Week | With 50% CRP decrease by week 4 | Without 50% CRP decrease by week 4 | |||
Pooled secukinumab 150 mg (N=140) | Pooled placebo (N=28) | Pooled secukinumab 150 mg (N=57) | Pooled placebo (N=165) | ||
ASAS20, % | 16 | 72.1*** | 35.7 | 33.3 | 27.9 |
156 | 77.8 | – | 56.2 | – | |
ASAS40, % | 16 | 49.3** | 14.3 | 15.8 | 12.1 |
156 | 64.1 | – | 32.3 | – | |
BASDAI, mean change from baseline | 16 | −2.69**** | −0.60 | −1.34 | −0.78 |
156 | −3.42 | – | −2.22 | – | |
BASDAI50, % | 16 | 42.1** | 10.7 | 17.5* | 9.1 |
156 | 60.8 | – | 33.1 | – | |
ASDAS inactive disease, % | 16 | 21.4 | 0.0 | 5.3 | 3.6 |
156 | 25.3 | – | 16.6 | – | |
ASAS partial remission, % | 16 | 18.6 | 0.0 | 5.3 | 4.2 |
156 | 31.8 | – | 7.7 | – |
*p<0.05 ;**p<0.01;***p<0.001; ****p<0.0001 vs placebo; missing values were imputed as non-response at week 16. MI and MMRM data presented at week 156 included n=120 and 39 with and without 50% CRP decrease by week 4, respectively. One placebo patient from each study (MEASURE 1 and 2) did not included in the analysis of 50% CRP decrease by week 4 due to unavailability of the post baseline CRP value. For BASDAI, LS mean change from baseline was presented using MMRM at weeks 16 and 156.
ASAS, Assessment of SpondyloArthritis international Society criteria; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C-reactive protein; LS, least squares; MI, multiple imputation; MMRM, mixed-effect model repeated measures; N, number of patients included in this pooled study at week 16; n, number of patients in this pooled study at week 156.