This is a Prospective, Single-arm, Multicenter, Observational Non-interventional Study (NIS) in Germany of Patient Characteristics, Usage, and Effectiveness of Abrocitinib in Patients With Moderate to Severe Atopic Dermatitis (AD)
Conditions: Dermatitis, Atopic
Sponsor: Pfizer

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 1 of 62 
 
NON-INTERVENTIONAL STUDY PROTOCOL 
Study Information 
Title 
This is a prospective, single-arm, 
multicenter, observational non-interventional 
study (NIS) in Germany of patient 
characteristics, usage and effectiveness of 
abrocitinib in patients with moderate to 
severe atopic dermatitis (AD) 
Protocol number 
B7451089 
Protocol version identifier 
Version 3.0 
Date 
29 September 2023 
Active substance 
Janus kinase (JAK)1 Inhibitor 
Abrocitinib 
ATC code: D11AH08 
Medicinal product 
CIBINQO® 
Research question and objectives 
The objectives of this non-interventional 
study are to examine patient characteristics, 
usage and effectiveness of abrocitinib in 
adult patients with moderate to severe AD 
who have been chosen to start treatment with 
abrocitinib in a real-world- context such as 
dermatological practices in Germany.  
Author 
Pfizer Pharma GmbH 
Linkstraße 10, D-10785 Berlin 
 
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. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)
PPD

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 2 of 62 
1. TABLE OF CONTENTS 
1. TABLE OF CONTENTS .......................................................................................................2 
2. LIST OF ABBREVIATIONS ................................................................................................4 
3. RESPONSIBLE PARTIES ....................................................................................................7 
3.1. Sponsor ......................................................................................................................7 
3.2. Principal Investigator(s) of the Protocol ...................................................................7 
3.2.1. Contributors to the Protocol..........................................................................7 
4. ABSTRACT ...........................................................................................................................8 
5. AMENDMENTS AND UPDATES .......................................................................................8 
6. MILESTONES .....................................................................................................................15 
7. RATIONALE AND BACKGROUND ................................................................................16 
7.1. Atopic Dermatitis ....................................................................................................16 
7.2. Current Standard of Care .........................................................................................16 
7.3. Abrocitinib: Mechanism of Action (MoA) .............................................................18 
7.4. Summary of Study Rationale ..................................................................................18 
8. RESEARCH QUESTION AND OBJECTIVES .................................................................20 
9. RESEARCH METHODS ....................................................................................................21 
9.1. Study Design ...........................................................................................................21 
9.1.1. Endpoints ....................................................................................................22 
9.2. Study Setting ...........................................................................................................24 
9.2.1. Inclusion Criteria ........................................................................................25 
9.2.2. Exclusion Criteria .......................................................................................25 
9.2.3. Study Period................................................................................................25 
9.2.4. Assessments ................................................................................................31 
9.3. Variables ..................................................................................................................35 
9.4. Data Sources ............................................................................................................40 
9.5. Study Size ................................................................................................................40 
9.6. Data Management ...................................................................................................41 
9.6.1. Case Report Forms (CRFs)/Data Collection Tools (DCTs)/Electronic 
Data Record .....................................................................................................42 
9.6.2. Record Retention ........................................................................................42 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 3 of 62 
9.7. Data Analysis ..........................................................................................................43 
9.8. Quality Control ........................................................................................................44 
9.9. Limitations of the Research Methods ......................................................................44 
9.10. Other Aspects ........................................................................................................45 
10. PROTECTION OF HUMAN SUBJECTS ........................................................................45 
10.1. Patient Information ................................................................................................45 
10.2. Patient Consent ......................................................................................................46 
10.3. Patient Withdrawal ................................................................................................46 
10.4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............47 
10.5. Ethical Conduct of the Study ................................................................................47 
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................47 
11.1. Single Reference Safety Document .......................................................................55 
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........56 
13. REFERENCES ..................................................................................................................57 
14. LIST OF TABLES .............................................................................................................61 
15. LIST OF FIGURES ...........................................................................................................61 
ANNEX 1. LIST OF STAND ALONE DOCUMENTS .........................................................62 
ANNEX 2. ADDITIONAL INFORMATION .........................................................................62 
 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 4 of 62 
2. LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AD 
Atopic dermatitis 
AE 
Adverse event 
AEM 
Adverse event monitoring 
AMG 
Medicinal Products Act 
ATP 
Adenosine Triphosphate 
BfArM 
Bundesinstitut für Arzneimittel und 
Medizinprodukte (German Federal Institute for 
Drugs and Medical Devices) 
BSA 
Body Surface Area 
CI 
Confidence Interval 
CIOMS 
Council for International Organizations of Medical 
Sciences 
CRA 
Clinical Research Associate 
CRO 
Clinical Research Organization 
CSA 
Cinical Study Agreement 
DLQI 
Dermatology Life Quality-Index 
EASI 
Eczema Area and Severity-Index 
eCRF 
Electronic case report form 
EDP 
Exposure During Pregnancy 
EMA 
European Medicines Agency 
EoS 
End of Study 
EQ-5D-5L 
EuroQol five-dimensional-five level 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 5 of 62 
Abbreviation 
Definition 
FSA 
Voluntary Self-Regulation for the Pharmaceutical 
Industry 
GEP 
Good Epidemiological Practice 
GPP 
Good Pharmacoepidemiology Practice 
HADS 
Hospital Anxiety and Depression Scale 
HCP 
Healthcare Professional 
IEA 
International Epidemiological Association 
IEC 
Independent Ethics Committee 
IGA 
Investigators Global Assessment 
IL 
Interleukin 
IRB 
Institutional Review Board 
ISPE 
International Society for Pharmacoepidemiology 
ISPOR 
International Society for Pharmacoeconomics and 
Outcomes Research 
JAK 
Januskinase 
MoA 
Mechanism of Action 
MOS 
12-item Sleep Scale from the Medical Outcomes 
Study 
NIS 
Non-Interventional study 
NRS 
Numerical Rating Scale 
PBI 
Patient Benefit Index 
PC 
Personal Computer  
PEI 
Paul-Ehrlich Institute 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 6 of 62 
Abbreviation 
Definition 
POEM 
Patient Oriented Eczema Measure 
PP-NRS 
Peak Pruritus Numeric Rating Scale 
PRO 
Patient reported outcome 
QD 
Once Daily 
QoL 
Quality of Life 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SCORAD 
Scoring Atopic Dermatitis 
SmPC 
Summary of Product Characteristics 
TCI 
Topical Calcineurin Inhibitor 
TCS 
Topical Corticosteroid 
Th2 
Type 2 helper T 
TYK2 
Tyrosine Kinase 2 
VAS 
Visual Analogue Scale 
VfA 
Verband der forschenden Pharma-Unternehmen 
(German association of research-based  
pharmaceutical companies) 
 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 7 of 62 
3. RESPONSIBLE PARTIES 
3.1. Sponsor  
Pfizer Pharma GmbH  
Linkstraße 10  
D-10785 Berlin  
Germany 
3.2. Principal Investigator(s) of the Protocol 
Name, degree(s) 
Job Title 
Affiliation 
Address 
Athanasios 
Tsianakas, 
PD Dr. med. 
Coordinating 
Investigator 
Fachklinik Bad  
Bentheim Abt. für  
Dermatologie und  
Allergologie 
Am Bade 1  
48455 Bad Bentheim 
Germany 
Laurens Neumann. 
Medical 
Affairs 
Scientist Field  
Pfizer Pharma GmbH 
Linkstraße 10 
10785 Berlin 
Germany 
 
3.2.1. Contributors to the Protocol 
Name, degree(s) 
Job Title 
Affiliation 
Address 
 MD Dr. 
 med. 
Pfizer Pharma GmbH 
Linkstraße 10 
10785 Berlin 
Germany 
PhD 
Pfizer Pharma GmbH 
Linkstraße 10 
10785 Berlin 
Germany 
 PhD 
Pfizer Pharma GmbH 
Linkstraße 10 
10785 Berlin 
Germany 
 MD Dr. 
med.  
Pfizer Pharma GmbH 
Linkstraße 10 
10785 Berlin 
Germany 
 Dr. 
Alcedis GmbH 
Winchesterstr. 3 
35394 Gießen 
Germany 
 Dr. 
Alcedis GmbH 
Winchesterstr. 3 
35394 Gießen 
Germany 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 8 of 62 
4. ABSTRACT 
Not applicable. 
5. AMENDMENTS AND UPDATES 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
2 
15-Feb-
2022 
administ
rative 
3, 6, 9, 10  Change of job title. 
Start of data 
collection 15 April 
2022. 
Adding milestones 
and dates of interim 
analyses. 
Clarify that patients 
who are unable to 
consent will not be 
included in this study. 
Administrative change of job title, 
updates of milestones (start of data 
collection and interim analyses), 
clarification of patients who are 
unable to consent in exclusion 
criteria and in patient consent 
according to recommendation of 
ethics commission. 
3 
04-
Aug-
2023 
substanti
al 
2, 3, 4, 5, 
6, 7, 8, 9, 
10, 11, 
13, 
Annex 1, 
Annex 2, 
Annex 3 
2: Correction of 
translation error.  
Correction of 
spelling. 
Addition of the 
abbreviations “AdV” 
and “EoS” to the list 
of abbreviaitons. 
Removal of “HCP”. 
English translation of “AMG” was 
incorrect. 
See summary.  
 
See summary.  
 
Because of word harmonization 
“HCP” is not used any more. 
 
 
 
 
3: Changes in study 
roster and job titles. 
NI-Study Lead changed, as well as 
removal of the project manager of 
the CRO, since project manager 
was added errantly to the 
contributions list. Role of
rephrased since
does 
not partake in study conduction. 
 
 
 
 
4: Removal of the 
abstract. 
As abstract is not necessary, it was 
removed to streamline the outline 
of the protocol. 
 
 
 
 
5: Amendments 
Update to the Summary of changes 
since several sections were 
updated. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)
PPD
PPD
PPD

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 9 of 62 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
 
 
 
 
6: Alignment of 
Milestones to actual 
study start, 
prolongation of the 
recruitment phase, 
and adaptation of 
interim analyses to be 
triggered by number 
of applicable patients 
only. Updating dates 
of start and end of 
data collection, and 
final study report. 
Slow recruitment pace does not 
allow to adhere to initial timelines. 
To avoid a negative impact on 
interim analyses, the interim 
analyses will only be triggered by 
the number of applicable patients 
only rather than a fixed date. Since 
date of FPFV is known all 
connected dates are updated as 
well. 
 
 
 
 
7: Correction of 
spelling and phrasing. 
 
 
Update to the study 
rationale and clarified 
that “first 
prescription” means 
“first prescription 
after inclusion in this 
oberservational 
study”.  
See summary. Rephrasing also to 
clarify that abrocitinib experienced 
patients may also be included. 
Updated to give scientific rationale 
to the enhanced endpoint (see 
Section 9). “First prescription” 
was clarified so that abrocitinib 
experienced patients may be 
included as well. 
 
 
 
 
8: Correction of 
spelling and phrasing. 
Removal of the 
endpoint physician’s 
satisfaction and 
expectation. 
 
 
 
 
Clarification that 
patient’s expectation 
and satisfaction with 
treatment will be 
assessed with the 
PBI. 
See summary. 
 
 
Initial setup of eCRF was 
conducted without implementation 
of the endpoint physician’s 
expectation. As these endpoints 
are not validated, both endpoints 
will be removed as no scientific 
benefit can be inferred from it. 
This endpoint is captured twice as 
validated PRO and as unvalidated 
standalone question in the eCRF. 
Doubled capturing was deemed 
unnecessary and the validated 
endpoint was chosen while the 
unvalidated was removed. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 10 of 62 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
 
 
 
 
9: Correction of 
spelling and phrasing. 
 
 
 
 
Exchanged endpoint 
3b with 3g 
 
Removal of the 
endpoint physician’s 
satisfaction and 
expectation. 
 
 
 
Enhancement of the 
comorbidity 
endpoints 
 
 
 
Prolongation of the 
recruitment phase and 
administrative 
changes resulting out 
of this. 
Updated start study 
start. 
See summary. 
Rephrasing also to clarify that 
abrocitinib experienced patients 
may also be included. 
Endpoints were the same and 
therefore one was redundant. 
 
 
Initial setup of eCRF was 
conducted without implementation 
of the endpoint physician’s 
expectation and satisfaction. As 
both endpoints are not validated, 
the endpoint will be removed as no 
scientific benefit can be inferred 
from it 
 
Enhancing the endpoint 
“comorbidities of interest” to 
include a qualitative outcome 
assessment for alopecia areata, 
allergic rhinits, asthma, chronic 
hand eczema, nasal polyps and 
prurigo nodularis. Scientific 
rationale was added in Section 7.4 
 
Slow recruitment pace interferes 
with planned timelines and study 
design 
 
 
 
Update because actual date is 
known now. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 11 of 62 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
 
 
 
 
9 (continued) 
Administrative 
changes due to new 
version of CT24-WI-
GL02-RF01 4.0 
Clarification of the 
inclusion and 
exclusion criteria to 
be more concise on 
the aspect that 
abrocitinib naïve and 
experienced patients 
can be enrolled as 
well as clarified the 
time periods. 
Renaming “schedule 
of activities” to 
“recommended 
schedule of 
activities”. 
 
Clarification that 
patient’s expectation 
and satisfaction with 
treatment will be 
assessed with the 
PBI. 
 
Clarification that 
certain endpoints will 
be observed even 
after treatment with 
abrocitinib is 
discontinued 
Updated template (CT24-WI-
GL02-RF01 6.0) 
 
 
 
Misunder-standings regarding the 
enrollment of abrocitinib naïve and 
experienced patients as well as 
uncertainity over the time periods. 
 
 
 
 
 
 
To avoid intervention and clarify 
that visits are oriented solely upon 
clinical routine the "schedule of 
activities” was rephrased to 
“recommended schedule of 
activitities”. 
This endpoint is captured twice as 
validated PRO and as unvalidated 
standalone question in the eCRF. 
Doubled capturing was deemed 
unnecessary and the validated 
endpoint was chosen while the 
unvalidated was removed. 
 
 
See summary 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 12 of 62 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
 
 
 
 
9. (continued) 
Updated Table 2 due 
to the further 
specification of 
endpoints as well as 
administrative 
changes to use more 
concise language. 
Updating the usage of 
paper-based 
questionnaire to 
patient preference. 
Includes 
administrative 
changes regarding 
this update. 
Differentiation of the 
phrase “Electronic 
plausibility checks” 
Clarification that 
eCRF serves as 
source document for 
the patient 
questionnaires. 
Updated monitorings 
to include remote 
monitorings as well. 
Also follow-up letters 
are added to the 
process and 
monitorings are 
announced to the sites 
in advance. 
 
 
See summary. 
 
 
 
 
 
 
 
Difficulties of patients using the 
tablet PC for ePROs 
 
 
 
 
 
 
 
“Edit checks” and “electronic 
plausibility checks” are more 
concise. 
See summary. 
 
 
 
 
See summary 
 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 13 of 62 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
 
 
 
 
10: Administrative 
changes. Correction 
of wrong translation 
of “AMG”, spelling, 
and phrasing. 
Clarified that 
treatment 
discontinuation does 
not constitute patient 
withdrawal. 
 
See summary. 
 
 
 
 
See summary.  
 
 
 
 
11: Administrative 
changes. Correction 
of spelling and 
phrasing. 
Updated Safety 
Language text; 
deletion of “Protocol-
specified admission 
during clinical study 
(eg, for a procedure 
required by the study 
protocol)”. 
Added a caption for 
table 3. 
Clarification of the 
safety reporting 
periods. 
 
Clarification to the 
reporting 
requirements of 
pregnancies (Annex 
1). 
 
See summary. 
 
 
Safety Language text was updated 
from CT24-WI-GL02-RF01A 2.0 
to CT24-WI-GL02-RF01A 3.0.  
 
 
 
 
 
See summary.  
 
Unconcise language regarding 
reporting periods suggesting 24 h 
reporting period for non-serious 
adverse events. 
Uncertainties to the reporting 
process. 
 
 
 
 
12: Adding references 
and harmonizing 
citation style. 
See summary. Some references 
were updated due to incoherent 
citation style. 
 
 
 
 
13: Adding 
hyperlinks and page 
numbers. Added a 
title of table 3. 
See summary. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 14 of 62 
Version 
Identifie
r 
Date 
Amend
ment 
Type 
(substan
tial or 
administ
rative) 
Protocol 
Section 
Changed 
Summary of 
Amendment(s) 
Reason 
 
 
 
 
Annex 1: Adding the 
document 
B7451089_Pregnancy 
Reporting 
Process_V1_16JUN2
023 to the list. 
Removal of Abstract 
from list of “List of 
stand alone 
documents”. 
Uncertainties to the reporting 
process. 
 
 
 
 
See above, section 4. 
 
 
 
 
Annex 2: Removal of 
Annex 2 
Removal due to updating template 
CT24-WI-GL02-RF01 4.0 to 
CT24-WI-GL02-RF01 6.0 
 
 
 
 
Annex 3: Renamed 
Annex 3 to Annex 2 
Removal of Annex 2. 
 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 15 of 62 
6. MILESTONES 
Milestone 
Planned date 
Start of data collection  
10 May 2022 
Interim Report 1 
When approximately 15 % of patients 
completed Visit 1 
Interim Report 2 
When approximately 40 % of patients 
completed Visit 4 
End of data collection  
31 May 2027 
Final study report 
30 April 2028 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 16 of 62 
7. RATIONALE AND BACKGROUND 
7.1. Atopic Dermatitis 
AD is a common inflammatory skin disease characterized by pruritus, eczematous lesions 
and its chronically relapsing course. For European countries, a prevalence of 4.4% was 
estimated among adults based on survey data from 20161 In Germany, approximately 13% of 
children and adolescents aged 0-17 years are at least temporarily affected by AD.2 Skin 
manifestations typically start in childhood and can persist into adulthood.3 
Clinical signs of AD are pruritus and eczematous lesions with unpredictable periods of acute 
worsening (exacerbation of signs and symptoms/exacerbations) alternating with periods of 
relative calm after treatment. Chronic lesions are characterized by lichenification, nodulation 
and excoriation, and patients usually have a dry, flaky skin.  
Although great strides have been made in understanding the causes, the complex 
pathophysiology of AD is still not completely understood. It has been established that the 
pathophysiology of AD includes a defective skin barrier function, allergic responses, 
defective antimicrobial immune defense, and a genetic predisposition. The predominant 
symptom of AD is pruritus, and the resulting scratching typically sets off an amplification 
cycle of atopic skin inflammation with an immense impact on the patients´ quality of life, 
including physical and psychosocial effects on both patients and families.4 The health-related 
impact on quality of life (QoL) correlates with disease severity and exceeds that seen in 
patients affected with diseases like asthma, epilepsy, and diabetes. Comorbidities include 
sleep deprivation from pruritus (more than 60% of AD cases), pain, anxiety, depression, 
suicidal ideation, obesity, food allergies, asthma, and allergic rhinitis/rhino conjunctivitis, 
which can be debilitating and negatively impact all areas of personal, academic, professional, 
and daily life for the patient and family members.4,5 Therefore, one of the most important 
treatment goals should be a reduction of pruritus and that patients can report freedom from 
itching. 
7.2. Current Standard of Care 
AD management aims to improve symptoms and establish long-term disease control by 
avoidance of individual trigger factors, skin barrier restoration through moisturizer use, and a 
step-up/step-down approach aimed at reducing inflammation.6 The choice of 
anti-inflammatory-therapy is largely based on AD severity/activity; mild AD can usually be 
controlled with topical treatments; more severe disease may require phototherapy and/or 
systemic immunomodulatory therapy.7 Systemic treatment of AD is usually reserved for 
patients with refractory and severe disease where topical treatments of AD are not effective 
or have not been well tolerated. Currently only a limited number of treatments are available 
especially for patients with severe AD: Systemic therapy options, such as oral 
corticosteroids, immunomodulators such as Ciclosporin (Cyclosporin A) are associated with 
potentially severe adverse effects and require careful monitoring. For these reasons, the use 
of these agents is limited to short courses or intermittent therapy. Further, none offers a cure; 
therefore, the main aims of existing treatments are to reduce the occurrence of acute flares, to 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 17 of 62 
increase the time between relapses, and to reduce pruritus and the resulting sleep 
disturbance.7-9 Other systemic agents to treat AD are under clinical development or recently 
approved.  
In Germany dupilumab, an injectable monoclonal antibody directed against interleukin-4 
receptor alpha, was approved in 2017 and offers a novel mechanism of action for the 
treatment of patients (>12 years) with moderate to severe AD and children (>6 years) for the 
treatment of severe AD. Dupilumab inhibits signaling of interleukin (IL)-4 and IL-13, and by 
doing so alters type 2 helper T (Th2) cell-mediated immune responses and improves 
epidermal barrier abnormalities in AD. While efficacy results from clinical studies of 
dupilumab are compelling,10 a large proportion of subjects fail to achieve a favorable 
response of Investigator’s Global Assessment (IGA) 0-1/Eczema Area and Severity Index 
(EASI-75) and continue to experience the burden of moderate to severe AD. Additionally, a 
slow onset of action (2 to 4 weeks), and an incomplete relief of pruritus highlights the need 
for faster-acting therapies that work in a larger percentage of patients, especially on pruritic 
symptoms. In addition, treatment with dupilumab has the risk of injection site reactions, 
allergic reactions, eye and eyelid inflammations and cold sores.11 Furthermore, dupilumab is 
delivered via subcutaneous injection, which may not be a method of administration tolerated 
well by all patients.  
In June 2021, the second injectable monoclonal antibody, tralokinumab received drug 
approval by the European Medicines Agency (EMA) for the treatment of adult patients with 
moderate to severe atopic dermatitis who are candidates for systemic therapy. Tralokinumab 
neutralizes IL-13, a cytokine which is supposed to play a key role in AD.12 The effectiveness 
of tralokinumab monotherapy has been shown in the ECZTRA 1 and ECZTRA 2 trials.13 
Besides very commonly reported side effects like upper respiratory tract infections and 
commonly reported side effects like eye redness and itching, eye infections, and injection 
side reactions, tralokinumab very rarely can cause serious side effects including 
hypersensitivity reactions such as anaphylaxis.14 
Baricitinib, a JAK1/2 inhibitor, has been approved in 2020 as first small molecule for adult 
patients with moderate to severe AD who are eligible for systemic therapy. Baricitinib is 
taken orally as a tablet. According to the applicable summary of product characteristics of 
baricitinib, laboratory monitoring of lipid parameters, neutrophil count, lymphocyte count, 
hemoglobin, and liver transaminases should be performed while taking baricitinib. The use of 
baricitinib is associated with an increased risk of infections such as upper respiratory tract 
infections.15 
Most recently (in July 2021), upadacitinib a JAK1 inhibitor as second small molecule has 
been approved by the EMA for the treatment of adults and adolescents (≥12 years) with 
moderate to severe atopic dermatitis. Like baricitinib, upadacitinib is also taken orally as a 
tablet. According to the applicable Summary of Product Characteristics (SmPC) monitoring 
of neutrophil and lymphocyte count, hemoglobin, liver transaminases, and lipid parameters is 
strictly recommended. Also, upadacitinib use is associated with an increased risk of 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 18 of 62 
infections. The most frequent serious infections reported with upadacitinib included 
pneumonia and cellulitis.16 
However, there is still an unmet medical need for a conveniently administered therapy with 
an acceptable safety profile, for continuous and intermittent use, which is effective for 
moderate to severe AD and has a rapid onset of action including for the relief of pruritus. 
7.3. Abrocitinib: Mechanism of Action (MoA) 
Abrocitinib (PF-04965842) is an orally bioavailable small molecule being developed as an 
oral treatment for patients with moderate to severe AD, therefore it provides a more 
convenient route of administration compared with the subcutaneous injection required for 
dupilumab and does not have the potential risk of injection site reactions. Unlike dupilumab, 
abrocitinib is a small molecule and there is no anticipated immunogenicity to abrocitinib, and 
so it is unlikely to generate antidrug antibodies and may be used intermittently.  
Abrocitinib selectively inhibits JAK-1 by blocking the adenosine triphosphate (ATP) binding 
site. It has a high degree of selectivity against other kinases in the human genome: 28-fold 
selectivity over JAK-2, >340-fold over JAK-3 and 43-fold over tyrosine kinase 2 (TYK2) as 
well as a good selectivity profile over the broader range of human kinases. A variety of pro-
inflammatory cytokines such as IL-4, IL-5, IL-13, IL-31 and IFN-γ, have been suggested to 
be involved in the pathogenesis of AD. Many of these pathogenic cytokines use JAK-1 for 
signaling. This suggests that selective JAK-1 inhibitors that modulate the activity of these 
cytokines represent a compelling approach to the treatment of inflammatory skin diseases 
such as AD.17 Broader inhibition of cytokines, including those important in the pathogenesis 
of AD, may result in an increased proportion of responders, with an acceptable safety profile. 
The first Phase 3 studies, B7451012 and B7451013, that evaluated 100 and 200 mg once 
daily (QD) abrocitinib in participants with moderate to severe AD, which were completed in 
2019, reported statistically significant improvement in efficacy endpoints in both treatment 
groups compared to the placebo group, with an acceptable safety profile.18,19 
7.4. Summary of Study Rationale 
Currently, there is a lack of real-world data regarding the effectiveness of the new systemic 
treatment class of JAK inhibitors in AD in daily clinical practice in Germany. Thus, this 
non-interventional study was designed to gather information about non-selected patients who 
have been chosen to start treatment with abrocitinib in dermatological practices in Germany. 
In order to gain valuable and solid insights into current and upcoming real-world treatment 
patterns starting with a systemic abrocitinib therapy, all subsequent therapy sequences with 
reasons for the respective therapy decisions will be systematically documented. Specific 
information on the patient´s medical and clinical history, the routine clinical management 
including the reasons for starting treatment, management of treatment initiation, prescribed 
concomitant medication, its dosage, and actual use by the treated patient will be recorded. In 
order to understand not only the treatment management and reasons for starting treatment 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 19 of 62 
with abrocitinib, but also the reasons for ending therapy with abrocitinib, all patients will be 
followed up for the full individual observation period of 12 months after first abrocitinib 
prescription after inclusion in this observational study regardless of whether they are 
constantly treated with abrocitinib. 
Taking into account the more diverse patient population in the real-world setting, this 
non-interventional study will further provide additional short-and long-term real-world 
evidence for the effectiveness of abrocitinib in patients of medical interest and need, who 
may have been underrepresented in the controlled settings of clinical trials and evaluate 
patient-relevant endpoints including measurements of patient-reported outcomes, such as 
quality of life, depression, pruritus, and sleep quality.  
Patient preference and satisfaction of a therapy strongly affects adherence to a prescribed 
medication, ultimately affecting treatment outcome and efficacy. A factor known to have an 
impact on patient satisfaction with a prescribed treatment is the route of administration. Here, 
several studies point to a preference for oral therapies. Thus, this non-interventional study 
will document patient's expectations and satisfaction with regards to the treatment.  
Based on the collected patient characteristics (ie, severity/duration of disease, pretreatment, 
comorbidities) and the heterogeneity of patient profiles encountered in a real-world setting, 
potential predictors of response and prognostic factors for an optimal treatment can be 
identified and on some of them shall be further elaborated. Hand eczema with its atopic 
subtype20 already has a strong association with atopic dermatitis.20 For instance, with atopic 
dermatitis and hand eczema, both, the skin barrier dysfunction associated with filaggrin 
mutations, is relevant.21,22 The treatment of hand eczema is quite challenging, but anti-
inflammatory treatment is important;20,23 including JAK inhibition as an interesting new 
therapy approach.23,24 The association of AD and asthma is well established.25 It is now 
recognized that type 2 cytokines, like IL-4, IL-5 and IL-13, play an important 
pathophysiological role.26 Successfully conducted clinical trials with dupilumab in patients 
with uncontrolled persistent asthma26 and moderate-to-severe uncontrolled asthma27 resulted 
in the end with a market authorization of dupilumab as add-on maintenance treatment for 
severe asthma with type 2 inflammation in the European Union.11 Also allergic rhinitis and 
polyposis nasi, as atopic morbidities, are driven by type 2 inflammation,28 resulting in market 
authorization for dupilumab in the European Union for chronic rhinosinusitis with nasal 
polyposis.11 Also in alopecia areata, clinical trials with JAK inhibition were conducted 
successfully29,30 with baricitinib gaining market authorization in the European Union.31 
Prurigo nodularis and AD share JAK inhibition as a same treatment target (binding of IL-31 
to its respective receptor32,33 mediated through a JAK1 and JAK2 signaling pathway34) 
showing efficacy against pruritus.33 Consequently, the impact of adequately treated AD with 
abrocitinib on comorbidities of interest, such as (allergic) asthma, (allergic) rhinitis, 
polyposis nasi, chronic hand eczema, as well as other commonly associated comborbidities, 
like prurigo nodularis32,35 and alopecia areata,36,37 shall be assessed. Above shown 
information will help to draw inferences and optimize future therapy with abrocitinib and its 
clinical management. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 20 of 62 
8. RESEARCH QUESTION AND OBJECTIVES 
The objectives of this non-interventional study are to examine patient characteristics, usage 
and effectiveness of abrocitinib in adult patients with moderate to severe AD who have been 
chosen to start treatment with abrocitinib in a real-world context such as dermatological 
practices in Germany. The following factors will be considered, if collected as part of the 
medical routine: 
Research Questions: 
Primary Objective: 
The primary objective of this non-interventional study is to describe the efficacy of 
abrocitinib treatment.  
• In terms of patients achieving a clear or almost clear AD morphology 3 months after 
first prescription of abrocitinib based on the IGA Questionnaire. 
• In terms of patients achieving a ≥75% improvement in lesion extent and severity 
3 months after first prescription of abrocitinib based on the EASI-75. 
Secondary Objectives: 
The secondary objectives of this non-interventional study are: 
• To document the efficacy of abrocitinib treatment based on physicians´ assessment: 
• Physician’s global assessment of AD: Scoring Atopic Dermatitis (SCORAD), 
EASI, IGA change to baseline. 
• To document the efficacy of abrocitinib treatment based on patients´ assessment: 
• Patient’s global assessment of AD: change in quality of life, Dermatology Life 
Quality-Index (DLQI), Patient Oriented Eczema Measure (POEM); 
• Patient´s assessment of anxiety and depression: Hospital Anxiety and 
Depression Scale (HADS); 
• Patient’s assessment of pruritus: Peak Pruritus Numeric Rating Scale (PP-NRS), 
mean-NRS and sleep: Medical Outcomes Study Sleep (MOS) Scale; 
• Meeting the patient’s expectations (change in the Patient Benefit Index [PBI]) 
with regard to medical treatment; 
• Number of days with topical-treatment use (topical corticosteroid (TCS)), topical 
calcineurin inhibitor (TCI); 
• Number of days with emollients use. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 21 of 62 
Explorative objectives: 
The explorative objectives of this non-interventional study are: 
• To document patient characteristics and treatment decisions in terms of:  
• Patient characteristics, clinical history, comorbidities and previous therapies; 
• Reasons for starting/ending treatment with abrocitinib, concomitant treatments; 
• Dosage and actual use of abrocitinib as assessed by the treating physician and the 
patient. 
• To assess the safety in terms of adverse and serious adverse events that will occur in 
the observation period. Severity categories (mild, moderate and severe) of adverse 
events will be assessed based on investigator´s assessment (when applicable). 
9. RESEARCH METHODS  
9.1. Study Design  
This prospective, single-arm, multi-center, observational non-interventional study in 
Germany does not interfere with the current routine practice of the treating physician. All 
treatment decisions, types and timing of disease monitoring, diagnostic or other medicinal 
procedures are at the discretion of the treating physician and patients and are not influenced 
or affected by the participation in this non-interventional study.  
All assessments described in this protocol are performed as part of normal clinical practice or 
standard practice guidelines for the patient population and healthcare provider specialty in 
the countries where this non-interventional study is being conducted. There will be no 
additional diagnostic or monitoring procedures that are outside the routine clinical practice.  
This is a 60-month, prospective, non-interventional, multicenter study to evaluate the 
effectiveness, usage and patient characteristics of abrocitinib in patients with moderate to 
severe AD in a real-world setting.  
Eligible patients will be followed up for 12 months from the date of enrollment. Patients who 
are switched from abrocitinib therapy to other therapies continue to be observed. Patient 
documentation is expected quarterly as per standard clinical practice. 
Strength of this non-interventional study is the observation of drug prescription and follow-
up visits in a daily medical care setting. Therapeutic strategies, patient selection and 
frequency of patient follow-up are decided by the treating physician. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 22 of 62 
9.1.1. Endpoints 
Primary Endpoints: 
a. Response based on achieving the IGA of clear (0) or almost clear (1) (on a 5-point 
scale) at month 3. 
b. Response based on achieving the EASI-75 at month 3. 
Secondary Endpoints: 
Physician´s global assessment of efficacy parameters (assessed at all visits [except for month 
3 for a. and b.]): 
a. Response based on achieving the IGA of clear (0) or almost clear (1) (on a 5-point 
scale).  
b. Percentage of patients with EASI-75 response compared to baseline. 
c. Response based on achieving the EASI-90. 
d. Response based on achieving the IGA of clear (0) or almost clear (1) and a reduction 
from baseline of ≥2 points.  
e. Percentage change of IGA compared to baseline. 
f. Percentage change of SCORAD compared to baseline.  
g. Absolute EASI values over time.  
h. Percentage change of EASI compared to baseline. 
i. Absolute change of IGA compared to baseline. 
Patient´s assessment of efficacy and quality parameters (assessed at all visits): 
a. Response based on achieving at least 4 points improvement of Pruritus NRS from 
baseline.  
b. Change of Peak-Pruritus NRS over time. 
c. Change of POEM from baseline. 
d. Change of MOS from baseline. 
e. Change of DLQI from baseline. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 23 of 62 
f. Change of HADS from baseline. 
g. Change of EuroQol five-dimensional-five level (EQ-5D-5L) from baseline. 
h. Patient’s satisfaction with treatment measured by PBI. 
i. Patient’s expectation of treatment measured as PBI at baseline. 
j. Number of days with topical-treatment use (TCS, TCI). 
k. Number of days with emollients use. 
Explorative Endpoints: 
Treatment characteristics (assessed at all visits): 
a. Concomitant treatments. 
b. Tolerability of abrocitinib and reasons for discontinuation.  
c. Dosage of abrocitinib. 
d. Compliance with abrocitinib treatment. 
Patient characteristics assessed at baseline visit only (except for c., f., g., and h. with 
additional assessment at subsequent visits): 
a. Demographic data of patient (age, sex, weight, occupation, alcohol/smoking, family 
history). 
b. Clinical history of AD treatment before non-interventional study start.  
c. Comorbidities of interest (atopic diseases, malignancies, cardiovascular diseases, 
alopecia areata, prurigo nodularis, hand eczema). If baseline visit had a positive 
anamnesis for the following: (allergic) asthma, (allergic) rhinitis, polyposis nasi, 
chronic hand eczema, prurigo nodularis and alopecia areata, a qualitative outcome 
assessment will be done (ie, assessment of investigator if comorbidity improves 
during abrocitinib therapy). 
d. Previous therapies and reasons for termination of previous treatments. 
e. Reasons for starting treatment with abrocitinib. 
f. Number of AD flares one year before start of treatment with abrocitinib and during 
observational period. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 24 of 62 
g. Number of absent days at work/study caused of AD one year before start of treatment 
with abrocitinib and during observational period. 
h. Number of AD hospitalizations in the observation period and one year before start of 
treatment with abrocitinib. 
Documentation of safety: 
a. Safety: incidence of adverse events and serious adverse events. 
b. Severity of adverse events (when applicable) (as assessed by the investigator 
according to the following categories: 
• Mild: Does not interfere with the patient´s usual function. 
• Moderate: Interferes to some extent with the patient´s usual function. 
• Severe: Interferes significantly with the patient´s usual function. 
9.2. Study Setting 
Figure 1. Timelines 
In total, this non-interventional study aims to enroll at least 750 patients at approximately 
80 study sites across Germany. The planned enrollment period is 48 months. With a planned 
observation duration of 12 months per patient, the entire study would last for 60 months. The 
non-interventional study started in April 2022 and will end in May 2027.  
 
Month 0 
Start of Study 
End of study 
End of 
Enrollment 
Month 48 
Month 60 
Observation 
12 months 
 
Overall study duration 60 months 
Enrollment 48 months 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 25 of 62 
9.2.1. Inclusion Criteria 
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the 
non-interventional study: 
1. Patients aged ≥18 years. 
2. Confirmed diagnosis of AD by dermatologist prior to study inclusion. 
3. Patient for whom the decision to initiate treatment with abrocitinib was made as part 
of routine clinical practice irrespective of the patient being  
a. abrocitinib naïve or,  
b. Patients who reinitialize treatment with abrocitinib after being off treatment for 
≥28 days prior to study inclusion. 
4. Patient is eligible for abrocitinib treatment according to SmPC.  
5. Evidence of a personally signed and dated informed consent document indicating that 
the patient has been informed of all pertinent aspects of the non-interventional study. 
9.2.2. Exclusion Criteria 
1. Patients meeting any of the following criteria will not be included in the non-
interventional study: Contraindications according to SmPC. 
2. Receipt of any investigational drug within 3 months or longer if required according to 
wash-out period prior to inclusion or participation in a clinical trial during 
observation period. 
3. Patients being treated with abrocitinib within a time period of <28 days prior to the 
timepoint of study inclusion. 
4. Patients who are investigational site staff members or patients who are Pfizer 
employees directly involved in the conduct of the non-interventional study. 
5. Patient who are unable to consent.  
9.2.3. Study Period 
The planned observation period of each patient is 12 months. In this time period up to 6 visits 
will be documented.  
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 26 of 62 
Figure 2. Study Period 
 
9.2.3.1. Study Procedure 
After contractual agreement and ethics committee approval, but before the start of the 
observational study at a respective site, the study team at this site will be informed in detail 
about the planned conduction of the NIS, the study objectives, the handling of the electronic 
case report form (eCRF), the documentation of safety events and all other relevant aspects. 
This will be done by the delegated Clinical Research Organization (CRO) (Alcedis GmbH, 
Gießen, Germany) via an online initiation. In addition, each participating site will receive a 
study binder containing all necessary and essential documents and information. In addition, 
each site will be provided with a tablet personal computer (PC) which is to be used solely for 
allowing patients to document the patient questionnaires as outlined in Section 9.2.3.2 
(Schedule of Activities) and needs to be returned to the CRO after the end of the study. 
Afterwards, the trained site staff will get access to the study´s eCRF, where the data and 
findings of the patient are documented.  
Following site initiation, the study site will be open for enrollment of patients. Patients can 
be included by the investigator if they fulfill all inclusion criteria and do not meet any of the 
exclusion criteria for the study and are started on treatment with abrocitinib for moderate to 
severe atopic dermatitis. Within this non-interventional study 6 visits may be documented. 
All visits shall be scheduled according to clinical practice. The treatment decision to initiate 
abrocitinib as well as the treatment of a patient itself is independent from the patient´s 
enrollment into the NIS and carried out as per standard of care. To provide accurate 
information regarding the treatment, the initial abrocitinib dose and all changes and the 
reasons for changes are documented during the course of the evaluation. The concomitant 
treatment of atopic dermatitis is determined by the investigator. 
Eligible patients must be informed orally and in written form about the nature and purpose of 
this non-interventional study by the investigator. After the patient has signed and dated the 
informed consent, the patient can be enrolled in the NIS.  
For each patient a unique patient number is generated automatically in the eCRF to ensure 
pseudonymized data collection. No direct identifiers like patient names, patient initials or 
specific birth dates will be documented in the eCRF. 
To allow source data verification during quality assurance visits, the patient´s name, address 
and unique study-specific patient number will be listed in a patient identification list at the 
respective site. The patient identification is to be kept strictly confidential.  
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 27 of 62 
Since patients are to complete the patient questionnaires via the tablet PC provided at the 
study site, participating patients will receive individual access data to gain access to the 
questionnaires. The access data for the respective patient of a site can be generated within the 
eCRF and will be handed out to the patient by the site staff. However, paper-based 
questionnaires are available as back up for patients that do not want to use the online version 
or in case of technical issues (eg, internet problems at a study site). If a patient fills out paper 
questionnaires, these will be sent by mail to the delegated CRO where the data will be 
entered into the eCRF by qualified and trained personnel. 
9.2.3.2. Schedule of Activities  
The recommended schedule of activities table provides an overview of the visits that may be 
documented. Refer to Section 9.2.4 Assessments section of the protocol for detailed 
information on each documentation and assessment. As this is a non-interventional study 
none of these visits are mandatory and every visit should be scheduled according to clinical 
practice. According to clinical practice the HCP may schedule additional visits to those listed 
on the schedule of activities, in order to conduct evaluations or assessments required to 
protect the well-being of the patient. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 28 of 62 
Table 1. 
Recommended Schedule of Activities 
Study period based on 
routine visits  
Baseline 
(Enroll
ment)  
Month  
1 
Month  
3 
Month  
6 
Month 
9 
Month 
12 
End of 
Study 
(EoS)  
Visit Number  
1 
2  
3 
4 
5 
6 
Informed consent 
X 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
Demographic data of patient 
(age, sex, weight, height, 
ethnicity, smoker/non-
smoker, education, 
occupation, alcohol 
consumption, insurance type) 
X 
 
 
 
 
 
Family history of atopic 
diseases 
X 
 
 
 
 
 
Clinical history (Herpes 
simplex, eczema herpeticum, 
herpes zoster) 
X 
 
 
 
 
 
Renal and/or liver impairment 
X 
 
 
 
 
 
Vaccination status (Herpes 
zoster, Covid-19, Influenza, 
Varicella) 
X 
 
 
 
 
X 
Age at initial diagnosis of AD  
X 
 
 
 
 
 
Previous treatments for 
diagnosed AD  
X 
 
 
 
 
 
Current comorbidities of 
interest (atopic diseases, 
malignancies, cardiovascular 
diseases) 
X 
 
 
 
 
 
If positive anamnesis at 
baseline exists: Improvement 
of asthma symptoms from 
baseline 
 
 
 
 
 
X 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 29 of 62 
Study period based on 
routine visits  
Baseline 
(Enroll
ment)  
Month  
1 
Month  
3 
Month  
6 
Month 
9 
Month 
12 
End of 
Study 
(EoS)  
If positive anamnesis at 
baseline exists: Improvement 
of allergic rhinitis symptoms 
from baseline 
 
 
 
 
 
X 
If positive anamnesis at 
baseline exists: Improvement 
of polyposis nasi symptoms 
from baseline 
 
 
 
 
 
X 
If positive anamnesis at 
baseline exists: Improvement 
of alopecia areata from 
baseline 
 
 
 
 
 
X 
If positive anamnesis at 
baseline exists: Improvement 
of prurigo nodularis from 
baseline 
 
 
 
 
 
X 
If positive anamnesis at 
baseline exists: Improvement 
of hand eczema from baseline 
 
 
 
 
 
X 
Number of flares during the 
last 12 months (first visit) and 
since the last visit (regardless 
of Abrocitinib treatment 
status*) 
X 
X 
X 
X 
X 
X 
Number of hospitalizations 
due to AD during the last 12 
months (first visit) and since 
the last visit (regardless of 
Abrocitinib treatment status*) 
X 
X 
X 
X 
X 
X 
Number of absent days at 
work/study due to AD one 
year before start of treatment 
with Abrocitinib (first visit) 
and since the last visit 
X 
X 
X 
X 
X 
X 
 
* This includes patients who discontinued treatment with Abrocitinib. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 30 of 62 
Study period based on 
routine visits  
Baseline 
(Enroll
ment)  
Month  
1 
Month  
3 
Month  
6 
Month 
9 
Month 
12 
End of 
Study 
(EoS)  
(regardless of Abrocitinib 
treatment status*) 
Reasons for start of therapy 
with 
Abrocitinib 
X 
 
 
 
 
 
Reasons for discontinuation 
of therapy with Abrocitinib 
 
X 
X 
X 
X 
X 
Compliance with Abrocitinib 
treatment 
 
X 
X 
X 
X 
X 
Dosage of Abrocitinib used 
X 
X 
X 
X 
X 
X 
Reasons for prescribed dosage 
X 
X 
X 
X 
X 
X 
Type and results of laboratory 
check controls 
X 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
Concomitant treatment AD 
specific (type and dosage) 
X 
X 
X 
X 
X 
X 
Number of days with topical- 
treatment use (TCS, TCI) & 
days with emollients use three 
months before start of 
treatment with Abrocitinib 
(first visit) and since the last 
visit (regardless of 
Abrocitinib treatment status* 
X 
X 
X 
X 
X 
X 
Concomitant (non-AD) 
treatment 
X 
 
 
 
 
 
SCORAD 
X 
X 
X 
X 
X 
X 
EASI 
X 
X 
X 
X 
X 
X 
 
* This includes patients who discontinued treatment with Abrocitinib. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 31 of 62 
Study period based on 
routine visits  
Baseline 
(Enroll
ment)  
Month  
1 
Month  
3 
Month  
6 
Month 
9 
Month 
12 
End of 
Study 
(EoS)  
IGA 
X 
X 
X 
X 
X 
X 
Pruritus-NRS 
X 
X 
X 
X 
X 
X 
PP-NRS 
X 
X 
X 
X 
X 
X 
DLQI 
X 
X 
X 
X 
X 
X 
POEM 
X 
X 
X 
X 
X 
X 
MOS 
X 
X 
X 
X 
X 
X 
PBI 
X 
X 
X 
X 
X 
X 
EQ-5D-5L 
X 
X 
X 
X 
X 
X 
HADS 
X 
X 
X 
X 
X 
X 
 
9.2.4. Assessments 
9.2.4.1. Demographic Data 
At the baseline Visit (Visit 1) age, sex, weight, height, ethnicity, smoker/non-smoker, 
education, occupation, alcohol consumption and insurance type (statutory and private health 
insurance) will be documented.  
9.2.4.2. Disease Characteristics and Previous AD Treatments 
At the baseline Visit (Visit 1) the presence of a family history of atopic diseases as well as a 
patient´s clinical history regarding herpes simplex, herpes zoster, eczema herpeticum will be 
documented. Furthermore, the age at initial diagnosis of AD, previous treatments for 
diagnosed AD as well as current comorbidities of interest (atopic diseases: asthma, allergic 
rhinitis, food allergies, nasal polyps; malignancies, cardiovascular diseases) and concomitant 
non-AD specific treatments will be documented. At the baseline visit the number of flares as 
well as the number of hospitalizations and the number of absent days at work/study caused 
by AD during the last 12 months prior to start of abrocitinib will be documented. At each of 
the subsequent visits (Visit 2-6), the number of flares, the number of hospitalizations due to 
AD, as well as the number of absent days at work/study since the last documented visit will 
be captured. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 32 of 62 
9.2.4.3. Vaccination Status 
At the baseline Visit (Visit 1) current vaccination status of patients will be assessed. Further 
vaccinations against Herpes Zoster, Covid-19, Influenza and Varicella will be assessed. At 
Visit 6 (Month 12) assessment of vaccination status of patients against Herpes Zoster, 
Covid-19, Influenza and Varicella in case complete vaccination status was not achieved at 
baseline visit. 
9.2.4.4. Laboratory Checks 
At each visit (Visit 1-6) the conduct (yes/no) and the respective value and test date (if 
applicable) of laboratory checks of the following parameters will be documented. Please note 
that no laboratory tests need to be performed for study purposes. Only the date of 
examination and the respective value of laboratory parameters that were routinely collected 
anyway should be documented. Relevant parameters:  
• Complete blood count including platelet count, absolute lymphocyte count, absolute 
neutrophil count; 
• Hemoglobin; 
• Lipid parameters.  
9.2.4.5. Treatment of Atopic Dermatitis with Abrocitinib  
At the baseline visit (Visit 1) reason of starting or re-starting treatment with abrocitinib will 
be documented. At each visit (Visit 1-6) dose of treatment with abrocitinib and reason for its 
choice will be documented. If an escalation or a de-escalation of dosage occurred since the 
last visit, in addition stop date of previous dosage, start date of new dosage and reason for 
switch (lack of efficacy or intolerability) will be documented. 
If treatment with abrocitinib got terminated since the last visit, reasons for ending abrocitinib 
treatment, stop date of treatment, start date of other new treatment and reason for switch 
(lack of efficacy or intolerability) will be documented. 
At Visits 2-6, the investigator will ask the patient for his or her self-assessment of 
compliance in terms of number of abrocitinib-free days since the last visit. 
9.2.4.6. Concomitant Treatment for Atopic Dermatitis 
At each visit (Visit 1-6) dose and type of concomitant treatment will be documented. At 
baseline visit the number of days with topical-treatment use (TCS, TCI) and emollients use 
three months before start of treatment with abrocitinib (first visit) and at each subsequent 
visit number of days with topical- treatment use (TCS, TCI) and emollients use days since 
the last visit (follow-up visits) will be assessed.  
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 33 of 62 
9.2.4.7. Treatment Expectation/Satisfaction 
At baseline (Visit 1), the reasons for starting or re-starting therapy with abrocitinib as well as 
the expectations of this treatment will be gathered from the patient. At subsequent visits 
(Visits 2-6) the treatment satisfaction with abrocitinib will be requested from the patient.  
9.2.4.8. Effectiveness Criteria 
The effectiveness of the treatment with abrocitinib will be documented using the following 
tools for the evaluation of the course of the disease: 
Indicator 
Definition/Calculation 
SCORAD 
Scoring Atopic dermatitis: validated scoring index for AD for 
severity, combining A: extent (0-100), B: severity (0-18) and C: 
subjective symptoms (0-20) based on itching and sleep deprivation, 
each scored (0-10). The SCORAD for an individual is calculated 
using the formula A/5 + 7B/2 + C (may range from 0 to 103).38 
EASI 
Eczema Area and Severity Index assesses both clinical signs of AD 
as well as extent of disease; scores can range from 0 to 72, with 
higher scores representing greater severity of AD.39 
IGA 
Investigators Global Assessment: assesses the severity of AD 
(excluding scalp, palms and soles) on a 5-point scale from 0 (clear) 
to 4 (severe) from the investigator's perspective 
 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 34 of 62 
9.2.4.9. Patient-Reported Criteria 
The patient-reported criteria will be documented using the following tools for the evaluation 
of the course of the disease: 
Pruritus-NRS 
The NRS is comprised of one item and represents the numbers 
0 (“no itch”) to 10 (“worst imaginable itch”). Subjects are asked 
to rate the intensity of their average pruritus using this scale.  
Peak-Pruritus-NRS 
Numeric rating scale: evaluates itching in the last 24 hours from 
no itching (0) to worst possible itching (10).40 
POEM 
Patient-oriented Eczema Measure: patient-reported measure that 
assesses AD symptoms. The patient himself evaluates the 
frequency of occurrence and severity of 7 symptoms (such as 
itching and burning of the skin) within the last week, each 
according to a 5-point Likert scale. The maximum POEM score is 
28 points.41 
DLQI 
The DLQI is a 10-item patient-reported measure that rates how 
much a patient´s skin problems have affected their life over the 
last week assigned to the following 6 dimensions: symptoms, 
daily life, leisure/sport, work/school, social life/relationship and 
treatment. For each question, 0 to 3 points are given, whereby 
3 points indicate the greatest possible impairment of the QoL in 
the queried area. The sum of scores ranges from 0 to 30, with 
higher scores indicating greater impairment of quality of life.42 
MOS 
The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 
12 items assessing sleep disturbance, sleep adequacy, 
somnolence, quantity of sleep, snoring, and awakening short of 
breath or with a headache.43 
PBI 
Measurement of patient defined treatment benefits according to 
German and international standards, contains two one-sided 
questionnaires which are to be completed by the patient before 
and after receiving a treatment. A total of 23 possible treatment 
goals are evaluated on an importance scale from 0 ("not at all") to 
5 ("very").44,45 
EQ-5D-5L 
Generic instrument for measuring quality of life, including health 
benefits and health status on a visual analogue scale (VAS), using 
the five dimensions (mobility, self-care, usual activities, 
pain/discomfort, anxiety/depression).46 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 35 of 62 
HADS 
The Hospital Anxiety and Depression Scale is a 14-item measure 
that identifies anxiety (7 items) and depression (7 items) among 
adults who are physically ill with lower scores indicating lower 
levels of anxiety and depression 
 
9.2.4.10. Safety 
All adverse events (AEs) that will occur during the observation period will be documented. 
For more information, please refer to Section 11. At the final visit or if a patient discontinues 
with abrocitinib, the healthcare professional (HCP) will be asked to assess the general 
tolerability of the treatment with abrocitinib and the reasons for discontinuation 
(intolerability or lack of efficacy) will be analyzed. When applicable severity categories 
(mild, moderate and severe) of adverse events will be assessed. 
9.3. Variables 
Table 2. 
List of Variables 
Variable 
Role 
Data source(s) 
Operational definition 
AD-treatment 
with Abrocitinib 
and/or without 
topicals – date 
of initiation 
Exposure, 
Potential 
confounder, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in the Statistical Analysis 
Plan (SAP) 
AD-treatment 
with Abrocitinib 
and/or without 
topicals – dose 
Exposure, 
Potential 
confounder, 
outcome, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in SAP 
AD-treatment 
with Abrocitinib 
and/or without 
topicals – 
tolerability/safet
y 
Potential 
confounder, 
potential 
subgroup 
identifier, 
safety outcome 
Case records 
Details will be provided 
in SAP 
Type and results 
of performed 
laboratory 
checks 
Potential 
confounder, 
potential 
subgroup 
identifier, 
safety outcome 
Case records 
Details will be provided 
in SAP 
Adverse events 
Safety outcome 
Case records 
Details will be provided 
in SAP 
Age (Year of 
birth) 
Baseline 
characteristics, 
potential 
Case records 
Details will be provided 
in SAP 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 36 of 62 
Variable 
Role 
Data source(s) 
Operational definition 
confounder, 
potential 
subgroup 
identifier  
Sex 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in SAP 
Height 
Baseline 
characteristics  
Case records 
Details will be provided 
in SAP 
Weight 
Baseline 
characteristics  
Case records 
Details will be provided 
in SAP 
Highest level of 
education 
Baseline 
characteristics, 
potential 
confounder  
Case records 
Details will be provided 
in SAP 
Ethnicity 
Baseline 
characteristics  
Case records 
Details will be provided 
in SAP 
Occupational 
status 
Baseline 
characteristics 
Case records 
Details will be provided 
in SAP 
Alcohol 
consumption 
status 
Baseline 
characteristics, 
potential 
confounder 
Case records 
Details will be provided 
in SAP 
Insurance type 
Baseline 
characteristics  
Case records 
Details will be provided 
in SAP 
Presence of 
family history 
of atopic 
diseases 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
History of 
herpes simplex 
and/or eczema 
herpeticum 
and/or herpes 
zoster 
Baseline 
characteristics 
Case records 
Details will be provided 
in SAP 
Vaccination 
status (Herpes 
zoster, Covid-
19, Influenza 
Varicella) 
Baseline 
characteristics 
Case records 
Details will be provided 
in SAP 
Age at initial 
diagnosis of AD 
Baseline 
characteristics, 
potential 
confounder  
Case records 
Details will be provided 
in SAP 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 37 of 62 
Variable 
Role 
Data source(s) 
Operational definition 
Smoking history 
and current 
smoking status 
Baseline 
characteristics, 
potential 
confounder  
Case records 
Details will be provided 
in SAP 
Renal and/or 
liver impairment 
Baseline 
characteristics 
Case records 
Details will be provided 
in SAP 
Comorbidities 
of interest 
(atopic diseases, 
malignancies, 
cardiovascular 
diseases) 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in SAP 
If positive 
anamnesis at 
baseline exists: 
Improvement of 
(allergic) 
asthma 
symptoms from 
baseline 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
If positive 
anamnesis at 
baseline exists: 
Improvement of 
(allergic) 
rhinitis 
symptoms from 
baseline 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
If positive 
anamnesis at 
baseline exists: 
Improvement of 
polyposis nasi 
symptoms from 
baseline 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
If positive 
anamnesis at 
baseline exists: 
Improvement of 
alopecia areata 
from baseline 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
If positive 
anamnesis at 
baseline exists: 
Improvement of 
chronic hand 
eczema 
symptoms from 
baseline 
Baseline 
characteristics, 
potential 
confounder, 
potential subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 38 of 62 
Variable 
Role 
Data source(s) 
Operational definition 
If positive 
anamnesis at 
baseline exists: 
Improvement of 
prurigo 
nodularis 
symptoms from 
baseline 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
Previous 
treatments for 
diagnosed AD 
Baseline 
characteristics, 
potential 
confounder, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in SAP 
Number of days 
with topical-
treatment use & 
number of days 
with emollients 
use 
Exposure, 
outcome variable 
Case records 
Details will be provided 
in SAP 
Concomitant 
treatment of AD 
(and dosage) 
Baseline 
characteristics, 
Exposure, 
outcome, 
potential 
confounder, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in SAP 
Concomitant 
(non-AD) 
treatment 
Baseline 
characteristics, 
outcome, 
potential 
confounder, 
potential 
subgroup 
identifier  
Case records 
Details will be provided 
in SAP 
Dosage of 
Abrocitinib used 
Exposure, 
potential 
confounder, 
outcome variable, 
potential 
subgroup 
identifier 
Case records 
Details will be provided 
in SAP 
Compliance 
with Abrocitinib 
treatment 
(patients´ 
reported 
compliance) 
potential 
confounder, 
outcome 
Case records 
Details will be provided 
in SAP 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 39 of 62 
Variable 
Role 
Data source(s) 
Operational definition 
Reasons for 
start of 
Abrocitinib 
therapy 
outcome variable 
Case records 
Details will be provided 
in SAP 
Reasons for 
prescribed dose 
of Abrocitinib 
therapy 
outcome variable 
Case records 
Details will be provided 
in SAP 
Reasons for 
discontinuation 
of Abrocitinib 
therapy 
outcome variable 
Case records 
Details will be provided 
in SAP 
Number of 
flares 
outcome variable 
Case records 
Details will be provided 
in SAP 
Number of 
hospitalizations 
due to AD 
outcome variable  
Case records 
Details will be provided 
in SAP 
Number of 
absent days at 
work/study due 
to AD 
outcome variable  
Case records 
Details will be provided 
in SAP 
SCORAD 
outcome variable  
Case records 
Details will be provided 
in SAP 
EASI 
outcome variable  
Case records  
Details will be provided 
in SAP 
IGA 
outcome variable  
Case records  
Details will be provided 
in SAP 
Pruritus-NRS 
outcome variable  
Case records 
 
Details will be provided 
in SAP 
PP- NRS 
outcome variable 
Case records  
Details will be provided 
in SAP 
DLQI 
outcome variable  
Case records  
Details will be provided 
in SAP 
POEM 
outcome variable  
Case records  
Details will be provided 
in SAP 
MOS-Sleep 
scale 
outcome variable  
Case records  
Details will be provided 
in SAP 
Patient Benefit 
Index 
outcome variable  
Case records  
Details will be provided 
in SAP 
EQ-5D-5L 
outcome variable  
Case records 
Details will be provided 
in SAP 
HADS 
outcome variable 
Case records 
Details will be provided 
in SAP 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 40 of 62 
9.4. Data Sources  
Patients will be enrolled in a consecutive manner by participating study sites. Site staff will 
review all necessary information from the patient´s medical record to determine eligibility for 
enrollment. Patients who fulfill the eligibility criteria will be invited to participate in the non-
interventional study. Upon providing written informed consent, patients will be enrolled. The 
investigator will document patient data collected during routine visits from medical records. 
All data including the physician´s global assessment of efficacy parameters will be 
documented in the clinical database (eCRF). 
For collection of efficacy and quality parameters assessed from the patient by using patient 
questionnaires, the patient should fill out the respective questionnaires during the study visit 
via the tablet PC provided to the study site (see also Section 9.2.3.1). Patients who are 
unwilling or unable to use the provided tablet PC are allowed to use paper-based 
questionnaires. Paper-based questionnaires will be checked by the site staff for any personal 
information. After this review is completed, a copy of the questionnaires will be sent to the 
CRO which will transcribe the questionnaires into the eCRF. With the patient´s access data, 
the patient can fill the questionnaires in a web-based manner so that the documented data are 
directly entered in the patient interface of the eCRF. In this case, the site has to send the filled 
questionnaires via mail to the delegated CRO in a timely manner so that the documented data 
can be transferred to the eCRF by qualified and trained personnel. The originals of the filled 
questionnaires (essential documents) are to be filed in the patient´s medical record by the site 
staff.  
9.5. Study Size 
In total, this non-interventional study seeks to enroll at least 750 from approximately 
80 study sites across Germany. The patients are planned to be enrolled over a period of 
60 months. This observational study aims to obtain real-world data on the patient 
characteristics, treatment patterns, effectiveness of abrocitinib and patient reported outcomes 
(PROs) beyond progression, rather than testing any pre-defined hypothesis. In accordance 
with the non-interventional nature of the study, the analyses will solely be of descriptive and 
explorative character. Therefore, a formal sample size calculation is not applicable. 
Furthermore, the large sample size was chosen to support a large range of analyses from 
overall general scientific questions to specific subgroup questions with sufficient precision. 
The sample size will ensure that the descriptive data mandated by the primary and secondary 
endpoints are sufficiently precise and meaningful at subgroup level as well.  
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 41 of 62 
9.6. Data Management  
As already mentioned in Section 9.2.3.1 and Section 9.4, the data are documented web-based 
in an eCRF in a pseudonymized manner either by the site personnel or by the patients via 
tablet PCs (patient questionnaires) or paper-based patient questionnaires provided to the 
study sites by the sponsor. In case a patient fills out paper-based patient questionnaires, the 
documented data are transferred to the eCRF by qualified and trained personnel of the 
delegated CRO. 
Edit checks and electronic plausibility checks (ie, triggering of automated queries) will be 
implemented in the eCRF to notify the user directly during data entry on invalid, missing, 
unexpectedly unusual or implausible data. Notifications on the latter 2 are implemented to 
encourage double checking for unusual data entries and ensure high quality data. Notification 
is done by using warning or error messages, whereby the latter prevents to save the eCRF 
form until the error is corrected by the user. 
In addition to these electronic checks, there are manual checks performed by data 
management personnel of the delegated CRO. They serve to verify the validity and 
plausibility of the entered data. These mainly relate to plausibility or cross-checks to verify 
the correctness and completeness of the data, as well as to protocol deviations and eligibility 
criteria. In addition, free text entries will be checked on plausibility or any "hidden" 
information (eg, the existence of a hidden AE/serious adverse event [SAE]) or "prohibited" 
information (such as a patient’s full name or documentation of data after withdrawal of 
consent). Based on the findings detected during such manual checks, queries will be raised 
and directly be entered into the eCRF forms by data management personnel and clinical 
research associates (CRAs). When data have been entered, reviewed and edited, the 
investigator will be allowed to electronically sign the eCRF according to the agreed project 
process. Within the eCRF, an audit trail is implemented to be able to trace by whom and 
when the data was entered or edited. In addition, the set queries and the corresponding 
answers are also captured and saved in the eCRF. 
During web-based data entry, encrypted transmissions are applied for client/server 
communication via the internet. State of the art encryption technology is used. In addition, 
the server identifies itself to the client workstation by means of a digital server certificate 
issued by an authorized certification authority. By this, it is ensured that data are only send to 
the server of Alcedis GmbH. 
Data are protected from potential virtual attacks and physical damage. Furthermore, an 
encrypted backup onto magnetic tape is performed on a regular basis. 
Retrieving data or reports as well as edit or read-only rights are controlled with individual 
passwords. Access authorization to the eCRF database is individually granted to participating 
investigators and data entry personnel by means of user accounts. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 42 of 62 
9.6.1. Case Report Forms (CRFs)/Data Collection Tools (DCTs)/Electronic Data Record 
As used in this protocol, the term CRF should be understood to refer to either a paper form or 
an electronic data record or both, depending on the data collection method used in this NIS. 
A CRF is required and should be completed for each included patient. The completed 
original CRFs are the sole property of Pfizer and should not be made available in any form to 
third parties, except for authorized representatives of Pfizer or appropriate regulatory 
authorities, without written permission from Pfizer. The investigator shall ensure that the 
CRFs are securely stored at the study site in encrypted electronic form and will be password 
protected to prevent access by unauthorized third parties. 
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs and any other data collection forms (source 
documents) and ensuring that they are accurate, authentic/original, attributable, complete, 
consistent, legible, timely (contemporaneous), enduring, and available when required. The 
CRFs must be signed by the investigator or by an authorized staff member to attest that the 
data contained on the CRFs are true. Any corrections to entries made in the CRFs or source 
documents must be dated, initialed, and explained (if necessary) and should not obscure the 
original entry. 
In most cases the source documents are the hospital or the physician's chart. In these cases, 
data collected on the CRFs must match those charts.  
In some cases, the CRF may also serve as the source document. In these cases, a document 
should be available at the investigator site and at Pfizer that clearly identifies those data that 
will be recorded on the CRF, and for which the CRF will stand as the source document.  
In this non-interventional study, the eCRF serves as source document for the patient 
questionnaires. The patients can enter the data for the respective questionnaires directly into 
the tablet, which are then automatically transferred to the eCRF. 
9.6.2. Record Retention 
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the 
investigator agrees to keep records, including the identity of all participating patients 
(sufficient information to link records, eg, CRFs and hospital records), all original signed 
informed consent documents, copies of all CRFs, safety reporting forms, source documents 
and essential documents, detailed records of treatment disposition, and adequate 
documentation of relevant correspondence (eg, letters, meeting minutes, and telephone call 
reports). The records should be retained by the investigator according to local regulations or 
as specified in the clinical study agreement (CSA), whichever is longer. The investigator 
must ensure that the records continue to be stored securely for so long as they are retained. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 43 of 62 
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (eg, retirement, relocation), Pfizer should be prospectively notified. The 
study records must be transferred to a designee acceptable to Pfizer, such as another 
investigator, another institution, or to an independent third party arranged by Pfizer.  
Investigator records must be kept for a minimum of 10 years after completion or 
discontinuation of the non-interventional study to comply with local German laws.  
The investigator must obtain Pfizer's written permission before disposing of any records, 
even if retention requirements have been met. 
9.7. Data Analysis  
Due to the nature of the study data, descriptive statistics will be used to summarize all 
endpoints. No formal hypothesis will be tested. 
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in the SAP, which will be dated, filed and maintained by the sponsor. The 
SAP may modify the plans outlined in the protocol; any major modifications of primary 
endpoint definitions or their analyses would be reflected in a protocol amendment. 
Appropriate analysis sets will be defined for statistical analysis. 
Time to event endpoints will be investigated using Kaplan-Meier methodology. The time to 
event will be summarized in terms of medians and 95% confidence interval (CIs). Kaplan-
Meier plots of the time to event over the study duration will be presented.  
Where appropriate, Cox-Proportional Hazards modelling will be used to assess differences 
between subgroups. 
Definition of time windows for study visits 
In order to collect comparable study data, Visits 1 to 3 occurring ±14 days and Visits 3 to 
6 occurring ±28 days of the scheduled visit date will be used for data analysis. However, for 
analysis of safety parameters, all AEs/SAEs documented within the applicable reporting 
period will be analyzed. 
Visit Label 
Target Day 
Definition [Day window] 
Enrollment 
1 
1 
Month 1 
30 
16 to 44 
Month 3 
91 
77 to 105 
Month 6 
182 
154 to 210  
Month 9 
273 
245 to 301 
Month 12 
365 
337 to 393 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 44 of 62 
• For the lab values, if the calculated study day for the labelled baseline visit is not study 
Day 1, but falls within 40 days before the start of the study dosing, then that data should 
be used for the baseline instead of leaving baseline missing.  
• For the other values, if the calculated study day for the labelled baseline visit is not study 
Day 1, but falls before the start of the study dosing, then that data should be used for the 
baseline instead of leaving baseline missing. 
• If baseline is missing there will be no imputation and although the subject’s data will be 
included in summary data it will not be included in any change from baseline analyses. 
If two or more routine visits fall into the same window, keep the one closest to the Target 
Day. If two routine visits are equal distance from the Target Day in absolute value, the later 
visit should be used. 
9.8. Quality Control 
All study sites will be adequately trained on the principles of the NIS and on the handling of 
the eCRF prior to enrolling patients. As outlined in Section 9.6, measures involving 
electronic checks and data management activities will be implemented to reduce 
documentation of implausible data and enhance data integrity. The delegated CRO will 
organize on-site and remote monitoring visits by qualified and trained clinical research 
associates (CRAs) to conduct monitoring visits for progress of the study, performance of the 
sites and source data verification. All monitoring activities are announced to the sites in 
advance. If findings are identified that could not be resolved during the monitoring, a 
follow-up letter is sent to the sites.  
9.9. Limitations of the Research Methods 
Randomized controlled trials are important and powerful tools in assessing efficacy and 
safety but have their limitations in terms of generalizability. In order to assess patient 
characteristics, usage and effectiveness of abrocitinib in a usual care setting, parameters need 
to be determined by performing observational studies.  
Inherent limitations of non-interventional, observational, non-controlled, non-randomized 
studies are generally the risk of selection/ascertainment bias and usually the lack of a parallel 
control group, which hampers the interpretation of the causality between treatment and 
outcomes. Furthermore, as with any "as observed" analysis, there is a potential risk of bias 
due to missing outcome data; which increases with an increasing number of missing outcome 
data.  
As data captured will be limited to information available from the investigator participating 
in the NIS under in usual care setting, there is a greater possibility that there will be 
individual items of missing data (eg, a specific lab value is not documented or a 
questionnaire not completed). Following up patients, even beyond treatment, discontinuation 
of abrocitinib and switch to other systemic therapies, should result in a higher proportion of 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 45 of 62 
the patients remaining in the NIS until the planned completion date. Where data are missing, 
information from the patient at other visits may be used in the primary analysis model to 
assess predictors of treatment decisions. If the different factors being considered in the 
primary statistical model to look at impact of treatment change are highly correlated, it may 
not be clear which of the factors is in fact driving the rate of treatment escalation. Other 
sensitivity analyses may be explored to assess the impact of any confounding. Further details 
will be included in the SAP.  
Patients selected for study inclusion represent a population who are initiated on abrocitinib as 
part of a usual care setting. The sample of patients will be obtained from investigators who 
are willing to participate in the NIS and there is a possibility that certain types of patients will 
be selected to be prescribed abrocitinib (selection bias) and join the study and this could 
potentially have an impact on findings of the primary analysis (if the ‘type’ is expected to 
impact the rate of treatment escalation). Therefore, study findings may not be generalizable 
to all AD patients. 
9.10. Other Aspects 
Not applicable. 
10. PROTECTION OF HUMAN SUBJECTS 
10.1. Patient Information  
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of patient personal data. Such 
measures will include omitting patient names or other directly identifiable data in any 
reports, publications, or other disclosures, except where required by applicable laws.  
The personal data will be stored at the study site in encrypted electronic and/or paper form 
and will be password protected or secured in a locked room to ensure that only authorized 
study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site shall be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law. 
To protect the rights and freedoms of natural persons with regard to the processing of 
personal data, when study data are compiled by the site for transfer to Pfizer and other 
authorized parties, patient names will be removed and will be replaced by a single, specific, 
numerical code, based on a numbering system defined by Pfizer. All other identifiable data 
transferred to Pfizer or other authorized parties will be identified by this single, 
patient-specific code. The investigator site will maintain a confidential list of patients who 
participated in the NIS, linking each patient’s numerical code to his or her actual identity. In 
case of data transfer, Pfizer will maintain high standards of confidentiality and protection of 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 46 of 62 
patients’ personal data consistent with the clinical study agreement and applicable privacy 
laws. 
10.2. Patient Consent 
The informed consent documents and any patient recruitment materials must be in 
compliance with local regulatory requirements and legal requirements, including applicable 
privacy laws. 
The informed consent documents used during the informed consent process and any patient 
recruitment materials must be reviewed and approved by Pfizer, approved by the institutional 
review board (IRB)/independent ethics committee (IEC) before use, and available for 
inspection. 
The investigator must ensure that each study patient, is fully informed about the nature and 
objectives of the non-interventional study, the sharing of data relating to the NIS and possible 
risks associated with participation, including the risks associated with the processing of the 
patient’s personal data. The investigator further must ensure that each study patient is fully 
informed about his or her right to access and correct his or her personal data and to withdraw 
consent for the processing of his or her personal data. 
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each patient before any study-specific activity is performed. The investigator 
will retain the original of each patient's signed consent document. 
10.3. Patient Withdrawal 
Patients may withdraw from the NIS at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, 
or administrative reasons.  In any circumstance, every effort should be made to document 
patient outcome, if applicable.  The investigator would inquire about the reason for 
withdrawal and follow-up with the patient regarding any unresolved adverse events.   
If the patient withdraws from the NIS, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent, if the patient provides explicit written consent. 
Treatment discontinuation does not constitute patient withdrawal. In case of treatment 
discontinuation, the patient may remain in the study where follow-up documentation can be 
provided. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 47 of 62 
10.4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the 
non-interventional study protocol, protocol amendments, and informed consent forms, and 
other relevant documents, if applicable, from the IRB/IEC. All correspondence with the 
IRB/IEC should be retained by the investigator. Copies of IRB/IEC approvals should be 
forwarded to Pfizer. 
10.5. Ethical Conduct of the Study 
The NIS will be 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 §67 (6) of the Medicinal Products Act (AMG, German Drug Law)) and the 
recommendations for the conduct of non-interventional studies 
(“Anwendungsbeobachtungen”) of the Federal Institute for Drugs and Medical Devices 
(BfArM) and the Paul-Ehrlich-Institut, recommendations for increasing the quality and 
transparency of non-interventional studies by the German Association of Research-Based 
Pharmaceutical Companies (VFA), the Code of Conduct for the Collaboration with 
Healthcare Professionals by the Voluntary Self-Regulation for the Pharmaceutical Industry 
(FSA) and the declaration of Helsinki. Furthermore, it will 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), Good Practices for Outcomes Research issued by the International 
Society for Pharmacoeconomics and Outcomes Research (ISPOR), International Ethical 
Guidelines for Epidemiological Research issued by the Council for International 
Organizations of Medical Sciences (CIOMS), European Medicines Agency (EMA).  
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS  
REQUIREMENTS 
The table below summarizes the requirements for recording safety events on the eCRF and 
for reporting safety events on the non-interventional study (NIS) adverse event monitoring 
(AEM) Report Form to Pfizer Safety. These requirements are delineated for three types of 
events: (1) serious adverse events (SAEs); (2) non-serious AEs (as applicable); and (3) 
scenarios involving drug exposure, including exposure during pregnancy, exposure during 
breast feeding, medication error, overdose, misuse, extravasation, lack of efficacy, and 
occupational exposure. These events are defined in the section “Definitions of Safety 
Events.”  
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 48 of 62 
Table 3. 
Technical Specifications for Safety Reporting. 
Safety event 
Recorded on the eCRF 
Reported via eCRF on the 
NIS AEM Report Form to 
Pfizer Safety within 24 
hours of awareness 
SAE 
All 
All 
Non-serious AE 
All 
None 
Scenarios involving exposure 
to a drug under study, 
including exposure during 
pregnancy, exposure during 
breast feeding, medication 
error, overdose, misuse, 
extravasation, lack of efficacy, 
and occupational exposure 
All  
(regardless of whether 
associated with an AE), 
except occupational 
exposure  
All  
(regardless of whether 
associated with an AE) 
Note: Any associated AE is 
reported together with the 
exposure scenario. 
 
For each AE, the investigator must pursue and obtain information adequate both to determine 
the outcome of the AE and to assess whether it meets the criteria for classification as a SAE 
(refer to section "Serious Adverse Events” below).  
Safety events according to the far right column of Table 3 above must be reported to Pfizer 
within 24 hours of awareness of the event by the investigator regardless of whether the 
event is determined by the investigator to be related to abrocitinib. In particular, if the 
SAE is fatal or life--threatening, notification to Pfizer must be made immediately, 
irrespective of the extent of available event information. This timeframe also applies to 
additional new (follow-up) information on previously forwarded safety event reports. In the 
rare situation that the investigator does not become immediately aware of the occurrence of a 
safety event, the investigator must report the event within 24 hours after learning of it and 
document the time of his/her first awareness of the events. In case of technical difficulties or 
other issues prohibiting the use of the eCRF, only then should the NIS AEM Report Form be 
used. 
For safety events that are considered serious or that are identified in the far right column of 
the table above that are reportable to Pfizer within 24 hours of awareness, the investigator is 
obligated to pursue and to provide any additional information to Pfizer in accordance with 
this 24-hour timeframe. In addition, an investigator may be requested by Pfizer to obtain 
specific follow-up information in an expedited fashion. This information is more detailed 
than that recorded on the eCRF. In general, this will include a description of the AE in 
sufficient detail to allow for a complete medical assessment of the case and independent 
determination of possible causality. Any information relevant to the event, such as 
concomitant medications and illnesses, must be provided. In the case of a patient death, a 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 49 of 62 
summary of available autopsy findings must be submitted as soon as possible to Pfizer or its 
designated representative.  
Reporting period  
For each patient, the safety event reporting period begins at the time of the patient’s informed 
consent, which is obtained prior to the patient’s enrollment in the study and lasts through the 
end of the observation period of the study; a report must be submitted to Pfizer Safety (or its 
designated representative) for any of the types of safety events listed in the table above 
occurring during this period. Most often, the date of informed consent is the same as the date 
of enrollment. In some situations, there may be a lag between the dates of informed consent 
and enrollment. In these instances, if a patient provides informed consent but is never 
enrolled in the study (eg, patient changes his/her mind about participation), the reporting 
period ends on the date of the decision to not enroll the patient. If the investigator becomes 
aware of a SAE occurring at any time after completion of the study and s/he considers the 
serious AE to be related to a Pfizer product, the SAE also must be reported to Pfizer Safety. 
Causality assessment 
The investigator is required to assess and record the causal relationship. For all AEs, 
sufficient information should be obtained by the investigator to determine the causality of 
each AE. For AEs with a causal relationship to abrocitinib, follow-up by the investigator is 
required until the event and/or its sequelae resolve or stabilize at a level acceptable to the 
investigator, and Pfizer concurs with that assessment.  
An investigator’s causality assessment is the determination of whether there exists a 
reasonable possibility that abrocitinib caused or contributed to an AE. If the investigator’s 
final determination of causality is “unknown” and s/he cannot determine whether abrocitinib 
caused the event, the safety event must be reported within 24 hours.  
If the investigator cannot determine the etiology of the event but s/he determines that 
abrocitinib did not cause the event, this should be clearly documented on the eCRF and in 
case of technical difficulties only, this also applies to the NIS AEM Report Form. 
DEFINITIONS OF SAFETY EVENTS 
Adverse events 
An AE is any untoward medical occurrence in a patient administered a medicinal product. 
The event need not necessarily have a causal relationship with the product treatment or 
usage. Examples of AEs include but are not limited to:  
• Abnormal test findings (see below for circumstances in which an abnormal test 
finding constitutes an AE); 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 50 of 62 
• Clinically significant signs and symptoms; 
• Changes in physical examination findings; 
• Hypersensitivity; 
• Progression/worsening of underlying disease; 
• Lack of efficacy;  
• Drug abuse;  
• Drug dependency. 
Additionally, for medicinal products, they may include the signs or symptoms resulting from: 
• Drug overdose; 
• Drug withdrawal; 
• Drug misuse;  
• Off-label use;  
• Drug interactions; 
• Extravasation; 
• Exposure during pregnancy; 
• Exposure during breast feeding; 
• Medication error; 
• Occupational exposure. 
Abnormal test findings 
The criteria for determining whether an abnormal objective test finding should be reported as 
an AE are as follows:  
• Test result is associated with accompanying symptoms, and/or 
• Test result requires additional diagnostic testing or medical/surgical intervention, 
and/or 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 51 of 62 
• Test result leads to a change in study dosing or discontinuation from the NIS, 
significant additional concomitant drug treatment, or other therapy; and/or 
• Test result is considered to be an AE by the investigator or sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an AE. Any abnormal test result that is determined to be an error does not require 
reporting as an AE. 
Serious adverse events 
A SAE is any untoward medical occurrence in a patient administered a medicinal or 
nutritional product (including pediatric formulas) at any dose that: 
• Results in death; 
• Is life-threatening; 
• Requires inpatient hospitalization or prolongation of hospitalization (see below for 
circumstances that do not constitute AEs); 
• Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions); 
• Results in congenital anomaly/birth defect. 
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event. An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization. However, if it is determined that the event may jeopardize 
the patient or may require intervention to prevent one of the other outcomes listed in the 
definition above, the important medical event should be reported as serious. 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; 
or development of drug dependency or drug abuse. 
Additionally, any suspected transmission via a Pfizer product of an infectious agent, 
pathogenic or non-pathogenic, is considered serious. The event may be suspected from 
clinical symptoms or laboratory findings indicating an infection in a patient exposed to a 
Pfizer product. The terms “suspected transmission” and “transmission” are considered 
synonymous. These cases are considered unexpected and handled as serious expedited cases 
by pharmacovigilance (PV) personnel. Such cases are also considered for reporting as 
product defects, if appropriate. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 52 of 62 
Hospitalization 
Hospitalization is defined as any initial admission (even if less than 24 hours) to a hospital or 
equivalent healthcare facility or any prolongation to an existing admission. Admission also 
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, neurological floor to a 
tuberculosis unit). An emergency room visit does not necessarily constitute a hospitalization; 
however, an event leading to an emergency room visit should be assessed for medical 
importance.  
Hospitalization in the absence of a medical AE is not in itself an AE and is not reportable. 
For example, the following reports of hospitalization without a medical AE are not to be 
reported.  
• Social admission (eg, patient has no place to sleep) 
• Administrative admission (eg, for yearly exam) 
• Optional admission not associated with a precipitating medical AE (eg, for elective 
cosmetic surgery) 
• Hospitalization for observation without a medical AE 
• Admission for treatment of a pre-existing condition not associated with the 
development of a new AE or with a worsening of the pre-existing condition (eg, for 
work-up of persistent pre-treatment lab abnormality). 
Scenarios necessitating reporting to Pfizer Safety within 24 hours  
Scenarios involving exposure during pregnancy, exposure during breastfeeding, medication 
error, overdose, misuse, extravasation, lack of efficacy, and occupational exposure are 
described below. 
Exposure during pregnancy 
An exposure during pregnancy (EDP) occurs if: 
1. A female becomes, or is found to be, pregnant either while receiving or having been 
exposed to (eg, environmental) abrocitinib, or the female becomes, or is found to be, 
pregnant after discontinuing and/or being exposed to abrocitinib (maternal exposure). 
An example of environmental exposure would be a case involving direct contact with a 
Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has been 
exposed to chemotherapeutic products). 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 53 of 62 
2. A male has been exposed, either due to treatment or environmental exposure to 
abrocitinib prior to or around the time of conception and/or is exposed during the partner 
pregnancy (paternal exposure). 
For exposure during pregnancy in studies of pregnant women, data on the exposure to 
abrocitinib during pregnancy, are not reportable unless associated with serious or non-serious 
adverse events. 
As a general rule, prospective and retrospective exposure during pregnancy reports from any 
source are reportable irrespective of the presence of an associated AE and the procedures for 
SAE reporting should be followed, with the exception of those studies conducted in pregnant 
women (as described in above), for which data on the exposure are not reportable unless 
associated with serious or non-serious adverse events. 
If a study participant or study participant’s partner becomes, or is found to be, pregnant 
during the study participant’s treatment with abrocitinib, this information must be submitted 
to Pfizer, irrespective of whether an AE has occurred using theNIS AEM Report Form and 
the EDP Supplemental Form (please refer to Annex 1). In addition, the information regarding 
environmental exposure to abrocitinib in a pregnant woman (eg, a patient reports that she is 
pregnant and has been exposed to a cytotoxic product by inhalation or spillage) must be 
submitted using the NIS AEM Report Form and the EDP Supplemental Form. The EDP 
Supplemental Form must not be submitted if consent by the pregnant person is not given and 
documented. This must be done irrespective of whether an AE has occurred.  
Information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy). 
Follow-up is conducted to obtain general information on the pregnancy; in addition, 
follow-up is conducted to obtain information on EDP outcome for all EDP reports with 
pregnancy outcome unknown. A pregnancy is followed until completion or until pregnancy 
termination (eg, induced abortion) and Pfizer is notified of the outcome. This information is 
provided as a follow-up to the initial EDP report. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure-test findings are conclusive for a congenital anomaly and the findings are 
reported). 
If the outcome of the pregnancy meets the criteria for an SAE (eg, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a 
live born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
procedures for reporting SAEs should be followed. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 54 of 62 
Additional information about pregnancy outcomes that are reported as SAEs follows:  
• Spontaneous abortion includes miscarriage and missed abortion; 
• Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to investigational product. 
Additional information regarding the exposure during pregnancy may be requested. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  
In the case of paternal exposure, the study participant will be provided with the Pregnant 
Partner Release of Information Form to deliver to his partner. It must be documented that the 
study participant was given this letter to provide to his partner. 
Exposure during breastfeeding 
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated AE. An exposure during breastfeeding report is not created when a Pfizer drug 
specifically approved for use in breastfeeding women (eg, vitamins) is administered in 
accord with authorized use. However, if the infant experiences an AE associated with such a 
drug’s administration, the AE is reported together with the exposure during breastfeeding. 
Medication error 
A medication error is any unintentional error in the prescribing, dispensing, or administration 
of a medicinal product that may cause or lead to inappropriate medication use or patient harm 
while in the control of the health care professional, patient, or consumer. Such events may be 
related to professional practice, health care products, procedures, and systems including: 
prescribing; order communication; product labeling, packaging, and nomenclature; 
compounding; dispensing; distribution; administration; education; monitoring; and use.   
Medication errors include: 
• Near misses, involving or not involving a patient directly (eg, inadvertent/erroneous 
administration, which is the accidental use of a product outside of labeling or 
prescription on the part of the healthcare provider or the patient/consumer); 
• Confusion with regard to invented name (eg, trade name, brand name). 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 55 of 62 
The investigator must submit the following medication errors to Pfizer, irrespective of the 
presence of an associated AE/SAE: 
• Medication errors involving patient exposure to the product, whether or not the 
medication error is accompanied by an AE. 
• Medication errors that do not involve a patient directly (eg, potential medication 
errors or near misses). When a medication error does not involve patient exposure to 
the product the following minimum criteria constitute a medication error report: 
• An identifiable reporter; 
• A suspect product; 
• The event medication error. 
Overdose, Misuse, Extravasation 
Reports of overdose, misuse, and extravasation associated with the use of a Pfizer product are 
reported to Pfizer by the investigator, irrespective of the presence of an associated AE/SAE.  
Lack of Efficacy 
• Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the 
investigator, irrespective of the presence of an associated AE/SAE or the indication 
for use of the Pfizer product. 
Occupational Exposure 
• Reports of occupational exposure to a Pfizer product are reported to Pfizer by the 
investigator, irrespective of the presence of an associated AE/SAE. 
11.1. Single Reference Safety Document 
The respective current local product label (“Fachinformation Germany”) will serve as the 
single reference safety document during the course of the non-interventional study, which 
will be used by Pfizer safety to assess any safety events reported to Pfizer Safety by the 
investigator during the course of this NIS. The single reference safety document should be 
used by the investigator for prescribing purposes and guidance.  
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 56 of 62 
12. 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.  
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study patients against any immediate hazard, and of 
any serious breaches of this NI study protocol that the investigator becomes aware of. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 57 of 62 
13. REFERENCES 
1. 
Barbarot S, Auziere S, Gadkari A, Girolomoni G, Puig L, Simpson EL, et al. 
Epidemiology of atopic dermatitis in adults: Results from an international survey. 
Allergy. 2018;73(6):1284-93. Epub 20180213. doi: 10.1111/all.13401. PubMed PMID: 
29319189. 
2. 
Schmitz R, Atzpodien K, Schlaud M. Prevalence and risk factors of atopic diseases in 
German children and adolescents. Pediatr Allergy Immunol. 2012;23(8):716-23. Epub 
20120813. doi: 10.1111/j.1399-3038.2012.01342.x. PubMed PMID: 22882467. 
3. 
Kim JP, Chao LX, Simpson EL, Silverberg JI. Persistence of atopic dermatitis (AD): A 
systematic review and meta-analysis. J Am Acad Dermatol. 2016;75(4):681-7 e11. 
Epub 20160817. doi: 10.1016/j.jaad.2016.05.028. PubMed PMID: 27544489; PubMed 
Central PMCID: PMC5216177. 
4. 
Ring J, Zink A, Arents BWM, Seitz IA, Mensing U, Schielein MC, et al. Atopic 
eczema: burden of disease and individual suffering - results from a large EU study in 
adults. J Eur Acad Dermatol Venereol. 2019;33(7):1331-40. Epub 20190606. doi: 
10.1111/jdv.15634. PubMed PMID: 31002197. 
5. 
Darsow U, Pfab F, Valet M, Tolle TR, Ring J. Itch and eczema. Chem Immunol 
Allergy. 2012;96:81-8. Epub 20120313. doi: 10.1159/000331890. PubMed PMID: 
22433375. 
6. 
Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med. 2005;352(22):2314-
24. doi: 10.1056/NEJMcp042803. PubMed PMID: 15930422. 
7. 
Werfel T, Heratizadeh A, Aberer W, Ahrens F, Augustin M, Biedermann T, et al. 
Aktualisierung „Systemtherapie bei Neurodermitis“ zur S2k-Leitlinie Neurodermitis. J 
Dtsch Dermatol Ges. 2021;19(1):151-69. doi: 10.1111/ddg.14371_g. PubMed PMID: 
33491881. 
8. 
Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003;361(9352):151-60. doi: 
10.1016/S0140-6736(03)12193-9. PubMed PMID: 12531593. 
9. 
Ring J, Alomar A, Bieber T, Deleuran M, Fink-Wagner A, Gelmetti C, et al. Guidelines 
for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 
2012;26(8):1045-60. doi: 10.1111/j.1468-3083.2012.04635.x. PubMed PMID: 
22805051. 
10. Gooderham MJ, Hong HC, Eshtiaghi P, Papp KA. Dupilumab: A review of its use in 
the treatment of atopic dermatitis. J Am Acad Dermatol. 2018;78(3 Suppl 1):S28-S36. 
doi: 10.1016/j.jaad.2017.12.022. PubMed PMID: 29471919. 
11. Sanofi. Dupixent: EPAR - Product Information. European Medicines Agency; 2023. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 58 of 62 
12. Tsoi LC, Rodriguez E, Degenhardt F, Baurecht H, Wehkamp U, Volks N, et al. Atopic 
Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity 
Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-9. Epub 20190111. doi: 
10.1016/j.jid.2018.12.018. PubMed PMID: 30641038; PubMed Central PMCID: 
PMC6711380. 
13. Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, et al. 
Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, 
randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 
and ECZTRA 2). Br J Dermatol. 2021;184(3):437-49. Epub 20201230. doi: 
10.1111/bjd.19574. PubMed PMID: 33000465; PubMed Central PMCID: 
PMC7986411. 
14. Pharma L. Adtralza : EPAR - Product Information. European Medicines Agency2022. 
15. Lilly E. Olumiant : EPAR - Product Information. European Medicines Agency2023. 
16. AbbVie. Rinvoq : EPAR - Product Information. European Medicines Agency2023. 
17. Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, et al. 
Long-term management of moderate-to-severe atopic dermatitis with dupilumab and 
concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, 
double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-303. 
Epub 20170504. doi: 10.1016/S0140-6736(17)31191-1. PubMed PMID: 28478972. 
18. Simpson EL, Sinclair R, Forman S, Wollenberg A, Aschoff R, Cork M, et al. Efficacy 
and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic 
dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-
controlled, phase 3 trial. Lancet. 2020;396(10246):255-66. doi: 10.1016/S0140-
6736(20)30732-7. PubMed PMID: 32711801. 
19. Silverberg JI, Simpson EL, Thyssen JP, Gooderham M, Chan G, Feeney C, et al. 
Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic 
Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020;156(8):863-73. doi: 
10.1001/jamadermatol.2020.1406. PubMed PMID: 32492087; PubMed Central 
PMCID: PMC7271424. 
20. Halling-Overgaard AS, Zachariae C, Thyssen JP. Management of Atopic Hand 
Dermatitis. Dermatol Clin. 2017;35(3):365-72. doi: 10.1016/j.det.2017.02.010. PubMed 
PMID: 28577805. 
21. Agner T, Elsner P. Hand eczema: epidemiology, prognosis and prevention. J Eur Acad 
Dermatol Venereol. 2020;34 Suppl 1:4-12. doi: 10.1111/jdv.16061. PubMed PMID: 
31860734. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 59 of 62 
22. Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345-
60. doi: 10.1016/S0140-6736(20)31286-1. PubMed PMID: 32738956. 
23. Elsner P, Agner T. Hand eczema: treatment. J Eur Acad Dermatol Venereol. 2020;34 
Suppl 1:13-21. doi: 10.1111/jdv.16062. PubMed PMID: 31860736. 
24. Cheng J, Facheris P, Ungar B, Guttman-Yassky E. Current emerging and investigational 
drugs for the treatment of chronic hand eczema. Expert Opin Investig Drugs. 
2022;31(8):843-53. Epub 20220617. doi: 10.1080/13543784.2022.2087059. PubMed 
PMID: 35658708. 
25. Davis DMR, Drucker AM, Alikhan A, Bercovitch L, Cohen DE, Darr JM, et al. 
American Academy of Dermatology Guidelines: Awareness of comorbidities associated 
with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86(6):1335-6 e18. Epub 
20220124. doi: 10.1016/j.jaad.2022.01.009. PubMed PMID: 35085682. 
26. Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, et al. Dupilumab efficacy 
and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-
dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind 
placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388(10039):31-44. 
Epub 20160427. doi: 10.1016/S0140-6736(16)30307-5. PubMed PMID: 27130691. 
27. Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab 
Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 
2018;378(26):2486-96. Epub 20180521. doi: 10.1056/NEJMoa1804092. PubMed 
PMID: 29782217. 
28. Laidlaw TM, Bachert C, Amin N, Desrosiers M, Hellings PW, Mullol J, et al. 
Dupilumab improves upper and lower airway disease control in chronic rhinosinusitis 
with nasal polyps and asthma. Ann Allergy Asthma Immunol. 2021;126(5):584-92 e1. 
Epub 20210116. doi: 10.1016/j.anai.2021.01.012. PubMed PMID: 33465455. 
29. King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, et al. Two Phase 
3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022;386(18):1687-99. Epub 
20220326. doi: 10.1056/NEJMoa2110343. PubMed PMID: 35334197. 
30. King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, et al. Efficacy and 
safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, 
double-blind, multicentre, phase 2b-3 trial. Lancet. 2023;401(10387):1518-29. Epub 
20230414. doi: 10.1016/S0140-6736(23)00222-2. PubMed PMID: 37062298. 
31. Agency EM. Olumiant: EPAR - Procedural steps taken and scientific information after 
authorisation. 2023. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 60 of 62 
32. Zeidler C, Yosipovitch G, Stander S. Prurigo Nodularis and Its Management. Dermatol 
Clin. 2018;36(3):189-97. Epub 20180320. doi: 10.1016/j.det.2018.02.003. PubMed 
PMID: 29929592. 
33. Stander S, Yosipovitch G, Legat FJ, Lacour JP, Paul C, Narbutt J, et al. Trial of 
Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 
2020;382(8):706-16. doi: 10.1056/NEJMoa1908316. PubMed PMID: 32074418. 
34. Furue M, Furue M. Interleukin-31 and Pruritic Skin. J Clin Med. 2021;10(9). Epub 
20210428. doi: 10.3390/jcm10091906. PubMed PMID: 33924978; PubMed Central 
PMCID: PMC8124688. 
35. Huang AH, Williams KA, Kwatra SG. Prurigo nodularis: Epidemiology and clinical 
features. J Am Acad Dermatol. 2020;83(6):1559-65. Epub 20200523. doi: 
10.1016/j.jaad.2020.04.183. PubMed PMID: 32454098. 
36. Paller A, Jaworski JC, Simpson EL, Boguniewicz M, Russell JJ, Block JK, et al. Major 
Comorbidities of Atopic Dermatitis: Beyond Allergic Disorders. Am J Clin Dermatol. 
2018;19(6):821-38. doi: 10.1007/s40257-018-0383-4. PubMed PMID: 30168085. 
37. Pratt CH, King LE, Jr., Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. 
Nat Rev Dis Primers. 2017;3:17011. Epub 20170316. doi: 10.1038/nrdp.2017.11. 
PubMed PMID: 28300084; PubMed Central PMCID: PMC5573125. 
38. Kunz B, Oranje AP, Labreze L, Stalder JF, Ring J, Taieb A. Clinical validation and 
guidelines for the SCORAD index: consensus report of the European Task Force on 
Atopic Dermatitis. Dermatology. 1997;195(1):10-9. doi: 10.1159/000245677. PubMed 
PMID: 9267730. 
39. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area 
and severity index (EASI): assessment of reliability in atopic dermatitis. EASI 
Evaluator Group. Exp Dermatol. 2001;10(1):11-8. doi: 10.1034/j.1600-
0625.2001.100102.x. PubMed PMID: 11168575. 
40. Yosipovitch G, Reaney M, Mastey V, Eckert L, Abbe A, Nelson L, et al. Peak Pruritus 
Numerical Rating Scale: psychometric validation and responder definition for assessing 
itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019;181(4):761-9. Epub 
20190501. doi: 10.1111/bjd.17744. PubMed PMID: 30729499; PubMed Central 
PMCID: PMC6850643. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 61 of 62 
41. Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: 
development and initial validation of a new tool for measuring atopic eczema severity 
from the patients' perspective. Arch Dermatol. 2004;140(12):1513-9. doi: 
10.1001/archderm.140.12.1513. PubMed PMID: 15611432. 
42. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical 
measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-6. doi: 
10.1111/j.1365-2230.1994.tb01167.x. PubMed PMID: 8033378. 
43. Hays RD, Stewart AL. Sleep measures. In: Stewart AL, Ware JE, editors. Measuring 
Functioning and Well-being: The Medical Outcomes Study Approach: Duke University 
Press; 1992. p. 235-59. 
44. Augustin M, Radtke MA, Zschocke I, Blome C, Behechtnejad J, Schafer I, et al. The 
patient benefit index: a novel approach in patient-defined outcomes measurement for 
skin diseases. Arch Dermatol Res. 2009;301(8):561-71. Epub 20090327. doi: 
10.1007/s00403-009-0928-8. PubMed PMID: 19326133. 
45. Blome C, Augustin M, Behechtnejad J, Rustenbach SJ. Dimensions of patient needs in 
dermatology: subscales of the patient benefit index. Arch Dermatol Res. 
2011;303(1):11-7. Epub 20100817. doi: 10.1007/s00403-010-1073-0. PubMed PMID. 
46. Greiner W, Weijnen T, Nieuwenhuizen M, Oppe S, Badia X, Busschbach J, et al. A 
single European currency for EQ-5D health states. Results from a six-country study. 
Eur J Health Econ. 2003;4(3):222-31. doi: 10.1007/s10198-003-0182-5. PubMed 
PMID: 15609189. 
 
14. LIST OF TABLES  
Table 1. 
Recommended Schedule of Activities ......................................................28 
Table 2. 
List of Variables .......................................................................................35 
Table 3. 
Technical Specifications for Safety Reporting. ........................................48 
 
15. LIST OF FIGURES 
Figure 1. 
Timelines ..................................................................................................24 
Figure 2. 
Study Period..............................................................................................26 
 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)

Abrocitinib 
B7451089 NON-INTERVENTIONAL STUDY PROTOCOL 
Amendment 2, Version 3.0, 29 September 2023 
 
 
PFIZER CONFIDENTIAL  
CT24-WI-GL02-RF01 6.0 Non-Interventional Study Protocol Template For Primary Data Collection Study 01-
Aug-2023 
Page 62 of 62 
ANNEX 1. LIST OF STAND ALONE DOCUMENTS 
Number 
Document 
reference number 
Date 
Title 
1 
Section 11 
16JUN2023 
B7451089_Pregnancy Reporting 
Process_V1_16JUN2023 
ANNEX 2. ADDITIONAL INFORMATION 
Not applicable. 
090177e1a0cd6d13\Final\Final On: 29-May-2024 07:24 (GMT)