Characteristic* | DE019 (MTX-IR) | PREMIER (MTX-naive) | OPTIMA (MTX-IR†) | ||
ADA+MTX (n=207) | PBO+MTX (n=200) | ADA+MTX (n=268) | PBO+MTX (n=257) | Rescue ADA (n=348) | |
Age, year | 56.1 (13.5) | 56.1 (12.0) | 51.9 (14.0) | 52.0 (13.1) | 51.2 (13.9) |
Female, n (%) | 158 (76) | 146 (73) | 193 (72) | 190 (74) | 266 (76) |
Rheumatoid factor positive, n (%) | 168 (81) | 179 (90) | 228 (85) | 215 (84) | 274 (79) |
Duration of RA, year | 11.0 (9.2) | 10.9 (8.8) | 0.7 (0.8) | 0.8 (0.9) | 0.8 (0.3) |
Prior DMARD use, n (%) | 207 (100) | 200 (100) | 87 (33) | 81 (32) | 348 (100) |
Prior MTX dose, mg/week | 17.4 (9.5) | 16.8 (4.2) | 0 | 0 | 19.4 (2.5) |
Corticosteroid use, n (%) | 90 (43) | 99 (50) | 96 (36) | 91 (35) | 149 (43) |
Corticosteroid dose, mg/day | 3.0 (5.8) | 2.6 (6.0) | 6.9 (2.5) | 6.8 (3.7) | 6.4 (2.2) |
DAS28(CRP) (range, 0–10) | 5.6 (0.9) | 5.8 (0.9) | 6.3 (0.9) | 6.3 (0.9) | 4.5 (1.2) |
DAS28(CRP)≥5.1, n (%) | 150 (73) | 155 (78) | 230 (89) | 235 (94) | 111 (32) |
CRP, mg/dL | 1.8 (2.3) | 1.8 (2.1) | 3.9 (4.2) | 4.0 (4.0) | 1.3 (2.2) |
SJC (0–66 joints) | 19.3 (9.8) | 19.0 (9.5) | 21.1 (11.2) | 22.1 (11.7) | 9.4 (9.2) |
TJC (0–68 joints) | 27.3 (12.7) | 28.1 (13.8) | 30.7 (14.2) | 32.3 (14.3) | 16.8 (14.7) |
HAQ-DI (range, 0–3) | 1.5 (0.6) | 1.5 (0.6) | 1.5 (0.6) | 1.5 (0.7) | 1.1 (0.6) |
mTSS (range, 0–398) | 72.1 (60.7) | 66.4 (47.4) | 18.1 (20.1) | 21.9 (22.2) | 13.0 (19.5) |
JE (range, 0–230) | 41.4 (33.4) | 37.2 (25.8) | 11.0 (12.3) | 13.6 (13.6) | 5.9 (9.3) |
JSN (range, 0–168) | 30.7 (29.2) | 29.2 (24.5) | 7.1 (9.6) | 8.2 (10.7) | 7.1 (11.6) |
*All values are mean (SD), unless otherwise indicated.
†OPTIMA enrolled MTX-naive patients; the Rescue ADA arm included patients treated with placebo+MTX who did not achieve stable low disease activity (ie, MTX-IR patients) at week 22 or 26, and received open-label ADA+MTX for an additional 52 weeks.
ADA, adalimumab; CRP, C-reactive protein; DAS28(CRP), 28-joint Disease Activity Score based on CRP; DMARD, (non-biological) disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire Disability Index; IR, inadequate response; JE, joint erosion; JSN, joint space narrowing; mTSS, modified total Sharp score; MTX, methotrexate; PBO, placebo; RA, rheumatoid arthritis; SJC, swollen joint count; TJC, tender joint count.