Patient demographics and disease characteristics (all randomized patients; n = 224).
| PBO, n = 114 | CZP, n = 110 | |
|---|---|---|
| Demographic | ||
| Age, yrs, mean (SD) | 52.7 (11.1) | 53.1 (11.8) |
| Sex, % female | 76.3 | 83.6 |
| Disease characteristics | ||
| Duration, yrs, mean (SD) | 7.9 (8.4) | 7.4 (8.1) |
| Duration > 2 yrs, n (%) | 88 (77.2) | 72 (65.5) |
| TJC, mean (SD)a | 16.0 (7.1) | 15.7 (7.6) |
| SJC, mean (SD)a | 11.0 (5.6) | 11.7 (5.3) |
| DAS28-CRP, mean (SD) | 5.5 (0.9) | 5.5 (1.0) |
| CRP, mg/l, median (min, max)b | 5.1 (0.6, 96.9) | 5.1 (0.6, 97.7) |
| CRP, ≤ 5 mg/l, n (%) | 56 (49.1) | 54 (49.1) |
| CRP, > 5 mg/l, n (%) | 58 (50.9) | 56 (50.9) |
| Concomitant therapy | ||
| Concomitant MTX use, n (%) | 78 (68.4) | 75 (68.2) |
| Concomitant MTX dose, mg/week, mean (SD) | 17.2 (5.0) | 15.9 (4.6) |
| Any concomitant DMARD, including MTX, n (%) | 91 (79.8) | 92 (83.6) |
| Corticosteroid use, n (%) | 42 (36.8) | 47 (42.7) |
↵a Assessment based on 28 joints.
↵b CRP < 5 mg/l is the central laboratory normal value. PBO: placebo; CZP: certolizumab pegol; CRP: C-reactive protein; DAS28: 28-joint disease activity score; DMARD: disease-modifying antirheumatic drug; MTX: methotrexate; SJC: swollen joint count; TJC: tender joint count.