Baseline demographics and disease characteristics
| SB4 50 mg | ETN 50 mg | Total | ||||
|---|---|---|---|---|---|---|
| N=299 | N=297 | N=596 | ||||
| Age (years), mean (SD) | 52.1 | (11.72) | 51.6 | (11.63) | 51.8 | (11.67) |
| Age group, n (%) | ||||||
| <65 years | 253 | (84.6) | 262 | (88.2) | 515 | (86.4) |
| ≥65 years | 46 | (15.4) | 35 | (11.8) | 81 | (13.6) |
| Gender n (%) | ||||||
| Male | 50 | (16.7) | 44 | (14.8) | 94 | (15.8) |
| Female | 249 | (83.3) | 253 | (85.2) | 502 | (84.2) |
| Race, n (%) | ||||||
| White | 279 | (93.3) | 273 | (91.9) | 552 | (92.6) |
| American Indian or Alaskan Native | 5 | (1.7) | 7 | (2.4) | 12 | (2.0) |
| Asian | 11 | (3.7) | 13 | (4.4) | 24 | (4.0) |
| Other | 4 | (1.3) | 4 | (1.3) | 8 | (1.3) |
| Weight (kg), mean (SD) | 72.5 | (15.93) | 71.0 | (14.63) | 71.8 | (15.30) |
| Height (cm), mean (SD) | 164.4 | (8.78) | 164.4 | (8.55) | 164.4 | (8.66) |
| BMI (kg/m2), mean (SD) | 26.8 | (5.51) | 26.3 | (5.30) | 26.6 | (5.41) |
| Disease duration (years), mean (SD) | 6.0 | (4.20) | 6.2 | (4.41) | 6.1 | (4.30) |
| Duration of MTX use (months), mean (SD) | 48.2 | (39.87) | 47.1 | (40.77) | 47.7 | (40.29) |
| MTX dose (mg/week), mean (SD) | 15.6 | (4.52) | 15.5 | (4.60) | 15.5 | (4.56) |
| Swollen joint count (0–66), mean (SD) | 15.4 | (7.48) | 15.0 | (7.30) | 15.2 | (7.39) |
| Tender joint count (0–68), mean (SD) | 23.5 | (11.90) | 23.6 | (12.64) | 23.5 | (12.26) |
| HAQ-DI (0–3), mean (SD) | 1.49 | (0.553) | 1.50 | (0.560) | 1.50 | (0.556) |
| Physician global assessment VAS (0–100), mean (SD) | 62.2 | (15.09) | 63.2 | (14.76) | 62.7 | (14.92) |
| Subject global assessment VAS (0–100), mean (SD) | 61.7 | (18.97) | 63.0 | (17.70) | 62.4 | (18.35) |
| Subject pain assessment VAS (0–100), mean (SD) | 61.8 | (20.22) | 62.3 | (19.22) | 62.1 | (19.71) |
| DAS28 (ESR), mean (SD) | 6.5 | (0.91) | 6.5 | (0.88) | 6.5 | (0.89) |
| C reactive protein (mg/dL), mean (SD) | 1.5 | (2.00) | 1.3 | (1.60) | 1.4 | (1.81) |
| Erythrocyte sedimentation rate (mm/h), mean (SD) | 46.5 | (22.10) | 46.4 | (22.62) | 46.5 | (22.34) |
| Rheumatoid factor positive, n (%) | 237 | (79.3) | 231 | (77.8) | 468 | (78.5) |
BMI, body mass index; DAS28, disease activity score in 28 joints; ETN, reference product etanercept; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; VAS, visual analogue scale.