Table 1

Baseline demographics and disease characteristics

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, year56.1 (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, year11.0 (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/week17.4 (9.5)16.8 (4.2)0019.4 (2.5)
Corticosteroid use, n (%)90 (43)99 (50)96 (36)91 (35)149 (43)
Corticosteroid dose, mg/day3.0 (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/dL1.8 (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.