Table 1.
Demographics and disease activity at entry into the double-blind study by original randomisation group for the double-blind (n=1197) and open-label extension (n=901) populations
| Parameter at double-blind study baseline | Double-blind study | Open-label extension | ||||
| Placebo + MTX (n=398) | Sarilumab q2w + MTX | Placebo + MTX (n=307) | Sarilumab q2w + MTX | |||
| 150 mg (n=400) | 200 mg (n=399) | 150 mg (n=300) | 200 mg (n=294) | |||
| Female, n (%) | 321 (81) | 319 (80) | 337 (84) | 246 (80) | 241 (80) | 246 (84) |
| Age, mean (SD), years | 50.9 (11.2) | 50.1 (11.9) | 50.8 (11.8) | 50.8 (10.7) | 50.3 (11.8) | 50.2 (11.6) |
| Prior biological DMARD use, n (%) | 86 (22) | 87 (22) | 84 (21) | 71 (23) | 75 (25) | 64 (22) |
| Duration of RA, mean (range), years | 9 (0–44) | 10 (0–45) | 9 (0–34) | 9 (0–44) | 10 (0–45) | 9 (0–34) |
| Seropositive for RF, n (%) | 336 (84) | 345 (87)* | 328 (83)* | 260 (85) | 261 (88)† | 250 (85)† |
| Seropositive for anti-CCP autoantibody, n (%) | 340 (85) | 359 (90)‡ | 337 (85)‡ | 264 (86) | 273 (91) | 255 (87)§ |
| Tender joint count (0–68), mean (SD) | 26.8 (13.7) | 27.2 (14.1) | 26.5 (14.5) | 26.8 (13.6) | 27.4 (14.4) | 26.9 (14.4) |
| Swollen joint count (0–66), mean (SD) | 16.7 (9.3) | 16.6 (9.0) | 16.8 (9.7) | 17.1 (9.4) | 16.7 (9.2) | 17.0 (9.5) |
| CRP, mean (SD), mg/L | 20.5 (23.0) | 22.5 (23.1) | 22.2 (23.8) | 20.1 (22.1) | 22.8 (24.0) | 21.5 (20.6) |
| DAS28-CRP, mean (SD) | 5.9 (0.9) | 6.0 (0.9) | 6.0 (0.9) | 5.9 (0.9) | 6.0 (0.9) | 6.0 (0.9) |
| HAQ-DI, mean (SD) | 1.6 (0.7) | 1.6 (0.6) | 1.7 (0.6) | 1.6 (0.7) | 1.6 (0.6) | 1.7 (0.6) |
*For RF, n=396 for sarilumab 150 mg and n=397 for sarilumab 200 mg.
†For RF, n=298 for sarilumab 150 mg and n=293 for sarilumab 200 mg.
‡For anti-CCP, n=398 for sarilumab 150 mg and n=293 for sarilumab 200 mg.
§n=293.
CCP, cyclic citrullinated peptide; CRP, C reactive protein; DAS28-CRP, Disease Activity Score (28 joints) using C reactive protein; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; q2w, every 2 weeks; RA, rheumatoid arthritis; RF, rheumatoid factor; SD, standard deviation.