Trial Outcomes & Findings for Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (NCT NCT04345367)

Results Overview

The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

727 participants

Primary outcome timeframe

Week 2

Results posted on

2022-07-08

Participant Flow

This was a double-blind, double-dummy, active-controlled study in adult participants with moderate to severe atopic dermatitis. The study was conducted across 143 sites in 15 countries.

A total of 940 participants were screened, of which 213 were screen failures and were not enrolled. 727 participants were enrolled in the study and assigned to a study intervention.

Participant milestones

Participant milestones
Measure	Abrocitinib 200 mg QD Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Overall Study STARTED	362	365
Overall Study COMPLETED	327	334
Overall Study NOT COMPLETED	35	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Abrocitinib 200 mg QD Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Overall Study Other	3	4
Overall Study Medication Error Without Associated Adverse Event	1	0
Overall Study Withdrawal by Subject	11	11
Overall Study Protocol Violation	4	3
Overall Study Lost to Follow-up	2	4
Overall Study Lack of Efficacy	2	0
Overall Study Death	2	0
Overall Study Adverse Event	10	9

Baseline Characteristics

Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.	Total n=727 Participants Total of all reporting groups
Age, Continuous	36.6 Years STANDARD_DEVIATION 14.6 • n=5 Participants	35.5 Years STANDARD_DEVIATION 13.3 • n=7 Participants	36.0 Years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	161 Participants n=7 Participants	330 Participants n=5 Participants
Sex: Female, Male Male	193 Participants n=5 Participants	204 Participants n=7 Participants	397 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	331 Participants n=5 Participants	337 Participants n=7 Participants	668 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	62 Participants n=5 Participants	83 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) White	269 Participants n=5 Participants	248 Participants n=7 Participants	517 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2

Population: Full Analysis Set (FAS) comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=357 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=364 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2	48.2 Percentage of participants Interval 43.0 to 53.4	25.5 Percentage of participants Interval 21.1 to 30.0

PRIMARY outcome

Timeframe: Week 4

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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, with higher scores indicating greater severity of AD.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=354 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=364 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4	28.5 Percentage of participants Interval 23.8 to 33.2	14.6 Percentage of participants Interval 10.9 to 18.2

SECONDARY outcome

Timeframe: Week 16

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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, with higher scores indicating greater severity of AD.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=357 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=360 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving EASI-90 Response at Week 16	54.3 Percentage of participants Interval 49.2 to 59.5	41.9 Percentage of participants Interval 36.8 to 47.0

SECONDARY outcome

Timeframe: Week 2, 8, 12, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.

EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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, with higher scores indicating greater severity of AD.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 Week 2	11.6 Percentage of participants Interval 8.3 to 14.9	7.2 Percentage of participants Interval 4.5 to 9.8
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 Week 8	45.4 Percentage of participants Interval 40.2 to 50.5	25.4 Percentage of participants Interval 20.9 to 29.9
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 Week 26	54.6 Percentage of participants Interval 49.4 to 59.8	47.6 Percentage of participants Interval 42.5 to 52.8
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 Week 12	47.6 Percentage of participants Interval 42.5 to 52.8	33.6 Percentage of participants Interval 28.7 to 38.5
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 Week 20	58.4 Percentage of participants Interval 53.3 to 63.5	45.7 Percentage of participants Interval 40.6 to 50.9

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.

EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % 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, with higher scores indicating greater severity of AD.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 2	29.4 Percentage of participants Interval 24.7 to 34.1	21.3 Percentage of participants Interval 17.1 to 25.5
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 4	57.6 Percentage of participants Interval 52.5 to 62.8	36.8 Percentage of participants Interval 31.9 to 41.8
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 8	71.0 Percentage of participants Interval 66.3 to 75.7	52.8 Percentage of participants Interval 47.6 to 57.9
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 20	76.1 Percentage of participants Interval 71.7 to 80.6	71.1 Percentage of participants Interval 66.4 to 75.7
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 26	73.0 Percentage of participants Interval 68.3 to 77.7	72.3 Percentage of participants Interval 67.7 to 76.9
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 12	76.3 Percentage of participants Interval 71.9 to 80.7	61.4 Percentage of participants Interval 56.4 to 66.4
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 Week 16	77.3 Percentage of participants Interval 73.0 to 81.7	67.8 Percentage of participants Interval 63.0 to 72.6

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.

IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 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.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 2	14.4 Percentage of participants Interval 10.8 to 18.0	7.2 Percentage of participants Interval 4.5 to 9.8
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 4	38.0 Percentage of participants Interval 32.9 to 43.0	17.6 Percentage of participants Interval 13.7 to 21.5
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 16	55.3 Percentage of participants Interval 50.2 to 60.5	42.5 Percentage of participants Interval 37.4 to 47.6
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 20	60.0 Percentage of participants Interval 54.9 to 65.1	50.8 Percentage of participants Interval 45.7 to 56.0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 26	55.6 Percentage of participants Interval 50.4 to 60.8	51.1 Percentage of participants Interval 46.0 to 56.3
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 8	50.1 Percentage of participants Interval 44.9 to 55.3	30.9 Percentage of participants Interval 26.2 to 35.7
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 Week 12	51.8 Percentage of participants Interval 46.6 to 57.0	36.0 Percentage of participants Interval 31.1 to 40.9

SECONDARY outcome

Timeframe: Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 12	41.5 Percentage of participants Interval 36.3 to 46.7	20.2 Percentage of participants Interval 16.0 to 24.4
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 5	26.4 Percentage of participants Interval 21.8 to 31.0	11.9 Percentage of participants Interval 8.5 to 15.3
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 6	28.4 Percentage of participants Interval 23.7 to 33.2	15.5 Percentage of participants Interval 11.7 to 19.3
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 7	33.1 Percentage of participants Interval 28.2 to 38.1	13.2 Percentage of participants Interval 9.7 to 16.8
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 8	36.3 Percentage of participants Interval 31.2 to 41.3	14.1 Percentage of participants Interval 10.5 to 17.8
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 9	38.5 Percentage of participants Interval 33.4 to 43.6	16.9 Percentage of participants Interval 12.9 to 20.8
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 10	40.0 Percentage of participants Interval 34.8 to 45.2	18.7 Percentage of participants Interval 14.6 to 22.8
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 11	40.1 Percentage of participants Interval 35.0 to 45.3	20.2 Percentage of participants Interval 16.0 to 24.4
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 13	44.0 Percentage of participants Interval 38.8 to 49.2	21.5 Percentage of participants Interval 17.2 to 25.7
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 14	45.5 Percentage of participants Interval 40.3 to 50.8	23.2 Percentage of participants Interval 18.8 to 27.6
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 15	48.6 Percentage of participants Interval 43.3 to 53.8	25.6 Percentage of participants Interval 21.1 to 30.1
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 3	15.1 Percentage of participants Interval 11.3 to 18.8	8.6 Percentage of participants Interval 5.6 to 11.5
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 4	22.1 Percentage of participants Interval 17.7 to 26.4	10.7 Percentage of participants Interval 7.5 to 13.9
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 Day 2	11.0 Percentage of participants Interval 7.5 to 14.4	3.8 Percentage of participants Interval 1.7 to 5.9

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 Week 4	58.1 Percentage of participants Interval 53.0 to 63.3	40.8 Percentage of participants Interval 35.7 to 45.8
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 Week 8	65.8 Percentage of participants Interval 60.9 to 70.7	52.7 Percentage of participants Interval 47.6 to 57.9
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 Week 12	66.0 Percentage of participants Interval 61.1 to 70.9	61.5 Percentage of participants Interval 56.5 to 66.5
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 Week 16	67.2 Percentage of participants Interval 62.4 to 72.1	63.6 Percentage of participants Interval 58.7 to 68.6
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 Week 20	65.3 Percentage of participants Interval 60.3 to 70.2	63.2 Percentage of participants Interval 58.2 to 68.1
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 Week 26	68.1 Percentage of participants Interval 63.2 to 72.9	63.1 Percentage of participants Interval 58.1 to 68.0

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=313 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=303 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)	11.0 Days Interval 9.0 to 14.0	25.0 Days Interval 21.0 to 30.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

The extent (%) to which a body region was involved with AD was determined 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. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total 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 was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 2	-42.7 Percent change Interval -46.0 to -39.4	-33.4 Percent change Interval -36.7 to -30.0
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 12	-78.8 Percent change Interval -81.9 to -75.7	-69.4 Percent change Interval -72.5 to -66.4
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 16	-80.6 Percent change Interval -83.5 to -77.8	-73.7 Percent change Interval -76.5 to -70.9
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 20	-82.2 Percent change Interval -84.8 to -79.6	-76.9 Percent change Interval -79.5 to -74.3
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 26	-82.3 Percent change Interval -85.0 to -79.6	-79.0 Percent change Interval -81.6 to -76.3
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 4	-62.0 Percent change Interval -65.5 to -58.5	-49.5 Percent change Interval -53.0 to -46.1
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 Week 8	-74.0 Percent change Interval -77.2 to -70.7	-62.8 Percent change Interval -66.0 to -59.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

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

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 2	-44.5 Percent change Interval -47.0 to -42.1	-33.5 Percent change Interval -35.9 to -31.0
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 4	-59.6 Percent change Interval -61.9 to -57.3	-46.8 Percent change Interval -49.1 to -44.5
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 8	-65.8 Percent change Interval -68.2 to -63.4	-55.6 Percent change Interval -58.0 to -53.3
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 12	-67.9 Percent change Interval -70.2 to -65.6	-60.6 Percent change Interval -62.9 to -58.3
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 16	-70.6 Percent change Interval -72.8 to -68.3	-64.4 Percent change Interval -66.7 to -62.2
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 20	-71.8 Percent change Interval -74.1 to -69.4	-66.8 Percent change Interval -69.1 to -64.5
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 Week 26	-71.5 Percent change Interval -73.9 to -69.1	-68.2 Percent change Interval -70.6 to -65.9

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12, 16 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 Week 26	-1.1 Units on a scale Interval -1.4 to -0.7	-1.2 Units on a scale Interval -1.5 to -0.9
Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 Week 12	-0.8 Units on a scale Interval -1.1 to -0.5	-0.8 Units on a scale Interval -1.1 to -0.6
Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 Week 16	-1.1 Units on a scale Interval -1.3 to -0.8	-1.2 Units on a scale Interval -1.4 to -0.9

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12, 16 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-D assessed the state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: total score was calculated as the sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 Week 16	-0.8 Units on a scale Interval -1.0 to -0.5	-0.9 Units on a scale Interval -1.1 to -0.7
Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 Week 12	-0.7 Units on a scale Interval -1.0 to -0.5	-0.7 Units on a scale Interval -1.0 to -0.5
Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 Week 26	-0.8 Units on a scale Interval -1.0 to -0.5	-1.0 Units on a scale Interval -1.3 to -0.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=361 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=363 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 Week 16	-10.8 Units on a scale Interval -11.2 to -10.4	-10.0 Units on a scale Interval -10.5 to -9.6
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 Week 12	-10.7 Units on a scale Interval -11.1 to -10.2	-9.7 Units on a scale Interval -10.1 to -9.3
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 Week 20	-10.8 Units on a scale Interval -11.2 to -10.3	-10.1 Units on a scale Interval -10.6 to -9.7
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 Week 26	-10.3 Units on a scale Interval -10.8 to -9.9	-10.0 Units on a scale Interval -10.5 to -9.6
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 Week 2	-8.6 Units on a scale Interval -9.1 to -8.2	-6.7 Units on a scale Interval -7.1 to -6.2

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12, 16 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=364 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 Week 12	12.370 Units on a scale Interval 10.917 to 13.822	11.552 Units on a scale Interval 10.123 to 12.981
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 Week 16	12.567 Units on a scale Interval 11.015 to 14.118	10.474 Units on a scale Interval 8.951 to 11.997
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 Week 26	13.484 Units on a scale Interval 11.982 to 14.985	14.300 Units on a scale Interval 12.836 to 15.764

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12, 16 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 Week 12	-14.2 Units on a scale Interval -14.9 to -13.6	-12.6 Units on a scale Interval -13.3 to -12.0
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 Week 16	-14.2 Units on a scale Interval -14.8 to -13.6	-12.8 Units on a scale Interval -13.4 to -12.2
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 Week 26	-13.8 Units on a scale Interval -14.5 to -13.1	-13.4 Units on a scale Interval -14.0 to -12.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12, 16 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Somnolence Score: Week 12	-7.7 Units on a scale Interval -9.1 to -6.2	-6.9 Units on a scale Interval -8.3 to -5.5
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Quantity Hours Slept Score: Week 12	0.7 Units on a scale Interval 0.5 to 0.9	0.5 Units on a scale Interval 0.2 to 0.7
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Quantity Hours Slept Score: Week 16	0.6 Units on a scale Interval 0.3 to 0.8	0.5 Units on a scale Interval 0.3 to 0.7
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Quantity Hours Slept Score: Week 26	0.5 Units on a scale Interval 0.3 to 0.7	0.4 Units on a scale Interval 0.2 to 0.6
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Short of Breath or Headache score: Week 12	-0.7 Units on a scale Interval -2.2 to 0.9	-1.9 Units on a scale Interval -3.4 to -0.4
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Short of Breath or Headache score: Week 16	-1.2 Units on a scale Interval -2.7 to 0.3	-1.3 Units on a scale Interval -2.8 to 0.2
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Snoring Score: Week 12	-5.3 Units on a scale Interval -7.0 to -3.6	-3.5 Units on a scale Interval -5.2 to -1.8
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Disturbance Score: Week 16	-21.5 Units on a scale Interval -23.2 to -19.7	-17.7 Units on a scale Interval -19.4 to -16.0
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Disturbance Score: Week 26	-21.2 Units on a scale Interval -23.0 to -19.5	-19.5 Units on a scale Interval -21.2 to -17.8
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Adequacy Score: Week 12	13.9 Units on a scale Interval 12.1 to 15.8	12.9 Units on a scale Interval 11.1 to 14.7
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Adequacy Score: Week 16	15.7 Units on a scale Interval 13.9 to 17.4	12.7 Units on a scale Interval 11.0 to 14.5
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Problems Index I Score: Week 26	-12.9 Units on a scale Interval -14.2 to -11.7	-12.1 Units on a scale Interval -13.3 to -10.9
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Problems Index II Score: Week 12	-14.4 Units on a scale Interval -15.7 to -13.1	-12.2 Units on a scale Interval -13.5 to -10.9
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Problems Index II Score: Week 16	-15.7 Units on a scale Interval -17.0 to -14.4	-12.8 Units on a scale Interval -14.0 to -11.5
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Problems Index II Score: Week 26	-15.4 Units on a scale Interval -16.7 to -14.1	-14.0 Units on a scale Interval -15.2 to -12.7
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Somnolence Score: Week 16	-9.8 Units on a scale Interval -11.3 to -8.4	-7.4 Units on a scale Interval -8.8 to -6.0
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Short of Breath or Headache score: Week 26	-2.0 Units on a scale Interval -3.5 to -0.6	-2.6 Units on a scale Interval -4.0 to -1.2
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Snoring Score: Week 16	-4.9 Units on a scale Interval -6.6 to -3.1	-4.0 Units on a scale Interval -5.7 to -2.3
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Snoring Score: Week 26	-3.9 Units on a scale Interval -5.7 to -2.0	-4.7 Units on a scale Interval -6.5 to -2.9
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Disturbance Score: Week 12	-20.5 Units on a scale Interval -22.3 to -18.8	-16.4 Units on a scale Interval -18.1 to -14.7
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Adequacy Score: Week 26	14.0 Units on a scale Interval 12.1 to 15.8	13.2 Units on a scale Interval 11.4 to 15.1
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Somnolence Score: Week 26	-9.9 Units on a scale Interval -11.3 to -8.5	-7.6 Units on a scale Interval -9.0 to -6.2
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Problems Index I Score: Week 12	-12.1 Units on a scale Interval -13.4 to -10.8	-10.9 Units on a scale Interval -12.2 to -9.6
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 Sleep Problems Index I Score: Week 16	-13.3 Units on a scale Interval -14.5 to -12.0	-11.0 Units on a scale Interval -12.2 to -9.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

The skin pain NRS was a participant reported outcome where participants were asked to rate the "worst skin pain" in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 Week 2	-3.7 Units on a scale Interval -3.9 to -3.4	-2.6 Units on a scale Interval -2.8 to -2.3
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 Week 26	-4.5 Units on a scale Interval -4.8 to -4.3	-4.3 Units on a scale Interval -4.6 to -4.1
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 Week 12	-4.5 Units on a scale Interval -4.7 to -4.2	-4.0 Units on a scale Interval -4.3 to -3.8
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 Week 16	-4.4 Units on a scale Interval -4.7 to -4.2	-4.2 Units on a scale Interval -4.4 to -4.0
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 Week 20	-4.8 Units on a scale Interval -5.0 to -4.5	-4.5 Units on a scale Interval -4.7 to -4.2

SECONDARY outcome

Timeframe: Day 1 up to Week 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention.

Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Medicated Topical Background Therapy-free Days	51.4 Days Interval 46.0 to 56.8	33.3 Days Interval 27.9 to 38.7

SECONDARY outcome

Timeframe: Week 2, 12, 16, 20 and 26

Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.

DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 Week 2	81.3 Percentage of participants Interval 77.2 to 85.4	67.5 Percentage of participants Interval 62.6 to 72.4
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 Week 12	85.4 Percentage of participants Interval 81.7 to 89.2	81.4 Percentage of participants Interval 77.4 to 85.5
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 Week 16	82.7 Percentage of participants Interval 78.7 to 86.8	84.2 Percentage of participants Interval 80.4 to 88.1
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 Week 20	81.8 Percentage of participants Interval 77.7 to 85.9	83.7 Percentage of participants Interval 79.8 to 87.6
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 Week 26	76.6 Percentage of participants Interval 72.1 to 81.2	80.8 Percentage of participants Interval 76.7 to 84.9

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)

Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Number of Participants With Treatment Emergent Adverse Events (AEs)	268 Participants	239 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)

Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; a congenital anomaly/birth defect and other important medical events.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation SAEs	6 Participants	6 Participants
Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation AEs Leading to Study Discontinuation	12 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)

Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The pre-defined criteria for laboratory parameters included: hemoglobin (\<9 grams per deciliter or decreases to \>=2 below baseline); platelets (\<75\*10\^3 cells per millimeter cube \[mm\^3\]); lymphocytes (\<0.5\*10\^3 cells per mm\^3); neutrophils (\<1\*10\^3 cells per mm\^3); aspartate aminotransferase and alanine aminotransferase (\>3\* upper limit of normal).

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria	38 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)

Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Vital signs including temperature, systolic and diastolic blood pressure, and pulse rate were measured in a seated position after 5 minutes rest. Clinically significant change from baseline in vital signs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)

Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator.

Outcome measures

Outcome measures
Measure	Abrocitinib 200 mg QD n=362 Participants Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 Participants Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data	0 Participants	0 Participants

Adverse Events

Abrocitinib 200 mg QD

Serious events: 6 serious events

Other events: 203 other events

Deaths: 2 deaths

Dupilumab 300 mg Q2W

Serious events: 6 serious events

Other events: 144 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abrocitinib 200 mg QD n=362 participants at risk Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 participants at risk Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Cardiac disorders Cardio-respiratory arrest	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Hepatobiliary disorders Cholecystitis acute	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations COVID-19	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations COVID-19 pneumonia	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Pneumonia	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications Upper limb fracture	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations Alanine aminotransferase increased	0.00% 0/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Haemorrhage intracranial	0.28% 1/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Abrocitinib 200 mg QD n=362 participants at risk Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention.	Dupilumab 300 mg Q2W n=365 participants at risk Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention.
Gastrointestinal disorders Diarrhoea	2.2% 8/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	2.2% 8/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders Nausea	19.3% 70/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	2.2% 8/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders Vomiting	3.0% 11/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	1.6% 6/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
General disorders Fatigue	2.8% 10/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	1.4% 5/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations COVID-19	3.9% 14/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	3.3% 12/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Conjunctivitis	2.2% 8/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	9.6% 35/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Folliculitis	3.3% 12/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.82% 3/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Herpes simplex	3.3% 12/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	1.4% 5/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Herpes zoster	2.5% 9/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.55% 2/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Nasopharyngitis	3.9% 14/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	3.3% 12/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Oral herpes	2.5% 9/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	4.1% 15/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Upper respiratory tract infection	2.8% 10/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	2.5% 9/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Urinary tract infection	2.2% 8/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	1.9% 7/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations Blood creatine phosphokinase increased	3.9% 14/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	3.6% 13/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations Natural killer cell count decreased	2.8% 10/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations SARS-CoV-2 test positive	4.1% 15/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	3.6% 13/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations Weight increased	2.2% 8/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.82% 3/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders Arthralgia	0.55% 2/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	2.2% 8/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Dizziness	2.8% 10/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	1.1% 4/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders Headache	13.0% 47/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	6.6% 24/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 8/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.27% 1/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders Acne	12.7% 46/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	2.7% 10/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders Dermatitis atopic	4.7% 17/362 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	3.6% 13/365 • From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.