Table 1.
Baseline demographics and disease characteristics (TP2 full analysis set)
| Characteristics | Continued SDZ ETN (n = 175) | Switched to SDZ ETN (n = 166) |
|---|---|---|
| Age (years) | 55.1 (10.99) | 52.2 (12.84) |
| Female, n (%) | 149 (85.1) | 131 (78.9) |
| Race,a n (%) | ||
| Caucasian | 169 (96.6) | 164 (98.8) |
| Functional RA status, n (%) | ||
| Class I | 20 (11.4) | 25 (15.1) |
| Class II | 122 (69.7) | 121 (72.9) |
| Class III | 33 (18.9) | 20 (12.0) |
| DAS28-CRP | 5.42 (0.92) | 5.54 (0.78) |
| DAS28-ESR | 6.34 (0.88) | 6.42 (0.76) |
| Tender 28 joint count | 14.1 (6.21) | 14.5 (5.57) |
| Swollen 28 joint count | 10.6 (5.22) | 11.0 (5.39) |
| C-reactive protein (mg/L) | 12.0 (21.63) | 11.3 (16.34) |
| HAQ-DI score | 1.45 (0.55) | 1.47 (0.56) |
| FACIT-fatigue score | 26.82 (9.55) | 25.32 (10.14) |
| Duration of rheumatoid arthritis (years) | 8.75 (8.22) | 8.11 (6.93) |
| Rheumatoid factor, positive,b n (%) | 130 (74.30) | 118 (71.10) |
| Anti-CCP, positive, b n (%) | 138 (78.90) | 119 (71.70) |
| Prior therapy,c n (%) | ||
| MTX only | 53 (30.3) | 46 (27.7) |
| MTX + any DMARDs | 68 (38.9) | 69 (41.6) |
| MTX + any anti-TNF | 30 (17.1) | 28 (16.9) |
| MTX + any other biologic | 24 (13.7) | 23 (13.9) |
| Previous DMARDs used, n (%) | ||
| 1 | 53 (30.3) | 46 (27.7) |
| 2 | 69 (39.4) | 62 (37.3) |
| 3 | 34 (19.4) | 39 (23.5) |
| 4 or more | 19 (10.9) | 19 (11.4) |
| MTX dose (mg/week) | 16.0 (4.9) | 17.0 (4.7) |
| Duration of MTX (months) | 56.3 (49.9) | 59.3 (52.4) |
Values are mean (SD) unless stated otherwise
CCP cyclic citrullinated peptide, DAS28-CRP disease activity score 28-joint count, C-reactive protein, DMARDs disease-modifying anti-rheumatic drugs, ESR erythrocyte sedimentation rate, ETN reference etanercept, FACIT Functional Assessment of Chronic Illness Therapy, HAQ-DI Health assessment questionnaire disability index, MTX methotrexate, RA rheumatoid arthritis, SDZ ETN Sandoz etanercept, SD standard deviation, TNF tumor necrosis factor, TP2 treatment period 2
aOther race categories in “continued SDZ ETN” group included Black or African American (n = 5), and American Indian or Alaska Native (n = 1), and in “switched to SDZ ETN” group included Asian (n = 1) and American Indian or Alaska Native (n = 1)
bRheumatoid factor ≤ 10 UI/mL and anti-CCP < 17 U/mL are considered negative
cPrior therapy strata is arranged according to the hierarchy