Trial Outcomes & Findings for A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis (NCT NCT05507580)

NCT ID: NCT05507580

Last Updated: 2025-07-29

Results Overview

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 461 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2025-07-29

Participant Flow

The study comprised of a 35-day Screening Period, a 12-week Double-Blind Treatment Period and a 12-week Single-Blind Treatment Period. During the Single-Blind Period, participants were blinded to the upadacitinib dose and Eczema Area and Severity Index (EASI) score evaluations.

Participant milestones

Measure	UPA 15 mg Double-Blind Treatment Period Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Double-Blind Treatment Period STARTED	229	232	0	0	0	0
Double-Blind Treatment Period COMPLETED	217	226	0	0	0	0
Double-Blind Treatment Period NOT COMPLETED	12	6	0	0	0	0
Single-Blind Treatment Period STARTED	0	0	72	144	133	91
Single-Blind Treatment Period COMPLETED	0	0	70	132	126	79
Single-Blind Treatment Period NOT COMPLETED	0	0	2	12	7	12

Reasons for withdrawal

Measure	UPA 15 mg Double-Blind Treatment Period Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Double-Blind Treatment Period Lost to Follow-up	0	1	0	0	0	0
Double-Blind Treatment Period Withdrawal by Subject	7	1	0	0	0	0
Double-Blind Treatment Period Other, not specified	5	4	0	0	0	0
Single-Blind Treatment Period Lost to Follow-up	0	0	0	0	2	1
Single-Blind Treatment Period Withdrawal by Subject	0	0	0	5	2	6
Single-Blind Treatment Period Other, not specified	0	0	2	7	3	5

Baseline Characteristics

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	UPA 15 mg Double-Blind Treatment Period n=229 Participants Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period n=232 Participants Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	Total n=461 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	219 Participants n=5 Participants	223 Participants n=7 Participants	442 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	67 Participants n=5 Participants	66 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	155 Participants n=5 Participants	158 Participants n=7 Participants	313 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	134 Participants n=5 Participants	122 Participants n=7 Participants	256 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	34.4 years STANDARD_DEVIATION 12.06 • n=5 Participants	32.7 years STANDARD_DEVIATION 10.83 • n=7 Participants	33.5 years STANDARD_DEVIATION 11.48 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	110 Participants n=7 Participants	205 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=71 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=133 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=130 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=82 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 24	74.6 percentage of participants Interval 64.5 to 84.8	48.1 percentage of participants Interval 39.6 to 56.6	68.5 percentage of participants Interval 60.5 to 76.4	29.3 percentage of participants Interval 19.4 to 39.1

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=71 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=133 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=130 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=82 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24	97.2 percentage of participants Interval 93.3 to 100.0	69.2 percentage of participants Interval 61.3 to 77.0	88.5 percentage of participants Interval 83.0 to 94.0	52.4 percentage of participants Interval 41.6 to 63.2

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=71 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=133 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=130 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=82 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 24	33.8 percentage of participants Interval 22.8 to 44.8	7.5 percentage of participants Interval 3.0 to 12.0	21.5 percentage of participants Interval 14.5 to 28.6	3.7 percentage of participants Interval 0.0 to 7.7

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=222 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=227 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 12	64.4 percentage of participants Interval 58.1 to 70.7	79.3 percentage of participants Interval 74.0 to 84.6	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=222 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=227 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 12	33.8 percentage of participants Interval 27.6 to 40.0	59.9 percentage of participants Interval 53.5 to 66.3	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=222 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=227 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 12	7.7 percentage of participants Interval 4.2 to 11.2	15.9 percentage of participants Interval 11.1 to 20.6	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=183 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=194 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 12 Among Those With WP-NRS > 1 at Baseline	18.0 percentage of participants Interval 12.5 to 23.6	32.5 percentage of participants Interval 25.9 to 39.1	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=52 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=82 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=100 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=59 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 24 Among Those With WP-NRS > 1 at Baseline	38.5 percentage of participants Interval 25.2 to 51.7	20.7 percentage of participants Interval 12.0 to 29.5	35.0 percentage of participants Interval 25.7 to 44.3	20.3 percentage of participants Interval 10.1 to 30.6

SECONDARY outcome

Timeframe: At Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis [no erythema, no induration/papulation, no lichenification, no oozing/crusting] Post-inflammatory hyperpigmentation and/or hypopigmentation may be present) to 4 - Severe (marked erythema [deep or bright red], marked induration/papulation, and/or marked lichenification).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=222 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=227 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 at Week 12	29.7 percentage of participants Interval 23.7 to 35.7	51.5 percentage of participants Interval 45.0 to 58.0	—	—

SECONDARY outcome

Timeframe: At Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis [no erythema, no induration/papulation, no lichenification, no oozing/crusting] Post-inflammatory hyperpigmentation and/or hypopigmentation may be present) to 4 - Severe (marked erythema [deep or bright red], marked induration/papulation, and/or marked lichenification).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=71 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=133 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=130 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=82 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 at Week 24	63.4 percentage of participants Interval 52.2 to 74.6	40.6 percentage of participants Interval 32.3 to 48.9	52.3 percentage of participants Interval 43.7 to 60.9	29.3 percentage of participants Interval 19.4 to 39.1

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=182 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=195 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥4 at Week 12 Among Those With Baseline WP-NRS ≥4	53.3 percentage of participants Interval 46.0 to 60.5	67.7 percentage of participants Interval 61.1 to 74.3	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=52 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=82 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=100 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=60 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥4 at Week 24 Among Those With Baseline WP-NRS ≥4	73.1 percentage of participants Interval 61.0 to 85.1	57.3 percentage of participants Interval 46.6 to 68.0	67.0 percentage of participants Interval 57.8 to 76.2	60.0 percentage of participants Interval 47.6 to 72.4

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=183 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=195 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 12 Among Those With Baseline WP-NRS >1	27.3 percentage of participants Interval 20.9 to 33.8	40.0 percentage of participants Interval 33.1 to 46.9	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=52 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=83 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=100 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=60 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 24 Among Those With Baseline WP-NRS >1	46.2 percentage of participants Interval 32.6 to 59.7	32.5 percentage of participants Interval 22.5 to 42.6	38.0 percentage of participants Interval 28.5 to 47.5	28.3 percentage of participants Interval 16.9 to 39.7

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=213 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=216 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 12 Among Those With Baseline DLQI ≥4	77.5 percentage of participants Interval 71.9 to 83.1	88.9 percentage of participants Interval 84.7 to 93.1	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=67 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=129 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=124 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=77 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 24 Among Those With Baseline DLQI ≥4	88.1 percentage of participants Interval 80.3 to 95.8	82.2 percentage of participants Interval 75.6 to 88.8	84.7 percentage of participants Interval 78.3 to 91.0	74.0 percentage of participants Interval 64.2 to 83.8

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT\_1) Population: all participants who were randomized in the Double-Blind Treatment Period; participants with available data, as observed analysis

DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=216 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=222 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 12 Among Those With Baseline DLQI >1	22.2 percentage of participants Interval 16.7 to 27.8	36.5 percentage of participants Interval 30.2 to 42.8	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT\_2) Population: all participants who were allocated to an assigned dose at Week 12 for the Single-Blind Treatment Period; participants with available data, as observed analysis

DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (AD) disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.

Outcome measures

Measure	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=69 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=129 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=127 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=79 Participants At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 24 Among Those With Baseline DLQI >1	42.0 percentage of participants Interval 30.4 to 53.7	24.0 percentage of participants Interval 16.7 to 31.4	35.4 percentage of participants Interval 27.1 to 43.8	15.2 percentage of participants Interval 7.3 to 23.1

Adverse Events

UPA 15 mg Double-Blind Treatment Period

Serious events: 8 serious events

Other events: 41 other events

Deaths: 0 deaths

UPA 30 mg Double-Blind Treatment Period

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	UPA 15 mg Double-Blind Treatment Period n=229 participants at risk Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period n=232 participants at risk Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=72 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=144 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=133 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=91 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/229 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	1.4% 1/72 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Cardiac disorders CORONARY ARTERY DISEASE	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Endocrine disorders TOXIC NODULAR GOITRE	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Infections and infestations EPIDIDYMITIS	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Infections and infestations ERYSIPELAS	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Infections and infestations PYELONEPHRITIS	0.00% 0/229 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.69% 1/144 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Injury, poisoning and procedural complications FALL	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Injury, poisoning and procedural complications HAND FRACTURE	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/229 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.75% 1/133 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE GENERALISED	0.44% 1/229 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/232 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/133 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/91 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.

Other adverse events

Measure	UPA 15 mg Double-Blind Treatment Period n=229 participants at risk Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period n=232 participants at risk Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=72 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=144 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period n=133 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.	UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period n=91 participants at risk At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a \< 90% reduction in the Eczema Area and Severity Index (EASI) (\< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period.
Infections and infestations NASOPHARYNGITIS	5.7% 13/229 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	9.1% 21/232 • Number of events 24 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	11.1% 8/72 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	4.2% 6/144 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	7.5% 10/133 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	2.2% 2/91 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Infections and infestations ORAL HERPES	1.7% 4/229 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.86% 2/232 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/144 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	2.3% 3/133 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	5.5% 5/91 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	3.5% 8/229 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	3.9% 9/232 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	6.9% 5/72 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	2.1% 3/144 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	3.0% 4/133 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	4.4% 4/91 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Skin and subcutaneous tissue disorders ACNE	7.0% 16/229 • Number of events 16 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	13.8% 32/232 • Number of events 32 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	1.4% 1/72 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	2.8% 4/144 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	6.0% 8/133 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	6.6% 6/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	3.1% 7/229 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	3.9% 9/232 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	8.3% 6/72 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	16.0% 23/144 • Number of events 24 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	12.0% 16/133 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	16.5% 15/91 • Number of events 15 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.
Skin and subcutaneous tissue disorders ECZEMA	1.3% 3/229 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.86% 2/232 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.00% 0/72 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	1.4% 2/144 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	0.75% 1/133 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.	5.5% 5/91 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 168 days for the Double-Blind Treatment Period groups and ranged from 168 to 169 days for the Single-Blind Treatment Period groups.

Additional Information

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