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 moderate to severe plaque psoriasis. Previous reports showed evidence for secukinumab’s efficacy with respect to PASI75 response at week 12 and to 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 PASI90 status versus PASI75 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 150 mg, secukinumab 300 mg, and placebo) and 1:1:1:1 in FIXTURE (including an etanercept 50 mg twice-weekly group). PRO was 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 (PASI90 or PASI75) and PRO meaningful response (DLQI (0 or1) or EQ-5D VAS (increase of at least 7 points) were compared using the chi-square test.
Results: Among the 1,144 subjects randomized to secukinumab (150 mg n = 572; 300 mg n = 572), 550 (48.3%) were PASI90 responders, and 292 (25.5%) were PASI75 responders at week 12. Subjects achieving both clinical response and DLQI response were significantly higher among the PASI90 compared with PASI75 responders at week 12 (70.0% vs 48.1%; P-value < 0.05). The response rates were similar between PASI90 and PASI75 responders (73.8% vs 70.9%; P-value > 0.05) who achieved EQ-5 D 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 of the DLQI associated with better improvements in objective skin clearing (PASI90 versus PASI75).
