Secukinumab Approved as New Biologic Treatment Option for Hidradenitis Suppurativa

The US Food and Drug Administration (FDA) recently announced approval of Cosentyx (secukinumab) for the treatment of hidradenitis suppurativa (HS). This is the first new biologic treatment in almost a decade for HS.¹

The approval was granted based on analyses from the Phase III programs SUNSHINE and SUNRISE, in which a higher proportion of patients given secukinumab 300 mg either every 2 weeks or every 4 weeks achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to placebo.² Secukinumab for HS has been approved as a 300-mg dose that should be administered every 4 weeks, with the option to increase to every 2 weeks if the patient has an inadequate response. In both studies, secukinumab was evaluated over 16-week (vs placebo) and 52-week treatment periods where its onset of action occurred as early as week 2. The efficacy increased to week 16 and was observed up to week 52.³

Secukinumab is the first and only fully human biologic that targets and blocks IL-17A, which is an important cytokine associated with the inflammation of psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis.^4,5 As a proven medicine, secukinumab has been studied clinically for more than 14 years.

Important safety information and caution when using secukinumab include an increased risk of infections, serious allergic reactions, inflammatory bowel disease, severe skin reactions, cold symptoms, diarrhea, and upper respiratory tract infections.¹

References
1. FDA approves Novartis Cosentyx as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade. News release. Novartis. October 31, 2023. Accessed November 1, 2023. https://www.novartis.com/us-en/news/media-releases/fda-approves-novartis-cosentyx-first-new-biologic-treatment-option-hidradenitis-suppurativa-patients-nearly-decade

2. Highlights of prescribing information. Novartis. October 31, 2023. Accessed November 1, 2023. https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf

3. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023;401(10378):747-761. doi:10.1016/S0140-6736(23)00022-3

4. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167(4):717-724. doi: 0.1111/j.1365-2133.2012.11099.x

5. McGonagle DG, McInnes IB, Kirkham BW, Sherlock J, Moots R. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Annals Rheum Dis. 2019;78(9):1167-1178. doi:10.1136/annrheumdis-2019-215356