Artikel
Secukinumab is superior to Ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 16-week results from the CLEAR study
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Veröffentlicht: | 1. September 2015 |
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Gliederung
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Introduction: CLEAR is a phase 3b study comparing the efficacy and safety of secukinumab with ustekinumab in moderate to severe plaque psoriasis.
Methods: In this 52-wk, multicenter, double-blind, parallel-group study (NCT02074982), subjects were randomized 1:1 to subcutaneous injection of secukinumab (300 mg) or ustekinumab (dosing per label). Secukinumab was administered at Baseline, Wks 1, 2 and 3, then every 4 wks from Wk 4 to 48. Primary objective: demonstrate the superiority of secukinumab vs. ustekinumab in PASI90 response at Wk 16 (non-responder imputation).
Results: Secukinumab (79.0%; n=334) was superior to ustekinumab (57.6%; n=335) in PASI90 response at Wk 16 (P<0.0001 [logistic regression model]). PASI100 response (clear skin) at Wk 16 was also achieved by a significantly greater proportion of subjects receiving secukinumab (44.3%) than ustekinumab (28.4%) (P<0.0001). Secukinumab was superior to ustekinumab with respect to PASI75 responses at Wk 4: 50.0% vs. 20.6% of subjects, respectively (P<0.0001). Secukinumab’s safety profile was similar to that of ustekinumab and consistent with that seen in secukinumab pivotal phase 3 studies.
Conclusion: Secukinumab treatment – even at early timepoints – has demonstrated superiority to ustekinumab in clearing skin of subjects with moderate to severe psoriasis, with a comparable safety profile.