Baseline demographics and disease characteristics (ITT population)
| Placebo+MTX (n=207) | Ocrelizumab (200 mg×2)+MTX (n=196) | Ocrelizumab (500 mg×2)+MTX (n=202) | |
|---|---|---|---|
| Female, n (%) | 153 (73.9) | 154 (78.6) | 161 (79.7) |
| Age (years), mean | 49.2 | 50.8 | 48.6 |
| Median | 50.0 | 51.5 | 48.0 |
| Race, n (%) | |||
| White | 149 (72.0) | 143 (73.0) | 135 (66.8) |
| Black | 13 (6.3) | 10 (5.1) | 16 (7.9) |
| Asian | 22 (10.6) | 18 (9.2) | 21 (10.4) |
| Other | 23 (11.1) | 23 (11.8) | 30 (14.9) |
| Region, n (%) | |||
| USA | 68 (32.9) | 69 (35.2) | 61 (30.2) |
| Rest of world | 139 (67.1) | 127 (64.8) | 141 (69.8) |
| Disease duration (years), mean | 1.23 | 1.23 | 1.20 |
| Median (range) | 0.65 (0.1–5.1) | 0.65 (0.1–5.0) | 0.60 (0.0–5.5) |
| Serologic status,* n (%) | |||
| RF+/ACPA+ | 182 (87.9) | 172 (87.8) | 174 (86.1) |
| RF+/ACPA− | 10 (4.8) | 13 (6.6) | 9 (4.5) |
| RF−/ACPA+ | 13 (6.3) | 10 (5.1) | 16 (7.9) |
| Patients with ≥1 previous DMARD, n (%) | 70 (33.8) | 66 (33.7) | 81 (40.1) |
| No. of previous DMARDs, mean | 1.3 | 1.3 | 1.3 |
| Corticosteroid use, n (%) | 83 (40.1) | 76 (38.8) | 85 (42.1) |
| Swollen joint count (66 joints), mean | 21.1 | 19.4 | 19.5 |
| Tender joint count (68 joints), mean | 31.7 | 30.8 | 30.0 |
| mTSS, mean | 13.3 | 15.8 | 12.4 |
| C reactive protein (mg/dl), mean | 3.8 | 3.5 | 3.4 |
| ESR (mm/h), mean | 60.0 | 55.8 | 58.1 |
| DAS28-ESR, mean | 7.1 | 7.0 | 6.9 |
| HAQ-DI, mean | 1.8 | 1.8 | 1.7 |
↵* Cut-off values: RF positive≥20 IU/ml, negative<20 IU/ml; ACPA positive≥5 IU/ml, negative<5 IU/ml.
ACPA, anticitrullinated peptide antibody; DAS28-ESR, Disease Activity Score in 28 joints erythrocyte sedimentation rate; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disease Index; ITT, intent-to-treat; mTSS, van der Heijde-modified total Sharp score; MTX, methotrexate; RF, rheumatoid factor.