Trial Outcomes & Findings for A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) (NCT NCT02955212)

Last Updated: 2021-09-27

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

PHASE3

Target enrollment

338 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2021-09-27

Participant Flow

Participants were enrolled at 37 sites in Brazil, China, and South Korea. The study consisted of a 12-week placebo-controlled, double-blind period (Period 1), and an open-label 52-week extension period (Period 2).

Participants who met eligibility criteria were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by country and the Chinese population was expected to comprise up to 80% of the total study population.

Participant milestones

Participant milestones
Measure	Placebo / Upadacitinib 15 mg Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.	Upadacitinib 15 mg / Upadacitinib 15 mg Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
Period 1: Double-blind Treatment Period STARTED	169	169
Period 1: Double-blind Treatment Period COMPLETED	153	157
Period 1: Double-blind Treatment Period NOT COMPLETED	16	12
Period 2: Open-label Extension STARTED	153	157
Period 2: Open-label Extension COMPLETED	136	139
Period 2: Open-label Extension NOT COMPLETED	17	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo / Upadacitinib 15 mg Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.	Upadacitinib 15 mg / Upadacitinib 15 mg Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
Period 1: Double-blind Treatment Period Adverse Event	4	7
Period 1: Double-blind Treatment Period Withdrawal by Subject	8	3
Period 1: Double-blind Treatment Period Lost to Follow-up	1	0
Period 1: Double-blind Treatment Period Other	3	2
Period 2: Open-label Extension Adverse Event	11	7
Period 2: Open-label Extension Withdrawal by Subject	1	4
Period 2: Open-label Extension Lack of Efficacy	3	2
Period 2: Open-label Extension COVID-19 Logistical Restrictions	0	1
Period 2: Open-label Extension Other	2	4

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.	Total n=338 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 11.39 • n=169 Participants	51.7 years STANDARD_DEVIATION 10.63 • n=169 Participants	51.7 years STANDARD_DEVIATION 11.00 • n=338 Participants
Sex: Female, Male Female	139 Participants n=169 Participants	135 Participants n=169 Participants	274 Participants n=338 Participants
Sex: Female, Male Male	30 Participants n=169 Participants	34 Participants n=169 Participants	64 Participants n=338 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=169 Participants	24 Participants n=169 Participants	45 Participants n=338 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=169 Participants	145 Participants n=169 Participants	293 Participants n=338 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=169 Participants	0 Participants n=169 Participants	0 Participants n=338 Participants
Race/Ethnicity, Customized White	19 Participants n=169 Participants	19 Participants n=169 Participants	38 Participants n=338 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=169 Participants	3 Participants n=169 Participants	6 Participants n=338 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	0 Participants n=169 Participants	0 Participants n=169 Participants	0 Participants n=338 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=169 Participants	0 Participants n=169 Participants	0 Participants n=338 Participants
Race/Ethnicity, Customized Asian	142 Participants n=169 Participants	141 Participants n=169 Participants	283 Participants n=338 Participants
Race/Ethnicity, Customized Multiple	5 Participants n=169 Participants	6 Participants n=169 Participants	11 Participants n=338 Participants
Enrollment by Country China	114 Participants n=169 Participants	114 Participants n=169 Participants	228 Participants n=338 Participants
Enrollment by Country South Korea	29 Participants n=169 Participants	29 Participants n=169 Participants	58 Participants n=338 Participants
Enrollment by Country Brazil	26 Participants n=169 Participants	26 Participants n=169 Participants	52 Participants n=338 Participants
Duration Since Rheumatoid Arthritis (RA) Diagnosis	7.5 years STANDARD_DEVIATION 7.55 • n=169 Participants	7.2 years STANDARD_DEVIATION 7.16 • n=169 Participants	7.3 years STANDARD_DEVIATION 7.35 • n=338 Participants
Tender Joint Count	23.0 joints STANDARD_DEVIATION 14.45 • n=169 Participants	21.5 joints STANDARD_DEVIATION 14.84 • n=169 Participants	22.3 joints STANDARD_DEVIATION 14.64 • n=338 Participants
Swollen Joint Count	11.9 joints STANDARD_DEVIATION 6.00 • n=169 Participants	11.9 joints STANDARD_DEVIATION 6.89 • n=169 Participants	11.9 joints STANDARD_DEVIATION 6.45 • n=338 Participants
Patient's Global Assessment of Disease Activity	63.9 units on a scale STANDARD_DEVIATION 22.32 • n=166 Participants • Participants with available data	64.4 units on a scale STANDARD_DEVIATION 20.52 • n=166 Participants • Participants with available data	64.1 units on a scale STANDARD_DEVIATION 21.41 • n=332 Participants • Participants with available data
Physician's Global Assessment of Disease Activity	67.0 units on a scale STANDARD_DEVIATION 13.83 • n=166 Participants • Participants with available data	66.7 units on a scale STANDARD_DEVIATION 17.51 • n=163 Participants • Participants with available data	66.9 units on a scale STANDARD_DEVIATION 15.74 • n=329 Participants • Participants with available data
Patient's Assessment of Pain	63.8 units on a scale STANDARD_DEVIATION 20.62 • n=166 Participants • Participants with available data	66.8 units on a scale STANDARD_DEVIATION 20.59 • n=165 Participants • Participants with available data	65.3 units on a scale STANDARD_DEVIATION 20.63 • n=331 Participants • Participants with available data
Health Assessment Questionnaire - Disability Index (HAQ-DI)	1.4 units on a scale STANDARD_DEVIATION 0.65 • n=166 Participants • Participants with available data	1.3 units on a scale STANDARD_DEVIATION 0.66 • n=166 Participants • Participants with available data	1.3 units on a scale STANDARD_DEVIATION 0.65 • n=332 Participants • Participants with available data
High-sensitivity C-reactive Protein (CRP)	20.2 mg/L STANDARD_DEVIATION 25.15 • n=169 Participants	20.0 mg/L STANDARD_DEVIATION 21.46 • n=169 Participants	20.1 mg/L STANDARD_DEVIATION 23.34 • n=338 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12	31.4 percentage of participants Interval 24.4 to 38.4	71.6 percentage of participants Interval 64.8 to 78.4

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; multiple imputation was used for missing data.

The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12	-0.95 units on a scale Interval -1.16 to -0.74	-2.56 units on a scale Interval -2.76 to -2.36

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; multiple imputation was used for missing data.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12	-0.18 units on a scale Interval -0.28 to -0.09	-0.62 units on a scale Interval -0.71 to -0.54

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.

The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=143 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12	3.36 units on a scale Interval 2.25 to 4.48	8.93 units on a scale Interval 7.8 to 10.07

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.

Low disease activity based on DAS28 (CRP) is defined a DAS28 (CRP) score of ≤ 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12	13.6 percentage of participants Interval 8.4 to 18.8	46.2 percentage of participants Interval 38.6 to 53.7

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 (CRP) data were missing at Week 12 were considered non-responders.

Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) score of less than 2.6. DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12	5.3 percentage of participants Interval 1.9 to 8.7	29.6 percentage of participants Interval 22.7 to 36.5

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom CDAI data were missing at Week 12 were considered non-responders.

Low disease activity based on CDAI is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), 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 76 with higher scores indicating higher disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12	11.2 percentage of participants Interval 6.5 to 16.0	35.5 percentage of participants Interval 28.3 to 42.7

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% 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

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12	8.3 percentage of participants Interval 4.1 to 12.4	40.8 percentage of participants Interval 33.4 to 48.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 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

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12	3.6 percentage of participants Interval 0.8 to 6.3	21.3 percentage of participants Interval 15.1 to 27.5

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 were considered non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Participants randomized to receive placebo once daily for 12 weeks in Period 1.	Upadacitinib 15 mg n=169 Participants Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1	5.9 percentage of participants Interval 2.4 to 9.5	25.4 percentage of participants Interval 18.9 to 32.0

Adverse Events

Period 1: Placebo

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Period 1: Upadacitinib 15 mg

Serious events: 12 serious events

Other events: 25 other events

Deaths: 0 deaths

Period 1+2: Upadacitinib 15 mg

Serious events: 55 serious events

Other events: 198 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Period 1: Placebo n=169 participants at risk Participants received placebo once daily for 12 weeks in Period 1.	Period 1: Upadacitinib 15 mg n=169 participants at risk Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1.	Period 1+2: Upadacitinib 15 mg n=322 participants at risk Participants originally assigned to placebo received upadacitinib 15 mg from Week 12 to Week 64. Participants originally assigned to upadacitinib received upadacitinib 15 mg from Week 0 to Week 64.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	6.5% 11/169 • Number of events 13 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	9.5% 16/169 • Number of events 16 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	20.2% 65/322 • Number of events 95 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Investigations ALANINE AMINOTRANSFERASE INCREASED	1.2% 2/169 • Number of events 2 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	5.3% 9/169 • Number of events 13 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	9.3% 30/322 • Number of events 43 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	8.1% 26/322 • Number of events 30 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	8.1% 26/322 • Number of events 37 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	6.2% 20/322 • Number of events 27 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	8.4% 27/322 • Number of events 34 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Infections and infestations HERPES ZOSTER	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	7.1% 23/322 • Number of events 24 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Infections and infestations LATENT TUBERCULOSIS	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	5.6% 18/322 • Number of events 18 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Infections and infestations NASOPHARYNGITIS	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	7.5% 24/322 • Number of events 29 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	5.9% 19/322 • Number of events 21 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	7.5% 24/322 • Number of events 33 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	9.0% 29/322 • Number of events 37 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Investigations WEIGHT INCREASED	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	7.1% 23/322 • Number of events 31 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
Vascular disorders HYPERTENSION	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	0.00% 0/169 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.	5.6% 18/322 • Number of events 18 • Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.

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