoplasmosis coccidioidomycosis or blastomycosis are endemic. 
 
x 
Advise your doctor if you have a history of recurrent infections or other conditions that 
increase the risk of infections. 
 

 
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x 
Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active 
HBV or if you think you might be at risk of contracting HBV.  Your doctor should test you 
for HBV. Humira can cause reactivation of HBV in people who carry this virus. In some 
rare cases, especially if you are taking other medicines that suppress the immune system, 
reactivation of HBV can be life-threatening.  
 
x 
If you are over 65 years you may be more susceptible to infections while taking Humira. 
 You and your doctor should pay special attention to signs of infection while you are 
being  
treated with Humira. It is important to tell your doctor if you get symptoms of 
infections, such as fever, wounds, feeling tired or dental problems. 
 
x 
If you are about to undergo surgery or dental procedures please inform your doctor that you 
are taking Humira. Your doctor may recommend temporary discontinuation of Humira. 
 
x 
If you have demyelinating disease such as multiple sclerosis, your doctor will decide if you 
should receive Humira. 
 
x 
Certain vaccines may cause infections and should not be given while receiving Humira.  
Please check with your doctor before you receive any vaccines. It is recommended that 
children, if possible, be brought up to date with all immunisations in agreement with 
current immunisation guidelines prior to initiating Humira therapy. If you received Humira 
while you were pregnant, your baby may be at higher risk for getting such an infection for 
up to approximately five months after the last dose you received during pregnancy.  It is 
important that you tell your baby's doctors and other health care professionals about your 
Humira use during your pregnancy so they can decide when your baby should receive any 
vaccine. 
 
x 
If you have mild heart failure and you are being treated with Humira, your heart failure 
status must be closely monitored by your doctor. It is important to tell your doctor if you 
have had or have a serious heart condition. If you develop new or worsening symptoms of 
heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your 
doctor immediately. Your doctor will decide if you should receive Humira. 
 
x 
In some patients the body may fail to produce enough of the blood cells that help your 
body fight infections or help you to stop bleeding. If you develop a fever that does not go 
away, bruise or bleed very easily or look very pale, call your doctor right away.  Your 
doctor may decide to stop treatment. 
 
x 
There have been very rare cases of certain kinds of cancer in children and adult patients 
taking Humira or other TNF blockers. People with more serious rheumatoid arthritis that 
have had the disease for a long time may have a higher than average risk of getting 
lymphoma (a kind of cancer that affects the lymph system), and leukemia (a kind of cancer 
that affects the blood and bone marrow). If you take Humira the risk of getting lymphoma, 

 
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leukemia, or other cancers may increase. On rare occasions, a specific and severe type of 
lymphoma has been observed in patients taking Humira. Some of those patients were also 
treated with azathioprine or 6- mercaptopurine. Tell your doctor if you are taking 
azathioprine or 6-mercaptopurine with Humira. In addition cases of non-melanoma skin 
cancer have been observed in patients taking Humira. If new skin lesions appear during or 
after therapy or if existing lesions change appearance, tell your doctor. 
 
x 
There have been cases of cancers other than lymphoma in patients with a specific type of 
lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another 
TNF blocker.  If you have COPD, or are a heavy smoker, you should discuss with your 
doctor whether treatment with a TNF blocker is appropriate for you. 
Children and adolescents 
x  Vaccinations: if possible children should be up to date with all vaccinations before using 
Humira. 
x Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the 
age of 2 years. 
Other medicines and Humira 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic 
agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), 
steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs). 
 
You should not take Humira with medicines containing the active substance, anakinra or 
abatacept.  If you have questions, please ask your doctor.  
 
Humira with food and drink 
 
Since Humira is injected under the skin (subcutaneously), food and drink should not affect 
Humira. 
Pregnancy and breast-feeding 
The effects of Humira in pregnant women are not known and so the use of Humira in pregnant 
women is not recommended.  You are advised to avoid becoming pregnant and must use 
adequate contraception while using Humira and for at least 5 months after the last Humira 
treatment. If you become pregnant, you should consult your doctor. 
 
It is not known whether adalimumab passes into breast milk. 

 
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If you are a breast-feeding mother, you should stop breast-feeding during Humira treatment and 
for at least 5 months after the last Humira treatment. If you received Humira during your 
pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell 
your baby’s doctors and other health care professionals about your Humira use during your 
pregnancy before the baby receives any vaccine (for more information see section on 
vaccination). 
 
If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 
for advice before taking this medicine. 
 
Driving and using machines 
 
 Humira may have a minor influence on your ability to drive, cycle  or use machines. Room 
spinning sensation and vision disturbances may occur after taking Humira. 
3. 
HOW TO USE HUMIRA 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure.  
 
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial 
spondyloarthritis without radiographic evidence of ankylosing spondylitis 
 
Humira is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid 
arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of 
ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every 
other week as a single dose.   
 
In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor determines 
that methotrexate is inappropriate, Humira can be given alone.  
 
If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, 
your doctor may decide to give 40 mg adalimumab every week. 
 
Children with polyarticular juvenile idiopathic arthritis 
 
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, 
aged 2 to 12 years depends on the height and weight of the child.  
 
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, 
aged 13 to 17 years, is 40 mg every other week. 
 

 
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Adults with Psoriasis 
 
The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given 
every other week starting one week after the initial dose. You should continue to inject Humira 
for as long as your doctor has told you. 
 
Adults with Crohn’s disease 
 
The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other 
week two weeks later.  If  a faster response is required your doctor may prescribe an initial dose 
of 160 mg (as 4 injections in one day or 2 injections per day for two consecutive days), followed 
by 80 mg two weeks later, and thereafter as 40 mg every other week. Depending on your 
response, your doctor may increase the dose frequency to 40 mg every week. 
 
Children or adolescents with Crohn's Disease 
 
Children or adolescents weighing less than 40 kg:   
 
The usual dose regimen is 40 mg initially followed by 20 mg two weeks later.  If a faster 
response is required, your doctor may prescribe an initial dose of 80 mg (as 2 injections in 1 day) 
followed by 40 mg two weeks later. 
 
Thereafter, the usual dose is 20 mg every other week.  Depending on your response, your doctor 
may increase the dose frequency to 20 mg every week.   
 
Children or adolescents weighing 40 kg or more:  
 
The usual dose regimen is 80 mg initially followed by 40 mg two weeks later.  If a faster 
response is required, your doctor may prescribe an initial dose of 160 mg (as 4 injections in 1 
day or as 2 injections per day for 2 consecutive days) followed by 80 mg two weeks later. 
 
Thereafter, the usual dose is 40mg every other week.  Depending on your response, your doctor 
may increase the dose frequency to 40 mg every week. 
 
For patients who do not require a full 40 mg dose of Humira, a 40mg vial is also available. 
 
Adults with ulcerative colitis 
 
The usual Humira dose for adults with ulcerative colitis is 160 mg at Week 0 (dose can be 
administered as four injections in one day or as two injections per day for two consecutive days) 
and 80 mg at Week 2, and thereafter 40 mg every other week.  Depending on your response, 
your doctor may increase the dose to 40 mg every week. 
Method and route of administration 

 
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Humira is administered by injection under the skin (by subcutaneous injection). 
 
Instructions for preparing and giving an injection of Humira: 
The following instructions explain how to inject Humira. Please read the instructions carefully 
and follow them step by step. You will be instructed by your doctor or his/her assistant on the 
technique of self-injection. Do not attempt to self-inject until you are sure that you understand 
how to prepare and give the injection. After proper training, the injection can be self-
administered or given by another person, for example a family member or friend.   
 
This injection should not be mixed in the same syringe or vial with any other medicine. 
1)  
Setting up 
x 
Wash your hands thoroughly  
x 
Set up the following items on a clean surface 
 
o 
One pre-filled syringe of Humira for injection      
o 
One alcohol pad 
 
 
 
x 
Look at the expiry date on the syringe. Do not use the product after the month and year 
shown. 
2) 
Choosing and preparing an injection site 
 
x 
Choose a site on your thigh or stomach 

 
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x 
Each new injection should be given at least 3 cm from the last injection site.  
o 
Do not inject in an area where the skin is reddened, bruised, or hard.  This may mean 
there is an infection. 
o 
Wipe the injection site with the enclosed alcohol pad, using a circular motion. 
o 
Do not touch the area again before injecting. 
3)  
Injecting Humira  
x 
Do NOT shake the syringe. 
x 
Remove cap from needle syringe, being careful not to touch the needle or let it touch any 
surface. 
x 
With one hand, gently grasp the cleaned areas of skin and hold firmly 
 
 
x 
With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up. 
x 
With one quick, short motion, push needle all the way into skin 
x 
Release the skin with the first hand 
x 
Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe 
x 
When the syringe is empty, remove the needle from skin, being careful to keep it at the 
same angle as when it was inserted 

 
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x 
Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.  
A little bleeding may occur.  Do not rub the injection site. Use a plaster if you want to. 
4)  
Throwing away supplies 
x 
The Humira syringe should NEVER be reused. NEVER recap a needle. 
x 
After injecting Humira, immediately throw away the used syringe in a special container as 
instructed by your doctor, nurse or pharmacist. 
x 
Keep this container out of the reach and sight of children 
If you use more Humira than you should: 
If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, you 
should call your doctor or pharmacist and tell him/her that you have taken more. Always take the 
outer carton of medicine with you, even if it is empty.  
If you forget touse Humira: 
If you forget to give yourself an injection, you should inject the next dose of Humira as soon as 
you remember.  Then take your next dose as you would have on your originally scheduled day, 
had you not forgotten a dose.  
 
If you stop using Humira: 
 
The decision to stop using Humira should be discussed with your doctor. Your symptoms may 
return upon discontinuation 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
4. 
POSSIBLE SIDE EFFECTS 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most 
side effects are mild to moderate.  However, some may be serious and require treatment. Side 
effects may occur at least up to 4 months after the last Humira injection.   
 
Tell your doctor immediately if you notice any of the following:  
x Severe rash, hives or other signs of allergic reaction;  
x Swollen face, hands, feet; 
x Trouble breathing, swallowing; 
x Shortness of breath with exertion or upon lying down or swelling of the feet; 
 
Tell your doctor as soon as possible if you notice any of the following:  

 
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x 
Signs of infection such as fever, feeling sick, wounds, dental problems, burning on 
urination; 
x 
Feeling weak or tired; 
x 
Coughing; 
x 
Tingling; 
x 
Numbness; 
x 
Double vision; 
x 
Arm or leg weakness; 
x 
A bump or open sore that doesn't heal. 
x  Signs and symptoms suggestive of blood disorders such as persistant fever, bruising, 
bleeding, paleness 
 
The symptoms described above can be signs of the below listed side effects, which have been 
observed with Humira: 
 
Very common (may affect more than 1 in 10 people):   
 
x 
injection site reactions (including pain, swelling, redness or itching); 
x 
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia); 
x 
headache; 
x 
abdominal pain; 
x 
nausea and vomiting; 
x 
rash; 
x 
musculoskeletal pain. 
 
Common (may affect up to 1 in 10people): 
 
x 
serious infections (including blood poisoning and influenza); 
x 
skin infections (including cellulitis and shingles); 
x 
ear infections; 
x 
oral infections (including tooth infections and cold sores); 
x 
reproductive tract infections; 
x 
urinary tract infection; 
x 
fungal infections; 
x 
joint infections; 
x 
benign tumours; 
x 
skin cancer; 
x 
allergic reactions (including seasonal allergy); 
x 
dehydration; 
x 
mood swings (including depression); 
x 
anxiety; 
x 
difficulty sleeping; 

 
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x 
sensation disorders such as tingling, prickling or numbness; 
x 
migraine; 
x 
nerve root compression(including low back pain and leg pain); 
x 
vision disturbances;  
x 
eye inflammation; 
x 
inflammation of the eye lid and eye swelling; 
x 
vertigo; 
x 
sensation of heart beating rapidly; 
x 
high blood pressure; 
x 
flushing; 
x 
haematoma; 
x 
cough; 
x 
asthma; 
x 
shortness of breath; 
x 
gastrointestinal bleeding; 
x 
dyspepsia (indigestion, bloating, heart burn); 
x 
acid reflux disease; 
x 
sicca syndrome (including dry eyes and dry mouth); 
x 
itching; 
x 
itchy rash; 
x 
bruising; 
x 
inflammation of the skin  (such as eczema); 
x 
breaking of finger nails and toe nails; 
x 
increased sweating; 
x 
hair loss; 
x 
new onset or worsening of psoriasis; 
x 
muscle spasms; 
x 
blood in urine; 
x 
kidney problems; 
x 
chest pain; 
x 
oedema; 
x 
fever; 
x 
reduction in blood platelets which increases risk of bleeding or bruising; 
x 
impaired healing. 
 
Uncommon (may affect up to 1 in 100 people):  
 
x 
opportunistic infections (which include tuberculosis and other infections that occur when 
resistance to disease is lowered); 
x 
neurological infections (including viral meningitis); 
x 
eye infections; 

 
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x 
bacterial infections; 
x 
diverticulitis (inflammation and infection of the large intestine); 
x 
cancer; 
x 
cancer that affects the lymph system; 
x 
melanoma; 
x 
immune disorders that could affect the lungs, skin and lymph nodes (most commonly 
presenting as sarcoidosis); 
x 
tremor; 
x 
neuropathy; 
x 
stroke; 
x 
double vision; 
x 
hearing loss, buzzing; 
x 
sensation of heart beating irregularly such as skipped beats; 
x 
heart problems that can cause shortness of breath or ankle swelling; 
x 
heart attack; 
x 
a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood 
vessel; 
x 
lung diseases causing shortness of breath (including inflammation); 
x 
pulmonary embolism (blockage in an artery of the lung); 
x 
pleural effusion (abnormal collection of fluid in the pleural space); 
x 
inflammation of the pancreas which causes severe pain in the abdomen and back; 
x 
difficulty in swallowing; 
x 
 facial oedema; 
x 
gallbladder inflammation, gallbladder stones; 
x 
fatty liver; 
x 
night sweats; 
x 
scar; 
x 
abnormal muscle breakdown; 
x 
systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other 
organ systems); 
x 
sleep interruptions; 
x 
impotence; 
x 
inflammations. 
 
Rare (may affect up to 1 in 1,000 people): 
 
x 
leukaemia (cancer affecting the blood and bone marrow); 
x 
Severe allergic reaction with shock; 
x 
multiple sclerosis; 
x 
nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may 
cause muscle weakness, abnormal sensations, tingling in the arms and upper body); 

 
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x 
heart stops pumping;  
x 
pulmonary fibrosis (scarring of the lung); 
x 
intestinal perforation; 
x 
hepatitis; 
x 
reactivation of hepatitis B; 
x 
autoimmune hepatitis (inflammation of the liver caused by the body's own immune system) 
x 
cutaneous vasculitis (inflammation of blood vessels in the skin); 
x 
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash); 
x 
facial oedema associated with allergic reactions; 
x 
erythema multiforme (inflammatory skin rash); 
x 
lupus-like syndrome. 
 
Not known (frequency cannot be estimated from available data): 
 
x 
hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal); 
x 
Merkel cell carcinoma (a type of skin cancer); 
x 
liver failure; 
x 
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle         
weakness). 
 
Some adverse experiences observed with Humira may not have symptoms and may only be 
discovered through blood tests. These include: 
 
Very common (may affect more than 1 in 10people):  
 
x 
low blood measurements for white blood cells; 
x 
low blood measurements for red blood cells; 
x 
increased lipids in the blood; 
x 
elevated liver enzymes. 
 
Common (may affect up to 1 in 10 people): 
 
x 
high blood measurements for white blood cells;   
x 
low blood measurements for platelets; 
x 
increased uric acid in the blood; 
x 
abnormal blood measurements for sodium; 
x 
low blood measurements for calcium; 
x 
low blood measurements for phosphate; 
x 
high blood sugar; 
x 
high blood measurements for lactate dehydrogenase; 
x 
autoantibodies present in the blood. 
 

 
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Rare (may affect up to 1 in 1,000 people): 
 
x 
low blood measurements for white blood cells, red blood cells and platelet count. 
 
Not known (frequency cannot be estimated from available data): 
 
• 
liver failure. 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist . 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 HUMIRA 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date stated on the label/blister/carton after EXP:. The 
expiry date refers to the last day of that month. 
 
Store in a refrigerator (2qC – 8qC). Do not freeze.  
 
Keep the pre-filled syringe in the outer carton in order to protect from light.   
 
Alternative Storage: 
 
When needed (for example when you are travelling), a single Humira pre-filled syringe may be 
stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it 
from light.  Once removed from the refrigerator for room temperature storage, the syringe must 
be used within 14 days or discarded, even if it is returned to the refrigerator.   
 
You should record the date when the syringe is first removed from refrigerator, and the date after 
which it should be discarded.   
 
Do not throw any medicines via wastewater or household waste. Ask your doctor or pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 
environment. 
Any unused product or waste material should be disposed of in accordance with local 
requirements. 

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6. 
CONTENTS OF THE PACK AND OTHER INFORMATION 
What Humira contains 
The active substance is adalimumab.
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen 
phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium 
hydroxide and water for injections. 
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. 
essentially ‘sodium-free’ and does not contain preservatives.
What the Humira pre-filled syringe looks like and contents of the pack 
Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 
40 mg adalimumab dissolved in 0.8 ml solution.
The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.Each pack 
contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.  
Not all pack sizes may be marketed. 
Humira is available as a vial, , a pre-filled syringeand a pre-filled pen. 
Marketing Authorisation Holder: 
AbbVie Ltd 
Maidenhead 
SL6 4XE 
United Kingdom  
Manufacturer:  
For any information about thismedicine, please contact the local representative of the Marketing 
Authorisation Holder. 

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This leaflet was last revised in 09/2013. 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

 
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Appendix C: 
AUSTRIAN CONSENSUS  STATEMENT TUBERCULOSIS  &  BIOLOGICALS 
Leeb B, Thalhammer F, Brezinschek H.P., Bröll H., Erlacher L., Gaugg M., Herold M., Indra A., 
Kneussl M., Knoflach P., Krause R., Novacek G., Papay P., Reinisch W., Rumetshofer R. 
Trautinger F., Weiss G., Wenisch C., Winkler S. 
(Österreichische Ärztezeitung, Supplementum, März 2011:1-12) 
 
Recommendations for the Tbc-Screening and performance of a preventive therapy by a 
scheduled therapy with biologicals are currently available for TNF-blocking agents only, but not 
for other biologicals 1,2. As basis for the recommendations of TB-Screening and preventive 
therapy with other biologicals there are the respective latest SPCs available.  If due to medical 
history, medical status, X-ray (or CT), TB-tests, as well as sputum, bacterial culture results in the 
diagnosis in an active TB TNF-blocking agents are at first contraindicated. Following a TB 
therapy must be initiated according to the usual scheme. Regarding the question when, after 
having started with a TB-treatment a therapy with TNF-blocking agents shall be started there 
exists no consensus. Even in case of high emergency of a TNF-blocking therapy it has to be 
await the intensive phase of the TB therapy (at least a combination of three drugs for at least 2 
months). If a TB is diagnosed based on medical history and treated lege artis as well as 
documented appropriately, a therapy with TNF blocking agents is possible without preventive 
therapy. Clinical monitoring on a regular basis are required. In case of afflictions further 
radiological examinations (thorax-X-ray and thorax-CT), at pulmonal abnormality sputum 
examinations respectively. Bronchial are recommended (ZN, PCR and Tbc-culture).Has a 
pulmonal or extrapulmonal TB existed without having performed a respective therapy, both a 
thorax-CT and a ZN-sputum examination including bacterial culture (alternative ZN and 
bacterial culture from bronchial lavage) shall be performed. If an active TB appears the course of 
action is as explained above (active therapy, TNF-alpha-blocking agents after two months at the 
earliest). Is in such a case an active TB ruled out a preventive therapy is indicated. However is 

 
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there a normal thorax-X-ray without any anamnestic indication of TB the further course of action 
depends on the results of the IGRA (resp.MMT). In case of the IGRA-test yields a positive result 
a preventive therapy shall be started. Should the result of the IGRA-test render inconclusive and 
a subsequent performed MMT positive, a preventive therapy is indicated too. The preventive 
therapy should be administered as monotherapy. Mainly lsoniazid (INH; 1x daily 300mg over a 
period of 9 months see Tab below) is used.. It is recommended   that even at a preventive 
treatment a therapy with TNF-alpha-blocking agents should not be started at once but rather at 
the end of at least 4 weeks medicinally preventive TB therapy. This has especially pragmatic 
reasons such as a better assignability to a potential hepatotoxicity or other side effects. If a 
patient suffer from an increased risk for the occurrence of a polyneuropathy (diabetes, alcohole 
abuse, macrocytic anaemia, specific medicinal therapy), he/she should be treated with daily 
50mg Pyridoxin (possibly by use of a Vitamin-B-combination therapy) in addition to INH. A 
potential alternative to INH represents Rifampicin (RIF; 1x daily .600mg over a period of 4 
months. see Tab.). As a matter of course a patient must be enlightened about potential side 
effects of a preventive therapy. Controls of liver laboratory findings should be performed, before 
start of a preventive therapy and at the beginning in a one week or two week basis, afterwards 
every 4 to 8 weeks – at medical conditions however at once– in order to identify a  hepatopathy 
in due time. In case of a medicinal preventive therapy must be interrupted after a biological 
therapy has already been commenced a tight control is recommended.  
 
Drug 
Dosage 
Maximal daily dose 
Isoniazid (INH) 
5mg/kg; >50kg: 300mg 
300mg 
Rifampicin (RIF) 
10mg/kg; at >50kg: 600mg; at 
< 50kg: 450mg 
600mg 
Reference: 
1.  Diel Ret al.: [Recommendations for tuberculosis screening before initiation of TNF-alpha-inhibitor treatment in rheumatic diseases].  
   Pneumologie 2009;63(6):329-334 
2.  British Thoracic Society Standards ofCare Committee: BTS recommendations for assessing risk and for managing Mycobacterium 
tubercul05is infection and disease in patients due to start anti-TNF-alpha treatment. Thorax2005;60(10):800-805 
 
 
 
 

 
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TUBERCULOSIS INFORMATION 
Diel R., Hauer B., Loddenkemer R., Manger B., Krüger K. 
RECOMMENDATIONS FOR TUBERCULOSIS SCREENING BEFORE INITIATION 
OF TNFα-INHIBITOR TREATMENT IN RHEUMATIC DISEASES 
German Central Committee for the fight against tuberculosis 
(Deutsches Zentralkomitee zur Bekämpfung der Tuberkulose DZK) 
Zeitschrift für Rheumatologie 2009, 68:411–416 
 
Due to the increased risk of tuberculosis (TB) under treatment with TNF-α inhibitors for 
rheumatoid arthritis and other autoimmune diseases, precautionary measures are required before 
initiating TNF-α-inhibitor therapy. Patients should have active TB ruled out and screening for 
latent TB infection should be performed. The screening should include chest X-ray, complete 
medical history, and the administration of a highly specific interferon-γ-release assay (IGRA). 
(In the future, the reimbursement of IGRA tests under an analogue procedure code is expected to 
be formalized by the application of a code specific to the TB-IGRA procedure.) As tuberculin 
skin test (TST) results can be expected to be either false-positive or false-negative in these 
patients, the TST, as commonly performed in the past, is recommended only in exceptional 
situations. For chemopreventive treatment of latent TB infection (LTBI), Isoniazid (INH) is 
usually given for 9 months. 
 
 
 
CDC Treatment Recommendations for Positive PPD 
 
CDC CENTERS FOR DISEASE CONTROL AND PREVENTION 
 
Treatment of Tuberculosis Infection (Preventive Therapy) 
 
When taken as prescribed, isoniazide therapy is highly effective in preventing latent tuberculosis 
(TB) infection from progressing to TB disease. 

 
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Who should receive preventive therapy? 
The following persons should be given high priority for preventive therapy if they have positive 
skin test results, regardless of their age:   
● Persons known to have or suspected of having HIV infection (5 mm or greater of 
induration); 
● Persons who have been in close contact with someone who has infectious TB disease 
(5 mm or greater); 
● Persons whose skin test results converted from negative to positive within the past 2 
years (10 mm or greater increase for persons < 35 years old; 15 mm increase for 
persons 35 years of age or older) including children < 4 years old who have a positive 
skin test result (10 mm or greater); 
● Persons with abnormal chest radiographs who have never been treated for TB or who 
have been inadequately treated for TB (5 mm or greater); 
● Persons who have injected drugs and who are HIV seronegative (10 mm or greater), 
and 
● Persons who have medical conditions that increase the risk for TB (10 mm or 
greater). These conditions include diabetes mellitus, prolonged corticosteroid therapy, 
immunosuppressive therapy, gastrectomy, some hematologic and reticuloendothelial 
diseases, and end-stage renal disease, silicosis, and body weight that is 10% or more 
below ideal. 
 
In addition, in the absence of any of the above risk factors, persons younger than 35 years old in 
the following groups should be evaluated for preventive therapy if their reaction to the tuberculin 
skin test is 10 mm or greater:   
● Foreign-born persons from countries where TB is common; 
● Medically underserved, low-income populations; and 
● Residents of long-term care facilities. 
 
Preventive therapy should also be considered for persons who are younger than 35 years old, 
who have positive skin test results, and who have no risk factors for TB. 
In addition, staff of facilities in which a person with infectious TB disease would pose a risk to 
large numbers of susceptible persons (e.g., health care facilities, correctional facilities, and 
nursing homes) should be evaluated for preventive therapy if they have a positive skin test result. 

 
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Persons who have a positive reaction to the tuberculin skin test should not be given preventive 
therapy until the possibility of TB disease has been ruled out. In addition, persons who are being 
considered for preventive therapy should be evaluated for medical contraindications, such as: 
● Previous isoniazide-associated hepatic injury; 
● History of severe adverse reactions to isoniazide, and; 
● Acute or active liver disease. 
 
Also, special precautions should be taken for some persons who are receiving preventive 
therapy. 
Precautions are indicated for:   
● Persons who are older than 35; 
● Persons who abuse alcohol; 
● Pregnant women; 
● Persons with chronic liver disease; 
● Persons with peripheral neuropathy; and 
● Persons who in the past have stopped using isoniazide because of adverse effects. 
 
Regimens for Preventive Therapy 
The usual preventive therapy regimen is 9 months of daily isoniazide, in a dosage of 
5 milligrams per kilogram of body weight. The maximum daily dose is 300 milligrams. HIV-
infected persons should receive 12 months of preventive therapy. For persons with a strain of M. 
tuberculosis that is resistant to isoniazide but susceptible to rifampin, CDC recommends the use 
of rifampin alone at a dose of 10 mg/kg with a max of 600 mg daily for preventive therapy. 
 
 
 
 
 
 
 
Appendix D: eCRF including Questionnaires 
 
 

 
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HUMIRA 
(Adalimumab) 
 
1.0 
INVESTIGATOR 
 
PMOS Investigator name:____________________________________________ 
 
Unique IMPACT investigator number:__________ 
 
 
2.0 
PATIENT DEMOGRAPHICS 
 
 
 
 
 
 
 
1.  
Patient meets all applicable inclusion criteria as outlined in the protocol:  
 y       n 
 
 
2.  
Patient gave written authorization to use data:      
 
 
 
Date of consent: _________________  
 
3.  
Year of birth: ~___~___~___~___~ (YYYY)   
 
4.  
Gender:       m      f    
 
5.  
Race:          caucasian        black        asian         other  
 
 
 
 
 
 
 
   
      
6.  
RA  
 or PsA       or  AS 
or  Ps 
or CD  
7. 
Duration of disease: ___________ years 
 
8. 
Results of TB – Screening: 
 
 
¾ Chest X-ray:   Date performed: _________________ 
 
Findings:    normal 
  Calcified granulomas:    absent: 
    Pleural scarring absent:  
 
 
   abnormal 
 
 
 
     present: 
 
 
     present: 
 
 
Comments, if abnormal:____________________________________________________ 
 
 
 
¾ Interferon gamma test: (IGRA interferon gamma release assay, ) 

 
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Date performed: _________________ 
 
Please tick which test was used. 
  Quantiferon –TB Gold In Tube 
  T-SPOT-TB 
If another type of IGRA assay is used please specify:_____________________________ 
 
Findings:  
negative  
positiv          indecisive 
 
Comments: __________________________________________________________ 
 
¾ PPD Skin Test:  Date performed: __________________ 
 
 
 
 
Date assessed:    __________________ 
 
Result: Induration  _______ mm 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
     pos.         neg.  
 
 
 
 
¾ PPD Skin Re – test:  
Date: _______________ 
 
 
 
 
 
Result: Induration  _______ mm 
 
      pos.         neg. 
 
 
 
10. 
Normal lab value (reference values):     ESR____________ (mm /1 hr) 
   
                                                                   CRP____________ (mg/dl) 
 
11. 
Pre-treatment of disease:  
(Please answer the following questions where applicable) 
 
11.1.  Biological –naїve - pre-treatment with DMARDs (please specify):  
 
________________________________________________________________________ 
 
________________________________________________________________________ 
 
11.2 
Pre-treatment with BDMARDs  
 
11.2.1 Which BDMARD was used ? 
 
________________________________________________________________________ 
 
________________________________________________________________________ 

 
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In the following table please fill in the start date, end date, dosage, units and frequency  
of the latest BDMARD which was used before the switch to Adalimumab.  
Start date:  
End date: 
 
~__~__~     ~__~__~      ~__~__~ 
    DD         MON          YY 
 
~__~__~    ~__~__~       ~__~__~ 
    DD         MON          YY 
 
Doasge 
Units 
Frequency 
 
 
 
 
11.2.2  Reason for switch to HUMIRA  
 
Never achieved satisfactory response:  
 
 
 
 y           n        
Achieved satisfactory response initially, but lost it over time:  
 y           n         
Discontinued treatment due to intolerance/side effect(s) : 
 
 y           n         
 
Others__________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
HUMIRA 
(Adalimumab) 
For each visit 
 
ESR (mm / 1 hr)  
 
 
 
CRP (mg/l) 
(Erythrocyte Sedimentation Rate)  
 
(C-Reactive Protein) 
 
~__~__~__~  
 
 
 
~__~__~__~.~__~ 

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Adalimumab  
For Visit 1, Visit 5, and as appropriate for Early Termination   
10-item Beliefs about Medicines Questionnaire (BMQ)  
We would like to ask you about your personal views about your medicine and medicine in general. Please 
circle how you feel about each of the statements. There is no right or wrong answer, we are interested in 
your personal views. 
1. My health, at present, depends on my medicines 
Score:1-5

 
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1. Do you ever forget to take your medicine ? 
 
2. Are you careless at times about taking your medicines ? 
 
3. When you feel better do you sometimes stop taking your medicine ? 
 
4. Sometimes if you feel worse when you take the medicine, do you stop taking it ? 
 
           
 
 
 
 
    Total Score (sum of points) =  
    
            
 
 
 
 
 
 
 
 
 
 
 
 
  
Adalimumab 
For Visit 3, Visit 5, and as appropriate for Early Termination 
Treatment Satisfaction Questionnaire for Medication (TSQM) 
 
 
1. How satisfied or dissatisfied are you with the ability of the medication to prevent or treat 
your condition? 
 
 
 

 
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2. How satisfied or dissatisfied are you with the way the medication relieves your 
symptoms? 
 
 
 
3. As a result of taking this medication, do you currently experience any side effects at all? 
 
 
 
 
 Remark for the physician.: If YES please document on the SAE-Form ! 
 
4. How dissatisfied are you by side effects that interfere with your physical health and 
ability to function (e.g., strength, energy levels)? 
 
 
 
 
5. How dissatisfied are you by side effects that interfere with your mental 
function (e.g., ability to think clearly, stay awake)? 
 
 
 
6. How dissatisfied are you by side effects that interfere with your mood or  
emotions (e.g., anxiety/fear, sadness, irritation/anger)? 
 
 
 

 
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7. How satisfied or dissatisfied are you with how easy the medication is to  
use? 
 
 
 
8. How satisfied or dissatisfied are you with how easy it is to plan when you  
will use the medication each time? 
 
 
 
9. How satisfied or dissatisfied are you by how often you are expected to  
use/take the medication? 
 
 
 
10. How satisfied are you that the good things about this medication outweigh  
the bad things? 
 

 
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11. Taking all things into account, how satisfied or dissatisfied are you with this  
medication? 
 
 
 
 
 
 
 
 
 
 
 
 
           
SCALE SCORING ALGORITHM: TSQM Scale scores range from 0 to 100 and no computed 
score should be lower or higher than these limits. 
 
EFFECTIVENESS: ([(Item 1 + Item 2) − 2] divided by (12) × 100 
 
SIDE EFFECTS: ([Sum of Item 4 to Item 6) - 3] divided by 12) × 100  
If one item is missing: ([(Sum of the two completed items) - 2] divided by (8) × 100 
 
CONVENIENCE: ([Sum of Item 7 to Item 9) - 3] divided by 18) × 100 
If one item is missing: ([(Sum of the two completed items) - 2] divided by (12) × 100 
 
GLOBAL SATISFACTION: ([Sum of Item 10 to Item 11) − 2] divided by 12) × 100 
 
 
 
 
 
 
 
 
 
 
 

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3.
How would you describe the overall level of pain/swelling in joints, other than neck, back 
or hips you have had? 
~__~__~.~__~cm
4.
How would you describe the overall level of discomfort you have had from any areas 
tender to touch or pressure? 
~__~__~.~__~cm
5.
How would you describe the overall level of morning stiffness you have had from the 
time you wake up? 
~__~__~.~__~cm
6.
How long does your morning stiffness generally last from the time you wake up? 
~__~__~.~__~cm
Scoring of the BASDAI: The BASDAI Score has a range from 0 to10. 
 
                                        
¾ Measure each item of the BASDAI in centimeters (out of a total of 10) 
¾ Calculation:  
BASDAI Score = 0.2 x (Item 1 + Item 2 + Item 3 + Item 4 + Item  5  +  Item 6) 
2 
2 
Psoriasis Area and Severity Index 
PASI Scoring and Calculation 
Assessor Requirements 
The assessor should be a dermatologist or experienced physician. 
None 
Very severe 
0
10
0
10
None 
Very severe 
0
10
None 
Very severe 
0
¼
½         ¾
1        1¼
1½        1 ¾   ≥2  hours

 
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PASI Scoring 
Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for 
erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the 
examination. The severity of each sign is assessed using a 5-point scale:   
● 0 = No symptoms 
● 1 = Slight 
● 2 = Moderate 
● 3 = Marked 
● 4 = Very marked 
 
The table outlines the characteristics of each category 
 
Erythema 
Desquamation 
Induration 
0 = none 
No redness 
No scaling 
No elevation over normal 
skin 
1 = slight 
Faint redness 
Fine 
scale 
partially 
covering lesions 
Slight 
but 
definite 
elevation, typically edges 
indistinct or sloped 
2 
= 
moderate 
Red coloration 
Fine to coarse scale 
covering most of all of 
the lesions 
Moderate elevation with 
rough or sloped edges 
3 = marked 
Very or bright red 
coloration 
Coarse, non tenacious 
scale 
predominates 
covering most or all of 
the lesions 
Marked elevation typically 
with hard or sharp edges 
4 
= 
very 
marked 
Extreme 
red 
coloration; dusky 
to 
deep 
red 
coloration 
Coarse, thick, tenacious 
scale over most or all 
lesions; rough surface 
Very 
marked 
elevation 
typically with hard sharp 
edges 
a. Do not include residual hyperpigmentation or hypopigmentation as erythema. 
 
The area affected by psoriasis within a given anatomic site is estimated as a percentage of the 
total area of that anatomic site and assigned a numerical value according to the degree of 
psoriatic involvement as follows:   
● 0 = no involvement 
● 1 = <10% 

 
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● 2 = 10 to <30% 
● 3 = 30 to <50% 
● 4 = 50 to <70% 
● 5 = 70 to <90% 
● 6 = 90 to 100% 
 
The Rule of Nines to determine the Affected Area Score 
This method uses the assumption that when recording the % affected Area Involvement for each 
body region (See Table below), the number recorded represents that % of psoriasis in this region 
as a fraction of the Total BSA. Thus, the sum of the regions equals the Total BSA for that 
subject. The assessor must convert to determine the Affected Area Score for the region. 
 
REFERENCE 
CHART 
3: 
Body 
Region (Rule of 9s) 
Head 
& 
Neck 
Upper 
Extremiti
es 
Trunk 
Axillae & 
Genitals 
Lower 
Extremiti
es 
& 
Buttocks 
Total BSA 
% 
of 
Total 
Body 
Surface when using the 
rule of 9s 
9% 
18% 
37% 
36% 
100% 
 
  
In order to calculate the Affected Area Score, the % Area Involvement noted on physical 
examination, must be divided by the % Total Body Surface. 
 
Example: Upper Extremity involvement = 10% of total BSA (using palm method).  Affected 
Area Score = 10/18 = 55%.  Affected Area Score = 4 (See Below). 
Assignments for the following body regions are as follows:   
● Neck:  include with the head 
● Buttocks:  include with the lower extremities 
● Axilla:  include with the trunk 
● Genitals:  include with the trunk 
● The inguinal canal separates the trunk and legs 
 

 
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PASI Score Calculation: 
The PASI score for each body region is obtained by multiplying the sum of the severity scores 
by the area score, then multiplying the result by the constant weighted value assigned to that 
body region. Since the head, upper extremities, trunk, and lower extremities correspond to 
approximately 10, 20, 30, and 40% of body surface area, respectively; the PASI score is 
calculated using the formula 
 
PASI = 0.1(Eh + Ih + Dh)Ah + 0.2(Eu + Iu + Du)Au + 0.3(Et + It + Dt)At + 0.4(El + Il + Dl)Al 
 
where E, I, D, and A denote erythema, induration, desquamation, and area, respectively, and h, u, 
t, and l denote head, upper extremities, trunk, and lower extremities, respectively. PASI scores 
range from 0.0 to 72.0 with the highest score representing complete erythroderma of the severest 
degree. 
Based on articles: Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 
1978;157(4):238-44, and Mease, P. J. Measures of Psoriatic Arthritis. Arthritis Care Res, 2011,63(Suppl 11): S64–
S85. 
 
Harvey-Bradshaw Index (HBI) 
 
HBI BASED ON PATIENT'S SYMPTOMS IN PREVIOUS 24 HOURS 
General Well-Being  
              0 = very well, 1 = slightly below par, 2 = poor, 3 = very poor, 4 = terrible  
Abdominal Pain  
 
               0 = none, 1 = mild, 2 = moderate, 3 = severe  
 
Number of Liquid Stools per Day  
Abdominal Mass  
              0 = none, 1 = dubious, 2 = definite, 3 = definite and tender  

 
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(Adalimumab) 
for each visit 
 
 
HUMIRA ADMINISTRATION 
 
Dosage Frequency: 
 
    Every other week        Other (please specify): _________________________________________ 
 
x Patient first visit (PFV):  ~__~__~ ~__~__~ ~__~__~ 
(DD/MM/YY) 
 
x Patient first dose (PFD):  ~__~__~ ~__~__~ ~__~__ ~  
(DD/MM/YY) 
 
x Patient last visit (PLV):    ~__~__~ ~__~__~  ~__~__~ 
(DD/MM/YY) 
 
x Patient last dose (PLD):    ~__~__~ ~__~__~  ~__~__~ 
(DD/MM/YY) 
 
 
Further applications (date): 
 
1. 
 
2. 
 
3. 
 
4. 
 
5. 
 
6. 
 
7. 
 
8. 
 
9. 
 
10. 
 
11. 
 
12. 
etc. 
HUMIRA 

 
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(Adalimumab) 
final visit 
 
FINAL STATEMENT: 
 
Final remarks about compliance and adherence:  
 
Please provide a final statement about compliance and adherence (non-adherent, adherent) of the 
patient in general.  
 
___________________________________________________________________________ 
 
___________________________________________________________________________ 
 
Tolerability: 
 
Serious Adverse Events :    
NO       YES (If yes, please complete Serious Adverse Event 
Form) 
 
Therapy with Humira:   
ongoing after PMOS 
 
 
 
 
 
stopped after __________________ 
 
 
 
 
Reasons for treatment change: 
 
 
 
 
 
Serious adverse events 
 
 
 
 
 
treatment failure 
 
 
 
 
 
other reasons (please specify): __________________________ 
 
 
 
 
 
 
 
HUMIRA 
(Adalimumab) 
early termination 
 

 
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Patient Information and  Declaration of Consent concerning authorization to 
use data 
 
 
Title of the this study:  
Assessment of Rheumatoid Arthritis, Psoriatic Arthritis and 
Ankylosing Spondylitis, Psoriasis, Crohns Disease, Colitis Ulcerosa,  
patients`adherence attitudes to maintenance therapy with a 
scheduled Adalimumab treatment in routine clinical practice 
 
 
Dear patient, 
 
Introduction and Purpose 
Your physician has decided your treatment in accordance with usual medical practice and you 
are treated as recommended in the product label. This treatment was decided after diligent 
clarifications and the decision of your physician, that this treatment will be advantageous for 
you.  
The aim of this post-marketing observational study (PMOS) is the assessment of Rheumatoid 
Arthritis, Psoriatic Arthritis,Ankylosing Spondylitis, Psoriasis, Crohns Disease and Colitis 
Ulcerosa patients` adherence attitudes/beliefs to maintenance therapy with a scheduled 
Adalimumab treatment in routine clinical practice. 
Therefore data about your attitudes/beliefs to an intented therapy and your medication adherence 
according to a physicians specification as well as your treatment satisfaction will be collected 
during the course of your treatment with Adalimumab.  Independently of the treatment duration, 
this data collection period will be for a maximum of 1 year.  
In this context, some important points concerning the protection of data privacy have to be 
adhered to. If you agree, you will be asked to sign and date this consent form and you will be 
given a copy of the signed form. 
 
Details 
This study is an observational study according to §2a paragraph 3 of the Austrian Pharmaceutical 
Act. The observational study will involve approximately140 individuals in  28 centers. 
Individuals will be observed for a maximum period of 1 year. Your participation in this 
observational study makes it necessary that you allow your doctor to disclose some of your 
medical data to the sponsor (Abbott Gesellschaft m.b.H., A-1230 Wien). The observational study 
does not ask or require that a particular treatment should be used, your treatment should be 
altered or additional testing should be performed.   
 
x 
Release of Medical Information, and Confidentiality and Authorization  
People from Abbott, its related companies or independent companies auditing the results on 
behalf of Abbott, or employees of regulatory authorities will have access to your medical records 

 
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for the purpose of collecting data, verifying that the data is correct and checking that the 
procedure is properly done. Your data will be anonymized with the purpose, that you cannot be 
identified. By signing this form you are allowing these people to see your medical records. If the 
results of the observational study are published, the published report will not identify you. 
 
If you cancel your authorization, your personal and anonymized data may not be used or 
provided anymore from the time of your withdrawal. Cancelling authorization does not affect 
information that has already been disclosed or information gathered as a result of your 
participation in the trial.  
Records identifying you will be kept confidential and, to the extent permitted by the data 
protection act, will not be made publicly available.  
You understand that you have the right to access your medical records as allowed by national 
law. 
x 
 
x 
Contact Information 
If you have any questions about this study, please ask your physician. 
 
x 
Declaration of Consent 
 
 
9 I agree to take part in this Post-Marketing Observational Study. I understand that I do not 
have to participate in this observational study and that I can withdraw my participation and 
my consent at any time without any loss of advantages or benefits that I am otherwise 
entitled to.  
9 I hereby declare my consent with the use, the storage, the processing and the transfer of my 
medical data disclosed during the observational study to Abbott Laboratories, its related 
companies and independent companies auditing the results of the observational study on 
behalf of Abbott, the supervisory authorities, and the Ethics Committee, as necessary. 
9 I declare my consent with the use, the storage, the processing and the transfer of my personal 
data disclosed during the study to Abbott Laboratories and its related companies and other 
companies hired by Abbott. I understand and declare my consent with the transfer of my 
personal and medical data to Abbott Laboratories and its related companies and other 
companies hired by Abbott which may be located in other countries, including the United 
States.  This includes but is not limited to the use of these data by licensees or franchisees of 
Abbott. I agree that these data may be used for scientific presentations, research and 
development operations of Abbott.   
9 I understand that I will receive a copy of this signed and dated consent form.  
9 By signing this form I have not given up any of the legal rights that I would have as a 
participant in this study.  
9 I understand that by my signature I am authorizing access to my personal data as described 
above under the heading Release of Medical Information and Confidentiality and 
Authorization. I understand that I may revoke my authorization to the use or disclosure of my 
personal or medical data at any time. 
 

 
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______________________________________ 
Patient Name (print)  
 
 
_______________________________________ 
 
 
 
 
 
 
Patient Signature  
 
 
 
 
 
 
Date 
 
 
________________________________________  
 
__________________ 
Signature and stamp of the responsible physician 
 
 
Date 
 
 
 

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16. Research Plan Signature Page 
AbbVie Inc. (AbbVie) 
Post Marketing Observational Study 
Protocol (P13-562) 
Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, 
Ankylosing Spondylitis, Plaque Psoriasis, Crohn’s Disease and 
Ulcerative Colitis patients` 
adherence attitudes to maintenance therapy with a scheduled 
adalimumab treatment in routine clinical practice 
Administrative Change, 27 October 2016 
Approved by: 
Date
Date
Date