The Impact of Difficult to Treat Sites on Biological Treatment Response in Patients With Moderate-to-Severe Plaque Psoriasis
Conditions: Plaque Psoriasis
Sponsor: Pfizer

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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
The Impact of Difficult to Treat Sites on 
Biological Treatment Response in Patients 
with Moderate-to-Severe Plaque Psoriasis
Protocol number
B1801416
Protocol version identifier
Version 3.0
Date
27 July 2021
Active substance
Etanercept
Medicinal product
Etanercept
Research question and objectives
This study aims to evaluate the impact of 
difficult to treat sites on biological response 
in moderate-to-severe plaque psoriasis in 
Iraqi patients.
Author
MD, M.Sc.
Pfizer – 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
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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................2
2. LIST OF ABBREVIATIONS................................................................................................4
3. RESPONSIBLE PARTIES....................................................................................................5
4. ABSTRACT...........................................................................................................................5
5. AMENDMENTS AND UPDATES.......................................................................................6
6. MILESTONES.......................................................................................................................7
7. RATIONALE AND BACKGROUND..................................................................................7
8. RESEARCH QUESTION AND OBJECTIVES ...................................................................7
9. RESEARCH METHODS ......................................................................................................8
9.1. Study Design .............................................................................................................8
9.2. Setting........................................................................................................................8
9.2.1. Inclusion Criteria ..........................................................................................8
9.2.2. Exclusion Criteria.........................................................................................9
9.3. Data Sources..............................................................................................................9
9.4. Study Size..................................................................................................................9
9.5. Data Management .....................................................................................................9
9.6. Data Analysis ............................................................................................................9
9.7. Quality Control..........................................................................................................9
9.8. Limitations of the Research Methods......................................................................10
10. OTHER ASPECTS............................................................................................................10
11. PROTECTION OF HUMAN SUBJECTS ........................................................................10
11.1. Patient Information................................................................................................10
11.2. Patient Consent......................................................................................................10
11.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............10
11.4. Ethical Conduct of the Study ................................................................................10
12. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................11
13. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........11
14. REFERENCES ..................................................................................................................12
15. LIST OF TABLES.............................................................................................................13

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16. LIST OF FIGURES ...........................................................................................................13
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS.........................................................13

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2. LIST OF ABBREVIATIONS
Abbreviation
Term
AE
Adverse Event
BSA
Body Surface Area
IEC
Independent Ethics Committee
IRB
Institutional Review Board

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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. ABSTRACT
See Annex 1.
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5. AMENDMENTS AND UPDATES
Amendment 
number
Date
Protocol section(s) 
changed
Summary of 
amendment(s)
Reason
1
28
May 
2021
Section 8.5 Data 
Management
Section 8.6 Data 
Analysis
Aligning with
standard template
Administrative
Administrative
2
10 
June 
2021
Section 4. Abstract
Section 5. Milestones
Aligned with Study 
Report
Aligned with Study 
Report
Administrative
Administrative
3
27 
July 
2021
Throughout Document
Spelling errors
Administrative

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6. MILESTONES
Milestone
Planned date
Actual Date 
Start of data collection 
20 July 2020
20 July 2020
End of data collection
01 August 2020
01 August 2020
Final study report
30 Jun 2021 2020
30 Jun 2021
7. RATIONALE AND BACKGROUND
Iraq has over 4 years of experience using Enbrel for treatment of plaque psoriasis (PsO) in
patients but the first PsO patients to receive Enbrel was in 2014. The dermatologists at the
Baghdad Teaching Hospital observed a positive response from patients on Enbrel and it was 
discussed during the medical to medical interaction. The difficult to treat sites (scalp, face, 
skin folds, palms/soles and nails) are a major obstacle in the treatment of PsO.1 The
biological treatment is indicated for moderate-to-severe plaque psoriasis patients with
difficult to treat sites. Since there is no local published data and limited regional data
regarding the use of Enbrel in Iraqi PsO patients with difficult to treat sites, this study is
essential. 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 PsO.
8. RESEARCH QUESTION AND OBJECTIVES
This study aims to see the efficacy of Enbrel as a biological treatment for PsO in Iraqi 
patients who have difficult to treat sites at presentation.
Primary objective: Efficacy of Enbrel in plaque psoriasis with difficult to treat sites by 
measuring the following baselines: BSA, PASI and DLQI. A comparison between 6 months 
after treatment and last visit follow-up will be analyzed.
Secondary objective:
Determine the adherence of patients to the biological treatment. 

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9. RESEARCH METHODS
9.1. Study Design
This is a retrospective analysis of approximately 400 patients that were diagnosed with 
moderate-to-severe plaque psoriasis with difficult to treat sites. Patients will receive Enbrel
as treatment for their disease and will include primary and secondary endpoints.
Primary objective: Efficacy of Enbrel in Moderate-to-Severe Plaque Psoriasis with difficult 
to treat sites by measuring the baselines of BSA, PASI and DLQI and compare it with 
6 months after treatment and last visit follow-up during study.
Secondary objective: 

Determine the compliance of patients with Moderate-to-Severe Plaque Psoriasis on
Enbrel.

Will take the baselines of BSA, PASI and DLQI for 6 months after treatment and last 
visit disease activity index to see the efficacy. 

The patients will be divided into 2 groups according to their adherence to Enbrel. and 
will be compared between both groups in BSA, PASI and DLQI at 6 months after 
treatment and last visit disease activity index.
Also the demographic characterization of patients will be obtained (patients age, gender, 
disease duration, etc.) during data collection.
9.2. Setting
The study population will be obtained from a local registry, including patients diagnosed 
with moderate-to-severe plaque psoriasis and have been receiving etanercept treatment for at 
least 1-year. Study population must be ≥18 years of age and have difficult to treat sites at 
presentation.
9.2.1. Inclusion Criteria
Patients must meet each of the following inclusion criteria to be eligible for inclusion in the 
study:
1. Moderate-to-severe plaque psoriasis patients who have been receiving etanercept for 
at least 1-year duration.
2. Have difficult to treat sites at presentation.
3. Age ≥18 years.
4. No history of using other biological treatments, other than etanercept for the 
treatment of moderate-to-severe PsO.

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9.2.2. Exclusion Criteria
Patients meeting any of the following criteria will not be included in the study:
1. Etanercept use for treatment of moderate-to-severe PsO less than 1-year duration.
2. Previous use of another biological treatment for treatment of moderate-to-severe PsO.
9.3. Data Sources
The data source will be from local registry at Dermatology Center of Baghdad Teaching
Hospital. The data are structured and will be analyzed by the investigator.
9.4. Study Size
This study will include approximately 400 patients from the registry that meet the inclusion 
criteria of having moderate-to-severe PsO with difficult to treat sites at presentation.
9.5. Data Management 
Data already exists in a structured format and will be extracted to an excel spreadsheet which
will be analyzed using the SPSS database (version 23).
9.6. Data Analysis 
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented as below.
All covariates will be summarized to get information about frequency distribution and mean, 
median or standard deviation. Numbers and percentages will be provided for dichotomous 
and polychotomous variables when performing descriptive analysis of categorical data. 
Means, medians, standard deviations and interquartile range as appropriate will be provided 
for continuous variables when performing descriptive analysis of continuous data.
The bivariate analysis will be conducted to determine if there is any association between the 
outcome and the exposure (the covariates). Unadjusted comparisons of baseline 
characteristics for 0, 4, and 12 months after treatment and last visit disease activity index 
against outcome measures will be provided. Appropriate tests will be used based on the
distribution of the measure: chi-square test will be used for categorical variables, t-test will 
be used for continuous variables, and the Kruskall-Wallis test for non-parametric variables; 
p-values will also be generated. 
No regression model will be built for this analysis.
9.7. Quality Control
N/A.

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9.8. Limitations of the Research Methods
The missing data that could lead to bias is an identified limitation in this study.
10. OTHER ASPECTS
Not applicable.
11. PROTECTION OF HUMAN SUBJECTS
11.1. Patient Information 
This study involves data that exist in anonymized structured format and contain no patient 
personal information. 
11.2. 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.
11.3. 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.
11.4. 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).

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12. 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.
13. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
competent authority in any area of the world, or if the investigator is aware of any new 
information which might influence the evaluation of the benefits and risks of a Pfizer 
product, Pfizer should be informed immediately.

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14. REFERENCES
1.
Kragballe, Knud. "Management of difficult to treat locations of psoriasis." Management 
of Psoriasis. Vol. 38. Karger Publishers, 2009. 160-171.

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15. LIST OF TABLES 
None.
16. LIST OF FIGURES
None.
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS 
Number
Document reference 
number
Date
Title
1
Section 4
15 June 2021
The Impact of Difficult to Treat Sites on 
Biological Treatment Response in Patients 
with Moderate-to-Severe Plaque Psoriasis

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