A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in India

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs.

Time frame: From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)

Population: Safety analysis set included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.

ADCT score is used to measure the participants perceived AD control. It consists of 6 questions (overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions) which are evaluated over the past week on scale from 0 to 4. Scores from all 6 questions are added up to provide ADCT score, ranging from 0 to 24, where higher scores indicate lower AD control.

Time frame: Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12

Population: FAS evaluated. Participants were analyzed according to the treatment arm they were randomized to. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified timepoints.

POEM is a 7-item participant reported outcome (PRO) measure to assess the impact of AD over the past week. Items were: dryness or roughness of skin in day, skin being itchy in day, skin flaking off in day, skin cracking in day, skin bleeding in day, skin weeping or oozing in day and sleep disturbed in night. Each item is scored from 0 to 4, depending on number of days/night (for sleep items) over the past week symptoms happened, where 0= no days, 1= 1-2 days, 2= 3-4 days, 3= 5-6 days and 4= every day. Scores from all items are added up, which results in POEM score, ranging from 0 to 28, where higher scores indicate greater severity of AD and greater symptom burden.

Time frame: Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12

Population: FAS evaluated. Participants were analyzed according to the treatment arm they were randomized to. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified timepoints.

EASI evaluates severity of participant's AD based on both severity of lesion clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\]-\[including axillae and groin\] and lower limbs \[l\]-\[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et + It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl +Ll); A = EASI area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. \>=75% improvement from baseline: decrease of 75% in EASI score from Baseline at Week 12.

Time frame: Baseline (prior to dosing on Day 1), Week 12

Population: FAS included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment arm they were randomized to. NRI was applied. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. Score for each body region was added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; lichenification; dryness) assessed as none =0, mild =1, moderate =2, severe =3. Severity scores were added to give B (0-18). C: pruritus and sleep, each was scored by participant/caregiver using visual analogue scale (VAS) where 0= no itch/no sleeplessness and 10= worst imaginable itch/sleeplessness. Scores for itch and sleeplessness were added to give C (0-20). Total SCORAD was calculated: A/5 + 7\*B/2 + C; total SCORAD range from 0-103; higher SCORAD scores = greater severity of AD. \>=75% improvement from baseline: decrease of 75% in SCORAD score from Baseline at Week 12.

Time frame: Baseline (prior to dosing on Day 1), Week 12

Population: FAS included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment arm they were randomized to. NRI was applied. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.

IGA assesses severity of AD on a 5-point scale (0 to 4: higher scores = more severity). Scores: 0= clear (no AD inflammatory signs except for any residual discolouration \[post-inflammatory hyperpigmentation and/or hypopigmentation\]); 1= almost clear (AD not entirely cleared- light pink residual lesions \[except post-inflammatory hyperpigmentation\], just barely 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). \>=2 points improvement from baseline: decrease of at least 2 points in IGA score from baseline at Week 12.

Time frame: Baseline (prior to dosing on Day 1), Week 12

Population: Full analysis set (FAS) included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment arm they were randomized to. Non-responder imputation (NRI) was applied. Number of Participants Analyzed signifies participants evaluable for this outcome measure.

MRI imaging session was performed when participant was in supine position in the confined space of the MRI scanner for approximately 30 mins. The assessments included evaluation of epiphyseal plate closure and mineralization of cartilage at the growth centers.

Time frame: Up to 1 year from randomization on Day 1 of main study

Population: Substudy analysis set included all participants who entered the substudy and who took at least 1 dose of study intervention during the substudy.