Demographics and baseline disease characteristics
| Characteristic | Ofatumumab 700 mg (n=129) | Placebo (n=131) |
|---|---|---|
| Mean (SD) age, years | 51.7 (11.24) | 53.6 (11.50) |
| Female, n (%) | 106 (82.2) | 108 (82.4) |
| Caucasian, n (%) | 122 (94.6) | 129 (98.5) |
| Mean (SD) disease duration, years | 7.93 (7.230) | 9.07 (8.987) |
| Median (min, max) methotrexate dose, mg/week | 15.0 (7.5, 25) | 15.0 (7.5, 25) |
| Previous DMARD, n (%) | ||
| 1–2 | 87 (67.4) | 88 (67.2) |
| 3–4 | 36 (27.9) | 32 (24.4) |
| >4 | 6 (4.7) | 11 (8.4) |
| Patients receiving oral corticosteroid, n (%) | 75 (58.1) | 84 (64.1) |
| Median (min, max) oral corticosteroid dose, mg/day* | 6.4 (1.6, 15.0) | 5.0 (1.6, 12.8) |
| RF positive, n (%) | 108 (83.7) | 111 (84.7) |
| Median (min, max) CRP, mg/l | 8.3 (0, 98) | 8.3 (0, 68) |
| Mean (SD) ESR, mm/h | 47.1 (25.38) | 44.4 (23.69) |
| Mean (SD) total RF, IU/ml† | 326.5 (593.60) | 250.4 (492.71) |
| Mean (SD) SJC (66 joints) | 16.2 (7.41) | 15.7 (6.88) |
| Mean (SD) TJC (68 joints) | 28.7 (13.36) | 26.6 (12.59) |
| Mean (SD) DAS28–CRP | 5.83 (0.794) | 5.63 (0.800) |
| Mean (SD) DAS28–ESR | 6.59 (0.828) | 6.41 (0.782) |
| Mean (SD) HAQ–DI | 1.7 (0.67) | 1.5 (0.65) |
| Mean (SD) FACIT–F | 25.2 (10.00) | 29.5 (9.54) |
* Prednisolone equivalent dose.
† At screening.
CRP, C-reactive protein; DAS28, disease activity score based on 28 joints; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; FACIT–F, functional assessment of chronic illness therapy–fatigue; HAQ–DI, health assessment questionnaire disability index; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count.