Trial Outcomes & Findings for Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors (NCT NCT04134728)

NCT ID: NCT04134728

Last Updated: 2023-07-17

Results Overview

ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 550 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2023-07-17

Participant Flow

Participants were randomized in a ratio of 6:6:6:1:1:1 to GSK3196165 90 milligram (mg):GSK3196165 150mg:Sarilumab:Placebo:Placebo:Placebo. At Week 12, participants randomized to one of the three placebo arms switched to active intervention arms (either GSK3196165 150mg, GSK3196165 90mg or Sarilumab), receiving the active intervention for 12 weeks. Participants randomized to 90mg, GSK3196165 150mg or Sarilumab from study day 1, received the active intervention for 24 weeks.

Analysis of this study were reported for GSK3196165 90mg, GSK3196165 150mg, Sarilumab and all placebo arms are pooled till Week 12 to primarily serve as reference for comparison of active treatment arms versus Placebo for efficacy objectives at Week 12. Total 550 participants were randomized and one participant from 90mg GSK3196165 withdrew before receiving active intervention due to Protocol Deviation. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=549).

Participant milestones

Measure	GSK3196165 90mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Placebo + csDMARD and GSK3196165 90mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to(\<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD until Week 12 later switched to Sarilumab 200mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Overall Study STARTED	156	158	156	26	26	27
Overall Study COMPLETED	143	144	133	23	25	26
Overall Study NOT COMPLETED	13	14	23	3	1	1

Reasons for withdrawal

Measure	GSK3196165 90mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Placebo + csDMARD and GSK3196165 90mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to(\<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200mg + csDMARD Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD until Week 12 later switched to Sarilumab 200mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Overall Study Adverse Event	3	2	9	0	0	0
Overall Study Lack of Efficacy	3	3	1	2	0	0
Overall Study Protocol-Specified Withdrawal Criterion Met	1	0	2	0	0	0
Overall Study Protocol Deviation	0	0	1	0	0	0
Overall Study Informed Consent Withdrawn	3	6	8	1	1	0
Overall Study Physician Decision	2	0	0	0	0	0
Overall Study Lost to Follow-up	1	2	1	0	0	1
Overall Study Investigator Site Closed	0	1	1	0	0	0

Baseline Characteristics

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

Baseline characteristics by cohort

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Placebo + csDMARD and GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to(\<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD until Week 12 later switched to Sarilumab 200mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Total n=549 Participants Total of all reporting groups
Age, Continuous	56.7 YEARS STANDARD_DEVIATION 10.59 • n=5 Participants	56.0 YEARS STANDARD_DEVIATION 10.52 • n=7 Participants	57.5 YEARS STANDARD_DEVIATION 10.69 • n=5 Participants	51.6 YEARS STANDARD_DEVIATION 11.19 • n=4 Participants	57.3 YEARS STANDARD_DEVIATION 8.99 • n=21 Participants	57.6 YEARS STANDARD_DEVIATION 10.89 • n=10 Participants	56.6 YEARS STANDARD_DEVIATION 10.60 • n=115 Participants
Sex: Female, Male Female	134 Participants n=5 Participants	135 Participants n=7 Participants	132 Participants n=5 Participants	22 Participants n=4 Participants	18 Participants n=21 Participants	25 Participants n=10 Participants	466 Participants n=115 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=10 Participants	83 Participants n=115 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 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=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized ASIAN	13 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	47 Participants n=115 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	5 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	23 Participants n=115 Participants
Race/Ethnicity, Customized MISSING	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized MULTIPLE	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized WHITE	137 Participants n=5 Participants	133 Participants n=7 Participants	138 Participants n=5 Participants	20 Participants n=4 Participants	24 Participants n=21 Participants	23 Participants n=10 Participants	475 Participants n=115 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo	44.8 Percentage of participants 4.19	50.7 Percentage of participants 4.12	57.5 Percentage of participants 4.19	37.7 Percentage of participants 5.74	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily living activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. Overall HAQ-DI score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) (Versus Placebo) at Week 12	-0.33 Scores on a scale Standard Error 0.044	-0.41 Scores on a scale Standard Error 0.043	-0.46 Scores on a scale Standard Error 0.044	-0.23 Scores on a scale Standard Error 0.061	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With Clinical Disease Activity Index (CDAI) Total Score <=10 (CDAI Low Disease Activity [LDA]) at Week 12	20.7 Percentage of participants 3.42	18.2 Percentage of participants 3.2	28.1 Percentage of participants 3.77	14.2 Percentage of participants 4.15	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. LDA is achieved when CDAI total score <=10.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	31.2 Percentage of participants	30.1 Percentage of participants	42.6 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. LDA is achieved when CDAI total score <=10.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	24.0 Percentage of participants	42.0 Percentage of participants	36.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. A negative CDAI total score change from baseline indicates an improvement in disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in CDAI Total Score at Week 12	-16.87 Scores on a scale Standard Error 1.03	-17.23 Scores on a scale Standard Error 1.018	-20.22 Scores on a scale Standard Error 1.027	-14.86 Scores on a scale Standard Error 1.438	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in CDAI Total Score at Week 24 for Treatment Arms That Started Study Intervention From Day 1	-20.93 Scores on a scale Standard Error 1.04	-20.75 Scores on a scale Standard Error 1.022	-23.22 Scores on a scale Standard Error 1.048	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in CDAI Total Score at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	-16.84 Scores on a scale Standard Error 2.476	-22.91 Scores on a scale Standard Error 2.439	-20.38 Scores on a scale Standard Error 2.380	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Arthritis Pain Visual Analogue Scale (VAS) at Week 12	-19.35 Score on scale Standard Error 2.127	-21.17 Score on scale Standard Error 2.088	-25.93 Score on scale Standard Error 2.12	-16.73 Score on scale Standard Error 2.939	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Arthritis Pain VAS at Week 24 for Treatment Arms That Started Study Intervention From Day 1	-25.06 Scores on a scale Standard Error 2.153	-24.31 Scores on a scale Standard Error 2.115	-30.62 Scores on a scale Standard Error 2.141	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Arthritis Pain VAS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	-16.98 Scores on a scale Standard Error 5.169	-32.74 Scores on a scale Standard Error 5.029	-18.60 Scores on a scale Standard Error 4.964	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 12	2.2 Percentage of participants 1.25	4.3 Percentage of participants 1.7	8.7 Percentage of participants 2.38	0.6 Percentage of participants 1.3	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	7.9 Percentage of participants 2.33	8.4 Percentage of participants 2.32	8.3 Percentage of participants 2.39	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	5.1 Percentage of participants	13.2 Percentage of participants	8.4 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

ACR20 is calculated as a 20% improvement from Baseline in TJC68 and SJC66 and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR20 at Week 24 for Treatment Arms That Started Study Intervention From Day 1	58.1 Percentage of participants 4.18	60.5 Percentage of participants 4.06	65.1 Percentage of participants 4.09	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

ACR20 is calculated as a 20% improvement from Baseline in TJC68 and SJC66 and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR20 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	61.2 Percentage of participants	70.7 Percentage of participants	55.8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

ACR50 is calculated as a 50% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With 50% Improvement in American College of Rheumatology Criteria (ACR50) at Week 12	18.2 Percentage of participants 3.28	22.5 Percentage of participants 3.47	25.9 Percentage of participants 3.74	11.5 Percentage of participants 3.79	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

ACR50 is calculated as a 50% improvement from Baseline in TJC68 and SJC66 and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR50 at Week 24 for Treatment Arms That Started Study Intervention From Day 1	23.6 Percentage of participants 3.6	30.1 Percentage of participants 3.81	42.9 Percentage of participants 4.25	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

ACR50 is calculated as a 50% improvement from Baseline in TJC68 and SJC66 and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR50 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	13.1 Percentage of participants	41.8 Percentage of participants	24.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

ACR70 is calculated as a 70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With 70% Improvement in American College of Rheumatology Criteria (ACR70) at Week 12	5.9 Percentage of participants 2.01	10.8 Percentage of participants 2.61	13.3 Percentage of participants 2.92	6.1 Percentage of participants 2.93	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

ACR70 is calculated as a 70% improvement from Baseline in TJC68 and SJC66 and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR70 at Week 24 for Treatment Arms That Started Study Intervention From Day 1	12.3 Percentage of participants 2.81	13.2 Percentage of participants 2.83	22.7 Percentage of participants 3.63	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

ACR70 is calculated as a 70% improvement from Baseline in TJC68 and SJC66 and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR70 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	4.9 Percentage of participants	21.4 Percentage of participants	12.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP<=3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12	17 Percentage of participants 3.19	17 Percentage of participants 3.14	40.1 Percentage of participants 4.16	13.2 Percentage of participants 4.06	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP<=3.2 . A negative change from baseline in DAS28-CRP indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	26.8 Percentage of participants 3.75	24.8 Percentage of participants 3.6	46.9 Percentage of participants 4.28	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP<=3.2 . A negative change from baseline in DAS28-CRP indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	12.5 Percentage of participants	43.1 Percentage of participants	55.9 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12	13.3 Percentage of participants 2.91	8.5 Percentage of participants 2.36	36.2 Percentage of participants 4.12	1.9 Percentage of participants 1.86	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	17.4 Percentage of participants 3.33	17.2 Percentage of participants 3.23	45.8 Percentage of participants 4.4	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	5.7 Percentage of participants	33.4 Percentage of participants	40.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP <2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12	10.2 Percentage of participants 2.58	7.2 Percentage of participants 2.19	22.2 Percentage of participants 3.51	1.8 Percentage of participants 1.75	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP arthritis is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP <2.6. A negative change from baseline in DAS28-CRP indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	16.2 Percentage of participants 3.14	13.9 Percentage of participants 2.88	32.6 Percentage of participants 4.03	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP arthritis is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP <2.6. A negative change from baseline in DAS28-CRP indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	6.8 Percentage of participants	26.6 Percentage of participants	32.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) at Week 12	3.1 Percentage of participants 1.51	5.7 Percentage of participants 1.97	23 Percentage of participants 3.64	0.7 Percentage of participants 1.47	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Treatment Arms That Started Study Intervention From Day 1	10.8 Percentage of participants 2.74	8.9 Percentage of participants 2.44	29.8 Percentage of participants 4.07	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	1.1 Percentage of participants	10.0 Percentage of participants	24.2 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR scores categorized using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change >1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with current DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 >5.1). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12	66.3 Percentage of participants 4.05	68.4 Percentage of participants 3.88	84.1 Percentage of participants 3.14	62.9 Percentage of participants 5.82	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR scores categorised using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change >1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with current DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 >5.1).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Treatment Arms That Started Study Intervention From Day 1	76.3 Percentage of participants 3.63	71.3 Percentage of participants 3.77	86.6 Percentage of participants 3	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR scores categorised using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change >1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with current DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 >5.1).

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	73.3 Percentage of participants	76.7 Percentage of participants	83.7 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (hsCRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR/EULAR Remission at Week 12	2 Percentage of participants	4 Percentage of participants	9 Percentage of participants	0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (CRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR/EULAR Remission at Week 24 for Treatment Arms That Started Study Intervention From Day 1	6 Percentage of participants	4 Percentage of participants	5 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (CRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Percentage of Participants With ACR/EULAR Remission at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	1 Percentage of participants	1 Percentage of participants	1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 DAS28-CRP	-1.34 Scores on a scale Standard Error 0.1	-1.42 Scores on a scale Standard Error 0.098	-2.15 Scores on a scale Standard Error 0.1	-1.08 Scores on a scale Standard Error 0.139	—	—	—
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 DAS28-ESR	-1.41 Scores on a scale Standard Error 0.109	-1.46 Scores on a scale Standard Error 0.106	-2.57 Scores on a scale Standard Error 0.108	-1.06 Scores on a scale Standard Error 0.152	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Treatment Arms That Started Study Intervention From Day 1 DAS28-CRP	-1.67 Scores on a scale Standard Error 0.108	-1.67 Scores on a scale Standard Error 0.106	-2.38 Scores on a scale Standard Error 0.109	—	—	—	—
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Treatment Arms That Started Study Intervention From Day 1 DAS28-ESR	-1.7 Scores on a scale Standard Error 0.121	-1.68 Scores on a scale Standard Error 0.117	-2.85 Scores on a scale Standard Error 0.121	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 DAS28-CRP	-1.25 Scores on a scale Standard Error 0.264	-2.08 Scores on a scale Standard Error 0.258	-2.15 Scores on a scale Standard Error 0.248	—	—	—	—
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 DAS28-ESR	-1.28 Scores on a scale Standard Error 0.282	-1.94 Scores on a scale Standard Error 0.294	-2.47 Scores on a scale Standard Error 0.266	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0=least difficulty to 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in HAQ-DI at Week 24 for Treatment Arms That Started Study Intervention From Day 1	-0.39 Scores on a scale Standard Error 0.05	-0.45 Scores on a scale Standard Error 0.049	-0.48 Scores on a scale Standard Error 0.05	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0=least difficulty to 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in HAQ-DI at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	-0.27 Scores on a scale Standard Error 0.121	-0.62 Scores on a scale Standard Error 0.119	-0.32 Scores on a scale Standard Error 0.116	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12	5.5 Scores on a scale Standard Error 0.735	6.8 Scores on a scale Standard Error 0.724	7.3 Scores on a scale Standard Error 0.749	5.45 Scores on a scale Standard Error 1.023	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in FACIT-Fatigue at Week 24 for Treatment Arms That Started Study Intervention From Day 1	6.55 Scores on a scale Standard Error 0.795	7.21 Scores on a scale Standard Error 0.777	7.99 Scores on a scale Standard Error 0.806	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in FACIT-Fatigue at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	5.48 Scores on a scale Standard Error 1.927	8.56 Scores on a scale Standard Error 1.852	7.21 Scores on a scale Standard Error 1.824	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Subject-completed Medical Outcomes Study Short-Form 36 (SF-36) Physical Component Scores (PCS) at Week 12	5.08 Scores on a scale Standard Error 0.619	5.03 Scores on a scale Standard Error 0.61	5.61 Scores on a scale Standard Error 0.627	3.72 Scores on a scale Standard Error 0.866	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 PCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1	5.67 Scores on a scale Standard Error 0.707	5.5 Scores on a scale Standard Error 0.694	7.18 Scores on a scale Standard Error 0.71	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 PCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	3.76 Scores on a scale Standard Error 1.687	8.63 Scores on a scale Standard Error 1.672	4.16 Scores on a scale Standard Error 1.611	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 Mental Component Scores (MCS) at Week 12	1.64 Scores on a scale Standard Error 0.731	3.45 Scores on a scale Standard Error 0.72	4.15 Scores on a scale Standard Error 0.744	1.61 Scores on a scale Standard Error 1.024	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 MCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1	2.22 Scores on a scale Standard Error 0.772	3.05 Scores on a scale Standard Error 0.756	3.61 Scores on a scale Standard Error 0.78	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=27 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 MCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	1.44 Scores on a scale Standard Error 1.891	1.10 Scores on a scale Standard Error 1.855	2.76 Scores on a scale Standard Error 1.800	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention and for whom data available for specific parameters. This population was based on the treatment the participants were randomized into.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=143 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=148 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=138 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=71 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 Domain Scores at Week 12 Bodily Pain - PCS	17 Scores on a scale Standard Deviation 21.45	16.8 Scores on a scale Standard Deviation 22.2	19.8 Scores on a scale Standard Deviation 23.27	10.7 Scores on a scale Standard Deviation 21.38	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 General Health - PCS	6.3 Scores on a scale Standard Deviation 15.89	6.7 Scores on a scale Standard Deviation 16.07	6.7 Scores on a scale Standard Deviation 15.69	4.2 Scores on a scale Standard Deviation 15.84	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 Role Physical - PCS	12.94 Scores on a scale Standard Deviation 22.371	14.19 Scores on a scale Standard Deviation 25.155	13.81 Scores on a scale Standard Deviation 23.488	10.74 Scores on a scale Standard Deviation 19.456	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 Physical Function - PCS	9.69 Scores on a scale Standard Deviation 21.423	14.22 Scores on a scale Standard Deviation 23.909	13.15 Scores on a scale Standard Deviation 24.135	6.55 Scores on a scale Standard Deviation 21.156	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 Mental Health - MCS	4.3 Scores on a scale Standard Deviation 19.3	7.6 Scores on a scale Standard Deviation 16.9	8.2 Scores on a scale Standard Deviation 18.55	4.8 Scores on a scale Standard Deviation 16.31	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 Role Emotional - MCS	5.77 Scores on a scale Standard Deviation 22.405	9.4 Scores on a scale Standard Deviation 25.128	10.93 Scores on a scale Standard Deviation 23.908	3.87 Scores on a scale Standard Deviation 22.219	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 Social Function - MCS	6.99 Scores on a scale Standard Deviation 23.107	10.73 Scores on a scale Standard Deviation 27.51	11.59 Scores on a scale Standard Deviation 24.383	6.87 Scores on a scale Standard Deviation 27.774	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 12 Vitality - MCS	9.48 Scores on a scale Standard Deviation 18.03	11.82 Scores on a scale Standard Deviation 19.94	13 Scores on a scale Standard Deviation 19.895	5.11 Scores on a scale Standard Deviation 18.61	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=140 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=147 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=136 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Bodily Pain - PCS	20.7 Scores on a scale Standard Deviation 22.82	18.5 Scores on a scale Standard Deviation 22.43	23.9 Scores on a scale Standard Deviation 27.29	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 General Health - PCS	6.4 Scores on a scale Standard Deviation 15.25	6.7 Scores on a scale Standard Deviation 16.3	8.8 Scores on a scale Standard Deviation 17.3	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Role Physical - PCS	13.97 Scores on a scale Standard Deviation 21.332	15.22 Scores on a scale Standard Deviation 27.352	17.37 Scores on a scale Standard Deviation 26.25	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Physical Function - PCS	11.43 Scores on a scale Standard Deviation 23.714	16.36 Scores on a scale Standard Deviation 25.64	18.86 Scores on a scale Standard Deviation 24.472	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Mental Health - MCS	6.1 Scores on a scale Standard Deviation 17.16	8.4 Scores on a scale Standard Deviation 19.63	10 Scores on a scale Standard Deviation 18.71	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Role Emotional - MCS	5.83 Scores on a scale Standard Deviation 23.522	7.99 Scores on a scale Standard Deviation 28.03	8.88 Scores on a scale Standard Deviation 26.589	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Social Function - MCS	9.46 Scores on a scale Standard Deviation 25.704	10.37 Scores on a scale Standard Deviation 29.237	12.04 Scores on a scale Standard Deviation 24.599	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Vitality - MCS	11.29 Scores on a scale Standard Deviation 17.913	13.22 Scores on a scale Standard Deviation 21.245	16.31 Scores on a scale Standard Deviation 19.854	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=23 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=24 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=25 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Bodily Pain - PCS	15.7 Scores on a scale Standard Deviation 21.91	20.4 Scores on a scale Standard Deviation 26.91	16.9 Scores on a scale Standard Deviation 23.99	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 General Health - PCS	5.6 Scores on a scale Standard Deviation 14.98	3.4 Scores on a scale Standard Deviation 17.47	4.4 Scores on a scale Standard Deviation 17.20	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Role Physical - PCS	10.33 Scores on a scale Standard Deviation 21.204	17.19 Scores on a scale Standard Deviation 19.352	12.25 Scores on a scale Standard Deviation 20.530	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Physical Function - PCS	7.39 Scores on a scale Standard Deviation 19.121	18.75 Scores on a scale Standard Deviation 23.417	6.20 Scores on a scale Standard Deviation 20.630	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Mental Health - MCS	5.9 Scores on a scale Standard Deviation 14.11	5.2 Scores on a scale Standard Deviation 23.29	5.4 Scores on a scale Standard Deviation 18.54	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Role Emotional - MCS	7.97 Scores on a scale Standard Deviation 21.242	4.17 Scores on a scale Standard Deviation 28.019	6.67 Scores on a scale Standard Deviation 28.667	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Social Function - MCS	13.04 Scores on a scale Standard Deviation 23.681	6.25 Scores on a scale Standard Deviation 37.771	5.50 Scores on a scale Standard Deviation 36.279	—	—	—	—
Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Vitality - MCS	8.42 Scores on a scale Standard Deviation 13.926	10.16 Scores on a scale Standard Deviation 27.263	11.75 Scores on a scale Standard Deviation 20.832	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Pooled Placebo collected data till Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected data from Week 12 to 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected data till Week 24

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD n=24 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD n=25 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD n=26 Participants Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Incidence of Adverse Events (AEs), Serious Adverse Event (SAEs), Adverse Events of Special Interest (AESI) AE	92 Participants	99 Participants	98 Participants	37 Participants	9 Participants	10 Participants	12 Participants
Incidence of Adverse Events (AEs), Serious Adverse Event (SAEs), Adverse Events of Special Interest (AESI) SAE	8 Participants	1 Participants	12 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Incidence of Adverse Events (AEs), Serious Adverse Event (SAEs), Adverse Events of Special Interest (AESI) AESI	16 Participants	15 Participants	33 Participants	0 Participants	2 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=141 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=143 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=138 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=70 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 12 Lymphocytes	-0.039 10^9/L (Giga cells per liter) Standard Deviation 0.5089	-0.01 10^9/L (Giga cells per liter) Standard Deviation 0.508	-0.057 10^9/L (Giga cells per liter) Standard Deviation 0.4989	0.009 10^9/L (Giga cells per liter) Standard Deviation 0.5354	—	—	—
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 12 Neutrophils	-0.255 10^9/L (Giga cells per liter) Standard Deviation 1.5469	-0.412 10^9/L (Giga cells per liter) Standard Deviation 2.0477	-1.843 10^9/L (Giga cells per liter) Standard Deviation 2.1359	-0.113 10^9/L (Giga cells per liter) Standard Deviation 1.4395	—	—	—
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 12 Platelets	-10.9 10^9/L (Giga cells per liter) Standard Deviation 56.51	-17.3 10^9/L (Giga cells per liter) Standard Deviation 60.17	-76.5 10^9/L (Giga cells per liter) Standard Deviation 62.76	-10.3 10^9/L (Giga cells per liter) Standard Deviation 62.82	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=138 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=141 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=127 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Lymphocytes	-0.079 10^9/L (Giga cells per liter) Standard Deviation 0.5135	0.012 10^9/L (Giga cells per liter) Standard Deviation 0.5939	-0.108 10^9/L (Giga cells per liter) Standard Deviation 0.52	—	—	—	—
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Neutrophils	-0.388 10^9/L (Giga cells per liter) Standard Deviation 1.692	-0.422 10^9/L (Giga cells per liter) Standard Deviation 1.7963	-1.99 10^9/L (Giga cells per liter) Standard Deviation 2.3395	—	—	—	—
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 Platelets	-9.3 10^9/L (Giga cells per liter) Standard Deviation 50.96	-9 10^9/L (Giga cells per liter) Standard Deviation 64.92	-79.2 10^9/L (Giga cells per liter) Standard Deviation 71.13	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=21 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=24 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Lymphocytes	-0.030 10^9/L (Giga cells per liter) Standard Deviation 0.4192	0.083 10^9/L (Giga cells per liter) Standard Deviation 0.3298	-0.094 10^9/L (Giga cells per liter) Standard Deviation 0.4478	—	—	—	—
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Neutrophils	-0.611 10^9/L (Giga cells per liter) Standard Deviation 1.7602	-0.643 10^9/L (Giga cells per liter) Standard Deviation 1.3489	-2.016 10^9/L (Giga cells per liter) Standard Deviation 2.1132	—	—	—	—
Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Platelets	-43.6 10^9/L (Giga cells per liter) Standard Deviation 53.10	-12.7 10^9/L (Giga cells per liter) Standard Deviation 74.80	-70.8 10^9/L (Giga cells per liter) Standard Deviation 82.58	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in White Blood Cell (WBC) Count (Giga Cells Per Liter) at Week 12	-0.29 10^9/L (Giga cells per liter) Standard Deviation 1.753	-0.42 10^9/L (Giga cells per liter) Standard Deviation 2.072	-1.95 10^9/L (Giga cells per liter) Standard Deviation 2.325	-0.09 10^9/L (Giga cells per liter) Standard Deviation 1.558	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	-0.45 10^9/L (Giga cells per liter) Standard Deviation 1.851	-0.43 10^9/L (Giga cells per liter) Standard Deviation 1.787	-2.15 10^9/L (Giga cells per liter) Standard Deviation 2.51	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=21 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=24 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	-0.66 10^9/L (Giga cells per liter) Standard Deviation 1.824	-0.60 10^9/L (Giga cells per liter) Standard Deviation 1.452	-2.05 10^9/L (Giga cells per liter) Standard Deviation 2.271	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in hematology parameter hemoglobin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 12	-0.9 g/L (Grams per liter) Standard Deviation 8.06	0.3 g/L (Grams per liter) Standard Deviation 8.54	5.5 g/L (Grams per liter) Standard Deviation 9.19	-2 g/L (Grams per liter) Standard Deviation 7.98	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in in hematology parameter hemoglobin level.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1	-1.9 g/L (Grams per liter) Standard Deviation 9.05	-1 g/L (Grams per liter) Standard Deviation 8.63	5.8 g/L (Grams per liter) Standard Deviation 11.07	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in in hematology parameter hemoglobin level.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=21 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=24 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	3.5 g/L (Grams per liter) Standard Deviation 7.44	0.2 g/L (Grams per liter) Standard Deviation 10.85	7.0 g/L (Grams per liter) Standard Deviation 11.51	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in laboratory parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) gamma-glutamyl transferase (GGT) levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=146 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=146 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=139 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=72 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12 AST	0.6 IU/L (International units per liter) Standard Deviation 10.29	0.7 IU/L (International units per liter) Standard Deviation 8.52	4.5 IU/L (International units per liter) Standard Deviation 11.43	0.3 IU/L (International units per liter) Standard Deviation 9.82	—	—	—
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12 ALT	0.8 IU/L (International units per liter) Standard Deviation 16.22	-0.7 IU/L (International units per liter) Standard Deviation 12.95	8.1 IU/L (International units per liter) Standard Deviation 21.3	-1 IU/L (International units per liter) Standard Deviation 10.8	—	—	—
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12 AP	0.7 IU/L (International units per liter) Standard Deviation 14.42	-3 IU/L (International units per liter) Standard Deviation 14.94	-15.6 IU/L (International units per liter) Standard Deviation 20.63	-1 IU/L (International units per liter) Standard Deviation 14.57	—	—	—
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12 GGT	-0.8 IU/L (International units per liter) Standard Deviation 14.24	-2.6 IU/L (International units per liter) Standard Deviation 15.23	0.6 IU/L (International units per liter) Standard Deviation 12.37	-1.8 IU/L (International units per liter) Standard Deviation 11.46	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on Safety Set that includes all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameters including AST, ALT, AP, GGT levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=141 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=145 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=129 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 AST	1.7 IU/L (International units per liter) Standard Deviation 7.89	2.1 IU/L (International units per liter) Standard Deviation 11.21	3.0 IU/L (International units per liter) Standard Deviation 9.29	—	—	—	—
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 ALT	1.6 IU/L (International units per liter) Standard Deviation 12.73	1.9 IU/L (International units per liter) Standard Deviation 20.52	6.2 IU/L (International units per liter) Standard Deviation 12.98	—	—	—	—
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 AP	1.8 IU/L (International units per liter) Standard Deviation 16.48	-1.7 IU/L (International units per liter) Standard Deviation 18.76	-14.3 IU/L (International units per liter) Standard Deviation 19.23	—	—	—	—
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 GGT	-0.3 IU/L (International units per liter) Standard Deviation 13.07	-0.3 IU/L (International units per liter) Standard Deviation 25.67	0.9 IU/L (International units per liter) Standard Deviation 15.73	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on Safety set that includes all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameters including AST, ALT, AP, GGT levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=21 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=25 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 AST	2.5 IU/L (International units per liter) Standard Deviation 6.12	3.0 IU/L (International units per liter) Standard Deviation 9.46	0.9 IU/L (International units per liter) Standard Deviation 17.04	—	—	—	—
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 ALT	3.3 IU/L (International units per liter) Standard Deviation 9.51	4.2 IU/L (International units per liter) Standard Deviation 13.08	3.5 IU/L (International units per liter) Standard Deviation 15.12	—	—	—	—
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 AP	2.0 IU/L (International units per liter) Standard Deviation 12.25	1.4 IU/L (International units per liter) Standard Deviation 13.68	-15.6 IU/L (International units per liter) Standard Deviation 18.77	—	—	—	—
Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 GGT	4.4 IU/L (International units per liter) Standard Deviation 13.92	-0.8 IU/L (International units per liter) Standard Deviation 7.11	-1.4 IU/L (International units per liter) Standard Deviation 13.04	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Albumin Level (Grams Per Liter) at Week 12	0 g/L (Grams per liter) Standard Deviation 2.5	0.3 g/L (Grams per liter) Standard Deviation 2.38	1.6 g/L (Grams per liter) Standard Deviation 2.64	-0.4 g/L (Grams per liter) Standard Deviation 2.9	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on Safety set that includes all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	0.2 g/L (Grams per liter) Standard Deviation 2.55	0.2 g/L (Grams per liter) Standard Deviation 2.50	2.0 g/L (Grams per liter) Standard Deviation 3.16	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on Safety set that includes all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=21 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=24 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	1.6 g/L (Grams per liter) Standard Deviation 3.75	0.5 g/L (Grams per liter) Standard Deviation 2.43	1.7 g/L (Grams per liter) Standard Deviation 2.76	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participant was randomized to.

Blood samples was collected for the assessment of change from baseline in laboratory parameter total bilirubin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 12	0.1 umol/L (Micromoles per liter) Standard Deviation 2.35	0.4 umol/L (Micromoles per liter) Standard Deviation 3.07	2.3 umol/L (Micromoles per liter) Standard Deviation 4.5	0.3 umol/L (Micromoles per liter) Standard Deviation 2.64	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in laboratory parameter bilirubin level.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	0.1 umol/L (Micromoles per liter) Standard Deviation 2.06	0.2 umol/L (Micromoles per liter) Standard Deviation 2.70	2.5 umol/L (Micromoles per liter) Standard Deviation 4.11	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameter bilirubin level.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=21 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=25 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	0.8 umol/L (Micromoles per liter) Standard Deviation 1.97	-0.2 umol/L (Micromoles per liter) Standard Deviation 3.17	1.1 umol/L (Micromoles per liter) Standard Deviation 3.39	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12.

Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	0.053 mmol/L (Millimoles per liter) Standard Deviation 1.0158	0.061 mmol/L (Millimoles per liter) Standard Deviation 0.7881	0.445 mmol/L (Millimoles per liter) Standard Deviation 0.8863	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=20 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=23 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=25 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	0.126 mmol/L (Millimoles per liter) Standard Deviation 0.8456	-0.006 mmol/L (Millimoles per liter) Standard Deviation 0.7593	0.731 mmol/L (Millimoles per liter) Standard Deviation 0.8654	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=140 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=142 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=125 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 HDL Cholesterol, Direct	0.044 mmol/L (Millimoles per liter) Standard Deviation 0.2523	0.051 mmol/L (Millimoles per liter) Standard Deviation 0.2931	0.063 mmol/L (Millimoles per liter) Standard Deviation 0.2784	—	—	—	—
Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 LDL Cholesterol	-0.026 mmol/L (Millimoles per liter) Standard Deviation 0.8577	0.021 mmol/L (Millimoles per liter) Standard Deviation 0.6769	0.334 mmol/L (Millimoles per liter) Standard Deviation 0.7472	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=20 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=23 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=25 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 HDL Cholesterol, Direct	0.049 mmol/L (Millimoles per liter) Standard Deviation 0.2578	0.000 mmol/L (Millimoles per liter) Standard Deviation 0.2511	0.107 mmol/L (Millimoles per liter) Standard Deviation 0.3202	—	—	—	—
Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 LDL Cholesterol	0.041 mmol/L (Millimoles per liter) Standard Deviation 0.7034	0.006 mmol/L (Millimoles per liter) Standard Deviation 0.6861	0.513 mmol/L (Millimoles per liter) Standard Deviation 0.6822	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 12

Population: Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1	0.075 mmol/L (Millimoles per liter) Standard Deviation 0.5799	-0.038 mmol/L (Millimoles per liter) Standard Deviation 0.5519	0.103 mmol/L (Millimoles per liter) Standard Deviation 0.7552	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=20 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=23 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=25 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12	0.072 mmol/L (Millimoles per liter) Standard Deviation 0.4498	-0.024 mmol/L (Millimoles per liter) Standard Deviation 0.5497	0.243 mmol/L (Millimoles per liter) Standard Deviation 0.8130	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: The analysis was performed on the randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. Pooled Placebo collected data till Week 12. Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Sarilumab 200mg or placebo+csDMARD collected data from Week 12 to 24. GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Sarilumab 200mg or placebo+csDMARD collected data till Week 24.

Number of participants who reported NCI-CTCAE Grade 3 or higher for hematological and clinical chemistry abnormalities were summarized.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=155 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=153 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=78 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD n=24 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD n=25 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD n=26 Participants Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Platelet count decreased, Total, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Platelet count decreased, Total, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Alanine aminotransferase increased, Total, Grade 3	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Alanine aminotransferase increased, Total, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Aspartate aminotransferase increased, Total, Grade 3	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Blood bilirubin increased, Total, Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Aspartate aminotransferase increased, Total, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Blood bilirubin increased, Total, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Lymphocyte count decreased, Total, Grade 3	6 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Lymphocyte count decreased, Total, Grade 4	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Lymphocyte count increased, Total, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Lymphocyte count increased, Total, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Neutrophil count decreased, Total, Grade 3	2 Participants	1 Participants	10 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 Neutrophil count decreased, Total, Grade 4	1 Participants	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline

Population: The analysis was performed on the safety set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD n=26 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD n=27 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody	334.008 ug/L (microgram per liter) Standard Deviation 823.7538	417.378 ug/L (microgram per liter) Standard Deviation 1632.7755	250.015 ug/L (microgram per liter) Standard Deviation 671.9296	237.1 ug/L (microgram per liter) Standard Deviation 357.4074	330.527 ug/L (microgram per liter) Standard Deviation 496.9961	142.446 ug/L (microgram per liter) Standard Deviation 169.6796	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: The analysis was performed on the safety set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples were collected for anti-GSK3196165 antibodies detection assay using tiered testing schema: screening, confirmation and titration steps was used for immunogenicity analysis.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=26 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD n=26 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD n=27 Participants Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Number of Participants With Anti-GSK3196165 Antibodies	4 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=139 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=141 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=134 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=71 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 12 Cholesterol	58.5438 mmol/L (Millimoles per liter) Standard Deviation 13.25606	59.1757 mmol/L (Millimoles per liter) Standard Deviation 14.83734	64.3791 mmol/L (Millimoles per liter) Standard Deviation 15.12089	58.6880 mmol/L (Millimoles per liter) Standard Deviation 14.62446	—	—	—
Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 12 4-Beta-Hydroxycholesterol	0.9897 mmol/L (Millimoles per liter) Standard Deviation 0.81483	1.0156 mmol/L (Millimoles per liter) Standard Deviation 0.57323	1.1148 mmol/L (Millimoles per liter) Standard Deviation 0.56873	1.0913 mmol/L (Millimoles per liter) Standard Deviation 1.03027	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=136 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=139 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=123 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1 4-Beta-Hydroxycholesterol	0.9766 mmol/L (Millimoles per liter) Standard Deviation 0.45665	1.0064 mmol/L (Millimoles per liter) Standard Deviation 0.58945	1.1925 mmol/L (Millimoles per liter) Standard Deviation 0.57339	—	—	—	—
Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1 Cholesterol	59.1937 mmol/L (Millimoles per liter) Standard Deviation 14.12055	58.9174 mmol/L (Millimoles per liter) Standard Deviation 15.00108	65.2270 mmol/L (Millimoles per liter) Standard Deviation 14.70946	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels.

Outcome measures

Measure	GSK3196165 90mg + csDMARD n=20 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=23 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=24 Participants Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 4-Beta-Hydroxycholesterol	1.0180 mmol/L (Millimoles per liter) Standard Deviation 0.42435	0.9467 mmol/L (Millimoles per liter) Standard Deviation 0.29136	1.3897 mmol/L (Millimoles per liter) Standard Deviation 1.31589	—	—	—	—
Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 Cholesterol	56.7570 mmol/L (Millimoles per liter) Standard Deviation 13.92076	62.4284 mmol/L (Millimoles per liter) Standard Deviation 13.72140	68.7768 mmol/L (Millimoles per liter) Standard Deviation 17.39453	—	—	—	—

Adverse Events

GSK3196165 90mg + csDMARD

Serious events: 8 serious events

Other events: 25 other events

Deaths: 1 deaths

GSK3196165 150mg + csDMARD

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Sarilumab 200mg + csDMARD

Serious events: 12 serious events

Other events: 41 other events

Deaths: 1 deaths

Pooled Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo + csDMARD and GSK3196165 90 mg + csDMARD

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo + csDMARD and GSK3196165 150 mg + csDMARD

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo + csDMARD and Sarilumab 200 mg + csDMARD

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK3196165 90mg + csDMARD n=156 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD n=24 participants at risk Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD n=25 participants at risk Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD n=26 participants at risk Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Blood and lymphatic system disorders Neutropenia	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	1.3% 2/156 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Cardiac disorders Atrial fibrillation	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	1.3% 2/156 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Congenital, familial and genetic disorders Gilbert's syndrome	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
General disorders Drowning	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations COVID-19	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations COVID-19 pneumonia	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	1.3% 2/156 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	3.8% 1/26 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations Liver abscess	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations Osteomyelitis bacterial	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.2% 1/24 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations Sepsis	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Injury, poisoning and procedural complications Humerus fracture	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.0% 1/25 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Injury, poisoning and procedural complications Post procedural hypotension	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Investigations Alanine aminotransferase increased	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Investigations Aspartate aminotransferase increased	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Nervous system disorders Optic neuritis	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.63% 1/158 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Nervous system disorders Sciatica	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Gastrointestinal disorders Food poisoning	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	1.3% 1/79 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	1.3% 1/79 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Cardiac disorders Myocardial infarction	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.0% 1/25 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Nervous system disorders Cerebellar hemorrhage	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.0% 1/25 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.

Other adverse events

Measure	GSK3196165 90mg + csDMARD n=156 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	GSK3196165 150mg + csDMARD n=158 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Sarilumab 200mg + csDMARD n=156 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.	Pooled Placebo n=79 participants at risk Participants between the ages of greater than or equal to (\>=)18 years and less than or equal to (\<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm.	Placebo + csDMARD and GSK3196165 90 mg + csDMARD n=24 participants at risk Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and GSK3196165 150 mg + csDMARD n=25 participants at risk Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.	Placebo + csDMARD and Sarilumab 200 mg + csDMARD n=26 participants at risk Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
Investigations Alanine aminotransferase increased	1.3% 2/156 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	3.8% 6/158 • Number of events 6 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	6.4% 10/156 • Number of events 11 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Respiratory, thoracic and mediastinal disorders Cough	3.2% 5/156 • Number of events 6 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	6.3% 10/158 • Number of events 10 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.64% 1/156 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
General disorders Injection site reaction	5.8% 9/156 • Number of events 17 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	6.3% 10/158 • Number of events 11 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	10.9% 17/156 • Number of events 35 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Blood and lymphatic system disorders Neutropenia	1.3% 2/156 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.63% 1/158 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	7.1% 11/156 • Number of events 12 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.0% 1/25 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	7.7% 2/26 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations Urinary tract infection	5.1% 8/156 • Number of events 10 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	5.1% 8/158 • Number of events 9 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	3.8% 6/156 • Number of events 6 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	6.3% 5/79 • Number of events 5 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/26 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations COVID-19	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	8.0% 2/25 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	3.8% 1/26 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Infections and infestations Latent tuberculosis	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/24 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.0% 1/25 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	7.7% 2/26 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/158 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/156 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/79 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	4.2% 1/24 • Number of events 1 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	0.00% 0/25 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.	7.7% 2/26 • Number of events 2 • All AEs and SAEs were collected from the start of study intervention. The Pooled Placebo collected during the timeframe Week 0 to Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 12 to Week 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected during the timeframe Week 0 to Week 24.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER