Table 2.
Efficacy endpoints at week 16 using non-responder imputation
| Endpoints | Secukinumab IV-300 mg (N = 76) | Secukinumab IV-150 mg (N = 74) | Placebo (N = 76) |
|---|---|---|---|
| ASAS20, n (%) | 46 (60.5)§ | 43 (58.1)‡ | 28 (36.8) |
| ASAS40, n (%) | 32 (42.1)‡ | 30 (40.5)‡ | 16 (21.1) |
| hsCRP (post-baseline/baseline ratio), mean change from baseline ± SE | 0.48 ± 1.1‡ | 0.55 ± 1.1‡ | 1.09 ± 1.1 |
| ASAS 5/6, n (%) | 30 (39.5)‡ | 31 (41.9)‡ | 11 (14.5) |
| BASDAI, mean change from baseline ± SE | -2.7 ± 0.3‡ | -2.3 ± 0.3‡ | -1.5 ± 0.3 |
| ASAS partial remission, n (%) | 16 (21.1)‡ | 7 (9.5) | 1 (1.3) |
Non-responder imputation (binary variables) and mixed-model repeated measures (continuous variables) data are presented
ASAS20 20% response according to criteria of the Assessment of Spondyloarthritis International Society, ASAS40 40% response according to ASAS criteria, hsCRP high-sensitivity C-reactive protein, BASDAI Bath Ankylosing Spondylitis Disease Activity Index
ASAS Assessment of SpondyloArthritis international Society, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, hsCRP high-sensitivity C-reactive protein, N number of patients, SE standard error
‡ P < 0.05, § P < 0.01 vs placebo. P values were adjusted for multiplicity of testing