Baseline demographic and disease characteristics
| ADA/MTX (n=87) | PBO/MTX (n=85) | p Value | |
|---|---|---|---|
| Female, n (%) | 61 (70.1) | 57 (67.1) | 0.67 |
| Age, mean±SD years | 47.2±12.12 | 52.5±14.34 | 0.009 |
| Disease duration, months±SD | 1.8±2.09 | 1.6±1.7 | 0.57 |
| Disease duration <4 months in days, n (%) | 76.0 (87.4) | 73.0 (85.9) | 0.96 |
| IgM RF positive, n (%) | 55 (63.2) | 59 (69.4) | 0.51 |
| ACPA positive, n (%) | 46 (52.9) | 45 (52.9) | 0.88 |
| DAS28, mean±SD | 6.2±0.8 | 6.3±0.9 | 0.60 |
| TJC 0–28, mean±SD | 13.0±6.5 | 13.1±5.9 | 0.61 |
| SJC 0–28, mean±SD | 10.2±5.0 | 10.7±4.5 | 0.61 |
| TJC 0–68, mean±SD | 20.9±12 | 19.4±10.6 | 0.38 |
| SJC 0–66, mean±SD | 13.6±7.1 | 14.0±6.9 | 0.76 |
| ESR in mm/in first hour median (IQR) | 33 (29–45) | 36 (29–55) | 0.33 |
| CRP in mg/l, median (IQR) | 12 (6–37) | 17 (7–34) | 0.46 |
| Patient's assessment of pain, 100 mm VAS, mean±SD | 62.3±18.8 | 60.9±18.6 | 0.59 |
| Patient's global assessment of disease activity, 100 mm VAS, mean±SD | 63.1±18.2 | 61.8±18.2 | 0.40 |
| Physician's global assessment of disease activity, 100 mm VAS, mean±SD | 62.4±13 | 65.2±13.8 | 0.21 |
| HAQ-DI score, 1–3 scale, mean±SD | 1.4±0.61 | 1.3±0.62 | 0.49 |
| SF-36 mental score, mean±SD | 46.7±9.9 | 45.2±10.2 | 0.34 |
| SF-36 physical score, mean±SD | 28.3±7.7 | 31.7±8.3 | 0.010 |
| Patients with complete radiographic data, n | 51 | 47 | |
| Total SHS, 0–448 scale, mean±SD | 6.3±5.0 | 11.4±14.8 | 0.19 |
| SHS erosion score, 0–280 scale, mean±SD | 2.2±3.0 | 4.4±8.7 | 0.62 |
| SHS joint space narrowing score, 0–168 scale, mean±SD | 4.1±3.6 | 7.0±7.3 | 0.047 |
| Ratingen score, 0–190 scale, mean±SD | 1.7±2.1 | 2.8±5.0 | 0.75 |
ACPA, anti-citrullinated protein antibodies; ADA, adalimumab; CRP, C reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index, German version; MTX, methotrexate; PBO, placebo; RF, rheumatoid factor; SF-36, Short-Form Health Survey with 36 questions; SHS, modified Sharp/van der Heijde Score; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.