Trial Outcomes & Findings for Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (NCT NCT04333147)

Last Updated: 2024-02-07

Results Overview

An AE is defined as 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. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2916 participants

Primary outcome timeframe

Up to approximately 145 Weeks

Results posted on

2024-02-07

Participant Flow

Participants who consented, were enrolled and assigned to receive Otilimab 90 milligram (mg) or 150 mg weekly. Participants who received Otilimab in their qualifying study (202018, 201790 and 201791) were enrolled into this study on the same dose. Participants who received an active comparator in their qualifying study were centrally randomized using Interactive Response Technology (IRT) in a ratio of 1:1 to receive either Otilimab 90 mg or 150 mg weekly.

The participants in this study 209564 (ContRAst X) were adults with Rheumatoid Arthritis (RA) who completed the treatment phase of a qualifying Otilimab clinical study (Phase 3 studies 201790 \[ContRAst 1\], 201791 \[ContRAst 2\] or 202018 \[ContRAst 3\]) and who, in the investigator's and participant's judgement would have benefited from extended treatment with Otilimab. One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision (N=1459).

Participant milestones

Participant milestones
Measure	Otilimab 90 mg Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Overall Study STARTED	1456	1459
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1456	1459

Reasons for withdrawal

Reasons for withdrawal
Measure	Otilimab 90 mg Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Overall Study Adverse Event	43	40
Overall Study Lack of Efficacy	49	48
Overall Study Lost to Follow-up	19	16
Overall Study Physician Decision	17	20
Overall Study Withdrawal by Subject	65	68
Overall Study INVESTIGATOR SITE CLOSED	6	2
Overall Study PROTOCOL-SPECIFIED WITHDRAWAL CRITERION MET	6	9
Overall Study STUDY TERMINATED BY SPONSOR	1251	1256

Baseline Characteristics

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Otilimab 90 mg n=1456 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1459 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.	Total n=2915 Participants Total of all reporting groups
Age, Continuous	55.2 YEARS STANDARD_DEVIATION 11.38 • n=5 Participants	55.7 YEARS STANDARD_DEVIATION 10.91 • n=7 Participants	55.4 YEARS STANDARD_DEVIATION 11.15 • n=5 Participants
Sex: Female, Male Female	1158 Participants n=5 Participants	1181 Participants n=7 Participants	2339 Participants n=5 Participants
Sex: Female, Male Male	298 Participants n=5 Participants	278 Participants n=7 Participants	576 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	40 Participants n=5 Participants	53 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	223 Participants n=5 Participants	206 Participants n=7 Participants	429 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	1147 Participants n=5 Participants	1157 Participants n=7 Participants	2304 Participants n=5 Participants
Race/Ethnicity, Customized MULTIPLE	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 145 Weeks

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

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1456 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1459 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Participants with AEs	902 Participants	931 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Participants with SAEs	123 Participants	114 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Participants with AESI	120 Participants	95 Participants

PRIMARY outcome

Timeframe: Baseline (Day 01) and 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. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1180 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1204 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Platelet Count at Week 24	-11.9 Giga cells per liter (10^9 cells/L) Standard Deviation 66.86	-9.7 Giga cells per liter (10^9 cells/L) Standard Deviation 66.82

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 48

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=706 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=702 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Platelet Count at Week 48	-12.5 Giga cells per liter (10^9 cells/L) Standard Deviation 66.47	-7.6 Giga cells per liter (10^9 cells/L) Standard Deviation 71.36

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 96

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=125 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=117 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Platelet Count at Week 96	-13.8 Giga cells per liter (10^9 cells/L) Standard Deviation 60.72	-5.7 Giga cells per liter (10^9 cells/L) Standard Deviation 72.81

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 144

Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=2 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Platelet Count at Week 144	17.0 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-37.5 Giga cells per liter (10^9 cells/L) Standard Deviation 40.31

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 24

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

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1195 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1212 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24	0.4 Gram Per Liter (g/L) Standard Deviation 10.10	0.3 Gram Per Liter (g/L) Standard Deviation 9.89

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 48

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

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=713 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=706 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48	-0.5 Gram Per Liter (g/L) Standard Deviation 10.38	-1.1 Gram Per Liter (g/L) Standard Deviation 10.62

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 96

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

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=127 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=119 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96	1.0 Gram Per Liter (g/L) Standard Deviation 11.37	1.2 Gram Per Liter (g/L) Standard Deviation 10.24

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 144

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

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=2 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144	-1.0 Gram Per Liter (g/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	2.0 Gram Per Liter (g/L) Standard Deviation 2.83

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 24

Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1350 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1212 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Neutrophils	-0.348 Giga cells per liter (10^9 cells/L) Standard Deviation 2.18	-0.390 Giga cells per liter (10^9 cells/L) Standard Deviation 2.13
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Lymphocytes	-0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.55	-0.012 Giga cells per liter (10^9 cells/L) Standard Deviation 0.55
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Monocytes	0.003 Giga cells per liter (10^9 cells/L) Standard Deviation 0.18	0.00 Giga cells per liter (10^9 cells/L) Standard Deviation 0.194
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Eosinophils	0.027 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1623	0.022 Giga cells per liter (10^9 cells/L) Standard Deviation 0.171
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Basophils	-0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0405	-0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.04
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Total WBC	-0.32 Giga cells per liter (10^9 cells/L) Standard Deviation 2.212	-0.38 Giga cells per liter (10^9 cells/L) Standard Deviation 2.230

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 48

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=709 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=703 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Neutrophils	-0.318 Giga cells per liter (10^9 cells/L) Standard Deviation 2.2215	-0.541 Giga cells per liter (10^9 cells/L) Standard Deviation 2.1426
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Lymphocytes	-0.022 Giga cells per liter (10^9 cells/L) Standard Deviation 0.5385	-0.051 Giga cells per liter (10^9 cells/L) Standard Deviation 0.5725
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Monocytes	-0.002 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1871	-0.013 Giga cells per liter (10^9 cells/L) Standard Deviation 0.2461
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Eosinophils	0.018 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1435	0.028 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1844
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Basophils	-0.004 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0391	-0.006 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0403
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Total WBC	-0.33 Giga cells per liter (10^9 cells/L) Standard Deviation 2.283	-0.58 Giga cells per liter (10^9 cells/L) Standard Deviation 2.262

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 96

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=127 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=119 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Total WBC	-0.18 Giga cells per liter (10^9 cells/L) Standard Deviation 2.043	-0.53 Giga cells per liter (10^9 cells/L) Standard Deviation 2.568
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Neutrophils	-0.243 Giga cells per liter (10^9 cells/L) Standard Deviation 1.8851	-0.582 Giga cells per liter (10^9 cells/L) Standard Deviation 2.4346
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Lymphocytes	0.090 Giga cells per liter (10^9 cells/L) Standard Deviation 0.6453	0.018 Giga cells per liter (10^9 cells/L) Standard Deviation 0.5816
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Monocytes	-0.042 Giga cells per liter (10^9 cells/L) Standard Deviation 0.2001	-0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.2035
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Eosinophils	0.025 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1725	0.029 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1526
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Basophils	-0.007 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0423	-0.013 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0346

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 144

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=2 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Neutrophils	-0.360 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-0.935 Giga cells per liter (10^9 cells/L) Standard Deviation 0.6718
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Lymphocytes	-0.320 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	0.010 Giga cells per liter (10^9 cells/L) Standard Deviation 0.3253
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Monocytes	-0.220 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	0.010 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0424
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Eosinophils	-0.130 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	—
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Basophils	0.000 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	0.000 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0141
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Total WBC	-1.00 Giga cells per liter (10^9 cells/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-0.85 Giga cells per liter (10^9 cells/L) Standard Deviation 1.061

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 24

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1232 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1402 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 Aspartate Aminotransferase (AST)	1.0 International units per liter (IU/L) Standard Deviation 11.09	0.8 International units per liter (IU/L) Standard Deviation 9.70
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 Alanine Aminotransferase (ALT)	0.0 International units per liter (IU/L) Standard Deviation 15.80	-0.1 International units per liter (IU/L) Standard Deviation 15.20
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 Alkaline Phosphatase (AP)	3.0 International units per liter (IU/L) Standard Deviation 18.85	3.1 International units per liter (IU/L) Standard Deviation 21.05
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 Gamma Glutamyl Transferase (GGT)	-0.9 International units per liter (IU/L) Standard Deviation 20.32	-0.4 International units per liter (IU/L) Standard Deviation 18.94
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 Creatine Kinase (CPK)	5.4 International units per liter (IU/L) Standard Deviation 103.03	-3.8 International units per liter (IU/L) Standard Deviation 66.66

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 48

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=762 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=749 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 Aspartate Aminotransferase (AST)	0.4 International units per liter (IU/L) Standard Deviation 11.11	0.4 International units per liter (IU/L) Standard Deviation 11.32
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 Alanine Aminotransferase (ALT)	-0.9 International units per liter (IU/L) Standard Deviation 16.35	-1.2 International units per liter (IU/L) Standard Deviation 16.26
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 Alkaline Phosphatase (AP)	5.4 International units per liter (IU/L) Standard Deviation 20.07	5.2 International units per liter (IU/L) Standard Deviation 21.32
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 Gamma Glutamyl Transferase (GGT)	-0.0 International units per liter (IU/L) Standard Deviation 22.44	-0.4 International units per liter (IU/L) Standard Deviation 22.14
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 Creatine Kinase (CPK)	7.8 International units per liter (IU/L) Standard Deviation 153.24	-3.7 International units per liter (IU/L) Standard Deviation 71.52

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 96

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=128 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=122 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 Aspartate Aminotransferase (AST)	0.1 International units per liter (IU/L) Standard Deviation 11.65	2.0 International units per liter (IU/L) Standard Deviation 7.47
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 Alanine Aminotransferase (ALT)	-2.4 International units per liter (IU/L) Standard Deviation 19.02	-1.1 International units per liter (IU/L) Standard Deviation 9.33
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 Alkaline Phosphatase (AP)	0.0 International units per liter (IU/L) Standard Deviation 18.98	8.6 International units per liter (IU/L) Standard Deviation 27.79
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 Gamma Glutamyl Transferase (GGT)	-1.9 International units per liter (IU/L) Standard Deviation 18.52	-0.1 International units per liter (IU/L) Standard Deviation 19.67
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 Creatine Kinase (CPK)	1.4 International units per liter (IU/L) Standard Deviation 39.73	3.6 International units per liter (IU/L) Standard Deviation 93.29

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 144

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=2 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 Aspartate Aminotransferase (AST)	-8.0 International units per liter (IU/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	2.0 International units per liter (IU/L) Standard Deviation 0.0
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 Alanine Aminotransferase (ALT)	-14.0 International units per liter (IU/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	—
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 Alkaline Phosphatase (AP)	39.0 International units per liter (IU/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-1.5 International units per liter (IU/L) Standard Deviation 6.36
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 Gamma Glutamyl Transferase (GGT)	-21.0 International units per liter (IU/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	5.0 International units per liter (IU/L) Standard Deviation 14.14
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 Creatine Kinase (CPK)	-47.0 International units per liter (IU/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-2.5 International units per liter (IU/L) Standard Deviation 31.82

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 24

Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1183 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1204 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 Cholesterol	-0.038 Millimoles per liter (mmol/L) Standard Deviation 0.8542	-0.011 Millimoles per liter (mmol/L) Standard Deviation 0.9685
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 HDL Cholesterol, Direct	-0.020 Millimoles per liter (mmol/L) Standard Deviation 0.2703	-0.022 Millimoles per liter (mmol/L) Standard Deviation 0.2869
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 LDL Cholesterol	-0.031 Millimoles per liter (mmol/L) Standard Deviation 0.7239	0.010 Millimoles per liter (mmol/L) Standard Deviation 0.7818
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 Triglycerides	0.033 Millimoles per liter (mmol/L) Standard Deviation 0.6503	0.011 Millimoles per liter (mmol/L) Standard Deviation 0.7895

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 48

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=730 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=719 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 Cholesterol	-0.053 Millimoles per liter (mmol/L) Standard Deviation 0.9271	-0.078 Millimoles per liter (mmol/L) Standard Deviation 0.9826
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 HDL Cholesterol, Direct	-0.021 Millimoles per liter (mmol/L) Standard Deviation 0.2979	-0.027 Millimoles per liter (mmol/L) Standard Deviation 0.2959
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 LDL Cholesterol	-0.038 Millimoles per liter (mmol/L) Standard Deviation 0.7865	-0.034 Millimoles per liter (mmol/L) Standard Deviation 0.7899
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 Triglycerides	0.015 Millimoles per liter (mmol/L) Standard Deviation 0.6772	-0.019 Millimoles per liter (mmol/L) Standard Deviation 0.7376

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 96

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=113 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=100 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 LDL Cholesterol	-0.159 Millimoles per liter (mmol/L) Standard Deviation 0.8948	-0.031 Millimoles per liter (mmol/L) Standard Deviation 0.8546
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 Cholesterol	-0.178 Millimoles per liter (mmol/L) Standard Deviation 1.0350	-0.130 Millimoles per liter (mmol/L) Standard Deviation 1.0570
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 HDL Cholesterol, Direct	-0.032 Millimoles per liter (mmol/L) Standard Deviation 0.2665	-0.058 Millimoles per liter (mmol/L) Standard Deviation 0.3233
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 Triglycerides	0.009 Millimoles per liter (mmol/L) Standard Deviation 0.8042	-0.056 Millimoles per liter (mmol/L) Standard Deviation 0.7262

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 144

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=2 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 LDL Cholesterol	-2.250 Millimoles per liter (mmol/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-1.750 Millimoles per liter (mmol/L) Standard Deviation 2.4183
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 Triglycerides	-0.580 Millimoles per liter (mmol/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-0.865 Millimoles per liter (mmol/L) Standard Deviation 0.9687
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 Cholesterol	-2.360 Millimoles per liter (mmol/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-2.240 Millimoles per liter (mmol/L) Standard Deviation 2.8709
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 HDL Cholesterol, Direct	0.160 Millimoles per liter (mmol/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	-0.095 Millimoles per liter (mmol/L) Standard Deviation 0.0212

PRIMARY outcome

Timeframe: Up to approximately 145 Weeks

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

Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1456 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1459 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Hyperkalemia, Total, Grade 4	2 Participants	0 Participants
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Hypercalcemia, Total, Grade 3	1 Participants	0 Participants
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Hypernatremia, Total, Grade 3	1 Participants	0 Participants
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Hypernatremia, Total, Grade 4	0 Participants	1 Participants
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Chronic Kidney Disease, Total, Grade 3	0 Participants	1 Participants
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Creatinine increased, Total, Grade 3	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 24

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1232 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1243 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 Total Bilirubin	0.3 Micromoles per liter (umol/L) Standard Deviation 2.87	0.3 Micromoles per liter (umol/L) Standard Deviation 2.92
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 Direct Bilirubin	0.053 Micromoles per liter (umol/L) Standard Deviation 0.764	0.027 Micromoles per liter (umol/L) Standard Deviation 0.641

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 48

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=762 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=749 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 Total Bilirubin	-0.0 Micromoles per liter (umol/L) Standard Deviation 2.85	0.1 Micromoles per liter (umol/L) Standard Deviation 3.04
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 Direct Bilirubin	0.011 Micromoles per liter (umol/L) Standard Deviation 0.777	0.040 Micromoles per liter (umol/L) Standard Deviation 0.690

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 96

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=128 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=123 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 Total Bilirubin	-0.2 Micromoles per liter (umol/L) Standard Deviation 3.22	0.5 Micromoles per liter (umol/L) Standard Deviation 3.49
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 Direct Bilirubin	0.047 Micromoles per liter (umol/L) Standard Deviation 0.815	0.041 Micromoles per liter (umol/L) Standard Deviation 0.827

PRIMARY outcome

Timeframe: Baseline (Day 01) and Week 144

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=2 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 Total Bilirubin	4.0 Micromoles per liter (umol/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	4.5 Micromoles per liter (umol/L) Standard Deviation 6.36
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 Direct Bilirubin	2.000 Micromoles per liter (umol/L) Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	1.500 Micromoles per liter (umol/L) Standard Deviation 0.707

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

Population: The analysis was performed on the intent to treat (ITT) set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), 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). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. 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. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1206 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1212 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 Week 24	47.0 Percentage of participants	46.0 Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 Week 48	44.0 Percentage of participants	47.0 Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 Week 96	40.0 Percentage of participants	47.0 Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 Week 144	—	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), 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). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1206 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1212 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 Week 24	11.0 Percentage of participants	10.0 Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 Week 48	12.0 Percentage of participants	9.0 Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 Week 96	13.0 Percentage of participants	9.0 Percentage of participants
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 Week 144	—	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

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). PtGA is transformed to a 0-10 scale before computing the total score. 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 greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1190 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1199 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 Week 48	25.0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 Week 96	26.0 Percentage of participants	28.0 Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 Week 144	—	0.0 Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 Week 24	26.0 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 132

The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1084 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1085 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 Week 24	15.0 Percentage of participants	14.0 Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 Week 48	14.0 Percentage of participants	13.0 Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 Week 96	16.0 Percentage of participants	12.0 Percentage of participants
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 Week 132	0.0 Percentage of participants	33.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

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. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI \<= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1190 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1199 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 Boolean-based ACR/EULAR, Week 24	7.0 Percentage of participants	6.0 Percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 Boolean-based ACR/EULAR, Week 48	8.0 Percentage of participants	4.0 Percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 Boolean-based ACR/EULAR, Week 96	8.0 Percentage of participants	9.0 Percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 Boolean-based ACR/EULAR, Week 144	—	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1206 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1212 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score Week 96	14.62 Scores on a scale Standard Deviation 11.443	15.22 Scores on a scale Standard Deviation 13.997
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score Week 144	—	11.30 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score Week 24	13.42 Scores on a scale Standard Deviation 10.669	14.26 Scores on a scale Standard Deviation 11.637
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score Week 48	13.85 Scores on a scale Standard Deviation 10.612	14.07 Scores on a scale Standard Deviation 11.186

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1338 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1199 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) Week 24	3.49 Scores on a scale Standard Deviation 1.237	3.55 Scores on a scale Standard Deviation 1.269
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) Week 48	3.51 Scores on a scale Standard Deviation 1.224	3.54 Scores on a scale Standard Deviation 1.232
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) Week 96	3.44 Scores on a scale Standard Deviation 1.188	3.52 Scores on a scale Standard Deviation 1.389
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) Week 144	—	3.21 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 132

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 millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1084 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1085 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Week 24	3.97 Scores on a scale Standard Deviation 1.295	4.01 Scores on a scale Standard Deviation 1.333
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Week 48	4.02 Scores on a scale Standard Deviation 1.284	4.05 Scores on a scale Standard Deviation 1.306
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Week 96	3.92 Scores on a scale Standard Deviation 1.216	4.04 Scores on a scale Standard Deviation 1.470
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Week 132	3.77 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.	4.26 Scores on a scale Standard Deviation 1.560

SECONDARY outcome

Timeframe: Week 24 and 48

Population: The analysis was performed on the ITT set that includes participants from qualifying studies 201790 and 201791 only who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=66 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=46 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) Week 24	23.26 Scores on a scale Standard Deviation 34.191	30.31 Scores on a scale Standard Deviation 40.236
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) Week 48	23.27 Scores on a scale Standard Deviation 33.953	30.34 Scores on a scale Standard Deviation 40.432

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1228 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1239 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) Week 24	1.045 Scores on a scale Standard Deviation 0.6764	1.060 Scores on a scale Standard Deviation 0.6849
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) Week 48	1.072 Scores on a scale Standard Deviation 0.6679	1.096 Scores on a scale Standard Deviation 0.6691
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) Week 96	1.074 Scores on a scale Standard Deviation 0.6852	1.156 Scores on a scale Standard Deviation 0.7582
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) Week 144	—	2.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

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

Outcome measures
Measure	Otilimab 90 mg n=1230 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1239 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) Week 24	34.6 Scores on a scale Standard Deviation 23.51	36.6 Scores on a scale Standard Deviation 23.85
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) Week 48	37.0 Scores on a scale Standard Deviation 23.55	36.0 Scores on a scale Standard Deviation 23.88
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) Week 96	39.3 Scores on a scale Standard Deviation 24.62	38.1 Scores on a scale Standard Deviation 27.08
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) Week 144	—	26.0 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1228 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1237 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) Week 96	48.66 T-score Standard Deviation 11.483	49.75 T-score Standard Deviation 11.351
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) Week 24	49.14 T-score Standard Deviation 10.386	49.44 T-score Standard Deviation 10.384
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) Week 48	49.54 T-score Standard Deviation 10.577	49.70 T-score Standard Deviation 10.557
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) Week 144	—	42.55 T-score Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

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 weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36.

Outcome measures

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1228 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1237 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values SF-36 Physical Component Scores (PCS) Week 24	41.19 T-Score Standard Deviation 8.173	40.67 T-Score Standard Deviation 8.232
Absolute Values SF-36 Physical Component Scores (PCS) Week 48	40.17 T-Score Standard Deviation 8.586	40.13 T-Score Standard Deviation 8.271
Absolute Values SF-36 Physical Component Scores (PCS) Week 96	39.18 T-Score Standard Deviation 9.280	38.86 T-Score Standard Deviation 8.879
Absolute Values SF-36 Physical Component Scores (PCS) Week 144	—	35.03 T-Score Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Week 24, 48, 96 and 144

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.

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1229 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1238 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Week 24	36.0 Scores on a scale Standard Deviation 10.33	35.9 Scores on a scale Standard Deviation 10.25
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Week 48	35.5 Scores on a scale Standard Deviation 10.53	35.4 Scores on a scale Standard Deviation 10.59
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Week 96	35.2 Scores on a scale Standard Deviation 10.77	34.8 Scores on a scale Standard Deviation 11.87
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Week 144	—	26.0 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.

SECONDARY outcome

Timeframe: Week 120

Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA

Outcome measures

Outcome measures
Measure	Otilimab 90 mg n=1456 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1459 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Number of Participants With Anti-GSK3196165 Antibodies	11 Participants	10 Participants

Adverse Events

Otilimab 90 mg

Serious events: 123 serious events

Other events: 279 other events

Deaths: 10 deaths

Otilimab 150 mg

Serious events: 114 serious events

Other events: 308 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Otilimab 90 mg n=1456 participants at risk Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1459 participants at risk Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Infections and infestations COVID-19	9.7% 141/1456 • Number of events 153 • All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.	9.7% 141/1459 • Number of events 148 • All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.
Infections and infestations Upper respiratory tract infection	4.5% 65/1456 • Number of events 74 • All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.	6.0% 88/1459 • Number of events 100 • All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	8.1% 118/1456 • Number of events 158 • All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.	8.8% 129/1459 • Number of events 175 • All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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

Measure	Otilimab 90 mg n=1228 Participants Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Otilimab 150 mg n=1237 Participants Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Absolute Values SF-36 Domain Scores Bodily Pain at Week 24	54.49 Scores on a scale Standard Deviation 21.457	53.83 Scores on a scale Standard Deviation 21.158
Absolute Values SF-36 Domain Scores Bodily Pain at Week 48	52.22 Scores on a scale Standard Deviation 21.099	52.94 Scores on a scale Standard Deviation 21.158
Absolute Values SF-36 Domain Scores Bodily Pain at Week 96	49.90 Scores on a scale Standard Deviation 20.943	51.11 Scores on a scale Standard Deviation 21.983
Absolute Values SF-36 Domain Scores Bodily Pain at Week 144	—	41.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores General Health at week 24	51.00 Scores on a scale Standard Deviation 18.744	50.30 Scores on a scale Standard Deviation 17.980
Absolute Values SF-36 Domain Scores General Health at week 48	50.35 Scores on a scale Standard Deviation 18.817	49.44 Scores on a scale Standard Deviation 17.645
Absolute Values SF-36 Domain Scores General Health at week 96	48.44 Scores on a scale Standard Deviation 20.029	46.73 Scores on a scale Standard Deviation 18.543
Absolute Values SF-36 Domain Scores General Health at week 144	—	45.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores Mental Health at week 24	67.47 Scores on a scale Standard Deviation 19.387	68.05 Scores on a scale Standard Deviation 19.150
Absolute Values SF-36 Domain Scores Mental Health at week 48	67.64 Scores on a scale Standard Deviation 19.701	67.97 Scores on a scale Standard Deviation 19.636
Absolute Values SF-36 Domain Scores Mental Health at week 96	66.90 Scores on a scale Standard Deviation 20.860	68.49 Scores on a scale Standard Deviation 20.217
Absolute Values SF-36 Domain Scores Mental Health at week 144	—	50.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores Physical Function at week 24	56.20 Scores on a scale Standard Deviation 25.644	55.28 Scores on a scale Standard Deviation 25.615
Absolute Values SF-36 Domain Scores Physical Function at week 48	54.23 Scores on a scale Standard Deviation 26.222	53.98 Scores on a scale Standard Deviation 25.397
Absolute Values SF-36 Domain Scores Physical Function at week 96	51.87 Scores on a scale Standard Deviation 25.735	50.92 Scores on a scale Standard Deviation 26.175
Absolute Values SF-36 Domain Scores Physical Function at week 144	—	35.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores Role Emotional At week 24	74.79 Scores on a scale Standard Deviation 24.653	75.09 Scores on a scale Standard Deviation 24.760
Absolute Values SF-36 Domain Scores Role Emotional At week 48	75.31 Scores on a scale Standard Deviation 24.008	76.18 Scores on a scale Standard Deviation 24.163
Absolute Values SF-36 Domain Scores Role Emotional At week 96	73.35 Scores on a scale Standard Deviation 25.188	74.44 Scores on a scale Standard Deviation 26.324
Absolute Values SF-36 Domain Scores Role Emotional At week 144	—	50.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores Role Physical at week 24	58.58 Scores on a scale Standard Deviation 23.155	57.78 Scores on a scale Standard Deviation 23.514
Absolute Values SF-36 Domain Scores Role Physical at week 48	56.49 Scores on a scale Standard Deviation 23.645	57.57 Scores on a scale Standard Deviation 23.463
Absolute Values SF-36 Domain Scores Role Physical at week 96	54.27 Scores on a scale Standard Deviation 23.818	55.15 Scores on a scale Standard Deviation 24.956
Absolute Values SF-36 Domain Scores Role Physical at week 144	—	25.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores Social Function at week 24	71.20 Scores on a scale Standard Deviation 24.001	71.39 Scores on a scale Standard Deviation 23.936
Absolute Values SF-36 Domain Scores Social Function at week 48	70.88 Scores on a scale Standard Deviation 24.596	71.29 Scores on a scale Standard Deviation 24.123
Absolute Values SF-36 Domain Scores Social Function at week 96	68.25 Scores on a scale Standard Deviation 24.065	69.43 Scores on a scale Standard Deviation 26.526
Absolute Values SF-36 Domain Scores Social Function at week 144	—	62.50 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
Absolute Values SF-36 Domain Scores Vitality at week 24	55.77 Scores on a scale Standard Deviation 20.690	55.18 Scores on a scale Standard Deviation 20.593
Absolute Values SF-36 Domain Scores Vitality at week 48	55.24 Scores on a scale Standard Deviation 20.972	54.49 Scores on a scale Standard Deviation 21.262
Absolute Values SF-36 Domain Scores Vitality at week 96	51.04 Scores on a scale Standard Deviation 23.127	54.25 Scores on a scale Standard Deviation 22.738
Absolute Values SF-36 Domain Scores Vitality at week 144	—	50.00 Scores on a scale Standard Deviation NA NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.