In 2015, the U.S. Food and Drug Administration (FDA) approved secukinumab (Cosentyx), the first fully-human IL-17A inhibitor approved to treat psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).1 And data recently presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland, demonstrates sustained efficacy and safety. The research in patients with moderate to severe plaque psoriasis showed that secukinumab conveyed high- and long-lasting skin clearance at five years.
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In the SCULPTURE study, Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 were randomized to double-blind maintenance treatment of 300 or 150 mg secukinumab given at a four-week, fixed-interval regimen or as needed. Patients who completed 52 weeks of the SCULPTURE study (N=642) were eligible to continue the same dose and regimen in the extension study. The five-year extension study (A2304E1) is a multicenter, double-blind and open-label extension of the Phase 3 SCULPTURE study.
The primary objective of the open-label extension was to assess the long-term safety and tolerability of secukinumab in patients with moderate to severe plaque psoriasis. Efficacy measures were the proportion of patients achieving PASI 75, PASI 90 and PASI 100. At Year 1, the PASI 75 response rate was 89%, and the PASI 90 response rate was 69%. This high rate maintained at Year 5, with a PASI 75 response rate of 89% and a PASI 90 response rate of 66%. Additionally at Year 1, 44% of psoriasis patients achieved completely clear skin (PASI 100), and this rate was maintained to Year 5 (41%). The drug continued to exhibit a favorable and consistent safety profile, with low immunogenicity.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Novartis. Press release: Novartis’ Cosentyx sets new benchmark in psoriasis with robust five-year sustained Phase III efficacy and safety data. 2017 Sep 19.