Secukinumab (N=24) | Placebo (N=13) | p Value | |
---|---|---|---|
HAQ-DI* | |||
Baseline, mean (SD) | 1.64 (0.66) | 1.20 (0.71) | |
Week 6, mean (SD) | –20.6 (30.3) | 0.25 (14.0) | 0.002 |
Patients with reduction from baseline >0.3 (n/nT;† %) | 7/20 (35.0%) | 0/10 (0.0%) | 0.038 |
Week 12, mean (SD) | –27.94 (35.5) | 6.34 (25.5) | 0.004 |
Patients with reduction from baseline >0.3 (n/nT;† %) | 9/21 (42.9%) | 1/11 (9.1%) | 0.056 |
Week 24/EOS, mean (SD) | –19.68 (30.037) | 17.09 (54.5) | 0.019 |
Patients with reduction from baseline >0.3 (n/nT;† %) | 9/23 (39.1%) | 1/11 (9.1%) | 0.077 |
SF-36 physical component score‡ | |||
Baseline, mean (SD) | 30.8 (10.0) | 36.1 (9.0) | |
Week 6, mean (SD) | 15.2 (28.4) | –0.51 (29.6) | 0.030 |
Week 12, mean (SD) | 20.4 (32.6) | –3.25 (19.4) | 0.037 |
Week 24/EOS, mean (SD) | 15.2 (28.1) | –2.61 (26.0) | 0.148 |
*p value comparison is for mean changes from baseline, secukinumab versus placebo.
†n, number of subjects with HAQ-DI reduction from baseline >0.3; nT, total number of subjects at visit with non-missing HAQ-DI values at baseline and at visit.
‡p value comparison is for mean changes from baseline, secukinumab versus placebo (mixed-effect model).
EOS, end of study; HAQ-DI, Health Assessment Questionnaire Disability Index; SF-36, Short Form Health Survey.