Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, atopic eczema, eczema, JAK, janus kinase
Brief summary
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
Interventions
Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.
COMBINATION_PRODUCTDupilumab 300 mg
Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Diagnosis of chronic atopic dermatitis (AD) for at least 6 months * Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4) * Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
Exclusion criteria
* Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation * Have increased risk of developing venous thromboembolism * Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study * Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab * Other active non-AD inflammatory skin diseases or conditions affecting skin * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2 | Week 2 | The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. |
| Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4 | Week 4 | EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26 | The extent (%) to which a body region was involved with AD was determined using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD. |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Baseline (Day 1), Week 12, 16 and 26 | POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity. |
| Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Baseline (Day 1), Week 12, 16 and 26 | The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure. |
| Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Baseline (Day 1), Week 2, 12, 16, 20 and 26 | The skin pain NRS was a participant reported outcome where participants were asked to rate the worst skin pain in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain. |
| Medicated Topical Background Therapy-free Days | Day 1 up to Week 26 | Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy. |
| Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 2, 12, 16, 20 and 26 | DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. |
| Percentage of Participants Achieving EASI-90 Response at Week 16 | Week 16 | EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD. |
| Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 2, 8, 12, 20 and 26 | EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD. |
| Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 2, 4, 8, 12, 16, 20 and 26 | EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD. |
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 2, 4, 8, 12, 16, 20 and 26 | IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. |
| Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. |
| Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 4, 8, 12, 16, 20 and 26 | The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. |
| Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) | Baseline (Day 1) up to Week 30 | The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. |
| Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26 | SCORAD is a scoring index for AD which combined extent (A), severity (B) and subjective symptoms (C). For A, a rule of 9 was used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region was added to determine A (range: 0-100). B: severity of each sign (erythema; edema/papulation; oozing/crusting; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores were added to give B (range: 0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using visual analog scale (VAS) where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss were added to give 'C' (range: 0-20). SCORAD total score was calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome. |
| Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Baseline (Day 1), Week 12, 16 and 26 | 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. |
| Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Baseline (Day 1), Week 12, 16 and 26 | 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Baseline (Day 1), Week 2, 12, 16, 20 and 26 | DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. |
| 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 | Baseline (Day 1), Week 12, 16 and 26 | The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From start of study intervention to 28 days post last dose of study intervention (Up to Week 30) | 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. |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data | From start of study intervention to 28 days post last dose of study intervention (Up to Week 30) | A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator. |
| Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation | From start of study intervention to 28 days post last dose of study intervention (Up to Week 30) | 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. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | From start of study intervention to 28 days post last dose of study intervention (Up to Week 30) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs. |
| Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria | From start of study intervention to 28 days post last dose of study intervention (Up to Week 30) | The pre-defined criteria for laboratory parameters included: hemoglobin (\<9 grams per deciliter or decreases to \>=2 below baseline); platelets (\<75\*10\^3 cells per millimeter cube \[mm\^3\]); lymphocytes (\<0.5\*10\^3 cells per mm\^3); neutrophils (\<1\*10\^3 cells per mm\^3); aspartate aminotransferase and alanine aminotransferase (\>3\* upper limit of normal). |
Countries
Australia, Bulgaria, Canada, Chile, Finland, Germany, Hungary, Italy, Latvia, Poland, Slovakia, South Korea, Spain, Taiwan, United States
Participant flow
Recruitment details
This was a double-blind, double-dummy, active-controlled study in adult participants with moderate to severe atopic dermatitis. The study was conducted across 143 sites in 15 countries.
Pre-assignment details
A total of 940 participants were screened, of which 213 were screen failures and were not enrolled. 727 participants were enrolled in the study and assigned to a study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Abrocitinib 200 mg QD Participants were administered abrocitinib 200 mg (2 x 100 mg) oral tablets once daily (QD) from Day 1 to Week 26 along with dupilumab-matching placebo administered as a subcutaneous injection once every 2 weeks (Q2W) until Week 24. Participants were followed for up to 4 weeks post last dose of study intervention. | 362 |
| Dupilumab 300 mg Q2W Participants were administered dupilumab 300 mg as a subcutaneous injection Q2W until Week 24 along with abrocitinib-matching placebo oral tablets administered once daily from Day 1 to Week 26. Participants were followed for up to 4 weeks post last dose of study intervention. | 365 |
| Total | 727 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 9 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Medication Error Without Associated Adverse Event | 1 | 0 |
| Overall Study | Other | 3 | 4 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 11 | 11 |
Baseline characteristics
| Characteristic | Dupilumab 300 mg Q2W | Total | Abrocitinib 200 mg QD |
|---|---|---|---|
| Age, Continuous | 35.5 Years STANDARD_DEVIATION 13.3 | 36.0 Years STANDARD_DEVIATION 14 | 36.6 Years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 57 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 337 Participants | 668 Participants | 331 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 83 Participants | 145 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 51 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 248 Participants | 517 Participants | 269 Participants |
| Sex: Female, Male Female | 161 Participants | 330 Participants | 169 Participants |
| Sex: Female, Male Male | 204 Participants | 397 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 362 | 0 / 365 |
| other Total, other adverse events | 203 / 362 | 144 / 365 |
| serious Total, serious adverse events | 6 / 362 | 6 / 365 |
Outcome results
Primary
Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Time frame: Week 4
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4 | 28.5 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4 | 14.6 Percentage of participants |
p-value: <0.000195% CI: [8.2, 20]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2
The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time frame: Week 2
Population: Full Analysis Set (FAS) comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2 | 48.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2 | 25.5 Percentage of participants |
p-value: <0.000195% CI: [15.8, 29.5]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26
DLQI is a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score, ranging from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Baseline (Day 1), Week 2, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 12 | -10.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 20 | -10.8 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 16 | -10.8 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 26 | -10.3 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 2 | -8.6 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 26 | -10.0 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 2 | -6.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 12 | -9.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 16 | -10.0 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 | Week 20 | -10.1 Units on a scale |
95% CI: [-2.6, -1.3]
95% CI: [-1.6, -0.4]
95% CI: [-1.4, -0.2]
95% CI: [-1.2, 0]
95% CI: [-1, 0.4]
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
The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measured health state. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline (Day 1), Week 12, 16 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 | Week 12 | 12.370 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 | Week 16 | 12.567 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 | Week 26 | 13.484 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 | Week 12 | 11.552 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 | Week 16 | 10.474 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 | Week 26 | 14.300 Units on a scale |
95% CI: [-1.22, 2.856]
95% CI: [-0.081, 4.267]
95% CI: [-2.914, 1.281]
Secondary
Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26
The MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II). An additional single item assessed quantity of sleep. Each of the sleep domains were scored on a range of 0 to 100, and higher scores indicated worse outcomes. The quantity of sleep scores ranged from 0 to 24 (number of hours slept). Change from baseline scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Time frame: Baseline (Day 1), Week 12, 16 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Snoring Score: Week 12 | -5.3 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Quantity Hours Slept Score: Week 16 | 0.6 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Quantity Hours Slept Score: Week 26 | 0.5 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Short of Breath or Headache score: Week 12 | -0.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Short of Breath or Headache score: Week 16 | -1.2 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Short of Breath or Headache score: Week 26 | -2.0 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Quantity Hours Slept Score: Week 12 | 0.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Snoring Score: Week 16 | -4.9 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Snoring Score: Week 26 | -3.9 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Disturbance Score: Week 12 | -20.5 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Disturbance Score: Week 16 | -21.5 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Disturbance Score: Week 26 | -21.2 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Adequacy Score: Week 12 | 13.9 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Adequacy Score: Week 16 | 15.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Adequacy Score: Week 26 | 14.0 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Somnolence Score: Week 12 | -7.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Somnolence Score: Week 16 | -9.8 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Somnolence Score: Week 26 | -9.9 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index I Score: Week 12 | -12.1 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index I Score: Week 16 | -13.3 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index I Score: Week 26 | -12.9 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index II Score: Week 12 | -14.4 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index II Score: Week 16 | -15.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index II Score: Week 26 | -15.4 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index II Score: Week 16 | -12.8 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Quantity Hours Slept Score: Week 12 | 0.5 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Adequacy Score: Week 12 | 12.9 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Quantity Hours Slept Score: Week 16 | 0.5 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index I Score: Week 12 | -10.9 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Quantity Hours Slept Score: Week 26 | 0.4 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Adequacy Score: Week 16 | 12.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Short of Breath or Headache score: Week 12 | -1.9 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index II Score: Week 12 | -12.2 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Short of Breath or Headache score: Week 16 | -1.3 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Adequacy Score: Week 26 | 13.2 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Short of Breath or Headache score: Week 26 | -2.6 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index I Score: Week 16 | -11.0 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Snoring Score: Week 12 | -3.5 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Somnolence Score: Week 12 | -6.9 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Snoring Score: Week 16 | -4.0 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index II Score: Week 26 | -14.0 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Snoring Score: Week 26 | -4.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Somnolence Score: Week 16 | -7.4 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Disturbance Score: Week 12 | -16.4 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Problems Index I Score: Week 26 | -12.1 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Disturbance Score: Week 16 | -17.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Somnolence Score: Week 26 | -7.6 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 | Sleep Disturbance Score: Week 26 | -19.5 Units on a scale |
95% CI: [-6.2, -1.4]
95% CI: [-4.1, 0.7]
95% CI: [-0.1, 0.6]
95% CI: [-0.2, 0.4]
95% CI: [-0.2, 0.4]
95% CI: [-0.9, 3.4]
95% CI: [-2, 2.2]
95% CI: [-1.5, 2.6]
95% CI: [-4.2, 0.5]
95% CI: [-3.3, 1.5]
95% CI: [-1.7, 3.4]
95% CI: [-6.6, -1.6]
95% CI: [-1.6, 3.6]
95% CI: [0.4, 5.4]
95% CI: [-1.9, 3.4]
95% CI: [-2.8, 1.3]
95% CI: [-4.4, -0.4]
95% CI: [-4.3, -0.3]
95% CI: [-3, 0.7]
95% CI: [-4, -0.5]
95% CI: [-2.5, 0.9]
95% CI: [-4, -0.3]
95% CI: [-4.8, -1.1]
95% CI: [-3.2, 0.4]
Secondary
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26
POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The item scores were added to provide a total score ranging from 0 to 28, where higher score indicated greater severity.
Time frame: Baseline (Day 1), Week 12, 16 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Week 12 | -14.2 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Week 16 | -14.2 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Week 26 | -13.8 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Week 12 | -12.6 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Week 16 | -12.8 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 | Week 26 | -13.4 Units on a scale |
95% CI: [-2.5, -0.7]
95% CI: [-2.2, -0.5]
95% CI: [-1.3, 0.5]
Secondary
Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26
The skin pain NRS was a participant reported outcome where participants were asked to rate the worst skin pain in the past 24 hours on a 11-point scale from 0=no skin pain to 10=worst skin pain imaginable. Higher scores indicated worse pain.
Time frame: Baseline (Day 1), Week 2, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 12 | -4.5 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 20 | -4.8 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 16 | -4.4 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 26 | -4.5 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 2 | -3.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 26 | -4.3 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 2 | -2.6 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 12 | -4.0 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 16 | -4.2 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 | Week 20 | -4.5 Units on a scale |
95% CI: [-1.5, -0.8]
95% CI: [-0.8, -0.1]
95% CI: [-0.6, 0.1]
95% CI: [-0.6, 0]
95% CI: [-0.5, 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
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.
Time frame: Baseline (Day 1), Week 12, 16 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Week 12 | -0.8 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Week 16 | -1.1 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Week 26 | -1.1 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Week 12 | -0.8 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Week 16 | -1.2 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 | Week 26 | -1.2 Units on a scale |
95% CI: [-0.4, 0.4]
95% CI: [-0.3, 0.5]
95% CI: [-0.3, 0.6]
Secondary
Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26
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.
Time frame: Baseline (Day 1), Week 12, 16 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Week 12 | -0.7 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Week 16 | -0.8 Units on a scale |
| Abrocitinib 200 mg QD | Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Week 26 | -0.8 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Week 12 | -0.7 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Week 16 | -0.9 Units on a scale |
| Dupilumab 300 mg Q2W | Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 | Week 26 | -1.0 Units on a scale |
95% CI: [-0.3, 0.3]
95% CI: [-0.2, 0.5]
95% CI: [-0.1, 0.6]
Secondary
Medicated Topical Background Therapy-free Days
Medicated topical background therapy-free days was defined as number of days where a participant maintained a response of EASI-90 or greater without the use of medicated topical background therapy.
Time frame: Day 1 up to Week 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Abrocitinib 200 mg QD | Medicated Topical Background Therapy-free Days | 51.4 Days |
| Dupilumab 300 mg Q2W | Medicated Topical Background Therapy-free Days | 33.3 Days |
Comparison: Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.95% CI: [10.5, 25.7]
Secondary
Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26
DLQI was a 10-item questionnaire that measured the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Week 2, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 12 | 85.4 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 20 | 81.8 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 16 | 82.7 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 26 | 76.6 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 2 | 81.3 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 26 | 80.8 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 2 | 67.5 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 12 | 81.4 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 16 | 84.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 | Week 20 | 83.7 Percentage of participants |
95% CI: [7.3, 20.1]
95% CI: [-1.6, 9.4]
95% CI: [-7.1, 4]
95% CI: [-7.6, 3.6]
95% CI: [-10.3, 1.9]
Secondary
Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26
EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Time frame: Week 2, 4, 8, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 8 | 71.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 16 | 77.3 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 4 | 57.6 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 20 | 76.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 12 | 76.3 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 26 | 73.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 2 | 29.4 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 26 | 72.3 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 2 | 21.3 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 4 | 36.8 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 8 | 52.8 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 12 | 61.4 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 16 | 67.8 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 | Week 20 | 71.1 Percentage of participants |
95% CI: [1.8, 14.4]
95% CI: [13.8, 28]
95% CI: [11.4, 25.3]
95% CI: [8.2, 21.5]
95% CI: [3, 16]
95% CI: [-1.4, 11.5]
95% CI: [-5.9, 7.2]
Secondary
Percentage of Participants Achieving EASI-90 Response at Week 16
EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Time frame: Week 16
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving EASI-90 Response at Week 16 | 54.3 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving EASI-90 Response at Week 16 | 41.9 Percentage of participants |
p-value: 0.000895% CI: [5.3, 19.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26
EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Time frame: Week 2, 8, 12, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 8 | 45.4 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 20 | 58.4 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 12 | 47.6 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 26 | 54.6 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 2 | 11.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 26 | 47.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 2 | 7.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 8 | 25.4 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 12 | 33.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 | Week 20 | 45.7 Percentage of participants |
95% CI: [0.2, 8.7]
95% CI: [13.2, 26.9]
95% CI: [6.9, 21.1]
95% CI: [5.5, 20]
95% CI: [-0.4, 14.3]
Secondary
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26
IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, except any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation); 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting.
Time frame: Week 2, 4, 8, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 8 | 50.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 16 | 55.3 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 4 | 38.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 20 | 60.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 12 | 51.8 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 26 | 55.6 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 2 | 14.4 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 26 | 51.1 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 2 | 7.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 4 | 17.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 8 | 30.9 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 12 | 36.0 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 16 | 42.5 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 | Week 20 | 50.8 Percentage of participants |
95% CI: [2.8, 11.7]
95% CI: [14.3, 26.9]
95% CI: [12.5, 26.4]
95% CI: [8.7, 23]
95% CI: [5.9, 20.2]
95% CI: [2, 16.4]
95% CI: [-2.8, 11.8]
Secondary
Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15
The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time frame: Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 9 | 38.5 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 4 | 22.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 10 | 40.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 6 | 28.4 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 11 | 40.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 5 | 26.4 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 12 | 41.5 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 7 | 33.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 13 | 44.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 3 | 15.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 14 | 45.5 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 8 | 36.3 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 15 | 48.6 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 2 | 11.0 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 15 | 25.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 5 | 11.9 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 2 | 3.8 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 3 | 8.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 6 | 15.5 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 7 | 13.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 8 | 14.1 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 9 | 16.9 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 10 | 18.7 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 11 | 20.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 12 | 20.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 13 | 21.5 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 14 | 23.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 | Day 4 | 10.7 Percentage of participants |
95% CI: [3.1, 11.1]
95% CI: [1.7, 11.3]
95% CI: [6, 16.8]
95% CI: [8.8, 20.3]
95% CI: [6.9, 19]
95% CI: [13.8, 26]
95% CI: [15.9, 28.3]
95% CI: [15.2, 28.1]
95% CI: [14.7, 27.9]
95% CI: [13.3, 26.6]
95% CI: [14.6, 27.9]
95% CI: [15.8, 29.2]
95% CI: [15.6, 29.2]
95% CI: [16, 29.9]
Secondary
Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26
The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time frame: Week 4, 8, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 4 | 58.1 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 8 | 65.8 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 12 | 66.0 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 16 | 67.2 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 20 | 65.3 Percentage of participants |
| Abrocitinib 200 mg QD | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 26 | 68.1 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 20 | 63.2 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 4 | 40.8 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 16 | 63.6 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 8 | 52.7 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 26 | 63.1 Percentage of participants |
| Dupilumab 300 mg Q2W | Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 | Week 12 | 61.5 Percentage of participants |
95% CI: [10.1, 24.5]
95% CI: [6, 20.1]
95% CI: [-2.5, 11.4]
95% CI: [-3.4, 10.5]
95% CI: [-4.9, 9]
95% CI: [-1.9, 11.9]
Secondary
Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26
The extent (%) to which a body region was involved with AD was determined using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Total number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual was derived as sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater severity of AD.
Time frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 8 | -74.0 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 16 | -80.6 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 4 | -62.0 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 20 | -82.2 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 12 | -78.8 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 26 | -82.3 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 2 | -42.7 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 26 | -79.0 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 2 | -33.4 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 4 | -49.5 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 8 | -62.8 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 12 | -69.4 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 16 | -73.7 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 | Week 20 | -76.9 Percent change |
95% CI: [-14, -4.6]
95% CI: [-17.4, -7.6]
95% CI: [-15.6, -6.6]
95% CI: [-13.7, -5.1]
95% CI: [-10.9, -2.9]
95% CI: [-9, -1.7]
95% CI: [-7.1, 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
SCORAD is a scoring index for AD which combined extent (A), severity (B) and subjective symptoms (C). For A, a rule of 9 was used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region was added to determine A (range: 0-100). B: severity of each sign (erythema; edema/papulation; oozing/crusting; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores were added to give B (range: 0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using visual analog scale (VAS) where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss were added to give 'C' (range: 0-20). SCORAD total score was calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Time frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20 and 26
Population: FAS comprised of all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 8 | -65.8 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 16 | -70.6 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 4 | -59.6 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 20 | -71.8 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 12 | -67.9 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 26 | -71.5 Percent change |
| Abrocitinib 200 mg QD | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 2 | -44.5 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 26 | -68.2 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 2 | -33.5 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 4 | -46.8 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 8 | -55.6 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 12 | -60.6 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 16 | -64.4 Percent change |
| Dupilumab 300 mg Q2W | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 | Week 20 | -66.8 Percent change |
95% CI: [-14.5, -7.6]
95% CI: [-16, -9.5]
95% CI: [-13.6, -6.8]
95% CI: [-10.5, -4.1]
95% CI: [-9.3, -3]
95% CI: [-8.2, -1.7]
95% CI: [-6.6, 0.1]
Secondary
Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4)
The severity of itch (pruritus) due to AD was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time frame: Baseline (Day 1) up to Week 30
Population: FAS comprised of all randomized participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abrocitinib 200 mg QD | Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) | 11.0 Days |
| Dupilumab 300 mg Q2W | Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) | 25.0 Days |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data
A single 12-lead ECG was performed after the participant has rested for at least 10 minutes quietly in the supine position. Clinically significant change from baseline in ECG data was determined by the investigator.
Time frame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg QD | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data | 0 Participants |
| Dupilumab 300 mg Q2W | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Data | 0 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
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.
Time frame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg QD | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Dupilumab 300 mg Q2W | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria
The pre-defined criteria for laboratory parameters included: hemoglobin (\<9 grams per deciliter or decreases to \>=2 below baseline); platelets (\<75\*10\^3 cells per millimeter cube \[mm\^3\]); lymphocytes (\<0.5\*10\^3 cells per mm\^3); neutrophils (\<1\*10\^3 cells per mm\^3); aspartate aminotransferase and alanine aminotransferase (\>3\* upper limit of normal).
Time frame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg QD | Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria | 38 Participants |
| Dupilumab 300 mg Q2W | Number of Participants With Laboratory Abnormalities Meeting Pre-Defined Criteria | 10 Participants |
Other Pre-specified
Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation
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.
Time frame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abrocitinib 200 mg QD | Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation | SAEs | 6 Participants |
| Abrocitinib 200 mg QD | Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 12 Participants |
| Dupilumab 300 mg Q2W | Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation | SAEs | 6 Participants |
| Dupilumab 300 mg Q2W | Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 9 Participants |
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent adverse event (TEAE) if the event started on or after the first dosing day until 28 days post last dose of study drug. AEs included both serious and non-serious AEs.
Time frame: From start of study intervention to 28 days post last dose of study intervention (Up to Week 30)
Population: Safety population comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg QD | Number of Participants With Treatment Emergent Adverse Events (AEs) | 268 Participants |
| Dupilumab 300 mg Q2W | Number of Participants With Treatment Emergent Adverse Events (AEs) | 239 Participants |