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Trial record 1 of 1 for:    m16-048
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A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925117
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Upadacitinib
Drug: Placebo
Enrollment 167
Recruitment Details

Participants were enrolled at 36 sites in 8 countries (Australia, Canada, Finland, Germany, Japan, Netherlands, Spain, and the United States [US]).

The study included a 16-week double-blind treatment period (Period 1) followed by a a 72-week double-blind treatment period (Period 2) for a total of 88 weeks of treatment.

Pre-assignment Details Participants were randomized in a 1:1:1:1 ratio, stratified by geographic region (US and Canada; European Union and Australia; and Japan). Participants who completed Period 1 were re-randomized at Week 16 in a 1:1 ratio within their original treatment group assignments to either upadacitinib or placebo. Rescue therapy was provided from Week 20.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg Placebo / Placebo Placebo / Upadacitinib 30 mg Upadacitinib 7.5 mg / Placebo Upadacitinib 7.5 mg / Upadacitinib 7.5 mg Upadacitinib 15 mg / Placebo Upadacitinib 15 mg / Upadacitinib 15 mg Upadacitinib 30 mg / Placebo Upadacitinib 30 mg / Upadacitinib 30 mg
Hide Arm/Group Description Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2. Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2. Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2. Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2. Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2. Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2. Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2. Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2. Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2. Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2. Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2. Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Period Title: Period 1 (Weeks 0 - 16)
Started 41 42 42 42 0 0 0 0 0 0 0 0
Received Treatment 40 42 42 42 0 0 0 0 0 0 0 0
Completed 23 31 37 39 0 0 0 0 0 0 0 0
Not Completed 18 11 5 3 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             1             3             1             2             0             0             0             0             0             0             0             0
Withdrawal by Subject             10             3             3             0             0             0             0             0             0             0             0             0
Lost to Follow-up             2             1             0             0             0             0             0             0             0             0             0             0
Other             5             4             1             1             0             0             0             0             0             0             0             0
Period Title: Period 2 (Weeks 16 - 88)
Started [1] 0 0 0 0 10 10 15 16 19 18 19 19
Rescued to Upadacitinib 30 mg 0 0 0 0 8 1 13 12 17 12 14 4
Completed 0 0 0 0 8 5 9 11 13 12 11 14
Not Completed 0 0 0 0 2 5 6 5 6 6 8 5
Reason Not Completed
Adverse Event             0             0             0             0             0             1             0             0             0             0             3             2
Withdrawal by Subject             0             0             0             0             0             1             4             3             2             2             2             2
Lost to Follow-up             0             0             0             0             1             2             1             1             1             0             0             1
Other             0             0             0             0             1             1             1             1             3             4             3             0
[1]
Four participants completed Week 16 but were not re-randomized into Period 2.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg Total
Hide Arm/Group Description Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. Total of all reporting groups
Overall Number of Baseline Participants 41 42 42 42 167
Hide Baseline Analysis Population Description
All randomized participants (intent-to-treat population)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
39.9  (17.52) 41.5  (15.36) 38.5  (15.24) 39.9  (15.30) 39.9  (15.77)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
< 40 years
25
  61.0%
22
  52.4%
25
  59.5%
22
  52.4%
94
  56.3%
40 - 64 years
11
  26.8%
16
  38.1%
14
  33.3%
17
  40.5%
58
  34.7%
≥ 65 years
5
  12.2%
4
   9.5%
3
   7.1%
3
   7.1%
15
   9.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
Female
17
  41.5%
14
  33.3%
12
  28.6%
20
  47.6%
63
  37.7%
Male
24
  58.5%
28
  66.7%
30
  71.4%
22
  52.4%
104
  62.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
Hispanic or Latino
0
   0.0%
2
   4.8%
2
   4.8%
1
   2.4%
5
   3.0%
Not Hispanic or Latino
41
 100.0%
40
  95.2%
40
  95.2%
41
  97.6%
162
  97.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
White
28
  68.3%
24
  57.1%
21
  50.0%
23
  54.8%
96
  57.5%
Black or African American
6
  14.6%
7
  16.7%
10
  23.8%
6
  14.3%
29
  17.4%
Asian
7
  17.1%
9
  21.4%
9
  21.4%
13
  31.0%
38
  22.8%
American Indian/Alaska Native
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   4.8%
1
   2.4%
0
   0.0%
3
   1.8%
Geographic Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
US/Canada
29
  70.7%
29
  69.0%
29
  69.0%
29
  69.0%
116
  69.5%
EU/Australia
10
  24.4%
11
  26.2%
10
  23.8%
10
  23.8%
41
  24.6%
Japan
2
   4.9%
2
   4.8%
3
   7.1%
3
   7.1%
10
   6.0%
Duration of Atopic Dermatitis Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 42 participants 42 participants 42 participants 166 participants
26.84  (18.76) 30.44  (18.07) 22.59  (15.78) 24.24  (13.58) 26.02  (16.76)
[1]
Measure Analysis Population Description: Participants with available data
Eczema Area and Severity Index (EASI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 42 participants 42 participants 42 participants 167 participants
32.62  (14.49) 31.42  (15.76) 31.40  (12.26) 28.15  (11.62) 30.89  (13.61)
[1]
Measure Description: EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.
1.Primary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
Hide Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from baseline indicates improvement.

Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with at least one post-baseline EASI assessment; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 39 42 42 42
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-23.0  (6.42) -39.4  (6.24) -61.7  (6.12) -74.4  (6.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -51.4
Confidence Interval (2-Sided) 95%
-66.5 to -36.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -38.7
Confidence Interval (2-Sided) 95%
-53.7 to -23.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -16.4
Confidence Interval (2-Sided) 95%
-31.4 to -1.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.61
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
Hide Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.

An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value.

Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
9.8 28.6 52.4 69.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 58.7
Confidence Interval (2-Sided) 95%
42.5 to 74.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 42.5
Confidence Interval (2-Sided) 95%
25.5 to 59.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 18.7
Confidence Interval (2-Sided) 95%
2.7 to 34.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
Hide Description

The Investigator's Global Assessment for Atopic Dermatitis (IGA) was scored on the following scale:

  • 0: Clear (No inflammatory signs of atopic dermatitis)
  • 1: Almost Clear (Just perceptible erythema and just perceptible papulation/infiltration)
  • 2: Mild (Mild erythema and mild papulation/infiltration)
  • 3: Moderate (Moderate erythema and moderate papulation/infiltration)
  • 4: Severe (Severe erythema and severe papulation/infiltration with or without oozing/crusting)

The percentage of participants with a score of 0 or 1 at Week 16 is reported.

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
2.4 14.3 31.0 50.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 46.9
Confidence Interval (2-Sided) 95%
31.1 to 62.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 28.6
Confidence Interval (2-Sided) 95%
13.8 to 43.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
0.3 to 23.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Hide Description Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percent change from Baseline at each week was calculated from a rolling weekly average.
Time Frame Baseline and Weeks 2, 8, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with a Baseline and at least one post-baseline measurement; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 37 40 37 42
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 2 Number Analyzed 37 participants 39 participants 37 participants 42 participants
1.7  (5.59) -29.3  (5.45) -46.0  (5.44) -57.6  (5.24)
Week 8 Number Analyzed 37 participants 40 participants 37 participants 42 participants
-6.7  (7.51) -35.5  (7.28) -45.1  (7.32) -73.1  (7.05)
Week 16 Number Analyzed 37 participants 40 participants 37 participants 42 participants
-9.7  (8.30) -39.6  (8.04) -48.0  (8.08) -68.9  (7.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -59.3
Confidence Interval (2-Sided) 95%
-72.3 to -46.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -47.7
Confidence Interval (2-Sided) 95%
-61.1 to -34.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -31.1
Confidence Interval (2-Sided) 95%
-44.3 to -17.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -66.4
Confidence Interval (2-Sided) 95%
-83.9 to -48.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -38.4
Confidence Interval (2-Sided) 95%
-56.4 to -20.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -28.9
Confidence Interval (2-Sided) 95%
-46.6 to -11.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -59.2
Confidence Interval (2-Sided) 95%
-78.6 to -39.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -38.3
Confidence Interval (2-Sided) 95%
-58.3 to -18.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of Percent Change from Baseline in Pruritus NRS at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -29.9
Confidence Interval (2-Sided) 95%
-49.4 to -10.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.90
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in EASI Score at Week 8
Hide Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1)] moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with at least one post-baseline measurement; Last observation carried forward (LOCF) imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 39 42 42 42
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-17.5  (6.27) -43.7  (6.09) -65.4  (5.97) -82.8  (5.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -65.3
Confidence Interval (2-Sided) 95%
-80.0 to -50.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -47.9
Confidence Interval (2-Sided) 95%
-62.6 to -33.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -26.2
Confidence Interval (2-Sided) 95%
-40.8 to -11.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.42
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
Hide Description SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with Baseline and at least one post-baseline measurement; Last observation carried forward imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 33 39 36 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 8 -7.0  (5.84) -35.4  (5.53) -44.1  (5.69) -65.3  (5.52)
Week 16 -12.4  (5.97) -32.5  (5.66) -46.9  (5.82) -60.4  (5.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of Percent Change from Baseline in SCORAD at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -58.3
Confidence Interval (2-Sided) 95%
-71.7 to -44.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of Percent Change from Baseline in SCORAD at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -37.1
Confidence Interval (2-Sided) 95%
-50.8 to -23.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of Percent Change from Baseline in SCORAD at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -28.4
Confidence Interval (2-Sided) 95%
-41.9 to -15.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of Percent Change from Baseline in SCORAD at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -48.0
Confidence Interval (2-Sided) 95%
-61.7 to -34.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of Percent Change from Baseline in SCORAD at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -34.5
Confidence Interval (2-Sided) 95%
-48.5 to -20.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of Percent Change from Baseline in SCORAD at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -20.2
Confidence Interval (2-Sided) 95%
-33.9 to -6.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.96
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Achieved an EASI 75 Response at Week 8
Hide Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.

An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value.

Participants with missing values at Week 8 were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; Non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
7.3 31.0 52.4 81.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 72.7
Confidence Interval (2-Sided) 95%
58.3 to 87.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 44.9
Confidence Interval (2-Sided) 95%
27.9 to 61.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 23.4
Confidence Interval (2-Sided) 95%
7.5 to 39.4
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
Hide Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.

An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value.

Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 22.0 54.8 71.4 92.9
Week 16 22.0 50.0 71.4 83.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of EASI 50 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 70.7
Confidence Interval (2-Sided) 95%
56.2 to 85.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of EASI 50 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 49.0
Confidence Interval (2-Sided) 95%
30.8 to 67.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of EASI 50 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 32.8
Confidence Interval (2-Sided) 95%
13.4 to 52.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of EASI 50 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 60.6
Confidence Interval (2-Sided) 95%
45.3 to 75.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of EASI 50 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 48.6
Confidence Interval (2-Sided) 95%
31.3 to 65.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of EASI 50 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 28.2
Confidence Interval (2-Sided) 95%
9.8 to 46.6
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
Hide Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.

An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value.

Participants with missing values at each time point were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 0.0 9.5 26.2 45.2
Week 16 2.4 14.3 26.2 50.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of EASI 90 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 43.8
Confidence Interval (2-Sided) 95%
29.1 to 58.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of EASI 90 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 26.1
Confidence Interval (2-Sided) 95%
12.6 to 39.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of EASI 90 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
-0.0 to 18.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of EASI 90 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 46.9
Confidence Interval (2-Sided) 95%
31.3 to 62.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of EASI 90 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 23.8
Confidence Interval (2-Sided) 95%
9.6 to 38.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of EASI 90 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
0.1 to 23.6
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
Hide Description

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 50 response is defined as participants with at least a 50% reduction (improvement) in SCORAD score relative to the Baseline value.

Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 7.3 33.3 42.9 76.2
Week 16 7.3 28.6 42.9 61.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of SCORAD 50 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 68.4
Confidence Interval (2-Sided) 95%
54.0 to 82.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of SCORAD 50 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 35.3
Confidence Interval (2-Sided) 95%
18.5 to 52.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of SCORAD 50 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 25.7
Confidence Interval (2-Sided) 95%
9.6 to 41.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of SCORAD 50 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 54.5
Confidence Interval (2-Sided) 95%
39.0 to 69.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of SCORAD 50 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 35.8
Confidence Interval (2-Sided) 95%
19.1 to 52.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of SCORAD 50 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 21.2
Confidence Interval (2-Sided) 95%
5.7 to 36.8
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
Hide Description

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 75 response is defined as participants with at least a 75% reduction (improvement) in SCORAD score relative to the Baseline value.

Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; Non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 0.0 9.5 9.5 31.0
Week 16 2.4 4.8 21.4 40.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of SCORAD 75 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
16.2 to 44.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of SCORAD 75 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
-0.1 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of SCORAD 75 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
0.1 to 18.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of SCORAD 75 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 37.7
Confidence Interval (2-Sided) 95%
22.2 to 53.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of SCORAD 75 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 19.0
Confidence Interval (2-Sided) 95%
5.6 to 32.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of SCORAD 75 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-6.0 to 10.8
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
Hide Description

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 90 response is defined as participants with at least a 90% reduction (improvement) in SCORAD score relative to the Baseline value.

Participants with missing values were counted as non-responders in this analysis (non-responder imputation).

Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 41 42 42 42
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 0.0 4.8 2.4 14.3
Week 16 0.0 2.4 9.5 23.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of SCORAD 90 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 14.2
Confidence Interval (2-Sided) 95%
3.2 to 25.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of SCORAD 90 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-3.4 to 8.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of SCORAD 90 Response at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-2.5 to 11.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments Analysis of SCORAD 90 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 23.3
Confidence Interval (2-Sided) 95%
10.4 to 36.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments Analysis of SCORAD 90 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
0.1 to 18.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments Analysis of SCORAD 90 Response at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-3.4 to 8.1
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Hide Description

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Time Frame Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were re-randomized at the entry of Period 2 (Week 16) with at least one post-Week 16 assessment; Last observation carried forward (LOCF) imputation was used.
Arm/Group Title Placebo / Placebo Placebo / Upadacitinib 30 mg Upadacitinib 7.5 mg / Placebo Upadacitinib 7.5 mg / Upadacitinib 7.5 mg Upadacitinib 15 mg / Placebo Upadacitinib 15 mg / Upadacitinib 15 mg Upadacitinib 30 mg / Placebo Upadacitinib 30 mg / Upadacitinib 30 mg
Hide Arm/Group Description:
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Overall Number of Participants Analyzed 10 10 15 15 17 18 14 19
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 20 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 16 participants 13 participants 18 participants
50.7  (33.50) 11.8  (30.59) 186.0  (46.53) 79.1  (48.42) 582.3  (172.19) 65.7  (178.24) 791.5  (262.34) -73.8  (215.54)
Week 24 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 16 participants 13 participants 19 participants
13.5  (17.13) -67.5  (15.64) 189.6  (44.17) 59.0  (45.97) 607.3  (169.49) 72.6  (175.44) 898.5  (248.78) -69.6  (200.01)
Week 32 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 16 participants 14 participants 19 participants
-2.3  (15.15) -83.1  (13.83) 181.5  (44.74) 63.5  (46.56) 613.3  (169.63) 151.7  (175.59) 771.5  (252.90) -28.8  (210.78)
Week 40 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 16 participants 14 participants 18 participants
-31.2  (18.16) -92.0  (16.58) 200.9  (41.58) 77.6  (43.27) 608.8  (169.95) 154.1  (175.92) 778.9  (344.45) 140.6  (293.17)
Week 52 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 18 participants 14 participants 18 participants
-29.8  (17.74) -90.1  (16.20) 189.1  (43.65) 74.4  (45.42) 613.8  (166.85) 104.1  (164.05) 799.5  (254.30) -13.3  (216.44)
Week 64 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 18 participants 14 participants 18 participants
-35.8  (17.34) -91.4  (15.83) 179.9  (44.91) 71.8  (46.74) 614.6  (166.57) 104.1  (163.78) 802.1  (278.76) 63.6  (237.26)
Week 76 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 17 participants 14 participants 19 participants
-37.3  (19.09) -90.3  (17.43) 201.4  (41.89) 77.7  (43.60) 614.0  (168.03) 130.2  (169.29) 787.8  (262.89) 24.4  (219.11)
Week 88 Number Analyzed 10 participants 10 participants 15 participants 15 participants 17 participants 18 participants 14 participants 18 participants
-37.7  (19.18) -84.6  (17.51) 170.7  (46.87) 69.1  (48.78) 617.5  (165.84) 99.3  (163.06) 769.7  (265.64) 39.0  (226.10)
14.Secondary Outcome
Title Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
Hide Description

Time to loss of EASI 50 response in Period 2 relative to Baseline among those who were re-randomized as EASI 75 responders at Week 16.

Time to loss of EASI 50 response was measured from Week 16 to the date of the first assessment in Period 2 where a participant's EASI score was higher than 50% of their Baseline score.

Participants with no loss of response were censored at their last treatment visit or the start of rescue treatment, whichever occurred first.

Time Frame From re-randomization at Week 16 until Week 88
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were re-randomized as EASI 75 responders at Week 16.
Arm/Group Title Placebo / Placebo Placebo / Upadacitinib 30 mg Upadacitinib 7.5 mg / Placebo Upadacitinib 7.5 mg / Upadacitinib 7.5 mg Upadacitinib 15 mg / Placebo Upadacitinib 15 mg / Upadacitinib 15 mg Upadacitinib 30 mg / Placebo Upadacitinib 30 mg / Upadacitinib 30 mg
Hide Arm/Group Description:
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Overall Number of Participants Analyzed 1 2 5 5 12 10 14 15
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
29 [1] 
(27 to NA)
NA [1] 
(29 to NA)
30
(17 to 55)
114 [1] 
(29 to NA)
28
(25 to 36)
NA [1] 
(NA to NA)
[1]
Could not be estimated due to the low number of events
15.Secondary Outcome
Title Percentage of Participants With an EASI 75 Response in Period 2 in Participants Who Were Re-randomized as EASI 75 Non-responders at Week 16
Hide Description

EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none [0], mild [1], moderate [2], or severe [3]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.

An EASI 75 response is defined as at least a 75% reduction (improvement) in EASI score relative to the Baseline value, and was analyzed in participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16.

Time Frame Weeks 20, 24, 32, 40, 52, 64, 76, and 88
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were re-randomized at Week 16 and were EASI 75 non-responders at Week 16, and with available data at each time point.
Arm/Group Title Placebo / Placebo Placebo / Upadacitinib 30 mg Upadacitinib 7.5 mg / Placebo Upadacitinib 7.5 mg / Upadacitinib 7.5 mg Upadacitinib 15 mg / Placebo Upadacitinib 15 mg / Upadacitinib 15 mg Upadacitinib 30 mg / Placebo Upadacitinib 30 mg / Upadacitinib 30 mg
Hide Arm/Group Description:
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to placebo were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 7.5 mg upadacitinib were re-randomized at Week 16 to receive 7.5 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 15 mg upadacitinib were re-randomized at Week 16 to receive 15 mg upadacitinib once a day for 72 weeks in Period 2.
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
Participants originally randomized to 30 mg upadacitinib were re-randomized at Week 16 to receive 30 mg upadacitinib once a day for 72 weeks in Period 2.
Overall Number of Participants Analyzed 9 8 10 11 7 8 5 4
Measure Type: Number
Unit of Measure: percentage of participants
Week 20 Number Analyzed 9 participants 8 participants 10 participants 11 participants 7 participants 8 participants 5 participants 4 participants
11.1 12.5 0 9.1 0 12.5 20.0 25.0
Week 24 Number Analyzed 1 participants 7 participants 0 participants 3 participants 1 participants 2 participants 3 participants 3 participants
100 85.7 33.3 0 0 33.3 33.3
Week 32 Number Analyzed 1 participants 6 participants 0 participants 2 participants 1 participants 2 participants 2 participants 2 participants
100 100 0 0 50.0 50.0 50.0
Week 40 Number Analyzed 1 participants 6 participants 0 participants 0 participants 1 participants 1 participants 1 participants 2 participants
100 66.7 0 100 0 50.0
Week 52 Number Analyzed 1 participants 6 participants 0 participants 0 participants 1 participants 1 participants 0 participants 2 participants
100 66.7 0 100 50.0
Week 64 Number Analyzed 1 participants 5 participants 0 participants 0 participants 1 participants 1 participants 0 participants 1 participants
100 80.0 0 100 100
Week 76 Number Analyzed 1 participants 3 participants 0 participants 0 participants 1 participants 1 participants 0 participants 1 participants
100 100 0 100 100
Week 88 Number Analyzed 1 participants 2 participants 0 participants 0 participants 1 participants 1 participants 0 participants 1 participants
100 100 0 100 100
16.Secondary Outcome
Title Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) of "0" or "1" at Weeks 8 and 16
Hide Description

The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A score of 0 or 1 means that the disease has no effect at all.

Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.

Time Frame Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Due to an error in the electronic device used to administer the questionnaire data were not available for any participants
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Change From Baseline in DLQI at Weeks 8 and 16
Hide Description

The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.

Dermatology Life Quality Index outcomes were defined but are not reported because of an error in the programming of the electronic device used to administer the questionnaire that precluded determination of these outcomes.

Time Frame Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Due to an error in the electronic device used to administer the questionnaire data were not available for any participants.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Hide Description

Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA.

Last observation carried forward imputation was used.

Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with at least one post-baseline measurement; Last observation carried forward (LOCF) imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 39 42 42 42
Least Squares Mean (Standard Error)
Unit of Measure: percentage of body surface area
-4.1  (3.58) -11.7  (3.48) -27.1  (3.43) -30.7  (3.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -26.5
Confidence Interval (2-Sided) 95%
-34.9 to -18.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -23.0
Confidence Interval (2-Sided) 95%
-31.4 to -14.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with stratum (geographic region), baseline value, and treatment in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.6
Confidence Interval (2-Sided) 95%
-16.0 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.25
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16
Hide Description Participants were asked to rate pruritus (itch) in the past 24 hours on a daily basis using a scale from 0 to 10, with 0 being no itch and 10 being the worst imaginable itch. The percentage of participants with reduction of ≥ 4 points from Baseline in pruritus NRS was assessed in participants with a baseline pruritus NRS of ≥ 4. Participants with missing values at Week 16 were counted as non-responders in this analysis (non-responder imputation).
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with Baseline pruritus NRS of ≥ 4; non-responder imputation was used.
Arm/Group Title Placebo Upadacitinib 7.5 mg Upadacitinib 15 mg Upadacitinib 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
Overall Number of Participants Analyzed 35 37 32 36
Measure Type: Number
Unit of Measure: percentage of participants
5.7 24.3 59.4 52.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 47.4
Confidence Interval (2-Sided) 95%
29.6 to 65.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 53.4
Confidence Interval (2-Sided) 95%
35.5 to 71.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Upadacitinib 7.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 18.6
Confidence Interval (2-Sided) 95%
2.8 to 34.3
Estimation Comments [Not Specified]
Time Frame From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
Adverse Event Reporting Description Any adverse event that occurred on or after the first dose of upadacitinib 30 mg rescue therapy in Period 2 is counted in the Period 1+2: Upadacitinib 30 mg group. Participants who received rescue therapy after placebo, upadacitinib 7.5 mg or 15 mg treatment in Period 2 are counted in the denominators of both Period 1+2: Placebo/Upadacitinib 7.5 mg/15 mg and Period 1+2: Upadacitinib 30 mg dose groups.
 
Arm/Group Title Period 1: Placebo Period 1: Upadacitinib 7.5 mg Period 1: Upadacitinib 15 mg Period 1: Upadacitinib 30 mg Period 1+2: Upadacitinib 7.5 mg Period 1+2: Upadacitinib 15 mg Period 1+2: Upadacitinib 30 mg Period 1+2: Placebo
Hide Arm/Group Description Participants received placebo once daily (QD) for 16 weeks in Period 1. Participants received upadacitinib 7.5 mg once daily for 16 weeks in Period 1 Participants received upadacitinib 15 mg once daily for 16 weeks in Period 1. Participants received upadacitinib 30 mg once daily for 16 weeks in Period 1. Participants originally randomized to upadacitinib 7.5 mg received upadacitinib 7.5 mg once daily for 16 weeks in Period 1; Participants re-randomized to upadacitinib 7.5 mg in Period 2 continued to receive upadacitinib 7.5 mg for 72 weeks in Period 2 or until rescue. Participants originally randomized to upadacitinib 15 mg received upadacitinib 15 mg once daily for 16 weeks in Period 1; Participants re-randomized to upadacitinib 15 mg in Period 2 continued to receive upadacitinib 15 mg for 72 weeks in Period 2 or until rescue.

Participants originally randomized to upadacitinib 30 mg received upadacitinib 30 mg once daily for 16 weeks in Period 1. Participants re-randomized to upadacitinib 30 mg in Period 2 continued to receive upadacitinib 30 mg for 72 weeks in Period 2.

Participants originally randomized to placebo and re-randomized to upadacitinib 30 mg at Week 16 received upadacitinib 30 mg from Week 16 to Week 88.

Participants re-randomized to placebo, upadacitinib 7.5 mg or 15 mg at Week 16 who were rescued starting at Week 20 or later received upadacitinib 30 mg until Week 88.

Participants originally randomized to placebo received placebo once daily for 16 weeks in Period 1.

Participants re-randomized to placebo in Period 2 continued to receive placebo for 72 weeks in Period 2 or until rescue.

All-Cause Mortality
Period 1: Placebo Period 1: Upadacitinib 7.5 mg Period 1: Upadacitinib 15 mg Period 1: Upadacitinib 30 mg Period 1+2: Upadacitinib 7.5 mg Period 1+2: Upadacitinib 15 mg Period 1+2: Upadacitinib 30 mg Period 1+2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/42 (0.00%)      0/42 (0.00%)      0/42 (0.00%)      0/42 (0.00%)      0/42 (0.00%)      2/114 (1.75%)      0/93 (0.00%)    
Hide Serious Adverse Events
Period 1: Placebo Period 1: Upadacitinib 7.5 mg Period 1: Upadacitinib 15 mg Period 1: Upadacitinib 30 mg Period 1+2: Upadacitinib 7.5 mg Period 1+2: Upadacitinib 15 mg Period 1+2: Upadacitinib 30 mg Period 1+2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      2/42 (4.76%)      1/42 (2.38%)      0/42 (0.00%)      2/42 (4.76%)      1/42 (2.38%)      7/114 (6.14%)      1/93 (1.08%)    
Cardiac disorders                 
ATRIAL FIBRILLATION  1  1/40 (2.50%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/114 (0.00%)  0 1/93 (1.08%)  1
CARDIO-RESPIRATORY ARREST  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
PERICARDITIS  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
Gastrointestinal disorders                 
OESOPHAGEAL FISTULA  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
Infections and infestations                 
APPENDICITIS  1  0/40 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1 0/114 (0.00%)  0 0/93 (0.00%)  0
PERICORONITIS  1  0/40 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/114 (0.00%)  0 0/93 (0.00%)  0
SEPSIS  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
SKIN INFECTION  1  0/40 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/114 (0.00%)  0 0/93 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
OSTEOARTHRITIS  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
ROTATOR CUFF SYNDROME  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
SQUAMOUS CELL CARCINOMA OF SKIN  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
Renal and urinary disorders                 
URETEROLITHIASIS  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
PULMONARY EMBOLISM  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 0/93 (0.00%)  0
Skin and subcutaneous tissue disorders                 
DERMATITIS ATOPIC  1  0/40 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/114 (0.00%)  0 0/93 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Period 1: Placebo Period 1: Upadacitinib 7.5 mg Period 1: Upadacitinib 15 mg Period 1: Upadacitinib 30 mg Period 1+2: Upadacitinib 7.5 mg Period 1+2: Upadacitinib 15 mg Period 1+2: Upadacitinib 30 mg Period 1+2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/40 (37.50%)      21/42 (50.00%)      17/42 (40.48%)      21/42 (50.00%)      23/42 (54.76%)      22/42 (52.38%)      68/114 (59.65%)      19/93 (20.43%)    
Gastrointestinal disorders                 
DIARRHOEA  1  2/40 (5.00%)  2 2/42 (4.76%)  2 2/42 (4.76%)  4 0/42 (0.00%)  0 2/42 (4.76%)  2 2/42 (4.76%)  5 2/114 (1.75%)  2 2/93 (2.15%)  2
NAUSEA  1  1/40 (2.50%)  1 3/42 (7.14%)  3 1/42 (2.38%)  1 3/42 (7.14%)  3 3/42 (7.14%)  3 1/42 (2.38%)  1 6/114 (5.26%)  8 2/93 (2.15%)  2
Infections and infestations                 
HERPES ZOSTER  1  0/40 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 10/114 (8.77%)  10 0/93 (0.00%)  0
IMPETIGO  1  0/40 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 2/42 (4.76%)  2 1/42 (2.38%)  1 0/42 (0.00%)  0 8/114 (7.02%)  8 0/93 (0.00%)  0
INFLUENZA  1  0/40 (0.00%)  0 3/42 (7.14%)  3 0/42 (0.00%)  0 0/42 (0.00%)  0 3/42 (7.14%)  3 0/42 (0.00%)  0 3/114 (2.63%)  4 0/93 (0.00%)  0
NASOPHARYNGITIS  1  1/40 (2.50%)  1 2/42 (4.76%)  2 4/42 (9.52%)  5 3/42 (7.14%)  3 3/42 (7.14%)  3 5/42 (11.90%)  6 11/114 (9.65%)  16 1/93 (1.08%)  1
UPPER RESPIRATORY TRACT INFECTION  1  4/40 (10.00%)  4 7/42 (16.67%)  7 5/42 (11.90%)  5 5/42 (11.90%)  9 7/42 (16.67%)  7 7/42 (16.67%)  7 26/114 (22.81%)  47 5/93 (5.38%)  5
URINARY TRACT INFECTION  1  0/40 (0.00%)  0 2/42 (4.76%)  2 2/42 (4.76%)  2 1/42 (2.38%)  1 2/42 (4.76%)  2 2/42 (4.76%)  2 6/114 (5.26%)  8 0/93 (0.00%)  0
Injury, poisoning and procedural complications                 
LIGAMENT SPRAIN  1  2/40 (5.00%)  2 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 2/93 (2.15%)  2
Investigations                 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  2/40 (5.00%)  2 0/42 (0.00%)  0 3/42 (7.14%)  3 4/42 (9.52%)  4 0/42 (0.00%)  0 3/42 (7.14%)  3 7/114 (6.14%)  8 3/93 (3.23%)  3
Nervous system disorders                 
HEADACHE  1  1/40 (2.50%)  1 3/42 (7.14%)  3 3/42 (7.14%)  3 4/42 (9.52%)  4 3/42 (7.14%)  3 3/42 (7.14%)  3 7/114 (6.14%)  7 2/93 (2.15%)  2
Renal and urinary disorders                 
HAEMATURIA  1  2/40 (5.00%)  2 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 2/93 (2.15%)  2
PROTEINURIA  1  2/40 (5.00%)  2 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/114 (0.88%)  1 2/93 (2.15%)  2
Respiratory, thoracic and mediastinal disorders                 
OROPHARYNGEAL PAIN  1  0/40 (0.00%)  0 3/42 (7.14%)  3 0/42 (0.00%)  0 0/42 (0.00%)  0 3/42 (7.14%)  3 0/42 (0.00%)  0 0/114 (0.00%)  0 0/93 (0.00%)  0
Skin and subcutaneous tissue disorders                 
ACNE  1  1/40 (2.50%)  1 4/42 (9.52%)  6 2/42 (4.76%)  2 6/42 (14.29%)  7 4/42 (9.52%)  6 2/42 (4.76%)  2 13/114 (11.40%)  14 1/93 (1.08%)  1
DERMATITIS ATOPIC  1  2/40 (5.00%)  2 5/42 (11.90%)  6 2/42 (4.76%)  2 4/42 (9.52%)  5 6/42 (14.29%)  7 5/42 (11.90%)  5 22/114 (19.30%)  25 2/93 (2.15%)  2
DERMATITIS CONTACT  1  2/40 (5.00%)  2 0/42 (0.00%)  0 1/42 (2.38%)  1 1/42 (2.38%)  1 0/42 (0.00%)  0 1/42 (2.38%)  1 2/114 (1.75%)  2 2/93 (2.15%)  2
1
Term from vocabulary, MedDRA 21.1