FDA Approves Cosentyx as Treatment Option for Hidradenitis Suppurativa

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The FDA has approved secukinumab (Cosentyx; Novartis) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults. Secukinumab is now the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS.

HS is a chronic, systemic, and often painful skin disease that can lead to recurring boil-like lumps that can burst into open wounds, causing irreversible scarring. Patients with HS potentially face an average of up to 10 years to receive a proper diagnosis for the condition, according to Novartis. During that time, patients may experience disease progression and their quality of life can be severely inhibited, as noted by studies published by Dermatology and New England Journal of Medicine. Until now, there has been only one biologic approved to treat HS, which is adalimumab.

The FDA’s decision was based on analyses from the largest phase 3 program in HS to date, SUNSHINE (NCT 03713619) and SUNRISE (NCT03713632), in which a higher proportion of patients administered secukinumab 300 mg either every two weeks or every four weeks achieved a hidradenitis suppurativa clinical response (HiSCR50) compared to placebo.

The primary endpoint across both trials, Hidradenitis Suppurativa Clinical Response (HiSCR50), was defined as at least a 50% reduction in abscess and inflammatory nodule count with no increase in the number of abscesses and/or draining tunnels. Secondary endpoints included a drop in abscess and inflammatory nodules by at least 50%, the proportion of patients experiencing a flare, and the proportion of patients with skin pain numeric rating scale 30 response up to 16 weeks of treatment.

In both the aforementioned SUNSHINE and SUNRISE studies, which evaluated secukinumab across 16-week and 52-week treatment periods compared with placebo, the onset of action of secukinumab occurred as early as week 2. Efficacy progressively increased to week 16 and was observed up to week 52. In these trials, a greater proportion of patients receiving secukinumab at 300 mg either every two weeks or every four weeks achieved HiSCR50 compared to placebo (44.5% vs 29.4% [*P<0.05] and 38.3% vs 26.1% [*P<0.05], respectively).

“HS is one of the most devastating and exhausting skin diseases. The pain of flares can be debilitating and limits my ability to work or participate in social activities. It can have a major impact on me physically and emotionally, including feelings of anxiety, stress, and isolation,” said Donna Atherton, EdD, founder and chief mission officer at the International Association of HS Network, in the press release. “The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease."

The safety profile of secukinumab observed in these HS trials was consistent with its known safety profile observed in the plaque psoriasis trials, affirming the differentiated safety profile of secukinumab.1

Secukinumab for HS is now approved as a 300 mg dose, and administered every four weeks, with the option to increase to every two weeks if the patient has an inadequate response.

“For many patients, the daily impact of HS and the search for symptom relief can last years –which can come with painful, irreversible physical and emotional scarring,” Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials, professor of dermatology at Harvard Medical School, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, says in a press release. “This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option.”

Reference

FDA Approves Novartis Cosentyx as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decade. Novartis. News release. October 31, 2023. Accessed on November 1, 2023. https://www.novartis.com/news/media-releases/fda-approves-novartis-cosentyx-first-new-biologic-treatment-option-hidradenitis-suppurativa-patients-nearly-decade