Table 3.
Efficacy endpoints at week 16 by anti-TNF status
| Endpoints | Secukinumab IV-300 mg | Secukinumab IV-150 mg | Placebo |
|---|---|---|---|
| Anti-TNF-naïve | N = 57 | N = 57 | N = 59 |
| ASAS20, n (%) | 37 (64.9)§ | 36 (63.2)‡ | 23 (39.0) |
| ASAS40, n (%) | 25 (43.9)‡ | 25 (43.9)‡ | 14 (23.7) |
| hsCRP (post-baseline/baseline ratio), LS mean change ± SE | 0.43 ± 1.1* | 0.51 ± 1.1† | 0.91 ± 1.1 |
| ASAS 5/6, n (%) | 24 (42.1)‡ | 26 (45.6)§ | 11 (18.6) |
| BASDAI, LS mean change ± SE | -3.2 ± 0.3§ | -2.6 ± 0.3 | -1.9 ± 0.3 |
| ASAS partial remission, n (%) | 12 (21.1)§ | 6 (10.5) | 1 (1.7) |
| Anti-TNF-IR | N = 19 | N = 17 | N = 17 |
| ASAS20, n (%) | 9 (47.4) | 7 (41.2) | 5 (29.4) |
| ASAS40, n (%) | 7 (36.8) | 5 (29.4) | 2 (11.8) |
| hsCRP (post-baseline/baseline ratio), LS mean change ± SE | 0.57 ± 1.2§ | 0.58 ± 1.3§ | 1.5 ± 1.2 |
| ASAS 5/6, n (%) | 6 (31.6)‡ | 5 (29.4)‡ | 0 |
| BASDAI, LS mean change ± SE | -1.8 ± 0.6 | -2.2 ± 0.6 | -0.9 ± 0.6 |
| ASAS partial remission, n (%) | 4 (21.1) | 1 (5.9) | 0 |
Non-responder imputation (binary variables) and mixed-model repeated measures (continuous variables) analyses are presented
TNF tumor necrosis factor, N number of patients, ASAS Assessment of SpondyloArthritis international Society, hsCRP high-sensitivity C-reactive protein, LS least squares, SE standard error, BASDAI Bath Ankylosing Spondylitis Disease Activity Index
‡ P < 0.05, § P < 0.01, † P < 0.001, * P < 0.0001 vs placebo. P-values are unadjusted