The approval marks the first new biologic treatment option for this patient population in nearly a decade.
The FDA has approved secukinumab (Cosentyx; Novartis) to treat moderate to severe hidradenitis suppurative (HS) in adults, making it the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), which is believed to be involved in the inflammation associated with HS.
HS is a chronic, systemic, painful skin disease characterized by recurring lumps that may burst into open wounds and cause irreversible scarring, often in intimate parts of the body. Individuals living with HS may take up to 10 years to get a correct diagnosis, and this delay can result in disease progression and severely impacts quality of life. Only 1 biologic has been approved for HS until now.
“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,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials, 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.”
The approval was based on results from the SUNSHINE and SUNRISE trials, which were the largest phase 3 program in HS to date with more than 1000 patients. They are identical, global phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies evaluating the short- and long-term efficacy, safety, and tolerability of 2 dose regimens of secukinumab in adults with moderate to severe HS.
The primary endpoint in both trials, a Hidradenitis Suppurativa Clinical Response (HiSCR50), was defined as at least a 50% decrease in abscess and inflammatory nodule count with no increase in the number of abscesses and/or draining tunnels. Secondary endpoints included a decrease 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 the trials, a higher proportion of patients given secukinumab at 300 mg either every 2 weeks or every 4 weeks achieved HiSCR50 compared to placebo (44.5% vs 29.4% [*P<0.05] and 38.3% vs 26.1% [*P<0.05], respectively). The approved dose is 300 mg administered every 4 weeks, with the option to increase to every 2 weeks if the patient has an inadequate response.
In both trials, which evaluated secukinumab across 16-week and 52-week treatment periods, the onset of action occurred as early as week 2. Efficacy progressively increased to week 16 and was observed up to week 52. The safety profile observed with secukinumab was consistent with its known safety profile in plaque psoriasis trials.
“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."
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