Baseline Characteristic | Initial ADA + MTX | Delayed ADA + MTX | ||||
---|---|---|---|---|---|---|
ADA 20 mg Weekly + MTX, n = 70 | ADA 40 mg Eow + MTX, n = 79 | PBO + MTX, n = 54 | ||||
Age, yrs | 55.1 ± 9.6 | 53.8 ± 11.3 | 53.8 ± 9.9 | |||
Women, n (%) | 53 (75.7) | 57 (72.2) | 38 (70.4) | |||
Rheumatoid factor-positive, n (%) | 55 (78.6) | 65 (82.3) | 50 (92.6) | |||
Duration of RA, yrs | 11.1 ± 9.4 | 11.0 ± 8.1 | 11.2 ± 8.2 | |||
Baseline DMARD use, n (%)a | 70 (100) | 79 (100) | 54 (100) | |||
Baseline oral corticosteroid use, n (%) | 31 (44.3) | 27 (34.2) | 29 (53.7) | |||
Characteristic | Baseline | Year 1 | Baseline | Year 1 | Baseline | Year 1 |
DAS28-CRP, range 0–10 | 5.6 ± 0.8 | 3.3 ± 1.1 | 5.6 ± 0.7 | 3.3 ± 1.0 | 5.6 ± 0.9 | 4.4 ± 1.4 |
CRP, mg/dl | 1.5 ± 1.2 | 1.0 ± 0.5 | 1.9 ± 1.8 | 0.9 ± 0.6 | 1.5 ± 1.4 | 1.2 ± 0.9 |
TJC (0–68 joints) | 26.3 ± 11.8 | 6.8 ± 8.2 | 25.0 ± 10.9 | 8.5 ± 9.9 | 27.9 ± 13.8 | 15.3 ±13.6 |
SJC (0–66 joints) | 19.1 ± 8.7 | 6.0 ± 7.4 | 19.1 ± 9.0 | 6.2 ± 7.6 | 20.0 ± 10.9 | 12.8 ± 10.7 |
HAQ-DI (range, 0–3) | 1.4 ± 0.6 | 0.6 ± 0.6 | 1.3 ± 0.6 | 0.6 ± 0.6 | 1.4 ± 0.6 | 1.0 ± 0.7 |
PGA (100 mm VAS) | 61.7 ± 14.4 | 16.8 ± 15.0 | 60.1 ± 17.0 | 16.1 ± 14.4 | 61.3 ± 19.1 | 34.7 ± 23.4 |
PaGA (100 mm VAS) | 46.2 ± 21.5 | 19.3 ± 19.4 | 49.0 ± 18.8 | 16.0 ± 15.6 | 49.2 ± 22.7 | 37.3 ± 27.1 |
Pain (100 mm VAS) | 49.4 ± 21.5 | 18.7 ± 16.5 | 54.3 ± 19.7 | 19.4 ± 17.8 | 52.2 ± 23.6 | 37.5 ± 26.1 |
mTSS (range, 0–380) | 53.5 ± 55.7 | 53.0 ± 54.8 | 52.9 ± 52.5 | 51.7 ± 51.8 | 45.0 ± 41.2 | 46.8 ± 41.9 |
JE (range, 0–220) | 26.1 ± 29.0 | 25.4 ± 28.2 | 27.7 ± 27.7 | 26.5 ± 27.3 | 21.9 ± 20.4 | 22.5 ± 20.6 |
JSN (range, 0–160) | 27.4 ± 28.5 | 27.6 ± 28.2 | 25.3 ± 26.7 | 25.2 ± 26.4 | 23.1 ± 23.8 | 24.4 ± 24.4 |
↵a Patients enrolled in DE019 received ongoing MTX therapy. ADA; adalimumab; MTX: methotrexate; eow: every other week; PBO: placebo; RA: rheumatoid arthritis; DMARD: disease-modifying antirheumatic drug; DAS28: 28-joint disease activity score; CRP: C-reactive protein; TJC: tender joint count; SJC: swollen joint count; HAQ-DI: Health Assessment Questionnaire-Disability Index; PGA: physician’s global assessment; VAS: visual analog scale; PaGA: patient’s global assessment; mTSS: modified total Sharp score; JE: joint erosion score; JSN: joint space narrowing score.