Demographic and baseline characteristics (efficacy analysis set; active-controlled period)*
| Characteristics | Placebo to sirukumab 50 mg q4w (n=226†) | Placebo to sirukumab 100 mg q2w (n=232) | Sirukumab 50 mg q4w (n=476‡) | Sirukumab 100 mg q2w (n=468‡) |
| Female sex, n (%) | 169 (74.8) | 187 (80.6) | 384 (80.7) | 380 (81.2) |
| Age, years | 52.8 (11.9) | 52.2 (11.8) | 52.7 (11.6) | 52.7 (11.0) |
| Race, n (%) | ||||
| White | 170 (75.2) | 161 (69.4) | 334 (70.2) | 339 (72.4) |
| Asian | 32 (14.2) | 37 (15.9) | 78 (16.4) | 81 (17.3) |
| Black or African American | 5 (2.2) | 10 (4.3) | 12 (2.5) | 9 (1.9) |
| American Indian or Alaska Native | 4 (1.8) | 2 (0.9) | 3 (0.6) | 4 (0.9) |
| Other§ | 14 (6.2) | 20 (8.6) | 46 (9.7) | 33 (7.1) |
| Not reported/unknown | 1 (0.4) | 2 (0.9) | 2 (0.4) | 2 (0.4) |
| Weight, kg | 73.2 (17.2) | 71.9 (16.3) | 72.4 (18.7) | 70.9 (16.2) |
| Disease duration, years | 8.1 (7.0) | 7.9 (6.8) | 8.8 (7.7) | 8.5 (7.1) |
| BMI, kg/m2 | 27.4 (6.0) | 27.0 (5.6) | 27.4 (6.5) | 26.8 (5.6) |
| CRP, mg/dL | 2.9 (4.5) | 2.4 (2.5) | 2.3 (2.4) | 2.3 (2.4) |
| RF positive, n (%) | 173 (76.9) | 188 (81.0) | 370 (78.1) | 394 (84.4) |
| Anti-CCP positive, n (%) | 189 (83.6) | 201 (87.0) | 410 (86.1) | 409 (87.8) |
| HAQ-DI score, range: 0–3 | 1.54 (0.65) | 1.55 (0.65) | 1.50 (0.61) | 1.51 (0.66) |
| DAS28 (CRP) | 6.0 (1.0) | 5.9 (0.9) | 5.9 (0.9) | 5.8 (0.9) |
| CDAI score | 39.94 (12.15) | 39.17 (12.18) | 38.79 (12.49) | 37.55 (11.83) |
| Concomitant MTX use, n (%) | 201 (88.9) | 203 (87.5) | 425 (89.3) | 409 (87.4) |
*Values are mean (SD) unless otherwise indicated. Data are shown for the active-controlled efficacy population, which included patients who reached Week 52 and entered into the blinded active treatment phase of the study.
†At Week 52, one patient initially randomised to placebo was rerandomised to sirukumab 50 mg q4w, but discontinued treatment and never received sirukumab treatment.
‡Five patients who continued treatment in the sirukumab 50 mg q4w group at Week 52 and two patients who continued treatment in the sirukumab 100 mg q2w group at Week 52 were not eligible for inclusion in active-controlled efficacy population (Week 52 to Week 104).
§No native Hawaiian or other Pacific Islanders were reported in any treatment group.
BMI, body mass index; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28 (CRP), Disease Activity Score in 28 joints based on CRP; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; RF, rheumatoid factor; q2w, every 2 weeks; q4w, every 4 weeks.