JADE Mono-2: Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03575871
• Collaborator: (none)
• Enrollment: 391
• Locations: 115
• Arms: 3
• Actual Duration (Months): 13.5
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic	Drug: PF-04965842 100 mg; Drug: PF-04965842 200 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 391 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
• Actual Study Start Date: Jun 29, 2018
• Actual Primary Completion Date: Aug 13, 2019
• Actual Study Completion Date: Aug 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-04965842 100 mg	Drug: PF-04965842 100 mg; PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
Experimental: PF-04965842 200 mg	Drug: PF-04965842 200 mg; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo Comparator: Placebo	Drug: Placebo; Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 [Baseline, Week 12]

   IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.

2. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12 [Baseline, Week 12]

   EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8 and 12]

   Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.

2. Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12 [Baseline, Week 12]

   PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.

3. Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus [Baseline up to Day 15]

   Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity.

4. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8 [Baseline, Weeks 2, 4, and 8]

   EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

5. Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8 [Baseline, Weeks 2, 4, and 8]

   IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.

6. Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12 [Weeks 2, 4, 8 and 12]

   IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.

7. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

   EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

8. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

   EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

9. Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

   EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

10. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

    EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

11. Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12 [Baseline, Weeks 2, 4, 8, and 12]

    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

12. Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12 [Weeks 2, 4, 8, and 12]

    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

13. Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.

14. Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

15. Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

16. Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

17. Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12 [Baseline, Weeks 2, 4, 8, and 12]

    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 12 years of age or older with a minimum body weight of 40 kg

• Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)

• Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

• Prior treatment with JAK inhibitors

• Other active nonAD inflammatory skin diseases or conditions affecting skin

• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator

• Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emmaus Research Center, Inc.	Anaheim	California	United States	92804
2	Advanced Research Center, Inc. - Los Alamitos Site	Los Alamitos	California	United States	90720
3	Peninsula Research Associates, Inc.	Rolling Hills Estates	California	United States	90274
4	Clinical Science Institute	Santa Monica	California	United States	90404
5	Asthma and Allergy Associates, PC	Colorado Springs	Colorado	United States	80907
6	Colorado Springs Dermatology Clinic, PC	Colorado Springs	Colorado	United States	80910
7	Olympian Clinical Research	Clearwater	Florida	United States	33756
8	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida	United States	32256
9	Precision Imaging	Jacksonville	Florida	United States	32256
10	Solutions Through Advanced Research, Inc.	Jacksonville	Florida	United States	32256
11	Clinical Neuroscience Solutions, Inc	Orlando	Florida	United States	32801
12	ForCare Clinical Research	Tampa	Florida	United States	33613
13	Imaging Center of Idaho	Caldwell	Idaho	United States	83605
14	ASR, LLC	Nampa	Idaho	United States	83687
15	Meridian Clinical Research	Baton Rouge	Louisiana	United States	70808
16	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
17	MediSearch Clinical Trials	Saint Joseph	Missouri	United States	64506
18	Sadick Research Group	New York	New York	United States	10075
19	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28411
20	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
21	The Ohio State University Dermatology East	Gahanna	Ohio	United States	43230
22	Tanenbaum Dermatology Center	Memphis	Tennessee	United States	38117
23	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee	United States	38119
24	Austin Institute for Clinical Research, Inc. - Central	Austin	Texas	United States	78705
25	Center for Clinical Studies, LTD. LLP	Houston	Texas	United States	77004
26	West Houston Dermatology, PA	Houston	Texas	United States	77082
27	Summit Clinical Research, LLC	Franklin	Virginia	United States	23851
28	Virginia Dermatology and Skin Cancer Center	Norfolk	Virginia	United States	23502
29	Australian Clinical Research Network	Maroubra	New South Wales	Australia	2035
30	The Skin Centre	Benowa	Queensland	Australia	4217
31	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland	Australia	4102
32	Skin and Cancer Foundation Inc	Carlton	Victoria	Australia
33	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
34	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
35	The Royal Children's Hospital (RCH)	Parkville	Victoria	Australia	3052
36	Medical Centre Asklepii OOD	Dupnitsa		Bulgaria	2600
37	MHAT Dr. Tota Venkova AD	Gabrovo		Bulgaria	5300
38	"Acibadem City Clinic MHAT Tokuda" EAD	Sofia		Bulgaria	1407
39	"DCC Aleksandrovska" EOOD	Sofia		Bulgaria	1431
40	Diagnostic Consultative Center Fokus-5	Sofia		Bulgaria	1463
41	Medical Centre Synexus Sofia EOOD	Sofia		Bulgaria	1784
42	University of British Columbia Department of Dermatology and Skin Science	Vancouver	British Columbia	Canada	V5Z 4E8
43	Winnipeg Clinic	Winnipeg	Manitoba	Canada	R3C 0N2
44	North York Research Inc.	North York	Ontario	Canada	M2M 4J5
45	Oshawa Clinic Dermatology Trials	Oshawa	Ontario	Canada	L1H 1B9
46	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario	Canada	L4C 9M7
47	Research Toronto	Toronto	Ontario	Canada	M4W 2N2
48	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec	Canada	J1L 0H8
49	Peking University First Hospital	Beijing	Beijing	China	100034
50	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100050
51	The Second Affiliated Hospital of Army Medical University, PLA	Chongqing	Chongqing	China	400037
52	The University of Hong Kong - Shenzhen Hospital	Shenzhen	Guangdong	China	518053
53	Tianjin Medical University General Hospital, Dermatological Department	Tianjin		China	300052
54	Dermamedica S.R.O.	Nachod		Czechia	547 01
55	Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni	Nachod		Czechia	547 01
56	Lekarna u Stribrneho orla	Nachod		Czechia	54701
57	Sanatorium profesora Arenbergera	Praha 1		Czechia	11000
58	Lekarna U sv. Ignace	Praha 2		Czechia	120 00
59	Dermatologicka Ambulance	Svitavy		Czechia	568 02
60	Lekarna na Hranicni	Svitavy		Czechia	56802
61	Fachklinik Bad Bentheim	Bad Bentheim		Germany	48455
62	ISA GmbH	Berlin		Germany	10789
63	Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,	Blankenfelde-Mahlow		Germany	15831
64	IKF Pneumologie GmbH & Co KG	Frankfurt		Germany	60596
65	Klinische Forschung Hamburg GmbH	Hamburg		Germany	20253
66	Universitaet Muenster	Münster		Germany	48149
67	Klinische Forschung Schwerin GmbH	Schwerin		Germany	19055
68	SE AOK Bor, Nemikortani es Boronkologiai Klinika	Budapest		Hungary	1085
69	Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete	Budapest		Hungary	1195
70	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
71	ALLERGO-DERM BAKOS Kft.	Szolnok		Hungary	5000
72	Queen's square Medical Facilities Queen's square Dermatology and Allergology	Yokohama	Kanagawa	Japan	220-6208
73	Noguchi Dermatology Clinic	Kamimashiki-gun	Kumamoto	Japan	861-3101
74	Yoshioka Dermatology Clinic	Neyagawa	Osaka	Japan	572-0838
75	Kume Clinic	Sakai	Osaka	Japan	593-8324
76	Sumire Dermatology Clinic	Edogawa-ku	Tokyo	Japan	133-0057
77	Matsuyama Dermatology Clinic	Nakano-ku	Tokyo	Japan	165-0026
78	Hoshikuma Dermatology・Allergy Clinic	Fukuoka		Japan	814-0171
79	Sanrui Hifuka	Saitama		Japan	330-0854
80	Soon Chun Hyang University Bucheon Hospital	Bucheon-si	Gyeonggi-do	Korea, Republic of	14584
81	The Catholic University of Korea, Incheon St.Mary's Hospital	Bupyeong-gu	Incheon	Korea, Republic of	21431
82	Inha University Hospital	Jung-gu	Incheon	Korea, Republic of	22332
83	Kyungpook National University Hospital	Daegu		Korea, Republic of	41944
84	Chonnam National University Hospital	Gwangju		Korea, Republic of	61469
85	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
86	Severance Hospital, Yonsei Univ. Health System	Seoul		Korea, Republic of	03722
87	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
88	Chung-Ang University Hospital	Seoul		Korea, Republic of	06973
89	Hallym university Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of	07441
90	Selga Freiberga private practice in dermatovenerology and cosmetology	Jelgava		Latvia	LV-3001
91	Riga 1st Hospital, Clinic for Dermatology and STD	Riga		Latvia	LV-1001
92	Aesthetic dermatology clinic of Prof. J. Kisis	Riga		Latvia	LV-1003
93	Health Centre 4 Ltd. Diagnostics Centre	Riga		Latvia	LV-1003
94	Health Centre 4 Ltd	Riga		Latvia	LV-1013
95	NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.	Bialystok		Poland	15-453
96	KLIMED Marek Klimkiewicz	Białystok		Poland	15-704
97	Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.	Krakow		Poland	31-011
98	Centrum Badań Klinicznych JCI	Kraków		Poland	30-348
99	Krakowskie Centrum Medyczne Sp. z o.o.	Kraków		Poland	31-501
100	Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz		Poland	90-242
101	KO-MED Centra Kliniczne Lublin II	Lublin		Poland	20-362
102	Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.	Poznan		Poland	60-848
103	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin		Poland	71-434
104	Synexus Polska Sp. z o. o. Oddzial w Warszawie	Warszawa		Poland	01-192
105	Centrum Medyczne AMED	Warszawa		Poland	01-518
106	MTZ Clinical Research Sp. z o.o.	Warszawa		Poland	02-106
107	Klinika Ambroziak Sp. z o.o.	Warszawa		Poland	02-758
108	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw		Poland	50-381
109	Lukasz Matusiak "4HEALTH"	Wrocław		Poland	50-566
110	Plymouth Hospitals NHS Trust, Derriford Hospital	Plymouth	Devon	United Kingdom	PL6 8DH
111	MAC Clinical Research	Blackpool	Lancashire	United Kingdom	FY2 0JH
112	MAC Clinical Research Ltd	Cannock	South Staffordshire	United Kingdom	WS11 0BN
113	Barnsley Hospital NHS Foundation Trust	Barnsley	South Yorkshire	United Kingdom	S75 2EP
114	University Hospital Bristol NHS Foundation Trust	Bristol		United Kingdom	BS2 8HW
115	MAC Clinical Research Ltd	Manchester		United Kingdom	M13 9NQ

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Dec 6, 2018
• Statistical Analysis Plan - Aug 26, 2019

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03575871
• Other Study ID Numbers: B7451013; MONO-2; 2018-001136-21
• First Posted: Jul 3, 2018
• Last Update Posted: Apr 21, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Abrocitinib

Study Results

Participant Flow

Recruitment Details	Participants with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilograms were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.
Pre-assignment Detail	This study was conducted from 29-June-2018 to 13-Aug-2019 at 106 sites in 13 countries.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Period Title: Overall Study
STARTED	158	155	78
COMPLETED	137	141	52
NOT COMPLETED	21	14	26

Baseline Characteristics

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo	Total
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Total of all reporting groups
Overall Participants	158	155	78	391
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.4 (15.8)	33.5 (14.7)	33.4 (13.8)	35.1 (15.1)
Sex: Female, Male (Count of Participants)
Female	64 40.5%	67 43.2%	31 39.7%	162 41.4%
Male	94 59.5%	88 56.8%	47 60.3%	229 58.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 1.9%	4 2.6%	2 2.6%	9 2.3%
Not Hispanic or Latino	154 97.5%	150 96.8%	73 93.6%	377 96.4%
Unknown or Not Reported	1 0.6%	1 0.6%	3 3.8%	5 1.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	46 29.1%	54 34.8%	29 37.2%	129 33%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	9 5.7%	6 3.9%	6 7.7%	21 5.4%
White	101 63.9%	91 58.7%	40 51.3%	232 59.3%
More than one race	1 0.6%	2 1.3%	1 1.3%	4 1%
Unknown or Not Reported	1 0.6%	2 1.3%	2 2.6%	5 1.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
Description	IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	155	155	77
Number (95% Confidence Interval) [percentage of participants]	28.4 18%	38.1 24.6%	9.1 11.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	19.3
	Confidence Interval	(2-Sided) 95%; 9.6 to 29.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	28.7
	Confidence Interval	(2-Sided) 95%; 18.6 to 38.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12
Description	EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	155	154	77
Number (95% Confidence Interval) [percentage of participants]	44.5 28.2%	61.0 39.4%	10.4 13.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	33.9
	Confidence Interval	(2-Sided) 95%; 23.3 to 44.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	50.5
	Confidence Interval	(2-Sided) 95%; 40.0 to 60.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12
Description	Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	156	153	76
Week 2	23.1 14.6%	35.3 22.8%	3.9 5%
Week 4	31.4 19.9%	50.3 32.5%	3.9 5%
Week 8	39.1 24.7%	51.6 33.3%	11.8 15.1%
Week 12	39.7 25.1%	49.0 31.6%	10.5 13.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	19.2
	Confidence Interval	(2-Sided) 95%; 11.0 to 27.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	31.2
	Confidence Interval	(2-Sided) 95%; 22.3 to 40.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	27.5
	Confidence Interval	(2-Sided) 95%; 18.9 to 36.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	46.4
	Confidence Interval	(2-Sided) 95%; 37.2 to 55.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	27.4
	Confidence Interval	(2-Sided) 95%; 16.8 to 38.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	39.8
	Confidence Interval	(2-Sided) 95%; 28.9 to 50.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	29.3
	Confidence Interval	(2-Sided) 95%; 18.9 to 39.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	38.6
	Confidence Interval	(2-Sided) 95%; 28.1 to 49.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12
Description	PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	156	155	77
Least Squares Mean (95% Confidence Interval) [units on a scale]	-2.4	-3.0	-0.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -2.3 to -1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 95%; -2.8 to -1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus
Description	Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity.
Time Frame	Baseline up to Day 15

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	90	110	20
Median (Inter-Quartile Range) [days]	58.0	29.0	112.0

6. Secondary Outcome

Title	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8
Description	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame	Baseline, Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies the number of participants evaluable at specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	10.2 6.5%	24.3 15.7%	1.3 1.7%
Week 4	26.5 16.8%	51.0 32.9%	6.5 8.3%
Week 8	43.3 27.4%	60.4 39%	12.8 16.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0150
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	8.8
	Confidence Interval	(2-Sided) 95%; 2.8 to 14.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	22.7
	Confidence Interval	(2-Sided) 95%; 15.0 to 30.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	20.0
	Confidence Interval	(2-Sided) 95%; 10.9 to 29.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	44.3
	Confidence Interval	(2-Sided) 95%; 34.8 to 53.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	30.4
	Confidence Interval	(2-Sided) 95%; 19.7 to 41.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	47.4
	Confidence Interval	(2-Sided) 95%; 36.8 to 58.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8
Description	IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time Frame	Baseline, Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies the number of participants evaluable at specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	5.1 3.2%	14.5 9.4%	0 0%
Week 4	14.2 9%	33.3 21.5%	1.3 1.7%
Week 8	22.3 14.1%	37.7 24.3%	10.3 13.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0459
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	5.1
	Confidence Interval	(2-Sided) 95%; 0.2 to 10.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	14.2
	Confidence Interval	(2-Sided) 95%; 7.8 to 20.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0019
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	12.9
	Confidence Interval	(2-Sided) 95%; 6.3 to 19.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	31.8
	Confidence Interval	(2-Sided) 95%; 23.6 to 39.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0246
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	11.9
	Confidence Interval	(2-Sided) 95%; 2.4 to 21.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	26.9
	Confidence Interval	(2-Sided) 95%; 17.0 to 36.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12
Description	IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
Time Frame	Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	0 0%	2.0 1.3%	0 0%
Week 4	1.9 1.2%	4.6 3%	0 0%
Week 8	1.3 0.8%	4.5 2.9%	0 0%
Week 12	5.2 3.3%	6.5 4.2%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -3.7 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2262
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -2.2 to 6.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2223
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -2.2 to 6.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0597
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	4.5
	Confidence Interval	(2-Sided) 95%; -0.2 to 9.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3207
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -2.7 to 5.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0586
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	4.5
	Confidence Interval	(2-Sided) 95%; -0.2 to 9.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0419
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; 0.3 to 10.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0244
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; 1.2 to 11.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12
Description	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	35.7 22.6%	55.3 35.7%	10.5 13.5%
Week 4	58.7 37.2%	78.4 50.6%	28.6 36.7%
Week 8	66.2 41.9%	82.5 53.2%	34.6 44.4%
Week 12	68.4 43.3%	79.9 51.5%	19.5 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	25.0
	Confidence Interval	(2-Sided) 95%; 14.8 to 35.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	44.2
	Confidence Interval	(2-Sided) 95%; 33.9 to 54.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	30.2
	Confidence Interval	(2-Sided) 95%; 17.5 to 42.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	49.8
	Confidence Interval	(2-Sided) 95%; 37.8 to 61.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	31.5
	Confidence Interval	(2-Sided) 95%; 18.8 to 44.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	47.6
	Confidence Interval	(2-Sided) 95%; 35.7 to 59.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	48.7
	Confidence Interval	(2-Sided) 95%; 37.2 to 60.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	60.1
	Confidence Interval	(2-Sided) 95%; 49.1 to 71.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12
Description	EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	2.5 1.6%	9.2 5.9%	0 0%
Week 4	9.7 6.1%	22.9 14.8%	0 0%
Week 8	17.2 10.9%	34.4 22.2%	2.6 3.3%
Week 12	23.9 15.1%	37.7 24.3%	3.9 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1623
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; -1.7 to 6.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0070
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	9.1
	Confidence Interval	(2-Sided) 95%; 3.4 to 14.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0049
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	9.7
	Confidence Interval	(2-Sided) 95%; 4.0 to 15.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	22.9
	Confidence Interval	(2-Sided) 95%; 15.5 to 30.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0013
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	14.6
	Confidence Interval	(2-Sided) 95%; 7.2 to 22.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	31.6
	Confidence Interval	(2-Sided) 95%; 23.1 to 40.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	20.1
	Confidence Interval	(2-Sided) 95%; 11.9 to 28.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	33.5
	Confidence Interval	(2-Sided) 95%; 24.6 to 42.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12
Description	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	0 0%	1.3 0.8%	0 0%
Week 4	1.3 0.8%	3.9 2.5%	0 0%
Week 8	1.3 0.8%	3.9 2.5%	0 0%
Week 12	5.2 3.3%	7.1 4.6%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -3.7 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3261
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -2.8 to 5.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3207
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -2.7 to 5.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0810
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; -0.8 to 8.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3207
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -2.7 to 5.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0810
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 95%; -0.7 to 8.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0419
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; 0.3 to 10.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0180
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; 1.8 to 12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12
Description	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Change at Week 2	-39.2	-51.3	-9.0
Change at Week 4	-54.3	-69.0	-24.4
Change at Week 8	-59.5	-73.2	-33.0
Change at Week 12	-60.0	-73.3	-28.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-30.2
	Confidence Interval	(2-Sided) 95%; -38.1 to -22.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-42.3
	Confidence Interval	(2-Sided) 95%; -50.3 to -34.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-29.9
	Confidence Interval	(2-Sided) 95%; -38.1 to -21.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-44.6
	Confidence Interval	(2-Sided) 95%; -52.8 to -36.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-26.4
	Confidence Interval	(2-Sided) 95%; -36.2 to -16.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-40.2
	Confidence Interval	(2-Sided) 95%; -50.0 to -30.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-31.4
	Confidence Interval	(2-Sided) 95%; -43.1 to -19.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-44.7
	Confidence Interval	(2-Sided) 95%; -56.4 to -33.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12
Description	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Change at Week 2	-27.8	-35.4	-1.3
Change at Week 4	-45.0	-55.7	-15.3
Change at Week 8	-53.4	-61.1	-20.5
Change at Week 12	-56.4	-65.0	-16.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-26.5
	Confidence Interval	(2-Sided) 95%; -35.5 to -17.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-34.1
	Confidence Interval	(2-Sided) 95%; -43.1 to -25.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-29.7
	Confidence Interval	(2-Sided) 95%; -39.0 to -20.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-40.5
	Confidence Interval	(2-Sided) 95%; -49.8 to -31.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-32.9
	Confidence Interval	(2-Sided) 95%; -44.6 to -21.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-40.6
	Confidence Interval	(2-Sided) 95%; -52.2 to -28.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-39.6
	Confidence Interval	(2-Sided) 95%; -51.8 to -27.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-48.2
	Confidence Interval	(2-Sided) 95%; -60.4 to -36.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12
Description	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	1.9 1.2%	5.9 3.8%	0 0%
Week 4	6.5 4.1%	17.0 11%	0 0%
Week 8	15.9 10.1%	27.3 17.6%	1.3 1.7%
Week 12	22.6 14.3%	34.4 22.2%	3.9 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2353
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -2.2 to 6.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0332
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	5.8
	Confidence Interval	(2-Sided) 95%; 0.8 to 10.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0227
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; 1.4 to 11.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	16.8
	Confidence Interval	(2-Sided) 95%; 10.1 to 23.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	14.5
	Confidence Interval	(2-Sided) 95%; 7.7 to 21.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	25.8
	Confidence Interval	(2-Sided) 95%; 18.1 to 33.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	18.5
	Confidence Interval	(2-Sided) 95%; 10.5 to 26.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	30.2
	Confidence Interval	(2-Sided) 95%; 21.4 to 39.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12
Description	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	12.7 8%	32.9 21.2%	0 0%
Week 4	36.1 22.8%	60.8 39.2%	7.8 10%
Week 8	43.3 27.4%	61.7 39.8%	15.4 19.7%
Week 12	49.0 31%	62.6 40.4%	12.8 16.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0011
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	12.7
	Confidence Interval	(2-Sided) 95%; 6.5 to 18.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	32.6
	Confidence Interval	(2-Sided) 95%; 24.6 to 40.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	28.3
	Confidence Interval	(2-Sided) 95%; 18.5 to 38.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	52.8
	Confidence Interval	(2-Sided) 95%; 43.2 to 62.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	28.0
	Confidence Interval	(2-Sided) 95%; 17.0 to 39.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	46.1
	Confidence Interval	(2-Sided) 95%; 35.2 to 57.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	36.2
	Confidence Interval	(2-Sided) 95%; 25.4 to 47.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	49.6
	Confidence Interval	(2-Sided) 95%; 38.9 to 60.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12
Description	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Week 2	1.9 1.2%	5.3 3.4%	0 0%
Week 4	7.1 4.5%	17.6 11.4%	0 0%
Week 8	11.5 7.3%	26.0 16.8%	0 0%
Week 12	18.7 11.8%	30.3 19.5%	2.6 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2261
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -2.2 to 6.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0451
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; 0.3 to 10.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0171
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; 1.8 to 12.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	17.7
	Confidence Interval	(2-Sided) 95%; 10.9 to 24.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0018
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category)
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	11.5
	Confidence Interval	(2-Sided) 95%; 5.5 to 17.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category)
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	25.7
	Confidence Interval	(2-Sided) 95%; 18.3 to 33.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	16.2
	Confidence Interval	(2-Sided) 95%; 8.8 to 23.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was adjusted by randomization strata (baseline disease severity and age category).
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	27.6
	Confidence Interval	(2-Sided) 95%; 19.3 to 35.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12
Description	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Change at Week 2	-2.3	-3.5	-0.6
Change at Week 4	-3.1	-4.3	-1.2
Change at Week 8	-3.4	-4.3	-1.8
Change at Week 12	-3.5	-4.2	-2.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -2.3 to -1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-2.9
	Confidence Interval	(2-Sided) 95%; -3.5 to -2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95%; -2.6 to -1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -3.8 to -2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -2.3 to -0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -3.3 to -1.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -2.2 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12
Description	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Change at Week 2	-1.9	-2.9	-0.5
Change at Week 4	-2.8	-3.9	-1.0
Change at Week 8	-3.1	-3.9	-1.5
Change at Week 12	-3.0	-3.8	-2.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -2.4 to -1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -3.6 to -2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -2.3 to -0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -3.1 to -1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0164
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -1.7 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -2.5 to -1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12
Description	SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame	Baseline, Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04965842 100 mg	PF-04965842 200 mg	Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.	Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Measure Participants	158	155	78
Change at Week 2	-27.2	-38.5	-6.3
Change at Week 4	-38.9	-53.1	-17.2
Change at Week 8	-42.6	-56.7	-23.1
Change at Week 12	-45.8	-56.2	-22.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-20.9
	Confidence Interval	(2-Sided) 95%; -26.6 to -15.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-32.1
	Confidence Interval	(2-Sided) 95%; -37.9 to -26.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-21.6
	Confidence Interval	(2-Sided) 95%; -28.1 to -15.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-35.9
	Confidence Interval	(2-Sided) 95%; -42.3 to -29.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-19.4
	Confidence Interval	(2-Sided) 95%; -26.8 to -12.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-33.6
	Confidence Interval	(2-Sided) 95%; -41.0 to -26.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 100 mg, Placebo
	Comments	Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-23.1
	Confidence Interval	(2-Sided) 95%; -32.3 to -13.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	PF-04965842 200 mg, Placebo
	Comments	Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS mean
	Estimated Value	-33.4
	Confidence Interval	(2-Sided) 95%; -42.6 to -24.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline up to Week 16
Adverse Event Reporting Description	Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Arm/Group Title	PF-04965842 100 mg		PF-04965842 200 mg		Placebo
Arm/Group Description	Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.		Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.		Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
All Cause Mortality
	PF-04965842 100 mg		PF-04965842 200 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Serious Adverse Events
	PF-04965842 100 mg		PF-04965842 200 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/158 (3.2%)		2/155 (1.3%)		1/78 (1.3%)
General disorders
Sudden death	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Immune system disorders
Anaphylactic shock	0/158 (0%)		1/155 (0.6%)		0/78 (0%)
Infections and infestations
Eczema herpeticum	0/158 (0%)		0/155 (0%)		1/78 (1.3%)
Herpangina	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Osteomyelitis bacterial	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Pneumonia	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Staphylococcal infection	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Staphylococcal skin infection	0/158 (0%)		0/155 (0%)		1/78 (1.3%)
Injury, poisoning and procedural complications
Femoral neck fracture	0/158 (0%)		1/155 (0.6%)		0/78 (0%)
Skin and subcutaneous tissue disorders
Dermatitis atopic	1/158 (0.6%)		0/155 (0%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	PF-04965842 100 mg		PF-04965842 200 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/158 (35.4%)		52/155 (33.5%)		22/78 (28.2%)
Gastrointestinal disorders
Nausea	12/158 (7.6%)		22/155 (14.2%)		2/78 (2.6%)
Vomiting	2/158 (1.3%)		8/155 (5.2%)		1/78 (1.3%)
Infections and infestations
Nasopharyngitis	20/158 (12.7%)		12/155 (7.7%)		5/78 (6.4%)
Upper respiratory tract infection	14/158 (8.9%)		5/155 (3.2%)		3/78 (3.8%)
Nervous system disorders
Headache	9/158 (5.7%)		12/155 (7.7%)		2/78 (2.6%)
Skin and subcutaneous tissue disorders
Acne	2/158 (1.3%)		9/155 (5.8%)		0/78 (0%)
Dermatitis atopic	9/158 (5.7%)		6/155 (3.9%)		12/78 (15.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.