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Clinical Trial Results:
A Phase 3b Randomized, Double-Blind, Double-Dummy, Active Controlled Multi-Center Study Assessing The Efficacy And Safety Of Abrocitinib Compared With Dupilumab In Adult Participants On Background Topical Therapy With Moderate To Severe Atopic Dermatitis

Summary
EudraCT number	2019-004013-13
Trial protocol	GB LV SK BE HU CZ DK FI BG FR IT
Global end of trial date	13 Jul 2021

Results information
Results version number	v1(current)
This version publication date	24 Jun 2022
First version publication date	24 Jun 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

B7451050

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, NY 10017, United States,

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Dec 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Jul 2021

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of abrocitinib 200 mg once daily (QD) versus dupilumab 300 mg once every 2 weeks (Q2W) (as per label guidelines) in adult subjects on background topical therapy with moderate to severe atopic dermatitis (AD).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Jun 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 51

Country: Number of subjects enrolled

Bulgaria: 17

Country: Number of subjects enrolled

Canada: 196

Country: Number of subjects enrolled

Chile: 37

Country: Number of subjects enrolled

Finland: 10

Country: Number of subjects enrolled

Germany: 66

Country: Number of subjects enrolled

Hungary: 21

Country: Number of subjects enrolled

Italy: 1

Country: Number of subjects enrolled

Korea, Republic of: 25

Country: Number of subjects enrolled

Latvia: 7

Country: Number of subjects enrolled

Poland: 135

Country: Number of subjects enrolled

Slovakia: 16

Country: Number of subjects enrolled

Spain: 9

Country: Number of subjects enrolled

Taiwan: 11

Country: Number of subjects enrolled

United States: 125

Worldwide total number of subjects

727

EEA total number of subjects

282

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

695

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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

Screening details

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

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Abrocitinib 200 mg QD

Arm description

Subjects 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. Subjects were followed for up to 4 weeks post last dose of study intervention.

Arm type

Experimental

Investigational medicinal product name

Dupilumab Matching Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Dupilumab-matching placebo was administered as a subcutaneous injection once every 2 weeks until Week 24.

Investigational medicinal product name

Abrocitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Abrocitinib was available as 100 mg tablets to be administered at a dose of 200 mg once daily orally from Day 1 to Week 26.

Dupilumab 300 mg Q2W

Arm description

Subjects 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. Subjects were followed for up to 4 weeks post last dose of study intervention.

Arm type

Active comparator

Investigational medicinal product name

Abrocitinib Matching Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Abrocitinib-matching placebo tablets were administered once daily orally from Day 1 to Week 26.

Investigational medicinal product name

Dupilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Dupilumab was administered at a dose of 300 mg as a subcutaneous injection Q2W until Week 24.

Number of subjects in period 1	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Started	362	365
Completed	327	334
Not completed	35	31
Consent withdrawn by subject	11	11
Adverse event, non-fatal	10	9
Death	2	-
Unspecified	3	4
Medication Error Without Associated Adverse Event	1	-
Lost to follow-up	2	4
Protocol deviation	4	3
Lack of efficacy	2	-

Baseline characteristics

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Reporting group title

Abrocitinib 200 mg QD

Reporting group description

Reporting group title

Dupilumab 300 mg Q2W

Reporting group description

Reporting group values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W	Total
Number of subjects	362	365	727
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	341	354	695
From 65-84 years	21	11	32
85 years and over	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	36.6 ( 14.6 )	35.5 ( 13.3 )	-
Sex: Female, Male
Units: Subjects
Female	169	161	330
Male	193	204	397
Race
Units: Subjects
American Indian or Alaska Native	1	0	1
Asian	62	83	145
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	25	26	51
White	269	248	517
More than one race	0	3	3
Unknown or Not Reported	4	5	9
Ethnicity
Units: Subjects
Hispanic or Latino	30	27	57
Not Hispanic or Latino	331	337	668
Unknown or Not Reported	1	1	2

End points

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Reporting group title

Abrocitinib 200 mg QD

Reporting group description

Reporting group title

Dupilumab 300 mg Q2W

Reporting group description

Primary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) from Baseline at Week 2

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End point title

Percentage of Subjects Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) from Baseline at Week 2

End point description

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Subjects 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. Full Analysis Set (FAS) comprised of all randomised subjects who received at least one dose of study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this end point.

End point type

Primary

End point timeframe

Week 2

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	357	364
Units: Percentage of subjects
number (confidence interval 95%)	48.2 (43.0 to 53.4)	25.5 (21.1 to 30.0)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

721

Analysis specification

Pre-specified

Analysis type

other ^[1]

P-value

< 0.0001 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Estimate of difference

Point estimate

22.6

Confidence interval

level

95%

sides

2-sided

lower limit

15.8

upper limit

29.5

Notes
[1] - The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.
[2] - Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.

Primary: Percentage of Subjects Achieving >= 90% Improvement from Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

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End point title

Percentage of Subjects Achieving >= 90% Improvement from Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

End point description

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) and lower limbs) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score=% 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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Week 4

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	354	364
Units: Percentage of subjects
number (confidence interval 95%)	28.5 (23.8 to 33.2)	14.6 (10.9 to 18.2)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

718

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Estimate of difference

Point estimate

14.1

Confidence interval

level

95%

sides

2-sided

lower limit

8.2

upper limit

Notes
[3] - CMH method adjusted by baseline disease severity.

Secondary: Percentage of Subjects Achieving EASI-90 Response at Week 16

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End point title

Percentage of Subjects Achieving EASI-90 Response at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	357	360
Units: Percentage of subjects
number (confidence interval 95%)	54.3 (49.2 to 59.5)	41.9 (36.8 to 47.0)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

717

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0008 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Estimate of difference

Point estimate

12.5

Confidence interval

level

95%

sides

2-sided

lower limit

5.3

upper limit

19.7

Notes
[4] - CMH method adjusted by baseline disease severity.

Secondary: Percentage of Subjects Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26

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End point title

Percentage of Subjects Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26

End point description

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) and lower limbs) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score=% 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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'n' signifies participants evaluable for the specified time points.

End point type

Secondary

End point timeframe

Week 2, 8, 12, 20 and 26

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percentage of subjects
number (confidence interval 95%)
Week 2; n=361, 362	11.6 (8.3 to 14.9)	7.2 (4.5 to 9.8)
Week 8; n=355, 362	45.4 (40.2 to 50.5)	25.4 (20.9 to 29.9)
Week 12; n=359, 363	47.6 (42.5 to 52.8)	33.6 (28.7 to 38.5)
Week 20; n=356, 363	58.4 (53.3 to 63.5)	45.7 (40.6 to 50.9)
Week 26; n=348, 361	54.6 (49.4 to 59.8)	47.6 (42.5 to 52.8)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

4.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

8.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

13.2

upper limit

26.9

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

6.9

upper limit

21.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

12.7

Confidence interval

level

95%

sides

2-sided

lower limit

5.5

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

6.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

14.3

Secondary: Percentage of Subjects Achieving >= 75% Improvement from Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26

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End point title

Percentage of Subjects Achieving >= 75% Improvement from Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26

End point description

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) and lower limbs) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score=% 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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'n' signifies participants evaluable for the specified time points.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percentage of subjects
number (confidence interval 95%)
Week 2; n=361, 362	29.4 (24.7 to 34.1)	21.3 (17.1 to 25.5)
Week 4; n=354, 364	57.6 (52.5 to 62.8)	36.8 (31.9 to 41.8)
Week 8; n=355, 362	71.0 (66.3 to 75.7)	52.8 (47.6 to 57.9)
Week 12; n=359, 363	76.3 (71.9 to 80.7)	61.4 (56.4 to 66.4)
Week 16; n=357, 360	77.3 (73.0 to 81.7)	67.8 (63.0 to 72.6)
Week 20; n=356, 363	76.1 (71.7 to 80.6)	71.1 (66.4 to 75.7)
Week 26; n=348, 361	73.0 (68.3 to 77.7)	72.3 (67.7 to 76.9)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

8.1

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

14.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

18.4

Confidence interval

level

95%

sides

2-sided

lower limit

11.4

upper limit

25.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

20.9

Confidence interval

level

95%

sides

2-sided

lower limit

13.8

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

14.9

Confidence interval

level

95%

sides

2-sided

lower limit

8.2

upper limit

21.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

9.5

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

11.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-5.9

upper limit

7.2

Secondary: Percentage of Subjects Achieving Investigator’s Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement from Baseline up to Week 26

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End point title

Percentage of Subjects Achieving Investigator’s Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement from Baseline up to Week 26

End point description

IGA=severity of AD on a 5 point scale (0 to 4, higher scores=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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'n' signifies subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percentage of subjects
number (confidence interval 95%)
Week 2; n=361, 362	14.4 (10.8 to 18.0)	7.2 (4.5 to 9.8)
Week 4; n=353, 364	38.0 (32.9 to 43.0)	17.6 (13.7 to 21.5)
Week 8; n=355, 362	50.1 (44.9 to 55.3)	30.9 (26.2 to 35.7)
Week 12; n=359, 364	51.8 (46.6 to 57.0)	36.0 (31.1 to 40.9)
Week 16; n=358, 360	55.3 (50.2 to 60.5)	42.5 (37.4 to 47.6)
Week 20; n=355, 364	60.0 (54.9 to 65.1)	50.8 (45.7 to 56.0)
Week 26; n=347, 362	55.6 (50.4 to 60.8)	51.1 (46.0 to 56.3)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

7.3

Confidence interval

level

95%

sides

2-sided

lower limit

2.8

upper limit

11.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

20.6

Confidence interval

level

95%

sides

2-sided

lower limit

14.3

upper limit

26.9

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

19.5

Confidence interval

level

95%

sides

2-sided

lower limit

12.5

upper limit

26.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

15.8

Confidence interval

level

95%

sides

2-sided

lower limit

8.7

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

5.9

upper limit

20.2

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

9.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

16.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

4.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

11.8

Secondary: Percentage of Subjects Achieving PP-NRS4 from Baseline at Days 2 to 15

Top of page

End point title

Percentage of Subjects Achieving PP-NRS4 from Baseline at Days 2 to 15

End point description

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Subjects 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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'n' signifies subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percentage of subjects
number (confidence interval 95%)
Day 2; n=319, 317	11.0 (7.5 to 14.4)	3.8 (1.7 to 5.9)
Day 3; n=345, 350	15.1 (11.3 to 18.8)	8.6 (5.6 to 11.5)
Day 4; n=349, 356	22.1 (17.7 to 26.4)	10.7 (7.5 to 13.9)
Day 5; n=352, 353	26.4 (21.8 to 31.0)	11.9 (8.5 to 15.3)
Day 6; n=348, 348	28.4 (23.7 to 33.2)	15.5 (11.7 to 19.3)
Day 7; n=347, 355	33.1 (28.2 to 38.1)	13.2 (9.7 to 16.8)
Day 8; n=353, 347	36.3 (31.2 to 41.3)	14.1 (10.5 to 17.8)
Day 9; n=348, 350	38.5 (33.4 to 43.6)	16.9 (12.9 to 20.8)
Day 10; n=345, 353	40.0 (34.8 to 45.2)	18.7 (14.6 to 22.8)
Day 11; n=349, 347	40.1 (35.0 to 45.3)	20.2 (16.0 to 24.4)
Day 12; n=347, 351	41.5 (36.3 to 46.7)	20.2 (16.0 to 24.4)
Day 13; n=348, 354	44.0 (38.8 to 49.2)	21.5 (17.2 to 25.7)
Day 14; n=347, 354	45.5 (40.3 to 50.8)	23.2 (18.8 to 27.6)
Day 15; n=350, 359	48.6 (43.3 to 53.8)	25.6 (21.1 to 30.1)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

7.1

Confidence interval

level

95%

sides

2-sided

lower limit

3.1

upper limit

11.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

6.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.7

upper limit

11.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

11.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

16.8

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

14.5

Confidence interval

level

95%

sides

2-sided

lower limit

8.8

upper limit

20.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

12.9

Confidence interval

level

95%

sides

2-sided

lower limit

6.9

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

19.9

Confidence interval

level

95%

sides

2-sided

lower limit

13.8

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

22.1

Confidence interval

level

95%

sides

2-sided

lower limit

15.9

upper limit

28.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of other

Point estimate

21.3

Confidence interval

level

95%

sides

2-sided

lower limit

14.7

upper limit

27.9

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

21.7

Confidence interval

level

95%

sides

2-sided

lower limit

15.2

upper limit

28.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

13.3

upper limit

26.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

21.3

Confidence interval

level

95%

sides

2-sided

lower limit

14.6

upper limit

27.9

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

22.4

Confidence interval

level

95%

sides

2-sided

lower limit

15.6

upper limit

29.2

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

22.5

Confidence interval

level

95%

sides

2-sided

lower limit

15.8

upper limit

29.2

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

22.9

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

29.9

Secondary: Percentage of Subjects Achieving PP-NRS4 from Baseline at Week 4, 8, 12, 16, 20 and 26

Top of page

End point title

Percentage of Subjects Achieving PP-NRS4 from Baseline at Week 4, 8, 12, 16, 20 and 26

End point description

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Subjects 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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'n' signifies subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percentage of subjects
number (confidence interval 95%)
Week 4; n=356, 363	58.1 (53.0 to 63.3)	40.8 (35.7 to 45.8)
Week 8; n=357, 364	65.8 (60.9 to 70.7)	52.7 (47.6 to 57.9)
Week 12; n=356, 364	66.0 (61.1 to 70.9)	61.5 (56.5 to 66.5)
Week 16; n=357, 363	67.2 (62.4 to 72.1)	63.6 (58.7 to 68.6)
Week 20; n=357, 364	65.3 (60.3 to 70.2)	63.2 (58.2 to 68.1)
Week 26; n=354, 363	68.1 (63.2 to 72.9)	63.1 (58.1 to 68.0)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

17.3

Confidence interval

level

95%

sides

2-sided

lower limit

10.1

upper limit

24.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

20.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

4.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

11.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

3.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

10.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

11.9

Secondary: Time to Achieve >=4 Points Improvement in PP-NRS4

Top of page

End point title

Time to Achieve >=4 Points Improvement in PP-NRS4

End point description

The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Subjects 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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Baseline (Day 1) up to Week 30

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	313	303
Units: Days
median (confidence interval 95%)	11.0 (9.0 to 14.0)	25.0 (21.0 to 30.0)

No statistical analyses for this end point

Secondary: Percent Change from Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26

Top of page

End point title

Percent Change from Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26

End point description

Extent (%) of body region involvement with AD was determined using handprint method. Number of handprints (size of subject's hand with fingers in a closed position) fitting in affected area of a body region was estimated. 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints=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 =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= 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. FAS=all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percent change
least squares mean (confidence interval 95%)
Week 2	-42.7 (-46.0 to -39.4)	-33.4 (-36.7 to -30.0)
Week 4	-62.0 (-65.5 to -58.5)	-49.5 (-53.0 to -46.1)
Week 8	-74.0 (-77.2 to -70.7)	-62.8 (-66.0 to -59.7)
Week 12	-78.8 (-81.9 to -75.7)	-69.4 (-72.5 to -66.4)
Week 16	-80.6 (-83.5 to -77.8)	-73.7 (-76.5 to -70.9)
Week 20	-82.2 (-84.8 to -79.6)	-76.9 (-79.5 to -74.3)
Week 26	-82.3 (-85.0 to -79.6)	-79.0 (-81.6 to -76.3)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-9.3

Confidence interval

level

95%

sides

2-sided

lower limit

-14

upper limit

-4.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-12.5

Confidence interval

level

95%

sides

2-sided

lower limit

-17.4

upper limit

-7.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-11.1

Confidence interval

level

95%

sides

2-sided

lower limit

-15.6

upper limit

-6.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-9.4

Confidence interval

level

95%

sides

2-sided

lower limit

-13.7

upper limit

-5.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-6.9

Confidence interval

level

95%

sides

2-sided

lower limit

-10.9

upper limit

-2.9

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-5.3

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

-1.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-3.4

Confidence interval

level

95%

sides

2-sided

lower limit

-7.1

upper limit

0.4

Secondary: Percent Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26

Top of page

End point title

Percent Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26

End point description

SCORAD=scoring index for AD combining extent (A), severity (B) and subjective symptoms (C). For A, rule of 9 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 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 scored by subject/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 =A/5+7*B/2+C; range (0-103);higher values=worse outcome. FAS=all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percent change
least squares mean (confidence interval 95%)
Week 2	-44.5 (-47.0 to -42.1)	-33.5 (-35.9 to -31.0)
Week 4	-59.6 (-61.9 to -57.3)	-46.8 (-49.1 to -44.5)
Week 8	-65.8 (-68.2 to -63.4)	-55.6 (-58.0 to -53.3)
Week 12	-67.9 (-70.2 to -65.6)	-60.6 (-62.9 to -58.3)
Week 16	-70.6 (-72.8 to -68.3)	-64.4 (-66.7 to -62.2)
Week 20	-71.8 (-74.1 to -69.4)	-66.8 (-69.1 to -64.5)
Week 26	-71.5 (-73.9 to -69.1)	-68.2 (-70.6 to -65.9)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-11

Confidence interval

level

95%

sides

2-sided

lower limit

-14.5

upper limit

-7.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-10.2

Confidence interval

level

95%

sides

2-sided

lower limit

-13.6

upper limit

-6.8

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-12.8

Confidence interval

level

95%

sides

2-sided

lower limit

-16

upper limit

-9.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-7.3

Confidence interval

level

95%

sides

2-sided

lower limit

-10.5

upper limit

-4.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-6.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9.3

upper limit

-3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-8.2

upper limit

-1.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

0.1

Secondary: Change from Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26

Top of page

End point title

Change from Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26

End point description

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. FAS comprised of all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Units on a scale
least squares mean (confidence interval 95%)
Week 12	-0.8 (-1.1 to -0.5)	-0.8 (-1.1 to -0.6)
Week 16	-1.1 (-1.3 to -0.8)	-1.2 (-1.4 to -0.9)
Week 26	-1.1 (-1.4 to -0.7)	-1.2 (-1.5 to -0.9)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

0.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

0.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

0.5

Secondary: Change from Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26

Top of page

End point title

Change from Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26

End point description

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. FAS comprised of all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Units on a scale
least squares mean (confidence interval 95%)
Week 12	-0.7 (-1.0 to -0.5)	-0.7 (-1.0 to -0.5)
Week 16	-0.8 (-1.0 to -0.5)	-0.9 (-1.1 to -0.7)
Week 26	-0.8 (-1.0 to -0.5)	-1.0 (-1.3 to -0.8)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

0.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.5

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26

Top of page

End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26

End point description

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 subjects. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this end point.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	361	363
Units: Units on a scale
least squares mean (confidence interval 95%)
Week 2	-8.6 (-9.1 to -8.2)	-6.7 (-7.1 to -6.2)
Week 12	-10.7 (-11.1 to -10.2)	-9.7 (-10.1 to -9.3)
Week 16	-10.8 (-11.2 to -10.4)	-10.0 (-10.5 to -9.6)
Week 20	-10.8 (-11.2 to -10.3)	-10.1 (-10.6 to -9.7)
Week 26	-10.3 (-10.8 to -9.9)	-10.0 (-10.5 to -9.6)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

724

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

-1.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

724

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

-0.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

724

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

-0.2

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

724

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

0.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

724

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

Secondary: 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

Top of page

End point title

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

End point description

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 subject’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. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this end point.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	364
Units: Units on a scale
least squares mean (confidence interval 95%)
Week 12	12.370 (10.917 to 13.822)	11.552 (10.123 to 12.981)
Week 16	12.567 (11.015 to 14.118)	10.474 (8.951 to 11.997)
Week 26	13.484 (11.982 to 14.985)	14.300 (12.836 to 15.764)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

726

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.818

Confidence interval

level

95%

sides

2-sided

lower limit

-1.22

upper limit

2.856

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

726

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.816

Confidence interval

level

95%

sides

2-sided

lower limit

-2.914

upper limit

1.281

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

726

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

2.093

Confidence interval

level

95%

sides

2-sided

lower limit

-0.081

upper limit

4.267

Secondary: Change from Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26

Top of page

End point title

Change from Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26

End point description

POEM was a 7-item patient 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. FAS comprised of all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Units on a scale
least squares mean (confidence interval 95%)
Week 12	-14.2 (-14.9 to -13.6)	-12.6 (-13.3 to -12.0)
Week 16	-14.2 (-14.8 to -13.6)	-12.8 (-13.4 to -12.2)
Week 26	-13.8 (-14.5 to -13.1)	-13.4 (-14.0 to -12.7)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

-0.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

-0.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

0.5

Secondary: Change from Baseline in Medical Outcomes Study – Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26

Top of page

End point title

Change from Baseline in Medical Outcomes Study – Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26

End point description

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 0-100, 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. FAS comprised of all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Units on a scale
least squares mean (confidence interval 95%)
Quantity Hours Slept Score: Week 12	0.7 (0.5 to 0.9)	0.5 (0.2 to 0.7)
Quantity Hours Slept Score: Week 16	0.6 (0.3 to 0.8)	0.5 (0.3 to 0.7)
Quantity Hours Slept Score: Week 26	0.5 (0.3 to 0.7)	0.4 (0.2 to 0.6)
Short of Breath or Headache score: Week 12	-0.7 (-2.2 to 0.9)	-1.9 (-3.4 to -0.4)
Short of Breath or Headache score: Week 16	-1.2 (-2.7 to 0.3)	-1.3 (-2.8 to 0.2)
Short of Breath or Headache score: Week 26	-2.0 (-3.5 to -0.6)	-2.6 (-4.0 to -1.2)
Snoring Score: Week 12	-5.3 (-7.0 to -3.6)	-3.5 (-5.2 to -1.8)
Snoring Score: Week 16	-4.9 (-6.6 to -3.1)	-4.0 (-5.7 to -2.3)
Snoring Score: Week 26	-3.9 (-5.7 to -2.0)	-4.7 (-6.5 to -2.9)
Sleep Disturbance Score: Week 12	-20.5 (-22.3 to -18.8)	-16.4 (-18.1 to -14.7)
Sleep Disturbance Score: Week 16	-21.5 (-23.2 to -19.7)	-17.7 (-19.4 to -16.0)
Sleep Disturbance Score: Week 26	-21.2 (-23.0 to -19.5)	-19.5 (-21.2 to -17.8)
Sleep Adequacy Score: Week 12	13.9 (12.1 to 15.8)	12.9 (11.1 to 14.7)
Sleep Adequacy Score: Week 16	15.7 (13.9 to 17.4)	12.7 (11.0 to 14.5)
Sleep Adequacy Score: Week 26	14.0 (12.1 to 15.8)	13.2 (11.4 to 15.1)
Sleep Somnolence Score: Week 12	-7.7 (-9.1 to -6.2)	-6.9 (-8.3 to -5.5)
Sleep Somnolence Score: Week 16	-9.8 (-11.3 to -8.4)	-7.4 (-8.8 to -6.0)
Sleep Somnolence Score: Week 26	-9.9 (-11.3 to -8.5)	-7.6 (-9.0 to -6.2)
Sleep Problems Index I Score: Week 12	-12.1 (-13.4 to -10.8)	-10.9 (-12.2 to -9.6)
Sleep Problems Index I Score: Week 16	-13.3 (-14.5 to -12.0)	-11.0 (-12.2 to -9.8)
Sleep Problems Index I Score: Week 26	-12.9 (-14.2 to -11.7)	-12.1 (-13.3 to -10.9)
Sleep Problems Index II Score: Week 12	-14.4 (-15.7 to -13.1)	-12.2 (-13.5 to -10.9)
Sleep Problems Index II Score: Week 16	-15.7 (-17.0 to -14.4)	-12.8 (-14.0 to -11.5)
Sleep Problems Index II Score: Week 26	-15.4 (-16.7 to -14.1)	-14.0 (-15.2 to -12.7)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

3.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

2.2

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

2.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.2

upper limit

0.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

1.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

3.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-4.1

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

-1.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

-1.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.1

upper limit

0.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

5.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

3.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

1.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

3.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

-0.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

-0.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

0.7

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-0.5

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

0.9

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.8

upper limit

-1.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-0.3

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

0.4

Secondary: Change from Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26

Top of page

End point title

Change from Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26

End point description

The skin pain NRS was a patient reported outcome where subjects 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. FAS comprised of all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Units on a scale
least squares mean (confidence interval 95%)
Week 2	-3.7 (-3.9 to -3.4)	-2.6 (-2.8 to -2.3)
Week 12	-4.5 (-4.7 to -4.2)	-4.0 (-4.3 to -3.8)
Week 16	-4.4 (-4.7 to -4.2)	-4.2 (-4.4 to -4.0)
Week 20	-4.8 (-5.0 to -4.5)	-4.5 (-4.7 to -4.2)
Week 26	-4.5 (-4.8 to -4.3)	-4.3 (-4.6 to -4.1)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

-0.8

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

0.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

0.1

Secondary: Medicated topical background therapy-free days

Top of page

End point title

Medicated topical background therapy-free days

End point description

Medicated topical background therapy-free days was defined as number of days where a subject maintained a response of EASI-90 or greater without the use of medicated topical background therapy. FAS comprised of all randomised subjects who received at least one dose of study intervention.

End point type

Secondary

End point timeframe

Day 1 up to Week 26

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Days
least squares mean (confidence interval 95%)	51.4 (46.0 to 56.8)	33.3 (27.9 to 38.7)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Least square mean difference

Point estimate

18.1

Confidence interval

level

95%

sides

2-sided

lower limit

10.5

upper limit

25.7

Secondary: Percentage of Subjects Achieving >=4 Points Improvement from Baseline in DLQI at Week 2, 12, 16, 20 and 26

Top of page

End point title

Percentage of Subjects Achieving >=4 Points Improvement from Baseline in DLQI at Week 2, 12, 16, 20 and 26

End point description

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 subjects. FAS comprised of all randomised subjects who received at least one dose of study intervention. Here, 'n' signifies subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Week 2, 12, 16, 20 and 26

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Percentage of subjects
number (confidence interval 95%)
Week 2; n=342, 351	81.3 (77.2 to 85.4)	67.5 (62.6 to 72.4)
Week 12; n=343, 350	85.4 (81.7 to 89.2)	81.4 (77.4 to 85.5)
Week 16; n=342, 349	82.7 (78.7 to 86.8)	84.2 (80.4 to 88.1)
Week 20; n=341, 350	81.8 (77.7 to 85.9)	83.7 (79.8 to 87.6)
Week 26; n=334, 349	76.6 (72.1 to 81.2)	80.8 (76.7 to 84.9)

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

13.7

Confidence interval

level

95%

sides

2-sided

lower limit

7.3

upper limit

20.1

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

9.4

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-7.1

upper limit

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-7.6

upper limit

3.6

Abrocitinib 200 mg QD vs Dupilumab 300 mg Q2W

Statistical analysis description

Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.

Comparison groups

Abrocitinib 200 mg QD v Dupilumab 300 mg Q2W

Number of subjects included in analysis

727

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Estimate of difference

Point estimate

-4.2

Confidence interval

level

95%

sides

2-sided

lower limit

-10.3

upper limit

1.9

Other pre-specified: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

Top of page

End point title

Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

End point description

An AE was any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a 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. Safety population comprised of all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Other pre-specified

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Subjects	268	239

No statistical analyses for this end point

Other pre-specified: Number of Subjects with Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation

Top of page

End point title

Number of Subjects with Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation

End point description

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

End point type

Other pre-specified

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Subjects
SAEs	6	6
AEs Leading to Study Discontinuation	12	9

No statistical analyses for this end point

Other pre-specified: Number of Subjects with Laboratory Abnormalities Meeting Pre-Defined Criteria

Top of page

End point title

Number of Subjects with Laboratory Abnormalities Meeting Pre-Defined Criteria

End point description

The pre-defined criteria for laboratory parameters included: haemoglobin (<9 grams per decilitre or decreases to >=2 below baseline); platelets (<75*10^3 cells per millimetre 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). Safety population comprised of all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Other pre-specified

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Subjects	38	10

No statistical analyses for this end point

Other pre-specified: Number of Subjects with Clinically Significant Change from Baseline in Vital Signs

Top of page

End point title

Number of Subjects with Clinically Significant Change from Baseline in Vital Signs

End point description

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

End point type

Other pre-specified

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Subjects	0	0

No statistical analyses for this end point

Other pre-specified: Number of Subjects with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Data

Top of page

End point title

Number of Subjects with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Data

End point description

A single 12-lead ECG was performed after the subject 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. Safety population comprised of all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.

End point type

Other pre-specified

End point timeframe

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

End point values	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Number of subjects analysed	362	365
Units: Subjects	0	0

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From start of study intervention up to 28 days after last dose of study intervention (Up to Week 30)

Adverse event reporting additional description

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 subject and non-serious for another subject, or a subject may have experienced both a serious and non-serious episode of the same event.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Abrocitinib 200 mg QD

Reporting group description

Subjects were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection Q2W until Week 24. Subjects were followed for up to 4 weeks post last dose of study intervention.

Reporting group title

Dupilumab 300 mg Q2W

Reporting group description

Serious adverse events	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 362 (1.66%)	6 / 365 (1.64%)
number of deaths (all causes)	2	0
number of deaths resulting from adverse events
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 362 (0.00%)	1 / 365 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Upper limb fracture
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardio-respiratory arrest
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Nervous system disorders
Haemorrhage intracranial
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 362 (0.00%)	1 / 365 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	0 / 362 (0.00%)	1 / 365 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Nephrotic syndrome
subjects affected / exposed	0 / 362 (0.00%)	1 / 365 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
subjects affected / exposed	0 / 362 (0.00%)	1 / 365 (0.27%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 362 (0.00%)	1 / 365 (0.27%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
COVID-19
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
COVID-19 pneumonia
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 362 (0.28%)	0 / 365 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Abrocitinib 200 mg QD	Dupilumab 300 mg Q2W
Total subjects affected by non serious adverse events
subjects affected / exposed	203 / 362 (56.08%)	144 / 365 (39.45%)
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	14 / 362 (3.87%)	13 / 365 (3.56%)
occurrences all number	14	13
Natural killer cell count decreased
subjects affected / exposed	10 / 362 (2.76%)	0 / 365 (0.00%)
occurrences all number	13	0
SARS-CoV-2 test positive
subjects affected / exposed	15 / 362 (4.14%)	13 / 365 (3.56%)
occurrences all number	15	13
Weight increased
subjects affected / exposed	8 / 362 (2.21%)	3 / 365 (0.82%)
occurrences all number	8	3
Nervous system disorders
Dizziness
subjects affected / exposed	10 / 362 (2.76%)	4 / 365 (1.10%)
occurrences all number	11	4
Headache
subjects affected / exposed	47 / 362 (12.98%)	24 / 365 (6.58%)
occurrences all number	57	26
General disorders and administration site conditions
Fatigue
subjects affected / exposed	10 / 362 (2.76%)	5 / 365 (1.37%)
occurrences all number	13	5
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	8 / 362 (2.21%)	8 / 365 (2.19%)
occurrences all number	9	10
Nausea
subjects affected / exposed	70 / 362 (19.34%)	8 / 365 (2.19%)
occurrences all number	79	12
Vomiting
subjects affected / exposed	11 / 362 (3.04%)	6 / 365 (1.64%)
occurrences all number	12	6
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	8 / 362 (2.21%)	1 / 365 (0.27%)
occurrences all number	8	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	46 / 362 (12.71%)	10 / 365 (2.74%)
occurrences all number	51	11
Dermatitis atopic
subjects affected / exposed	17 / 362 (4.70%)	13 / 365 (3.56%)
occurrences all number	20	14
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 362 (0.55%)	8 / 365 (2.19%)
occurrences all number	2	8
Infections and infestations
COVID-19
subjects affected / exposed	14 / 362 (3.87%)	12 / 365 (3.29%)
occurrences all number	14	12
Conjunctivitis
subjects affected / exposed	8 / 362 (2.21%)	35 / 365 (9.59%)
occurrences all number	8	41
Herpes simplex
subjects affected / exposed	12 / 362 (3.31%)	5 / 365 (1.37%)
occurrences all number	13	5
Folliculitis
subjects affected / exposed	12 / 362 (3.31%)	3 / 365 (0.82%)
occurrences all number	13	3
Nasopharyngitis
subjects affected / exposed	14 / 362 (3.87%)	12 / 365 (3.29%)
occurrences all number	15	12
Herpes zoster
subjects affected / exposed	9 / 362 (2.49%)	2 / 365 (0.55%)
occurrences all number	9	2
Oral herpes
subjects affected / exposed	9 / 362 (2.49%)	15 / 365 (4.11%)
occurrences all number	9	20
Upper respiratory tract infection
subjects affected / exposed	10 / 362 (2.76%)	9 / 365 (2.47%)
occurrences all number	11	9
Urinary tract infection
subjects affected / exposed	8 / 362 (2.21%)	7 / 365 (1.92%)
occurrences all number	9	7

More information

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Were there any global substantial amendments to the protocol? Yes

14 Jul 2020

Amendment 1: Country specific changes for Czech republic Section 5.2: Subjects with increased risk of developing venous thromboembolism were excluded. Section 6.5.2.: If a subject required high potency topical therapy or systemic rescue therapy, they were to be permanently discontinued from the study intervention, have an End of Treatment visit and enter the 4-week follow-up period.

14 Aug 2020

Amendment 2: Per updated safety information, subjects with increased risk of developing venous thromboembolism were excluded. Inclusion criterion updated to require a clinical diagnosis of AD at least 6 months prior to Day 1 instead of at least 1 year. Exclusion of prior use of dupilumab has been expanded to include all IL-4 and IL-13 antagonists. Healthcare Resource Utilization (HCRU) assessment was moved from Week 16 to Week 12. Requirements for mental health professional assessments and recurrent suicidal ideation and behavior were clarified. Data collection requirements for adverse events of conjunctivitis were added. Temporary discontinuation timeframe updated for the injectable study intervention and requirement added for subjects who need systemic rescue therapy to temporarily discontinue study intervention while taking systemic rescue therapy. Added isoniazid as a prohibited concomitant medication.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3b Randomized, Double-Blind, Double-Dummy, Active Controlled Multi-Center Study Assessing The Efficacy And Safety Of Abrocitinib Compared With Dupilumab In Adult Participants On Background Topical Therapy With Moderate To Severe Atopic Dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) from Baseline at Week 2

Primary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) from Baseline at Week 2

Primary: Percentage of Subjects Achieving >= 90% Improvement from Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

Primary: Percentage of Subjects Achieving >= 90% Improvement from Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4

Secondary: Percentage of Subjects Achieving EASI-90 Response at Week 16

Secondary: Percentage of Subjects Achieving EASI-90 Response at Week 16

Secondary: Percentage of Subjects Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26

Secondary: Percentage of Subjects Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26

Secondary: Percentage of Subjects Achieving >= 75% Improvement from Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26

Secondary: Percentage of Subjects Achieving >= 75% Improvement from Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26

Secondary: Percentage of Subjects Achieving Investigator’s Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement from Baseline up to Week 26

Secondary: Percentage of Subjects Achieving Investigator’s Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement from Baseline up to Week 26

Secondary: Percentage of Subjects Achieving PP-NRS4 from Baseline at Days 2 to 15

Secondary: Percentage of Subjects Achieving PP-NRS4 from Baseline at Days 2 to 15

Secondary: Percentage of Subjects Achieving PP-NRS4 from Baseline at Week 4, 8, 12, 16, 20 and 26

Secondary: Percentage of Subjects Achieving PP-NRS4 from Baseline at Week 4, 8, 12, 16, 20 and 26

Secondary: Time to Achieve >=4 Points Improvement in PP-NRS4

Secondary: Time to Achieve >=4 Points Improvement in PP-NRS4

Secondary: Percent Change from Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26

Secondary: Percent Change from Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26

Secondary: Percent Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26

Secondary: Percent Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26

Secondary: Change from Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26

Secondary: Change from Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26

Secondary: Change from Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26

Secondary: Change from Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26

Secondary: 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

Secondary: 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

Secondary: Change from Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26

Secondary: Change from Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26

Secondary: Change from Baseline in Medical Outcomes Study – Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26

Secondary: Change from Baseline in Medical Outcomes Study – Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26

Secondary: Change from Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26

Secondary: Change from Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26

Secondary: Medicated topical background therapy-free days

Secondary: Medicated topical background therapy-free days

Secondary: Percentage of Subjects Achieving >=4 Points Improvement from Baseline in DLQI at Week 2, 12, 16, 20 and 26

Secondary: Percentage of Subjects Achieving >=4 Points Improvement from Baseline in DLQI at Week 2, 12, 16, 20 and 26

Other pre-specified: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

Other pre-specified: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

Other pre-specified: Number of Subjects with Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation

Other pre-specified: Number of Subjects with Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation

Other pre-specified: Number of Subjects with Laboratory Abnormalities Meeting Pre-Defined Criteria

Other pre-specified: Number of Subjects with Laboratory Abnormalities Meeting Pre-Defined Criteria

Other pre-specified: Number of Subjects with Clinically Significant Change from Baseline in Vital Signs

Other pre-specified: Number of Subjects with Clinically Significant Change from Baseline in Vital Signs

Other pre-specified: Number of Subjects with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Data

Other pre-specified: Number of Subjects with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Data

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3b Randomized, Double-Blind, Double-Dummy, Active Controlled Multi-Center Study Assessing The Efficacy And Safety Of Abrocitinib Compared With Dupilumab In Adult Participants On Background Topical Therapy With Moderate To Severe Atopic Dermatitis