Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study)

Journal of the European Academy of Dermatology and Venereology

5 years ago

Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study)

S Xia, U Mrowietz, C Leonardi, A Lacombe, D Thaçi, R Mazur, R Bissonnette, P Charef, M Milutinovic, D Toth, T Luger, M Patekar

Background Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has been shown to have significant efficacy and a favorable safety profile in the treatment of moderate to severe psoriasis and psoriatic arthritis. Objective To assess the efficacy and safety of secukinumab through 5 years of treatment in moderate to severe psoriasis. Methods In the core SCULPTURE study, Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 continued receiving subcutaneous secukinumab until Year 1. Thereafter, patients entered the extension phase and continued treatment as per the core trial. Treatment was double-blinded until the end of Year 3 and open-label from Year 4. Here we focus on the 300 mg fixed-interval (every 4 weeks) treatment, the recommended per label dose. Efficacy data are primarily reported as observed but multiple imputation (MI) and last observation carried forward (LOCF) techniques were also undertaken as supportive analyses. Results At Year 1, 168 patients entered the extension study and at the end of Year 5, 126 patients completed 300mg (every 4 weeks) treatment. PASI 75/90/100 responses at Year 1 (88.9%, 68.5% and 43.8%, respectively) were sustained to Year 5 (88.5%, 66.4% and 41%). PASI responses were consistent regardless of the analysis undertaken (as observed, MI, or LOCF). The average improvement in mean PASI was approximately 90% through 5 years compared to core study baseline. DLQI (dermatology life quality index) 0/1 response also sustained through 5 years (72.7% at Year 1 and 65.5% at Year 5). The safety profile of secukinumab remained favorable, with no cumulative or unexpected safety concerns identified. Conclusion Secukinumab 300 mg treatment delivered high and sustained levels of skin clearance and improved quality of life through 5 years in patients with moderate to severe psoriasis. Favorable safety established in the secukinumab phase 2/3 program was maintained to 5 years. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/jdv.14878