Trial Outcomes & Findings for A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone (NCT NCT02066389)

NCT ID: NCT02066389

Last Updated: 2021-07-30

Results Overview

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 300 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2021-07-30

Participant Flow

A total of 300 adults with rheumatoid arthritis (RA) were enrolled at 59 study sites located in 16 countries.

Eligible participants were randomly assigned in a 1:1:1:1:1:1 ratio to receive 1 of 5 doses of upadacitinib or placebo for 12 weeks. Participants who completed the 12-week treatment period completed a 30-day follow-up visit or had the option to enter an open-label extension study M13-538 (NCT02049138).

Participant milestones

Measure	Placebo Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Overall Study STARTED	50	50	50	50	50	50
Overall Study Received Study Drug	50	50	50	50	50	49
Overall Study COMPLETED	45	49	44	47	43	45
Overall Study NOT COMPLETED	5	1	6	3	7	5

Reasons for withdrawal

Measure	Placebo Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Overall Study Adverse Event	1	1	1	1	5	1
Overall Study Withdrawal by Subject	4	0	5	1	1	2
Overall Study Lost to Follow-up	0	0	0	1	1	1
Overall Study Randomized in Error	0	0	0	0	0	1

Baseline Characteristics

A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone

Baseline characteristics by cohort

Measure	Placebo n=50 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=50 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=50 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=50 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.	Total n=299 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 11.51 • n=5 Participants	53.1 years STANDARD_DEVIATION 12.15 • n=7 Participants	54.8 years STANDARD_DEVIATION 12.47 • n=5 Participants	55.7 years STANDARD_DEVIATION 11.65 • n=4 Participants	54.6 years STANDARD_DEVIATION 13.65 • n=21 Participants	56.2 years STANDARD_DEVIATION 11.79 • n=8 Participants	54.8 years STANDARD_DEVIATION 12.16 • n=8 Participants
Age, Customized 18 to < 45 years	9 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants	7 Participants n=8 Participants	56 Participants n=8 Participants
Age, Customized 45 to < 65 years	32 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	32 Participants n=4 Participants	25 Participants n=21 Participants	27 Participants n=8 Participants	176 Participants n=8 Participants
Age, Customized ≤ 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	15 Participants n=8 Participants	67 Participants n=8 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	40 Participants n=7 Participants	34 Participants n=5 Participants	41 Participants n=4 Participants	42 Participants n=21 Participants	42 Participants n=8 Participants	237 Participants n=8 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	62 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=8 Participants	68 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	42 Participants n=7 Participants	33 Participants n=5 Participants	33 Participants n=4 Participants	43 Participants n=21 Participants	41 Participants n=8 Participants	231 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized White	50 Participants n=5 Participants	48 Participants n=7 Participants	49 Participants n=5 Participants	48 Participants n=4 Participants	49 Participants n=21 Participants	49 Participants n=8 Participants	293 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Multi-race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:

1. ≥ 20% improvement in 68-tender joint count;

2. ≥ 20% improvement in 66-swollen joint count; and

3. ≥ 20% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=46 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=48 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=49 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=47 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12	50.0 percentage of participants	64.6 percentage of participants	73.5 percentage of participants	81.6 percentage of participants	76.6 percentage of participants	81.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

A participant was a responder if the following 3 criteria for improvement from baseline were met:

• ≥ 50% improvement in 68-tender joint count;
• ≥ 50% improvement in 66-swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Physician's global assessment of disease activity
• Patient's global assessment of disease activity
• Patient's assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=46 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=48 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=47 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=48 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12	19.6 percentage of participants	39.6 percentage of participants	49.0 percentage of participants	50.0 percentage of participants	44.7 percentage of participants	43.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

A participant was a responder if the following 3 criteria for improvement from baseline were met:

• ≥ 70% improvement in tender joint count;
• ≥ 70% improvement in swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=46 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=47 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=47 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=48 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12	6.5 percentage of participants	23.4 percentage of participants	30.6 percentage of participants	16.0 percentage of participants	27.7 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale (VAS) from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity.

LDA is defined as a DAS28(CRP) score < 3.2.

Outcome measures

Measure	Placebo n=47 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=49 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=49 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12	21.3 percentage of participants	49.0 percentage of participants	57.1 percentage of participants	46.0 percentage of participants	51.0 percentage of participants	42.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to 10 where higher scores indicate more disease activity.

CR is defined as a DAS28(CRP) score < 2.6.

Outcome measures

Measure	Placebo n=47 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=49 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=49 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Secondary: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12	14.9 percentage of participants	36.7 percentage of participants	38.8 percentage of participants	34.0 percentage of participants	42.9 percentage of participants	22.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.

LDA is defined as a CDAI score ≤ 10.

Outcome measures

Measure	Placebo n=47 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=49 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=49 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on CDAI at Week 12	21.3 percentage of participants	40.8 percentage of participants	40.8 percentage of participants	40.0 percentage of participants	49.0 percentage of participants	36.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.

CR is defined as a CDAI score ≤ 2.8.

Outcome measures

Measure	Placebo n=47 Participants Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=49 Participants Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=49 Participants Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 Participants Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=49 Participants Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 Participants Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Percentage of Participants Achieving Clinical Remission Based on CDAI at Week 12	4.3 percentage of participants	12.2 percentage of participants	14.3 percentage of participants	6.0 percentage of participants	14.3 percentage of participants	6.1 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Upadacitinib 3 mg BID

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Upadacitinib 6 mg BID

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Upadacitinib 12 mg BID

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Upadacitinib 18 mg BID

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Upadacitinib 24 mg QD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=50 participants at risk Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=50 participants at risk Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=50 participants at risk Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 participants at risk Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=50 participants at risk Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 participants at risk Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
General disorders PYREXIA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Infections and infestations PNEUMONIA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Injury, poisoning and procedural complications FOREARM FRACTURE	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Nervous system disorders SCIATICA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Nervous system disorders SYNCOPE	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).

Other adverse events

Measure	Placebo n=50 participants at risk Participants received placebo capsules twice daily for 12 weeks.	Upadacitinib 3 mg BID n=50 participants at risk Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 6 mg BID n=50 participants at risk Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 12 mg BID n=50 participants at risk Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 18 mg BID n=50 participants at risk Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.	Upadacitinib 24 mg QD n=49 participants at risk Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Gastrointestinal disorders DIARRHOEA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Infections and infestations INFLUENZA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	8.0% 4/50 • Number of events 4 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Infections and infestations NASOPHARYNGITIS	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	4.0% 2/50 • Number of events 2 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	8.0% 4/50 • Number of events 4 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	4.0% 2/50 • Number of events 2 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.1% 3/49 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	4.0% 2/50 • Number of events 2 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Metabolism and nutrition disorders DYSLIPIDAEMIA	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Nervous system disorders HEADACHE	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	4.0% 2/50 • Number of events 2 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 4 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/49 • Number of events 2 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/50 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	6.0% 3/50 • Number of events 3 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	2.0% 1/50 • Number of events 1 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).	0.00% 0/49 • From the first dose of study drug until 30 days after last dose (up to 16 weeks).

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