Baseline* demographics and clinical characteristics in all patients, stratified by treatment arm of the qualifying trial
Otilimab 90 mg (C1 & C2) N=946 | Otilimab 90 mg (C3) N=155 | Otilimab 150 mg (C1 & C2) N=943 | Otilimab 150 mg (C3) N=163 | Tofacitinib 150 mg (C1 & C2) N=561 | Sarilumab 200 mg (C3) N=147 | |
Baseline demographics | ||||||
Sex, female, n (%) | 733 (77) | 132 (85) | 755 (80) | 137 (84) | 456 (81) | 126 (86) |
Age, years, mean (SD) | 54.8 (11.5) | 56.8 (10.6) | 55.5 (10.9) | 56.6 (10.3) | 55.1 (11.3) | 58.0 (10.7) |
Race, n (%) | ||||||
White | 740 (78) | 135 (87) | 730 (77) | 140 (86) | 431 (77) | 128 (87) |
Asian | 146 (15) | 15 (10) | 147 (16) | 16 (10) | 92 (16) | 13 (9) |
Black or African American | 20 (2) | 5 (3) | 15 (2) | 6 (4) | 9 (2) | 6 (4) |
Baseline clinical characteristics, mean (SD) | ||||||
TJC68 | 8.4 (9.8) | 10.3 (11.1) | 8.8 (10.2) | 10.0 (10.8) | 6.5 (8.6) | 9.1 (11.9) |
SJC66 | 4.5 (6.1) | 5.8 (7.1) | 4.7 (6.5) | 5.5 (5.8) | 3.2 (4.8) | 5.6 (7.6) |
Pain VAS | 34.8 (24.1) | 42.2 (25.6) | 35.2 (24.0) | 39.8 (25.9) | 29.3 (24.2) | 35.8 (25.2) |
PtGA | 35.2 (23.2) | 42.9 (25.4) | 35.9 (22.7) | 40.3 (24.3) | 30.3 (22.9) | 35.9 (25.0) |
PhGA | 25.7 (20.7) | 27.7 (21.7) | 24.8 (19.0) | 27.7 (21.1) | 20.9 (18.1) | 27.6 (21.8) |
CRP (mg/L) | 13.0 (17.5) | 15.2 (25.0) | 11.9 (19.1) | 11.6 (17.9) | 7.4 (12.3) | 2.2 (4.5) |
HAQ-DI | 1.0 (0.7) | 1.2 (0.7) | 1.1 (0.7) | 1.1 (0.7) | 1.0 (0.7) | 1.1 (0.7) |
DAS28-CRP | 3.7 (1.3) | 4.1 (1.3) | 3.7 (1.3) | 4.0 (1.3) | 3.2 (1.3) | 3.3 (1.2) |
CDAI total score | 15.0 (12.1) | 17.9 (12.9) | 15.2 (11.9) | 17.6 (12.5) | 11.8 (10.6) | 16.2 (13.0) |
FACIT-Fatigue | 36.4 (10.1) | 33.2 (10.3) | 35.6 (10.0) | 34.8 (10.2) | 37.5 (9.5) | 36.2 (9.8) |
SF-36 MCS | 49.4 (10.5) | 48.0 (10.4) | 49.2 (10.0) | 49.3 (10.4) | 49.6 (10.0) | 50.6 (10.6) |
SF-36 PCS | 40.9 (8.3) | 38.6 (9.2) | 40.7 (8.4) | 39.2 (8.9) | 42.7 (8.4) | 40.6 (9.0) |
RA disease history, mean (SD) | ||||||
Time since RA diagnosis (years) | 10.4 (7.7) | 12.5 (7.9) | 10.4 (7.9) | 11.3 (7.4) | 10.6 (8.1) | 13.2 (8.8) |
Baseline RA functional class, n (%) | ||||||
I | 104 (11) | 23 (15) | 121 (13) | 24 (15) | 69 (12) | 28 (19) |
II | 690 (73) | 103 (66) | 661 (70) | 120 (74) | 400 (71) | 97 (66) |
III | 152 (16) | 29 (19) | 161 (17) | 19 (12) | 92 (16) | 22 (15) |
Stratum (previously failed medication),† n (%) | ||||||
csDMARDs only | 853 (90) | 0 | 858 (91) | 0 | 498 (89) | 0 |
one bDMARD | 61 (6) | 83 (54) | 61 (6) | 82 (50) | 40 (7) | 70 (48) |
>1 bDMARD | 32 (3) | 25 (16) | 24 (3) | 28 (17) | 23 (4) | 29 (20) |
≥1 JAK inhibitor | 0 | 47 (30) | 0 | 53 (33) | 0 | 48 (33) |
RA medications taken at baseline | ||||||
MTX, n (%) | 858 (91) | 137 (88) | 837 (89) | 139 (85) | 494 (88) | 129 (88) |
MTX dose at baseline, mg/week, mean (SD) | 17.2 (7.2) | 16.9 (5.0) | 16.9 (7.2) | 17.4 (4.6) | 17.1 (4.7) | 16.8 (4.6) |
2 csDMARDs, n (%) | 70 (7) | 11 (7) | 69 (7) | 15 (9) | 29 (5) | 5 (3) |
Corticosteroids, n (%) | 446 (47) | 71 (46) | 447 (47) | 75 (46) | 269 (48) | 78 (53) |
Corticosteroid dose (mg/day), mean (SD) | 6.0 (2.7) | 5.8 (2.5) | 5.7 (2.6) | 6.3 (5.6) | 5.8 (2.7) | 5.6 (2.3) |
*Baseline values were captured in the assessment before the first dose of otilimab administered in contRAst X, with the exception of those reported in the ‘Stratum (previously failed medication)’ rows, which were captured at the start of the qualifying study.
†Patients from contRAst 2 and contRAst 3 are reported in their qualifying trial randomisation stratum; patients from contRast 1 are placed in the ‘csDMARDS only’ stratum.
b/csDMARD, biologic/conventional synthetic disease-modifying antirheumatic drug; C1, contRAst 1; C2, contRAst 2; C3, contRAst 3; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, Disease Activity Score-28 joints; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; JAK, Janus kinase; MCS, Mental Component Summary; MTX, methotrexate; PCS, Physical Component Summary; PhGA, Physician’s Global Assessment; PtGA, Patient’s Global Assessment; RA, rheumatoid arthritis; SF-36, Short Form-36; SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analogue Scale.