Efficacy of Etanercept in Iraqi Patients With Moderate to Severe Psoriasis: 5 Years Data From Local Registry.
Conditions: Plaque Psoriasis
Sponsor: Pfizer

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 1 of 10
NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
Efficacy of Etanercept in Iraqi Patients with 
Moderate to Severe Psoriasis: 5 Years Data
from local registry.
Protocol number
B1801412
Protocol version identifier
3.0
Date
28 July 2021
Active substance
Etanercept
Medicinal product
Etanercept
Research question and objectives
This study aims to evaluate the efficacy of 
Enbrel as a biological treatment in moderate 
to severe plaque psoriasis patients in Iraq.
Author
MD, M.Sc.
Pfizer Inc– Iraq
This document contains confidential information belonging to Pfizer.  Except as otherwise agreed to in 
writing, by accepting or reviewing this document, you agree to hold this information in confidence and not 
copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes.  In 
the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified.
PPD
PPD

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 2 of 10
1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................2
2. LIST OF ABBREVIATIONS................................................................................................4
3. RESPONSIBLE PARTIES....................................................................................................5
4. AMENDMENTS AND UPDATES.......................................................................................5
5. MILESTONES.......................................................................................................................6
6. RATIONALE AND BACKGROUND..................................................................................6
7. RESEARCH QUESTION AND OBJECTIVES ...................................................................6
8. RESEARCH METHODS ......................................................................................................7
8.1. Study Design .............................................................................................................7
8.2. Setting........................................................................................................................7
8.2.1. Inclusion Criteria ..........................................................................................7
8.2.2. Exclusion Criteria.........................................................................................7
8.3. Data Sources..............................................................................................................8
8.4. Study Size..................................................................................................................8
8.5. Data Management .....................................................................................................8
8.6. Data Analysis ............................................................................................................8
8.7. Quality Control..........................................................................................................8
8.8. Limitations of the Research Methods........................................................................8
8.9. Other Aspects ............................................................................................................8
9. PROTECTION OF HUMAN SUBJECTS ............................................................................8
9.1. Patient Information....................................................................................................8
9.2. Patient Consent..........................................................................................................8
9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ................9
9.4. Ethical Conduct of the Study ....................................................................................9
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ........................................................................................................................9
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS..........9
12. REFERENCES ....................................................................................................................9
13. LIST OF TABLES...............................................................................................................9
14. LIST OF FIGURES .............................................................................................................9

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 3 of 10
ANNEX 1. LIST OF STAND ALONE DOCUMENTS .........................................................10

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 4 of 10
2. LIST OF ABBREVIATIONS
Abbreviation
Definition
AE
Adverse Event
BSA
Body Surface Area 
DLQI
Dermatology Life Quality Index 
IEC
Independent Ethics Committee
IRB
Institutional Review Board
PASI
Psoriasis Area and Severity Index
SPSS 
Statistical Package for the Social Science (Software)

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 5 of 10
3. RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol
Name, degree(s)
Job Title
Affiliation
Address
 MD, 
M.Sc.
Medical Advisor
NI Study Lead
Pfizer Inc – Iraq
 
4. AMENDMENTS AND UPDATES
Amendment 
number
Date
Protocol 
section(s) 
changed
Summary of amendment(s)
Reason
1
23 July 
2021
Throughout 
document
Spelling errors
Administrative
Section 5 
Milestones
Aligned dates with Study Report
Administrative
2
28 July 
2021
Throughout 
document
Spelling errors
Administrative
Section 5
Milestones
Align dates with Study Report
Administrative
PPD
PPD

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 6 of 10
5. MILESTONES
Milestone
Planned date
Start of data collection 
01 September 2020
End of data collection
01 October 2020
Final study report
01 September 2021
6. RATIONALE AND BACKGROUND
Iraq has over 5 years of experience in using Enbrel as a treatment for psoriasis patients, 
starting in 2014 when the first psoriasis patients received the first dose of Enbrel. 
Dermatologists in Baghdad Teaching Hospital observed a positive response in patients with 
psoriasis using a biological treatment such as Enbrel, this observation discussed this during 
our medical to medical interaction. Local data indicates the value of adherence and efficacy 
to treatment with Enbrel in patients with moderate-to-severe plaque psoriasis after five years 
of use. This study aims to address the need for evaluating local and regional data of Enbrel 
use in Iraqi psoriasis patients, as there is no local published and limited regional data,
currently. With the expected number of patients for this study, this would be the largest 
regional study for the evaluation of data on Enbrel use in Iraqi patients with moderate-to-
severe psoriasis.
This study will evaluate local data available in Iraqi patients with moderate-to-severe 
psoriasis on Enbrel treatment with regards to efficacy, treatment-regimen adherence, and 
patient characterization (ie, age, gender, and smoking status).
7. RESEARCH QUESTION AND OBJECTIVES
This study aims to evaluate the efficacy of Enbrel as a biological treatment in moderate-to-
severe plaque psoriasis patients in Iraq.
Primary objective: Efficacy of Enbrel in patients with moderate-to-severe plaque psoriasis 
by measuring baseline BSA, PASI, and DLQI scores compared to BSA, PASI, and DLQI 
scores after 6 months of initiation of treatment and compared to the last visit follow-up BSA, 
PASI, and DLQI scores.
Secondary objective:
Determine the first year adherence of patients with moderate-to-severe plaque psoriasis on a 
Enbrel treatment.

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 7 of 10
8. RESEARCH METHODS 
8.1. Study Design
This is a retrospective analysis of approximately 400 Iraqi patients diagnosed with moderate-
to-severe plaque psoriasis that received Enbrel as treatment for disease. 
Baseline, 6 months after initiation of Enbrel treatment and last visit follow-up, BSA, PASI, 
and DLQI scores for identified patients will be collected and used to evaluate efficacy. 
Patients will be further divided into 2 groups according to their adherence to Enbrel treatment 
(The adherent group will include the patients who were adherent to Enbrel treatment for one 
and seven years, and the non-adherent group will include patients who did not adhere to 
Enbrel).There will then be a comparison between both groups; in BSA, PASI, and DLQI 
scores at baseline, 6-months after Enbrel treatment, and at last visit follow-up after Enbrel 
treatment.
Patient demographic information (eg, age gender, disease duration) will be analyzed 
throughout the study.
8.2. Setting
Patients ≥18 years of age will be identified from the local registry at the Dermatology Center 
in Baghdad Teaching Hospital. Patients diagnosed with moderate-to-severe plaque psoriasis 
and have been receiving Enbrel treatment for at least 1-year duration are eligible for 
inclusion in the study.
8.2.1. Inclusion Criteria
Patients must meet each of the following inclusion criteria to be eligible for inclusion in the 
study:
1. Confirmed diagnosis of moderate-to-severe plaque psoriasis and receiving etanercept 
treatment for a minimum duration of 1 year.
2. Age ≥18 years old.
3. No history of using a biological treatment, other than etanercept, for treatment of 
moderate to severe plaque psoriasis or any other reason.
8.2.2. Exclusion Criteria
Patients meeting any of the following criteria will not be included in the study:
1. Etanercept use for treatment moderate-to-severe plaque psoriasis less than 1-year
duration.
2. Previous use of other biological treatments for any reason.

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 8 of 10
8.3. Data Sources
Data will be collected from the local registry at the Dermatology Center of Baghdad 
Teaching Hospital. The data are structured and will be analyzed by the investigator.
8.4. Study Size
This study will include approximately 400 patients from the local registry that meet the 
inclusion criteria detailed in that described previously.
8.5. Data Management 
The structured data is exported into an Excel spreadsheet. It will then be transferred to the 
SPSS database (version 23) which will be used for data management and analysis.
8.6. Data Analysis 
Categorical covariances will be described by frequency distribution while continuous 
covariates will be expressed in terms of their mean and standard deviation or median and 
interquartile range as appropriate. The unadjusted comparisons between groups of the 
covariates and the outcomes will be evaluated using chi-squared tests for categorical data, 
while for continuous data, the student’s t-test for normally distributed variables and the 
Kruskall-Wallis test for non-parametric data will be used.
8.7. Quality Control
Not applicable.
8.8. Limitations of the Research Methods
Missing data that could lead to bias is an identified limitation in this study.
8.9. Other Aspects
Not applicable.
9. PROTECTION OF HUMAN SUBJECTS
9.1. Patient Information 
This study involves data that exist in anonymized structured format and contain no patient 
personal information. 
9.2. Patient Consent
As this study involves anonymized structured data, which according to applicable legal 
requirements do not contain data subject to privacy laws, obtaining informed consent from
patients by Pfizer is not required.

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 9 of 10
9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
There must be prospective approval of the study protocol, protocol amendments, and other 
relevant documents (eg, informed consent forms if applicable) from the relevant IRBs/IECs.  
All correspondence with the IRB/IEC must be retained.  Copies of IRB/IEC approvals must 
be forwarded to Pfizer.
9.4. Ethical Conduct of the Study
The study conducted in accordance with legal and regulatory requirements, as well as, with 
scientific purpose, value, and rigor and follow generally accepted research practices 
described in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the 
International Society for Pharmacoepidemiology (ISPE), Good Epidemiological Practice 
(GEP) guidelines issued by the International Epidemiological Association (IEA), and Good 
Practices for Outcomes Research issued by the International Society for Pharmacoeconomics 
and Outcomes Research (ISPOR).
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS
This study involves data that exist as structured data by the time of study start.
In these data sources, individual patient data are not retrieved or validated, and it is not 
possible to link (ie, identify a potential association between) a particular product and 
medical event for any individual.  Thus, the minimum criteria for reporting an adverse event 
(AE) (ie, identifiable patient, identifiable reporter, a suspect product, and event) cannot be 
met.
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
In the event of any prohibition or restriction imposed (eg, clinical hold) by any applicable 
competent authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of a Pfizer product, 
Pfizer should be informed immediately.
12. REFERENCES
Not applicable.
13. LIST OF TABLES 
Not applicable.
14. LIST OF FIGURES
Not applicable.

Etanercept
B1801412 -NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 28 July 2021
PFIZER CONFIDENTIAL
Page 10 of 10
ANNEX 1. LIST OF STAND ALONE DOCUMENTS
None.

Document Approval Record
Document Name:
	
     
  
  


Document Title:
	
     
  
  


Signed By:
Date(GMT)
Signing Capacity
%&'&

 ()
)%
" **
PPD