Demographics and baseline disease characteristics
| Characteristic | Placebo + MTX (n=172) | Rituximab 2×500 mg + MTX (n=167) | Rituximab 2×1000 mg + MTX (n=170) |
|---|---|---|---|
| Mean (SD) age, years | 52.16 (12.390) | 51.91 (12.926) | 51.30 (12.644) |
| Female, n (%) | 147 (85.5) | 133 (79.6) | 138 (81.2) |
| Caucasian, n (%) | 142 (82.6) | 134 (80.2) | 137 (80.6) |
| Mean (SD) disease duration, years | 7.48 (7.642) | 7.10 (6.969) | 6.61 (7.294) |
| Mean (SD) MTX dose, mg/week | 16.6 (4.30) | 15.4 (4.02) | 16.1 (4.25) |
| Mean (SD) number of previous DMARDs* | 1.1 (1.10) | 1.2 (1.25) | 1.1 (1.11) |
| Patients receiving oral steroids, n (%) | 82 (47.7) | 80 (47.9) | 67 (39.4) |
| Mean (SD) OCS dose, mg/day | 6.3 (2.68) | 5.8 (2.52) | 6.1 (2.58) |
| RF positive, n (%) | 129 (75.0) | 126 (75.4) | 125 (73.5) |
| Mean (SD) total RF, IU/ml | 264.1 (492.03) | 307.2 (774.94) | 288.1 (539.5) |
| Mean (SD) SJC (66 joints) | 20.9 (11.26) | 18.6 (9.62) | 19.5 (10.32) |
| Mean (SD) TJC (68 joints) | 30.2 (15.94) | 27.1 (14.10) | 28.7 (14.98) |
| Mean (SD) DAS28-ESR | 6.54 (1.015) | 6.40 (0.951) | 6.49 (1.061) |
| Mean (SD) DAS28-CRP | 5.95 (0.972) | 5.81 (0.912) | 5.86 (0.967) |
↵* Excludes MTX.
CRP, C reactive protein; DAS28, Disease Activity Score (28 joints); DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; MTX, methotrexate; OCS, oral corticosteroid; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count.