Demographics and disease characteristics at baseline (intent-to-treat population)
| Characteristics* | ADA+MTX (n=515) | PBO+MTX (n=517) |
|---|---|---|
| Demographics | ||
| Female, n (%) | 380 (74) | 382 (74) |
| White, n (%) | 460 (89) | 464 (90) |
| Age, mean (SD), years | 50.7 (14.5) | 50.4 (13.6) |
| Disease duration, mean (SD), months | 4.0 (3.6) | 4.5 (7.2) |
| Previous DMARD use, n (%) | 54 (11) | 51 (10) |
| Concomitant systemic corticosteroid use, n (%) | 212 (41) | 239 (46) |
| Concomitant NSAID use, n (%) | 401 (78) | 410 (79) |
| Disease characteristics | ||
| RF+, n (%)† | 445 (87) | 457 (89) |
| Anti-CCP+, n (%)‡ | 426 (84) | 430 (84) |
| CRP, mean (SD), mg/l | 27 (32) | 30 (33) |
| TJC (0–28; 0–68), mean (SD) | 16 (6.6); 29 (15) | 16 (6.7); 27 (15) |
| SJC (0–28; 0–66), mean (SD) | 13 (5.8); 18 (11) | 12 (5.8); 18 (11) |
| DAS28(CRP), mean (SD)§ | 6.0 (1.0) | 6.0 (1.0) |
| DAS28(CRP) ≥5.1, n (%)§ | 421 (83) | 403 (80) |
| SDAI, mean (SD)¶ | 44.0 (14.2) | 43.3 (14.6) |
| SDAI >26, n (%) | 459 (89) | 453 (88) |
| Patient's pain assessment, mean (SD), 0–100 mm VAS | 65 (21) | 65 (21) |
| Patient's global assessment, mean (SD), 0–100 mm VAS | 64 (23) | 63 (22) |
| Physician's global assessment, mean (SD), 0–100 mm VAS** | 63 (18) | 62 (18) |
| HAQ-DI (0–3), mean (SD)†† | 1.61 (0.69) | 1.60 (0.65) |
| mTSS, mean (SD)‡‡ | 11.8 (18.1) | 11.2 (17.4) |
| JSN, mean (SD)‡‡ | 6.4 (10.4) | 6.1 (10.2) |
| Joint erosion, mean (SD)‡‡ | 5.4 (9.1) | 5.1 (8.4) |
| More than one erosion, n (%)‡‡ | 419 (82) | 433 (84) |
↵* p>0.05 for all characteristics.
↵† n=510 (ADA+MTX) and n=511 (PBO+MTX).
↵‡ n=509 (ADA+MTX) and n=513 (PBO+MTX).
↵§ n=507 (ADA+MTX) and n=505 (PBO+MTX).
↵¶ n=504 (ADA+MTX) and n=505 (PBO+MTX).
↵** n=512 (ADA+MTX).
↵†† n=514 (ADA+MTX) and n=516 (PBO+MTX).
↵‡‡ n=508 (ADA+MTX) and n=514 (PBO+MTX).
ADA, adalimumab; anti-CCP, anticyclic citrullinated peptide; CRP, C-reactive protein; DAS28, disease activity score in 28 joints; DMARD, disease-modifying antirheumatic drug; HAQ-DI, health assessment questionnaire disability index; JSN, joint space narrowing; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PBO, placebo; RF, rheumatoid factor; SD, standard deviation; SDAI, simplified disease activity index; SJC, swollen joint count; TJC, tender joint count; mTSS, modified total Sharp score; VAS, visual analogue scale.