Table 1.
Demographic and baseline characteristics
| Characteristic | Placebo (n=556) |
Sirukumab | Total (n=1670) |
|
| 50 mg q4w (n=557) |
100 mg q2w (n=557) |
|||
| Female sex, n (%) | 436 (78.4) | 447 (80.3) | 452 (81.1) | 1335 (79.9) |
| Age, years | 52.9 (11.9) | 52.9 (11.8) | 53.0 (11.3) | 52.9 (11.7) |
| Race, n (%) | ||||
| White | 403 (72.5) | 397 (71.3) | 408 (73.2) | 1208 (72.3) |
| Asian | 88 (15.8) | 89 (16.0) | 95 (17.1) | 272 (16.3) |
| Black or African-American | 16 (2.9) | 15 (2.7) | 10 (1.8) | 41 (2.5) |
| American Indian or Alaska Native | 6 (1.1) | 4 (0.7) | 4 (0.7) | 14 (0.8) |
| Other* | 39 (7.0) | 49 (8.8) | 38 (6.8) | 126 (7.5) |
| Not reported/unknown | 4 (0.7) | 3 (0.5) | 2 (0.4) | 9 (0.5) |
| Region, n (%) | ||||
| Eastern Europe | 271 (48.7) | 263 (47.2) | 273 (49.0) | 807 (48.3) |
| North America | 85 (15.3) | 96 (17.2) | 91 (16.3) | 272 (16.3) |
| Asia-Pacific | 87 (15.6) | 89 (16.0) | 91 (16.3) | 267 (16.0) |
| Latin America | 73 (13.1) | 75 (13.5) | 76 (13.6) | 224 (13.4) |
| South Africa | 40 (7.2) | 34 (6.1) | 26 (4.7) | 100 (6.0) |
| Weight, kg | 72.7 (17.4) | 72.3 (18.6) | 71.6 (17.1) | 72.2 (17.7) |
| Disease duration, years | 8.3 (7.0) | 8.7 (7.5) | 8.8 (7.6) | 8.6 (7.4) |
| BMI, kg/m2 | 27.4 (6.0) | 27.3 (6.4) | 27.2 (6.0) | 27.3 (6.2) |
| CRP, mg/L | 25 (34) | 24 (26) | 24 (26) | 24 (29) |
| RF positive, n (%) | 444 (79.9) | 433 (77.7) | 468 (84.0)† | 1345 (80.5) |
| Anti-CCP positive, n (%) | 467 (84.0) | 476 (85.5) | 484 (86.9) | 1427 (85.4) |
| SHS | 41.9 (46.7) | 41.8 (45.4) | 42.5 (49.3) | 42.1 (47.1) |
| HAQ-DI score, range: 0–3 | 1.6 (0.7) | 1.5 (0.6) | 1.5 (0.7) | 1.5 (0.6) |
| DAS28 (CRP) | 5.9 (0.9) | 5.9 (0.9) | 5.8 (0.9)‡ | 5.9 (0.9) |
| Prior medication use§ | ||||
| 1 DMARD | 183 (32.9) | 179 (32.1) | 173 (31.1) | 535 (32.0) |
| ≥2 DMARDs | 373 (67.1) | 378 (67.9) | 384 (68.9) | 1135 (68.0) |
| MTX | 547 (98.4) | 550 (98.7) | 548 (98.4) | 1645 (98.5) |
| Sulfasalazine | 174 (31.4) | 167 (30.0) | 152 (27.3) | 493 (29.5) |
| Systemic corticosteroids | 422 (75.9) | 407 (73.1) | 418 (75.0) | 1247 (74.7) |
| Baseline medication use, n (%) | ||||
| DMARDs | 508 (91.4) | 517 (92.8) | 511 (91.7) | 1536 (92.0) |
| NSAIDs | 434 (78.1) | 420 (75.4) | 454 (81.5)¶ | 1308 (78.3) |
| Corticosteroids | 341 (61.3) | 331 (59.4) | 360 (64.6) | 1032 (61.8) |
Values are mean (SD) unless otherwise indicated.
Differences in demographic and baseline characteristics among groups were not significant, except where noted.
*No Native Hawaiian or other Pacific Islanders were reported in any treatment group.
†p=0.01 versus sirukumab 50 mg q4w based on χ2 test.
‡p=0.02 versus placebo based on t-test.
§All randomised patients took ≥1 DMARD.
¶p=0.01 versus sirukumab 50 mg q4w based on χ2 test.
q2w, every 2 weeks; q4w, every 4 weeks; BMI, body mass index; CCP, cyclic citrullinated peptide; CRP, C reactive protein; DAS28 (CRP), 28-joint Disease Activity Score based on C reactive protein; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire–Disability Index; MTX, methotrexate; NSAID, nonsteroidal anti-inflammatory drug; RF, rheumatoid factor; SHS, Sharp/van der Heijde score.