1. Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa: Primary Endpoint Analysis from the SUNSHINE and SUNRISE Phase III Trials
- Author
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Afsaneh Alavi, Gregor Jemec, Alice Gottlieb, Xiaoling Wei, Magdalena Wozniak, Lorenz Uhlmann, Angela Llobet Martinez, Deborah Keefe, Ruvie Martin, Li Chen, Elisa Muscianisi, and Helen Boreham
- Abstract
The primary endpoint analyses from the SUNSHINE and SUNRISE Phase III trials of secukinumab in moderate-to-severe hidradenitis suppurativa (HS) were featured in an oral presentation as part of the late-breaking news session at the 31st annual European Academy of Dermatology and Venereology (EADV) congress. Known collectively as the SUNNY trials, the SUNSHINE and SUNRISE studies represent the largest Phase III trials conducted in HS to date. The primary endpoint was met in both studies for the every 2 weeks (Q2W) regimen, and in one for the every 4 weeks (Q4W) regimen, demonstrating the superiority of secukinumab over placebo in patients with moderate-to-severe HS. Secukinumab delivered rapid symptom relief and showed a favourable safety profile consistent with its use in other indications. Available data on file from the Week 52 database lock support the sustained efficacy beyond Week 16 with no new safety findings. Based on the positive outcomes of these milestone clinical trials, secukinumab is expected to be a new, safe, and effective biologic treatment option with a novel mode of action, targeting IL-17A, for moderate-to-severe HS.
- Published
- 2022
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