Table 1*.
Baseline characteristics and disease history (TP1 full analysis set)
| Characteristics | GP2015 (n=186) |
ETN (n=190) |
| Age (years) | 55.2 (11.22) | 53.1 (12.70) |
| Male, n (%) | 28 (15.1) | 40 (21.1) |
| Race, n (%) | ||
| Caucasian | 180 (96.8) | 185 (97.4) |
| African American | 5 (2.7) | 1 (0.5) |
| Asian | 0 | 3 (1.6) |
| American Indian or Alaska Native | 1 (0.5) | 1 (0.5) |
| DAS28-CRP | 5.43 (0.92) | 5.55 (0.78) |
| Tender 28-joint count | 14.2 (6.18) | 14.8 (5.78) |
| Swollen 28-joint count | 10.5 (5.28) | 11.1 (5.39) |
| C reactive protein (mg/L) | 11.7 (21.09) | 11.0 (15.83) |
| HAQ-DI score | 1.45 (0.55) | 1.44 (0.58) |
| FACIT fatigue score | 26.95 (9.60) | 25.28 (10.09) |
| Duration of rheumatoid arthritis (years) | 8.79 (8.25) | 8.18 (6.92) |
| Rheumatoid factor, positive, n (%) | 137 (73.70) | 140 (73.70) |
| Anti-CCP, positive, n (%) | 144 (77.40) | 140 (73.70) |
| Prior therapy*, n (%) | ||
| MTX only | 56 (30.1) | 58 (30.5) |
| MTX+any DMARDs | 73 (39.2) | 72 (37.9) |
| MTX+any anti-TNF | 31 (16.7) | 33 (17.4) |
| MTX+any other biologic | 26 (14.0) | 27 (14.2) |
| Previous DMARDs used, n (%) | ||
| 1 | 56 (30.1) | 58 (30.5) |
| 2 | 75 (40.3) | 69 (36.3) |
| 3 | 36 (19.4) | 39 (20.5) |
| 4 or more | 19 (10.2) | 24 (12.6) |
| MTX dose (mg/week) | 16.0 (4.9) | 17.1 (4.6) |
| Prior duration of MTX (months) | 55.6 (49.7) | 59.5 (51.7) |
Prior therapy strata is arranged according to the hierarchy; values are mean (SD) unless otherwise stated; rheumatoid factor ≤10 IU/mL and anti-CCP <17 U/mL are considered negative.
CCP, cyclic citrullinated peptide; DAS28-CRP, disease activity score 28-joint count C reactive protein; DMARD, disease-modifying antirheumatic drug; ETN, reference etanercept; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; TNF, tumour necrosis factor; TP1, treatment period 1.