Table 1 Demographics and patient characteristics at baseline (randomized population)
Sarilumab | ||||
|---|---|---|---|---|
Placebo to 150 mg q2w + MTX(n = 42) | Placebo to 200 mg q2w + MTX(n = 40) | 150 mg q2w + MTX(n = 81) | 200 mg q2w + MTX(n = 80) | |
Age, mean (SD) years | 51.9 (11.0) | 55.0 (11.9) | 56.1 (9.5) | 55.3 (11.0) |
Female/male, % | 81.0/19.0 | 77.5/22.5 | 77.8/22.2 | 76.3/23.8 |
Weight, mean (SD) kg | 54.5 (11.9) | 58.7 (12.3) | 56.6 (12.4) | 56.7 (10.9) |
Race, % | ||||
Asian | 100 | 100 | 100 | 100 |
MTX dosage, mean (SD) mg/week | 9.4 (3.2) | 10.4 (3.2) | 10.1 (3.0) | 10.1 (3.0) |
Prior biologic DMARD use, n (%) | 16 (38.1) | 7 (17.5) | 28 (34.6) | 22 (27.5) |
Baseline corticosteroids, n (%) | 22 (52.4) | 17 (42.5) | 42 (51.9) | 46 (57.5) |
Duration of RA, mean (range) years | 7.6 (0.3–43.1) | 8.8 (0.3–35.2) | 7.0 (0.3–37.5) | 8.3 (0.3–33.6) |
Seropositive for rheumatoid factor, n (%) | 32 (76.2) | 24 (61.5)a | 62 (76.5) | 60 (75.0) |
Anti-CCP antibody positive, n (%) | 36 (85.7) | 32 (82.1)a | 71 (87.7) | 71 (88.8) |
DAS28-CRP, mean (SD) | 5.6 (0.8) | 5.3 (1.0) | 5.7 (1.0) | 5.4 (0.9) |
TJC, mean (SD) | 18.9 (10.2) | 17.2 (10.4) | 19.3 (12.1) | 17.9 (12.4) |
SJC, mean (SD) | 15.1 (7.6) | 14.1 (8.7) | 16.1 (9.0) | 14.4 (9.7) |
CRP, mean (SD) mg/l | 23.7 (19.9) | 21.0 (22.8) | 22.9 (19.9) | 23.1 (20.6) |
SDAI, mean (SD) | 36.7 (10.2) | 34.3 (12.1) | 38.2 (13.2) | 35.2 (12.9) |
CDAI, mean (SD) | 34.4 (9.5) | 31.9 (11.2) | 35.9 (12.6) | 32.9 (11.9) |
HAQ-DI score, mean (SD) | 1.1 (0.6) | 1.0 (0.7) | 1.2 (0.7) | 1.1 (0.7) |