Baseline demographic and disease characteristics, prior to open-label rituximab.
| Characteristics | Placebo Retreatment, n = 157 | Rituximab Retreatment, n = 318 |
|---|---|---|
| Mean age (SD), yrs | 54 (11) | 54 (11) |
| Range | 28–80 | 25–80 |
| Female, n (%) | 124 (79) | 257 (81) |
| Race, n (%) | ||
| White | 126 (80) | 248 (78) |
| Black | 12 (8) | 26 (8) |
| Hispanic | 15 (10) | 30 (9) |
| Other | 4 (2) | 9 (3) |
| Disease characteristics | ||
| Rheumatoid factor-positive, n (%)a | 118 (75) | 244 (77) |
| Anti-CCP-positive, n (%)b | 119 (78) | 223 (74) |
| Mean (IU/ml) for RF-positive patients | 523 | 628 |
| Mean (SD) RA duration, yrs | 11 (8.5) | 12 (9.2) |
| Mean (SD) tender joint count (68–joint count) | 33 (18.0) | 32 (15.6) |
| Mean (SD) swollen joint count (66–joint count) | 22 (13.2) | 22 (11.5) |
| Mean (SD) DAS28 | 6.7 (1.0) | 6.7 (1.0)* |
| Mean (SD) C-reactive protein, mg/dl | 2.2 (3.0) | 1.9 (2.4) |
| Mean erythrocyte sedimentation rate (SD), mm/h | 44.6 (26.30) | 42.4 (26.10)** |
| Mean (SD) HAQ-DI | 1.5 (0.6) | 1.5 (0.6)** |
| Mean (SD) MTX dose, mg/week | 16.4 (4.6) | 16.4 (4.6) |
| Mean (SD) prednisone dose, mg/day | 7.4 (2.62) | 7.1 (3.00) |
| Number (%) patients on steroids | 79 (50.3) | 164 (51.6) |
| Prior use of TNF inhibitor(s), n (%) | ||
| 1 previous TNF inhibitor | 84 (53) | 181 (57) |
| 2 previous TNF inhibitors | 55 (35) | 101 (32) |
| 3 previous TNF inhibitors | 18 (12) | 35 (11) |
| Mean no. of previous DMARD (%) (excluding MTX, including TNF inhibitors) | 4.1 (1.9) | 4.1 (2.0) |
Anti-CCP: anti-cyclic citrullinated peptide; DAS28-ESR: Disease Activity Score 28 and erythrocyte sedimentation rate; DMARD: disease-modifying antirheumatic drug; MTX: methotrexate.
↵a Rheumatoid factor positivity is defined as ≥ 15 IU/ml.
↵b Anti-CCP positivity is defined as ≥ 20 units.
↵* Five patients were not measured.
↵** Three patients were not measured.