FDA Approves Secukinumab for Hidradenitis Suppurativa

The US Food and Drug Administration (FDA) has approved secukinumab (Cosentyx) for the treatment of hidradenitis suppurativa (HS) in adults with moderate to severe disease.¹

The approval, granted to Novartis, marks the first indication to treat HS with an interleukin 17A (IL-17A) pathway-targeting biologic—a drug class that which has been previously highlighted by experts as a promising prospect in the management of the chronic, systemic, dermatologic condition.

Secukinumab’s approval was based on findings from the pivotal phase 3 SUNRISE and SUNSHINE trials, in which a 300 mg dose of secukinumab administered once every 2 or 4 weeks was associated with a significantly increased proportion of patients achieving 50% improvement in Hidradenitis Suppurativa Clinical Response (HiSCR50) versus the placebo arms at 52 and 16 weeks, respectively.

In an interview with HCPLive this February, SUNRISE and SUNSHINE study author Alexa Kimball, MD, MPH, expressed her own satisfaction with the observed significant and continued improvement observed by patients through a year of treatment.²

“Over time, we are still going to have to do some further work to sort out what the right doses are at the beginning, at the end,” Kimball said. “It's different from some of the other skin diseases we treat, in that it does feel like higher doses at the beginning might be more important in this disease, and that the persistence of some of our therapies might also be better.”

Secukinumab was approved by the FDA as a 300 mg dose therapy administered subcutaneously every 4 weeks, with the option to increase to every 2 weeks if a patient’s response has been inadequate.

Previously, the most recently approved drug to HS was adalimumab (Humira), in September 2015—also the first FDA-approved drug indicated for the burdensome condition, wherein patients experience large, painful subcutaneous lumps in intertriginous regions of the body. The advent of secukinumab and other IL-17 inhibitors under investigation for HS could provide more than just another option for prescribing dermatologists.

Jennifer Hsiao, MD, clinical associate professor of dermatology at Keck School of Medicine of USC, told HCPLive this summer that she anticipates secukinumab and other members of its drug class will provide a simpler treatment administration, a reduced risk of cardiovascular adverse effects relative to tumor necrosis factor (TNF) inhibitors, and greater long-term efficacy in patients with HS.³

“I think in general, the paradigm is hopefully shifting for patients with moderate to severe HS away from doing repeated courses of oral antibiotics, repeated incisions and drainages of their lesions,” Hsiao said. “Really, those are short-term band-aids, and not long-term therapeutic offerings.”

Matthew Zirwas, MD, director of clinical trials and the dermatitis center at Dermatologists of Greater Columbus, told HCPLive this summer that he projects a future wherein IL-17 inhibitors serve a role in setting up more feasible, HS-resolving surgical interventions.⁴

“Really what that looks like—whether we’re talking about adalimumab…bimekizumab or (secukinumab)—you put them on the drug, you let their disease get calmed down, probably about 3 months in,” Zirwas said. “And any residual fissure, fistulas, lesions, anything at that point, you can excise them or you can deroof them. You almost think of the medical therapy as neoadjuvant.”

“You’re not going to get rid of scars, you’re not going to get rid of fistulas, but you’re going to make the inflammatory lesions and fistulas stop being inflamed, painful and symptomatic,” Zirwas continued. “I think it’s going to be a baseline (biologic) therapy, then they’ll have prescription for minocycline (for flare risk). That’s how I imagine I’ll be managing HS in the future.”

References

1. ^{Novartis. FDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade. Press release. Published online October 31, 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. ^{Smith T. Alexa Kimball, MD, MPH: Updates on Secukinumab Treatment for Hidradenitis Suppurativa. HCPLive. Published February 13, 2023. https://www.hcplive.com/view/alexa-kimball-md-mph-updates-secukinumab-treatment-hidradenitis-suppurativa}
3. ^{Kunzmann K. Jennifer Hsiao, MD: IL-17 Inhibitors for Hidradenitis Suppurativa. HCPLive. Published June 11, 2023. https://www.hcplive.com/view/jennifer-hsiao-il-17-inhibitors-hidradenitis-suppurativa}
4. ^{Kunzmann K. Matthew Zirwas, MD: How Do Emerging HS Treatments Line Up? HCPLive. Published June 22, 2023. https://www.hcplive.com/view/matthew-zirwas-how-do-emerging-hs-treatments-line-up}