Introduction and Objectives: Secukinumab (AIN457), a fully human anti-interleukin 17A monoclonal antibody, was evaluated in phase 3 clinical studies for efficacy and safety in subjects with moderate to severe plaque psoriasis. This analysis focused on the impact of skin clearance at week 12, on speed of response to two patient reported outcome (PRO) measures—the Dermatology Life Quality Index (DLQI) and the visual analog scale (VAS) from the EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D).
Materials and Methods: ERASURE and FIXTURE, two multicenter phase 3 trials, were used in this pooled analysis. Patients aged = 18 years were randomized 1:1:1 in ERASURE to subcutaneous treatment groups (secukinumab 150 mg, secukinumab 300 mg, and placebo) and 1:1:1:1 in FIXTURE (including an etanercept 50 mg twice-weekly group). For the present analysis, psoriasis clinical improvement was assessed at week 12 by Psoriasis Area and Severity Index (PASI) with PASI 75 representing 75%-89% reduction in symptoms and PASI 90 representing 90%-100% reduction. The DLQI and EQ-5D were administered at baseline and weeks 4, 8, 12, 24, 36, and 52. DLQI meaningful response was defined as no psoriasis impairment (DLQI total score of 0 or1), and EQ-5D meaningful response was defined as an increase of 7 points or more on the EQ-5D VAS. Time to response was computed as the period from the randomization date to the date when a prespecified response in DLQI (score of 0 or 1) or EQ-5D VAS (increase of at least 7 points) had occurred. Median time to response was estimated using Kaplan-Meier methods comparing PASI75 and PASI90 groups using a stratified log-rank test, stratifying for geographical region and by body weight.
Results: The median time to response on the DLQI was significantly faster for the PASI90 group compared to the PASI75 group (DLQI response: 8 weeks vs. 12 weeks; P-value less than 0.05). Further, both PASI90 and PASI75 groups achieved a median EQ-5D VAS time to response of 4 weeks.
Conclusion: Secukinumab treatment provides fast relief from patient-reported psoriasis quality of life burden in patients with moderate to severe plaque psoriasis. Those with PASI90 response achieved relief faster than those with PASI75 response.
