Etanercept + Methotrexate (n=260) |
DMARD + Methotrexate (n=126) |
|
---|---|---|
Demographic and Baseline Characteristics | ||
Age, mean (SD), y | 48.4 (11.8) | 48.4 (11.2) |
Female, n (%) | 227 (87.3) | 115 (91.3) |
Ethnicitya | ||
White, n (%) | 120 (46.2) | 55 (43.7) |
Mestizos, n (%) | 57 (21.9) | 32 (25.4) |
African-Latin American, n (%) | 36 (13.8) | 22 (17.5) |
Other, n (%) | 47 (18.1) | 17 (13.5) |
Body mass index, (kg/m2) mean (SD) | 26.4 (4.9) | 27.3 (5.0) |
Prior tobacco use, n (%) | 63 (24.2) | 30 (23.8) |
Baseline Disease Characteristics | ||
Disease duration, mean (SD), y | 7.8 (6.9) | 9.0 (7.7) |
C-reactive protein (mg/L), mean (SD) | 21.4 (26.1) | 20.4 (21.9) |
Rheumatoid factor positive, n (%) | 227 (87.3) | 104 (82.5) |
Cyclic citrulinated peptide antibody positive, n (%) | 232 (89.2) | 107 (84.9) |
Erythrocyte sedimentation rate (mm/h), mean (SD) | 43.1 (16.6) | 42.7 (16.1) |
DAS28 (ESR), mean (SD) | 6.6 (0.8) | 6.7 (0.8) |
Tender joint count, mean (SD)b | 25.3 (11.8) | 27.1 (12.6) |
Swollen joint count, mean (SD)b | 18.4 (8.5) | 19.8 (10.5) |
Physician global assessment (1–10), mean (SD) | 6.7 (1.6) | 6.7 (1.6) |
Duration of morning stiffness, min, mean (SD) | 182.5 (265.4) | 142.7 (149.6) |
Prior Medication Use | ||
Prior methotrexate use, n (%) | 260 (100.0) | 126 (100.0) |
Prior NSAID use, n (%) | 216 (83.1) | 110 (87.3) |
Prior corticosteroid use, n (%) | 194 (74.6) | 93 (73.8) |
Baseline Patient-Reported Characteristics | ||
Total HAQ disability index, mean (SD) | 1.6 (0.7) | 1.6 (0.7) |
Subject global assessment (1–10), mean (SD) | 7.1 (2.0) | 7.2 (1.9) |
VAS general health (0–100 mm), mean (SD) | 59.7 (21.4) | 61.6 (20.5) |
VAS pain (0–100 mm), mean (SD) | 64.9 (21.2) | 64.9 (21.5) |
VAS fatigue (0–100 mm), mean (SD) | 55.7 (26.0) | 58.1 (25.6) |
SF-36 PCS, mean (SD) | 30.4 (7.2) | 30.1 (6.8) |
SF-36 MCS, mean (SD) | 40.2 (11.1) | 39.7 (10.1) |
SF-36 vitality domain score, mean (SD) | 12.3 (3.8) | 12.2 (3.8) |