Trial Outcomes & Findings for A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis (NCT NCT02925117)
NCT ID: NCT02925117
Last Updated: 2020-07-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2020-07-16
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
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.
|
Upadacitinib 7.5 mg
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.
|
Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg
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.
|
Placebo / Placebo
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
|
Placebo / Upadacitinib 30 mg
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.
|
Upadacitinib 7.5 mg / Placebo
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.
|
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
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.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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 1 (Weeks 0 - 16)
STARTED
|
41
|
42
|
42
|
42
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 - 16)
Received Treatment
|
40
|
42
|
42
|
42
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 - 16)
COMPLETED
|
23
|
31
|
37
|
39
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 - 16)
NOT COMPLETED
|
18
|
11
|
5
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 16 - 88)
STARTED
|
0
|
0
|
0
|
0
|
10
|
10
|
15
|
16
|
19
|
18
|
19
|
19
|
|
Period 2 (Weeks 16 - 88)
Rescued to Upadacitinib 30 mg
|
0
|
0
|
0
|
0
|
8
|
1
|
13
|
12
|
17
|
12
|
14
|
4
|
|
Period 2 (Weeks 16 - 88)
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
5
|
9
|
11
|
13
|
12
|
11
|
14
|
|
Period 2 (Weeks 16 - 88)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
5
|
6
|
5
|
6
|
6
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Upadacitinib 7.5 mg
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.
|
Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg
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.
|
Placebo / Placebo
Participants originally randomized to placebo were re-randomized at Week 16 to receive placebo tablets once a day for 72 weeks in Period 2.
|
Placebo / Upadacitinib 30 mg
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.
|
Upadacitinib 7.5 mg / Placebo
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.
|
Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
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.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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 1 (Weeks 0 - 16)
Adverse Event
|
1
|
3
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 - 16)
Withdrawal by Subject
|
10
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 - 16)
Lost to Follow-up
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 - 16)
Other
|
5
|
4
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 16 - 88)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Period 2 (Weeks 16 - 88)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
3
|
2
|
2
|
2
|
2
|
|
Period 2 (Weeks 16 - 88)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
1
|
|
Period 2 (Weeks 16 - 88)
Other
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
3
|
4
|
3
|
0
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 17.52 • n=41 Participants
|
41.5 years
STANDARD_DEVIATION 15.36 • n=42 Participants
|
38.5 years
STANDARD_DEVIATION 15.24 • n=42 Participants
|
39.9 years
STANDARD_DEVIATION 15.30 • n=42 Participants
|
39.9 years
STANDARD_DEVIATION 15.77 • n=167 Participants
|
|
Age, Customized
< 40 years
|
25 Participants
n=41 Participants
|
22 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
94 Participants
n=167 Participants
|
|
Age, Customized
40 - 64 years
|
11 Participants
n=41 Participants
|
16 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
58 Participants
n=167 Participants
|
|
Age, Customized
≥ 65 years
|
5 Participants
n=41 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
15 Participants
n=167 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=41 Participants
|
14 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
63 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=41 Participants
|
28 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
104 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=41 Participants
|
40 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
162 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=167 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=41 Participants
|
24 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
96 Participants
n=167 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=41 Participants
|
7 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
29 Participants
n=167 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=41 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
38 Participants
n=167 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=167 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=167 Participants
|
|
Geographic Region
US/Canada
|
29 Participants
n=41 Participants
|
29 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
116 Participants
n=167 Participants
|
|
Geographic Region
EU/Australia
|
10 Participants
n=41 Participants
|
11 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
41 Participants
n=167 Participants
|
|
Geographic Region
Japan
|
2 Participants
n=41 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=167 Participants
|
|
Duration of Atopic Dermatitis Diagnosis
|
26.84 years
STANDARD_DEVIATION 18.76 • n=40 Participants • Participants with available data
|
30.44 years
STANDARD_DEVIATION 18.07 • n=42 Participants • Participants with available data
|
22.59 years
STANDARD_DEVIATION 15.78 • n=42 Participants • Participants with available data
|
24.24 years
STANDARD_DEVIATION 13.58 • n=42 Participants • Participants with available data
|
26.02 years
STANDARD_DEVIATION 16.76 • n=166 Participants • Participants with available data
|
|
Eczema Area and Severity Index (EASI)
|
32.62 units on a scale
STANDARD_DEVIATION 14.49 • n=41 Participants
|
31.42 units on a scale
STANDARD_DEVIATION 15.76 • n=42 Participants
|
31.40 units on a scale
STANDARD_DEVIATION 12.26 • n=42 Participants
|
28.15 units on a scale
STANDARD_DEVIATION 11.62 • n=42 Participants
|
30.89 units on a scale
STANDARD_DEVIATION 13.61 • n=167 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Randomized participants with at least one post-baseline EASI assessment; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
|
-23.0 percent change
Standard Error 6.42
|
-39.4 percent change
Standard Error 6.24
|
-61.7 percent change
Standard Error 6.12
|
-74.4 percent change
Standard Error 6.13
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: All randomized participants; non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) at Week 16
|
9.8 percentage of participants
|
28.6 percentage of participants
|
52.4 percentage of participants
|
69.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants; non-responder imputation was used.
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.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving an Investigator Global Assessment (IGA) of "0" or "1" at Week 16
|
2.4 percentage of participants
|
14.3 percentage of participants
|
31.0 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 8, and 16Population: Randomized participants with a Baseline and at least one post-baseline measurement; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=40 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=37 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Week 2
|
1.7 percent change
Standard Error 5.59
|
-29.3 percent change
Standard Error 5.45
|
-46.0 percent change
Standard Error 5.44
|
-57.6 percent change
Standard Error 5.24
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Week 8
|
-6.7 percent change
Standard Error 7.51
|
-35.5 percent change
Standard Error 7.28
|
-45.1 percent change
Standard Error 7.32
|
-73.1 percent change
Standard Error 7.05
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline to Weeks 2, 8, and 16 in Pruritus Numerical Rating Scale (NRS)
Week 16
|
-9.7 percent change
Standard Error 8.30
|
-39.6 percent change
Standard Error 8.04
|
-48.0 percent change
Standard Error 8.08
|
-68.9 percent change
Standard Error 7.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Randomized participants with at least one post-baseline measurement; Last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in EASI Score at Week 8
|
-17.5 percent change
Standard Error 6.27
|
-43.7 percent change
Standard Error 6.09
|
-65.4 percent change
Standard Error 5.97
|
-82.8 percent change
Standard Error 5.98
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: Randomized participants with Baseline and at least one post-baseline measurement; Last observation carried forward imputation was used.
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.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=39 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=36 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=40 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
Week 8
|
-7.0 percent change
Standard Error 5.84
|
-35.4 percent change
Standard Error 5.53
|
-44.1 percent change
Standard Error 5.69
|
-65.3 percent change
Standard Error 5.52
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Weeks 8 and 16
Week 16
|
-12.4 percent change
Standard Error 5.97
|
-32.5 percent change
Standard Error 5.66
|
-46.9 percent change
Standard Error 5.82
|
-60.4 percent change
Standard Error 5.65
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All randomized participants; Non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an EASI 75 Response at Week 8
|
7.3 percentage of participants
|
31.0 percentage of participants
|
52.4 percentage of participants
|
81.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: All randomized participants; non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
Week 8
|
22.0 percentage of participants
|
54.8 percentage of participants
|
71.4 percentage of participants
|
92.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved an EASI 50 Response at Weeks 8 and 16
Week 16
|
22.0 percentage of participants
|
50.0 percentage of participants
|
71.4 percentage of participants
|
83.3 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: All randomized participants; non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
Week 16
|
2.4 percentage of participants
|
14.3 percentage of participants
|
26.2 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved an EASI 90 Response at Weeks 8 and 16
Week 8
|
0.0 percentage of participants
|
9.5 percentage of participants
|
26.2 percentage of participants
|
45.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: All randomized participants; non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
Week 8
|
7.3 percentage of participants
|
33.3 percentage of participants
|
42.9 percentage of participants
|
76.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved a SCORAD 50 Response at Weeks 8 and 16
Week 16
|
7.3 percentage of participants
|
28.6 percentage of participants
|
42.9 percentage of participants
|
61.9 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: All randomized participants; Non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
Week 8
|
0.0 percentage of participants
|
9.5 percentage of participants
|
9.5 percentage of participants
|
31.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved a SCORAD 75 Response at Weeks 8 and 16
Week 16
|
2.4 percentage of participants
|
4.8 percentage of participants
|
21.4 percentage of participants
|
40.5 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: All randomized participants; non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
Week 8
|
0.0 percentage of participants
|
4.8 percentage of participants
|
2.4 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved a SCORAD 90 Response at Weeks 8 and 16
Week 16
|
0.0 percentage of participants
|
2.4 percentage of participants
|
9.5 percentage of participants
|
23.8 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Re-randomization (Week 16) and Weeks 20, 24, 32, 40, 52, 64, 76, and 88Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=10 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=15 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=15 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
n=17 Participants
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
n=18 Participants
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.
|
Upadacitinib 30 mg / Placebo
n=14 Participants
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
n=19 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 20
|
50.7 percent change
Standard Error 33.50
|
11.8 percent change
Standard Error 30.59
|
186.0 percent change
Standard Error 46.53
|
79.1 percent change
Standard Error 48.42
|
582.3 percent change
Standard Error 172.19
|
65.7 percent change
Standard Error 178.24
|
791.5 percent change
Standard Error 262.34
|
-73.8 percent change
Standard Error 215.54
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 24
|
13.5 percent change
Standard Error 17.13
|
-67.5 percent change
Standard Error 15.64
|
189.6 percent change
Standard Error 44.17
|
59.0 percent change
Standard Error 45.97
|
607.3 percent change
Standard Error 169.49
|
72.6 percent change
Standard Error 175.44
|
898.5 percent change
Standard Error 248.78
|
-69.6 percent change
Standard Error 200.01
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 32
|
-2.3 percent change
Standard Error 15.15
|
-83.1 percent change
Standard Error 13.83
|
181.5 percent change
Standard Error 44.74
|
63.5 percent change
Standard Error 46.56
|
613.3 percent change
Standard Error 169.63
|
151.7 percent change
Standard Error 175.59
|
771.5 percent change
Standard Error 252.90
|
-28.8 percent change
Standard Error 210.78
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 40
|
-31.2 percent change
Standard Error 18.16
|
-92.0 percent change
Standard Error 16.58
|
200.9 percent change
Standard Error 41.58
|
77.6 percent change
Standard Error 43.27
|
608.8 percent change
Standard Error 169.95
|
154.1 percent change
Standard Error 175.92
|
778.9 percent change
Standard Error 344.45
|
140.6 percent change
Standard Error 293.17
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 52
|
-29.8 percent change
Standard Error 17.74
|
-90.1 percent change
Standard Error 16.20
|
189.1 percent change
Standard Error 43.65
|
74.4 percent change
Standard Error 45.42
|
613.8 percent change
Standard Error 166.85
|
104.1 percent change
Standard Error 164.05
|
799.5 percent change
Standard Error 254.30
|
-13.3 percent change
Standard Error 216.44
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 64
|
-35.8 percent change
Standard Error 17.34
|
-91.4 percent change
Standard Error 15.83
|
179.9 percent change
Standard Error 44.91
|
71.8 percent change
Standard Error 46.74
|
614.6 percent change
Standard Error 166.57
|
104.1 percent change
Standard Error 163.78
|
802.1 percent change
Standard Error 278.76
|
63.6 percent change
Standard Error 237.26
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 76
|
-37.3 percent change
Standard Error 19.09
|
-90.3 percent change
Standard Error 17.43
|
201.4 percent change
Standard Error 41.89
|
77.7 percent change
Standard Error 43.60
|
614.0 percent change
Standard Error 168.03
|
130.2 percent change
Standard Error 169.29
|
787.8 percent change
Standard Error 262.89
|
24.4 percent change
Standard Error 219.11
|
|
Percent Change From Re-randomization (Week 16) in EASI Score in Period 2
Week 88
|
-37.7 percent change
Standard Error 19.18
|
-84.6 percent change
Standard Error 17.51
|
170.7 percent change
Standard Error 46.87
|
69.1 percent change
Standard Error 48.78
|
617.5 percent change
Standard Error 165.84
|
99.3 percent change
Standard Error 163.06
|
769.7 percent change
Standard Error 265.64
|
39.0 percent change
Standard Error 226.10
|
SECONDARY outcome
Timeframe: From re-randomization at Week 16 until Week 88Population: Participants who were re-randomized as EASI 75 responders at Week 16.
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.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=2 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=5 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=5 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
n=12 Participants
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
n=10 Participants
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.
|
Upadacitinib 30 mg / Placebo
n=14 Participants
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
n=15 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Loss of EASI 50 Response Relative to Baseline Among Participants Re-randomized as EASI 75 Responders at Week 16
|
NA days
Could not be estimated due to the low number of events
|
NA days
Could not be estimated due to the low number of events
|
29 days
Interval 27.0 to
Could not be estimated due to the low number of events
|
NA days
Interval 29.0 to
Could not be estimated due to the low number of events
|
30 days
Interval 17.0 to 55.0
|
114 days
Interval 29.0 to
Could not be estimated due to the low number of events
|
28 days
Interval 25.0 to 36.0
|
NA days
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: Weeks 20, 24, 32, 40, 52, 64, 76, and 88Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=8 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=10 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=11 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
n=7 Participants
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
n=8 Participants
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.
|
Upadacitinib 30 mg / Placebo
n=5 Participants
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
n=4 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
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
Week 20
|
11.1 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
|
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
Week 24
|
100 percentage of participants
|
85.7 percentage of participants
|
—
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
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
Week 32
|
100 percentage of participants
|
100 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
|
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
Week 40
|
100 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
0 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
|
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
Week 52
|
100 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
0 percentage of participants
|
100 percentage of participants
|
—
|
50.0 percentage of participants
|
|
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
Week 64
|
100 percentage of participants
|
80.0 percentage of participants
|
—
|
—
|
0 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
|
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
Week 76
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
0 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
|
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
Week 88
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
0 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 8 and 16Population: Due to an error in the electronic device used to administer the questionnaire data were not available for any participants
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 8 and 16Population: Due to an error in the electronic device used to administer the questionnaire data were not available for any participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Randomized participants with at least one post-baseline measurement; Last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=42 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=42 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=42 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
|
-4.1 percentage of body surface area
Standard Error 3.58
|
-11.7 percentage of body surface area
Standard Error 3.48
|
-27.1 percentage of body surface area
Standard Error 3.43
|
-30.7 percentage of body surface area
Standard Error 3.43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Randomized participants with Baseline pruritus NRS of ≥ 4; non-responder imputation was used.
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).
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1.
|
Upadacitinib 7.5 mg
n=37 Participants
Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg
n=32 Participants
Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1.
|
Upadacitinib 30 mg
n=36 Participants
Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1.
|
Upadacitinib 15 mg / Placebo
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.
|
Upadacitinib 15 mg / Upadacitinib 15 mg
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.
|
Upadacitinib 30 mg / Placebo
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.
|
Upadacitinib 30 mg / Upadacitinib 30 mg
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.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Reduction of ≥ 4 Points From Baseline in Pruritus NRS at Week 16
|
5.7 percentage of participants
|
24.3 percentage of participants
|
59.4 percentage of participants
|
52.8 percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
Period 1: Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 1: Upadacitinib 7.5 mg
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Period 1: Upadacitinib 15 mg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Period 1: Upadacitinib 30 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 7.5 mg
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 15 mg
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Period 1+2: Upadacitinib 30 mg
Serious events: 7 serious events
Other events: 68 other events
Deaths: 2 deaths
Period 1+2: Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Placebo
n=40 participants at risk
Participants received placebo once daily (QD) for 16 weeks in Period 1.
|
Period 1: Upadacitinib 7.5 mg
n=42 participants at risk
Participants received upadacitinib 7.5 mg once daily for 16 weeks in Period 1
|
Period 1: Upadacitinib 15 mg
n=42 participants at risk
Participants received upadacitinib 15 mg once daily for 16 weeks in Period 1.
|
Period 1: Upadacitinib 30 mg
n=42 participants at risk
Participants received upadacitinib 30 mg once daily for 16 weeks in Period 1.
|
Period 1+2: Upadacitinib 7.5 mg
n=42 participants at risk
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.
|
Period 1+2: Upadacitinib 15 mg
n=42 participants at risk
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.
|
Period 1+2: Upadacitinib 30 mg
n=114 participants at risk
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.
|
Period 1+2: Placebo
n=93 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.5%
1/40 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/114 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
1.1%
1/93 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Gastrointestinal disorders
OESOPHAGEAL FISTULA
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/114 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
PERICORONITIS
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/114 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/114 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/114 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
Other adverse events
| Measure |
Period 1: Placebo
n=40 participants at risk
Participants received placebo once daily (QD) for 16 weeks in Period 1.
|
Period 1: Upadacitinib 7.5 mg
n=42 participants at risk
Participants received upadacitinib 7.5 mg once daily for 16 weeks in Period 1
|
Period 1: Upadacitinib 15 mg
n=42 participants at risk
Participants received upadacitinib 15 mg once daily for 16 weeks in Period 1.
|
Period 1: Upadacitinib 30 mg
n=42 participants at risk
Participants received upadacitinib 30 mg once daily for 16 weeks in Period 1.
|
Period 1+2: Upadacitinib 7.5 mg
n=42 participants at risk
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.
|
Period 1+2: Upadacitinib 15 mg
n=42 participants at risk
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.
|
Period 1+2: Upadacitinib 30 mg
n=114 participants at risk
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.
|
Period 1+2: Placebo
n=93 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 4 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 5 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
1.8%
2/114 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Gastrointestinal disorders
NAUSEA
|
2.5%
1/40 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
5.3%
6/114 • Number of events 8 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
8.8%
10/114 • Number of events 10 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
IMPETIGO
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.0%
8/114 • Number of events 8 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.6%
3/114 • Number of events 4 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.5%
1/40 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.5%
4/42 • Number of events 5 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
11.9%
5/42 • Number of events 6 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.6%
11/114 • Number of events 16 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
1.1%
1/93 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.0%
4/40 • Number of events 4 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
16.7%
7/42 • Number of events 7 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
11.9%
5/42 • Number of events 5 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
11.9%
5/42 • Number of events 9 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
16.7%
7/42 • Number of events 7 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
16.7%
7/42 • Number of events 7 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
22.8%
26/114 • Number of events 47 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
5.4%
5/93 • Number of events 5 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
5.3%
6/114 • Number of events 8 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.5%
4/42 • Number of events 4 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
6.1%
7/114 • Number of events 8 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
3.2%
3/93 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Nervous system disorders
HEADACHE
|
2.5%
1/40 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.5%
4/42 • Number of events 4 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
6.1%
7/114 • Number of events 7 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Renal and urinary disorders
HAEMATURIA
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Renal and urinary disorders
PROTEINURIA
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.88%
1/114 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/40 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
7.1%
3/42 • Number of events 3 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/114 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/93 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
2.5%
1/40 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.5%
4/42 • Number of events 6 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
14.3%
6/42 • Number of events 7 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.5%
4/42 • Number of events 6 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
11.4%
13/114 • Number of events 14 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
1.1%
1/93 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
11.9%
5/42 • Number of events 6 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
4.8%
2/42 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
9.5%
4/42 • Number of events 5 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
14.3%
6/42 • Number of events 7 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
11.9%
5/42 • Number of events 5 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
19.3%
22/114 • Number of events 25 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
5.0%
2/40 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
0.00%
0/42 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.4%
1/42 • Number of events 1 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
1.8%
2/114 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
2.2%
2/93 • Number of events 2 • From the first dose of study drug up to 30 days after last dose. Period 1: 16 weeks, Period 2: 72 weeks.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER