Demographics and baseline characteristics
| Placebo (n=52) | SAR 100 mg q2w (n=51) | SAR 150 mg q2w (n=51) | SAR 100 mg qw (n=50) | SAR 200 mg q2w (n=52) | SAR 150 mg qw (n=50) | All (n=306) | |
|---|---|---|---|---|---|---|---|
| Population | |||||||
| Age, mean (SD) | 55.2 (12.5) | 53.5 (11.8) | 51.2 (12.9) | 53.9 (12.3) | 48.7 (12.4) | 50.9 (11.1) | 52.2 (12.3) |
| Female, N (%) | 38 (73.1) | 38 (74.5) | 42 (82.4) | 41 (82.0) | 42 (80.8) | 42 (84.0) | 243 (79.4) |
| Caucasian/White, N (%) | 49 (94.2) | 49 (96.1) | 49 (96.1) | 47 (94.0) | 47 (90.4) | 46 (92.0) | 287 (93.8) |
| Region, N (%) | |||||||
| Western countries | 16 (30.8) | 15 (29.4) | 16 (31.4) | 14 (28.0) | 16 (30.8) | 17 (34.0) | 94 (30.7) |
| South America | 13 (25.0) | 14 (27.5) | 13 (25.5) | 13 (26.0) | 14 (26.9) | 13 (26.0) | 80 (26.1) |
| Rest of the world | 23 (44.2) | 22 (43.1) | 22 (43.1) | 23 (46.0) | 22 (42.3) | 20 (40.0) | 132 (43.1) |
| Baseline Disease Characteristics | |||||||
| Duration of RA (years), mean (SD) | 8.07 (8.62) | 9.76 (9.08) | 7.74 (7.20) | 8.07 (8.68) | 5.95 (6.18) | 7.30 (8.28) | 7.81 (8.08) |
| Average MTX dose (mg/wk), mean (SD) | 16.9 (4.2) | 16.2 (4.1) | 17.1 (6.4) | 16.7 (3.5) | 16.6 (3.8) | 16.4 (4.9) | 16.6 (4.5) |
| Prior biological DMARD use, N (%) | 12 (23.1) | 13 (25.5) | 12 (23.5) | 12 (24.0) | 14 (26.9) | 12 (24.0) | 75 (24.5) |
| RF positive, N (%) | 35 (67.3) | 42 (82.4) | 44 (86.3) | 35 (70.0) | 44 (86.3) | 43 (86.0) | 243 (79.7) |
| Anti-CCP antibody positive, N (%) | 16 (72.7) | 16 (80.0) | 21 (95.5) | 14 (70.0) | 20 (87.0) | 18 (85.7) | 105 (82.0) |
| TJC (0–68), mean (SD) | 27.09 (16.12) | 30.31 (14.68) | 26.94 (16.79) | 29.12 (15.36) | 25.52 (14.21) | 25.36 (11.97) | 27.39 (14.93) |
| SJC (0–66), mean (SD) | 17.45 (11.68) | 19.53 (9.46) | 17.59 (10.60) | 16.76 (9.05) | 16.63 (8.94) | 16.29 (8.33) | 17.38 (9.73) |
| DAS28(CRP), mean (SD) | 6.08 (0.86) | 6.28 (0.92) | 6.11 (0.91) | 6.05 (0.79) | 6.06 (0.90) | 6.07 (0.65) | 6.11 (0.84) |
| CRP (mg/L), median | 21.8 | 19.8 | 17.6 | 17.0 | 19.0 | 17.1 | 19.2 |
All patients received methotrexate (MTX) 10–25 mg/week.
anti-CCP, anti-cyclic citrullinated peptide; CRP, C reactive protein; DAS28, disease activity score 28 joint count; DMARDs, disease-modifying antirheumatic drugs; q2w, every 2 weeks; qw, every week; RA, rheumatoid arthritis; RF, rheumatoid factor; SAR, sarilumab; SJC, swollen joint count; TJC, tender joint count.