Table 1.
Demographic and baseline characteristics of the patients
| Characteristic | Secukinumab IV-300 mg (N = 76) | Secukinumab IV-150 mg (N = 74) | Placebo (N = 76) |
|---|---|---|---|
| Age (years), mean (SD) | 42.1 (11.8) | 42.9 (11.1) | 42.7 (11.4) |
| Male, n (%) | 50 (65.8) | 46 (62.2) | 40 (52.6) |
| White, n (%) | 52 (68.4) | 54 (73.0) | 58 (76.3) |
| Weight (kg), mean (SD) | 82.7 (16.9) | 80.3 (19.2) | 79.0 (15.5) |
| Time since AS diagnosis (years), mean (SD) | 5.3 (7.3) | 6.0 (7.2) | 5.2 (6.4) |
| HLA-B27-positive at baseline, n (%) | 56 (73.7) | 52 (70.3) | 53 (69.7) |
| Anti-TNF-naïve, n (%) | 57 (75.0) | 57 (77.0) | 59 (77.6) |
| Total BASDAI score, mean (SD) | 7.0 (1.4) | 7.0 (1.4) | 6.9 (1.3) |
| hsCRP (mg/L), median (min–max) | 13.3 (0.2–65.1) | 21.1 (0.4–111.3) | 20.0 (0.2–112.5) |
| Total back pain score (0–100 mm scale), mean (SD) | 74.1 (15.1) | 75.2 (14.9) | 75 (13.9) |
| Baseline systemic treatment, n (%) | |||
| Methotrexate use at randomization | 13 (17.1) | 10 (13.5) | 6 (7.9) |
| Sulfasalazine use at randomization | 20 (26.3) | 14 (18.9) | 19 (25.0) |
| Corticosteroid use at randomization | 6 (7.9) | 9 (12.2) | 14 (18.4) |
| NSAID use at randomization | 63 (82.9) | 62 (83.8) | 64 (84.2) |
n number of patients, SD standard deviation, AS ankylosing spondylitis, HLA human leukocyte antigen, TNF tumor necrosis factor, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, hsCRP high-sensitivity C-reactive protein, NSAID non-steroidal anti-inflammatory drugs