FDA approves Cosentyx (secukinumab) as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade

Cosentyx is 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 causes recurring boil-like lumps that may burst into open wounds and cause irreversible scarring, often in the most intimate parts of the body. It may take people living with HS an average of up to 10 years to get a correct diagnosis, which can result in disease progression and significantly impact their quality of life. Until now, there has been only one biologic approved to treat HS.

“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, Professor of Dermatology at Harvard Medical School, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston. “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 FDA approval was based on analyses from the largest Phase III program in HS to date, SUNSHINE and SUNRISE, in which a higher proportion of patients given Cosentyx 300 mg either every two weeks or every four weeks achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to placebo. Cosentyx for HS is approved as a 300 mg dose, administered every four weeks, with the option to increase to every two weeks if the patient has an inadequate response.

Results from the FDA-requested analyses at Week 16 showed that a significantly higher proportion of patients achieved HiSCR50 when treated with Cosentyx 300 mg dosed every two weeks (after standard weekly loading doses), compared with placebo in both the SUNSHINE and SUNRISE trials (44.5% vs 29.4% [P<0.05] and 38.3% vs 26.1% [p><0.05], respectively). a greater proportion of patients randomized to cosentyx 300 mg dosed every four weeks (after standard weekly loading doses) achieved hiscr50 compared with placebo in both sunshine (41.3% vs 29.4%) and sunrise (42.5% vs 26.1% [p><0.05]) trials. an exploratory analysis assessed the long-term effects of cosentyx for each of the primary and secondary endpoints for up to 52 weeks. hiscr values observed at week 16 following either dose regimen of cosentyx were improved over time to week 52 (sunshine: secq2w [56.4%]; secq4w [56.3%]; sunrise: secq2w [65.0%]; secq4w [62.2%]), with rapid improvements seen in patients who switched from placebo at week 16.