Table 1.
Baseline demographics and disease characteristics (all patients enrolled)
| Category | DRL_ RI N = 91 |
RTX-US N = 92 |
RTX-EU N = 93 |
|---|---|---|---|
| Age, mean ± SD, years | 44.1 ± 10.96 | 44.0 ± 10.36 | 45.5 ± 10.41 |
| Age group, n (%) | |||
| 18–30 years | 12 (13.2) | 10 (10.9) | 11 (11.8) |
| 31–60 years | 72 (79.1) | 76 (82.6) | 76 (81.7) |
| 61–65 years | 7 (7.7) | 6 (6.5) | 6 (6.5) |
| Gender, n (%) | |||
| Female | 81 (89.0) | 81 (88.0) | 81 (87.1) |
| Male | 10 (11.0) | 11 (12.0) | 12 (12.9) |
| Race, n (%) | |||
| Asian | 78 (85.7) | 78 (84.8) | 78 (83.9) |
| White | 13 (14.3) | 14 (15.2) | 15 (16.1) |
| Ethnicity, n (%) | |||
| Not Hispanic or Latino | 84 (92.3) | 89 (96.7) | 89 (95.7) |
| Other | 7 (7.7) | 3 (3.3) | 4 (4.3) |
| Weight, mean ± SD, kg | 61.77 ± 13.87 | 61.76 ± 17.23 | 62.95 ± 15.82 |
| BMI, mean ± SD, kg/m2 | 24.61 ± 4.63 | 24.80 ± 5.73 | 25.17 ± 5.29 |
| Total swollen joints 66-joint count, mean ± SD | 16.2 ± 7.87 | 13.5 ± 5.97 | 13.5 ± 5.99 |
| Total tender joints 68-joint count, mean ± SD | 24.2 ± 10.50 | 20.5 ± 11.34 | 18.6 ± 9.18 |
| DAS28-CRP score, mean ± SD | 6.03 ± 0.67 | 5.72 ± 0.76 | 5.74 ± 0.70 |
| HAQ-DI score, mean ± SD | 1.56 ± 0.63 | 1.44 ± 0.51 | 1.46 ± 0.58 |
| LTBI status, n (%) | |||
| Positive | 19 (20.9) | 20 (21.7) | 16 (17.2) |
| Negative | 66 (72.5) | 63 (68.5) | 61 (65.6) |
| Indeterminate | 6 (6.6) | 9 (9.8) | 16 (17.2) |
Percentages are based on the number of patients within each treatment group under the all patients randomized set (N)
BMI body mass index, CRP C-reactive protein, DAS28 Disease Activity Score in 28 joints, HAQ-DI Health Assessment Questionnaire–Disease Index, LTBI latent tuberculosis infection, RTX-EU MabThera®, RTX-US Rituxan®, SD standard deviation