INTRODUCTION AND OBJECTIVES: Secukinumab, an antiinterleukin- 17A antibody, was evaluated in phase 3 clinical studies for efficacy and safety in subjects with moderate-to severe plaque psoriasis. This analysis evaluates the benefit on patient-reported outcome (PRO) responses of achieving improvements in objective skin clearing (as defined by PASI90 status versus PASI75 status).
MATERIALS AND METHODS: Patients aged greater than or =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 less than 0.05). The response rates were similar between PASI90 and PASI75 responders (73.8% vs 70.9%; P-value greater than 0.05) who achieved EQ-5 D VAS response at week 12.
CONCLUSIONS: Results showed a meaningful reduction of the DLQI associated with better improvements in objective skin clearing (PASI90 versus PASI75).
