Secukinumab Gains FDA Approval to Treat Hidradenitis Suppurativa

The FDA has approved secukinumab (Cosentyx) to treat moderate to severe hidradenitis suppurativa (HS) in adults.¹ The treatment is the second biologic approved to treat HS, a chronic, systemic, and often painful skin disease that causes recurring boil-like lumps that may burst into open wounds and cause irreversible scarring.²

The approval was based on the results of the phase 3 trials SUNSHINE and SUNRISE. Secukinumab targets and blocks interleukin-17A (IL-17A), which is involved in the inflammation of psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis.

Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials

“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, and president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, said in a statement.¹ “This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option.”

Combined, SUNSHINE and SUNRISE had more than 1000 patients enrolled. The trials were identical, global phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies evaluating safety, efficacy, and tolerability of 2 dose regimens of secukinumab over 16 weeks and 52 weeks.³ Patients received 300 mg of secukinumab every 2 weeks or every 4 weeks or placebo.

At 16 weeks, a higher proportion of patients achieved a 50% decrease in abscess and inflammatory nodules based on Hidradenitis Suppurativa Clinical Response (HiSCR50) whether on the every-2-week or every-4-week dose. For the 2-week dose, 44.5% achieved HiSCR50 on secukinumab vs 29.4% on placebo in SUNSHINE and 38.3% achieved HiSCR50 on secukinumab vs 26.1% on placebo in SUNRISE. For the 4-week dose, 41.3% achieved HiSCR50 on secukinumab vs 29.4% on placebo in SUNSHINE and 42.5% achieved HiSCR50 on secukinumab vs 26.1% on placebo in SUNRISE.

Over the 52 weeks, the HiSCR50 values observed at 16 weeks improved over time to 56.4% and 65.0% for the 2-week doses in SUNSHINE and SUNRISE, respectively, and to 56.3% and 62.2% for the 4-week doses in SUNSHINE and SUNRISE, respectively. There were also rapid improvements for patients who switched from placebo at week 16.

“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, International Association of Hidradenitis Suppurativa Network.¹ “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.”

Secukinumab is also approved to treat plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, nonradiographic axial spondyloarthritis, and enthesitis-related arthritis.

References

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

2. Hidradenitis suppurativa. MedLine Plus. National Library of Medicine. Accessed October 31, 2023. https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/

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