Introduction/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 moderateto-severe plaque psoriasis. Previous reports showed evidence for secukinumab’s efficacy with respect to Psoriasis Area and Severity Index (PASI) 75 and 90 response at Week 12 and to Investigator’s Global Assessment (IGA) mod 2011 response (0 or 1) at Week 12. This analysis evaluates the further benefit on patient-reported outcome (PRO) responses of achieving improvements in objective skin clearing (as defined by PASI 90 status vs. PASI 75–89 status).
Materials/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 150mg, secukinumab 300mg, and placebo) and 1:1:1:1 in FIXTURE (including an etanercept 50mg twice-weekly group). PROs were assessed using the Dermatology Life Quality Index (DLQI) and the visual analog scale (VAS) from the EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D) at baseline and Weeks 4, 8, 12, 24, 36, and 52. Subjects achieving clinical response (PASI 90 or PASI 75-89) and PRO meaningful response (DLQI [0 or1] or EQ-5D VAS (>7 points) were compared using the chi-square test.
Results: Among the 1,144 subjects randomized to secukinumab (150mg, n=572; 300mg, n=572), 550 (48.3%) were PASI 90 responders, and 292 (25.5%) were PASI 75 to 89 responders at Week 12. Subjects achieving both clinical response and DLQI response were significantly higher among the PASI 90 compared with PASI 75 to 89 responders at Week 12 (70.0% vs. 48.1%; P<0.05). The response rates were similar between PASI 90 and PASI 75 to 89 responders (73.8% vs. 70.9%; P>0.05) who achieved EQ-5D VAS response at Week 12.
Conclusions: Psoriasis skin clearing is related to improvements in some measures of health-related quality of life and health status, with a meaningful reduction in DLQI associated with better improvements in objective skin clearing (PASI 90 vs. PASI 75–89).
