Baseline demographics and disease characteristics. Data are given as mean (SD) unless otherwise indicated.
| Characteristics | Dose Groups | |||||
|---|---|---|---|---|---|---|
| SBI/Pbo/Pbo, n = 43 | SBI/SBI/Pbo, n = 42 | SBI/Pbo/SBI, n = 43 | SBI/SBI/SBI, n = 41 | Pbo/Pbo/Pbo, n = 40 | Total, n = 209 | |
| Age, yrs | 56.8 (10.8) | 53.9 (10.8) | 52.9 (14.2) | 57.9 (10.6) | 52.0 (13.6) | 54.7 (12.2) |
| Female, n (%) | 35 (81.4) | 30 (71.4) | 34 (79.1) | 32 (78.1) | 33 (82.5) | 164 (78.5) |
| Race, n (%) | ||||||
| Asian | 7 (16.3) | 8 (19.1) | 7 (16.3) | 7 (17.1) | 7 (17.5) | 36 (17.2) |
| Black | 1 (2.3) | 1 (2.4) | 1 (2.3) | 1 (2.4) | 1 (2.5) | 5 (2.4) |
| White | 35 (81.4) | 33 (78.6) | 33 (76.7) | 32 (78.1) | 31 (77.5) | 164 (78.5) |
| Other | 0 | 0 | 2 (4.7) | 1 (2.4) | 1 (2.5) | 4 (1.9) |
| Duration of RA, yrs | 9.0 (8.7) | 8.9 (8.1) | 8.9 (8.6) | 7.8 (7.3) | 7.7 (6.5) | 8.5 (7.8) |
| Anti-TNF–naive, n (%) | 33 (76.7) | 31 (73.8) | 32 (74.4) | 30 (73.2) | 29 (72.5) | 155 (74.2) |
| Baseline MTX dose, mg/week | 15.7 (5.0) | 16.8 (5.3) | 14.8 (5.8) | 14.6 (6.2) | 15.8 (5.9) | 15.5 (5.7) |
| Concomitant corticosteroids, n (%) | 25 (58.1) | 27 (64.3) | 19 (44.2) | 21 (51.2) | 19 (47.5) | 111 (53.1) |
| CRP, mg/l | 15.9 (16.2) | 15.8 (20.2) | 22.2 (22.4) | 14.1 (16.3) | 21.8 (34.0) | 18.0 (22.7) |
| ESR, mm/h | 41.9 (16.4) | 41.2 (18.5) | 47.0 (26.3) | 40.6 (16.1) | 43.3 (18.0) | 42.8 (19.4) |
| B cell count, cells/µl | 191.3 (152.1) | 194.8 (159.5) | 185.0 (134.7) | 151.2 (87.7) | 183.7 (93.5) | 181.2 (129.5) |
| DAS28-CRP | 5.7 (0.8) | 5.5 (0.8) | 5.8 (1.0) | 5.5 (0.9) | 5.5 (1.1) | 5.6 (0.9) |
| General health VAS (0–100) | 54.7 (19.5) | 62.1 (20.0) | 65.2 (17.8) | 63.6 (17.4) | 60.3 (22.6) | 61.2 (19.7) |
| Pain VAS (0–100) | 49.5 (21.0) | 58.8 (20.5) | 61.4 (19.1) | 54.2 (21.4) | 59.3 (20.0) | 56.6 (20.7) |
| FACIT | 29.0 (10.0) | 28.3 (9.9) | 25.5 (10.9) | 26.5 (10.0) | 26.5 (12.7) | 27.2 (10.7) |
| TJC28 | 15.1 (6.3) | 13.0 (6.0) | 14.2 (5.9) | 13.4 (6.4) | 13.4 (7.3) | 13.8 (6.4) |
| SJC28 | 11.4 (4.6) | 10.5 (4.8) | 11.9 (6.0) | 10.4 (5.2) | 10.4 (5.3) | 10.9 (5.2) |
| HAQ-DI | 1.5 (0.6) | 1.5 (0.6) | 1.5 (0.6) | 1.4 (0.7) | 1.4 (0.8) | 1.5 (0.6) |
| PGA | 6.4 (1.6) | 6.7 (1.6) | 6.7 (1.5) | 6.4 (1.4) | 6.5 (2.0) | 6.5 (1.6) |
| PtGA | 5.9 (2.2) | 6.4 (1.9) | 6.7 (1.8) | 6.6 (1.8) | 6.9 (2.0) | 6.5 (2.0) |
SBI: SBI-087; Pbo: placebo; RA: rheumatoid arthritis; TNF: tumor necrosis factor; MTX: methotrexate; CRP: C-reactive protein; DAS28-CRP: 28-joint Disease Activity Score using CRP; ESR: erythrocyte sedimentation rate; VAS: visual analog scale; FACIT: Functional Assessment of Chronic Illness Therapy; TJC28: tender joint count of 28 joints; SJC28: swollen joint count of 28 joints; HAQ-DI: Health Assessment Questionnaire–Disability Index; PGA: physician’s global assessment; PtGA: patient’s global assessment.