The U.S. Food and Drug Administration (FDA) has approved secukinumab (Cosentyx) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults.1
Novartis’s approval marks the first indication for a biologic targeting the interleukin 17A (IL-17A) pathway to treat HS, a drug class that experts have previously highlighted as having broad promise in the management of chronic, systemic chronic diseases. prospect. , dermatological conditions.
Approval of secukinumab was based on results from the pivotal Phase 3 SUNRISE and SUNSHINE trials, in which secukinumab at a dose of 300 mg administered every 2 or 4 weeks was associated with a significant increase in the proportion of patients with a 50% improvement in clinical response in hidradenitis suppurativa (HiSCR50) Comparisons were made with placebo at weeks 52 and 16.
during an interview HCP live broadcast In February, Alexa Kimball, MD, MPH, author of the SUNRISE and SUNSHINE studies, expressed satisfaction with the significant and sustained improvements patients observed over a year of treatment.2
“We still need to do some further work over time to determine the correct dosage to start and end with,” Kimball said. “It’s different from some of the other skin conditions we treat in that higher doses initially may be more important in this disease, and the durability of some of our therapies may also be better.”
Secukinumab is FDA-approved at a dose of 300 mg subcutaneously every 4 weeks, with the option to increase to every 2 weeks if the patient responds inadequately.
Previously, the most recently approved drug to treat HS was adalimumab (Humira), which was launched in September 2015. It was also the first drug approved by the FDA to treat this burdensome condition, which affects patients. Large, painful subcutaneous lumps appear in areas of the body that have been intertriaged. The emergence of secukinumab and other IL-17 inhibitors being studied for the treatment of HS may not only provide dermatologists with another option.
Jennifer Hsiao, MD, clinical associate professor of dermatology at the Keck School of Medicine of USC, tells us HCP live broadcast This summer, she expects secukinumab and other members of its drug class will offer simpler treatment management, reduce the risk of cardiovascular adverse effects relative to tumor necrosis factor (TNF) inhibitors, and provide better options for HS patients. Long term efficacy.3
“I think that, in general, for patients with moderate to severe heat stroke, this pattern will hopefully change from repeated courses of oral antibiotics and repeated incisions and drainage of lesions,” Hsiao said. “Really, these are short-term Band-Aids, not long-term treatment products.”
Matthew Zirwas, MD, director of the Greater Columbus Dermatology Clinical Trials and Dermatitis Center, tells us HCP live broadcast This summer, he predicted that IL-17 inhibitors will play a role in establishing more feasible surgical interventions to address HS in the future.4
“Realistically, whether we’re talking about adalimumab … bimekizumab or (secukinumab) — you give them the drug and you calm down their disease in about three months,” Zirwas said. “Any remaining fissures, fistulas, lesions, anything at this point, you can either resect them or remove them. “You almost think of medical therapy as neoadjuvant therapy. “
“You’re not going to get rid of the scars, you’re not going to get rid of the fistulas, but you’re going to make the inflammatory lesions and the fistulas stop being inflamed and painful and symptomatic,” Zilvas continued. “I think it will be a baseline (biological) treatment and then they will prescribe minocycline (for attack risk prevention). That’s how I imagine HS will be managed in the future.”
refer to
- Novartis. The FDA approves Novartis Cosentyx® as the first new biologic treatment option for patients with hidradenitis suppurativa 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 ten years
- Smith T. Alexa Kimball, MD, MPH: Update on secukinumab in the treatment of hidradenitis suppurativa. HCP live broadcast. Published February 13, 2023. https://www.hcplive.com/view/alexa-kimball-md-mph-updates-secukinumab-treatment-hidradenitis-suppurativa
- Kunzmann K. Jennifer Hsiao, MD: IL-17 inhibitors in the treatment of hidradenitis suppurativa. HCP live broadcast. Published June 11, 2023. https://www.hcplive.com/view/jennifer-hsiao-il-17-inhibitors-hidradenitis-suppurativa
- Kunzmann K. Matthew Zirwas, MD: How do emerging treatments for HS rank? HCPLive. Published on June 22, 2023. https://www.hcplive.com/view/matthew-zirwas-how-do-emerging-hs-treatments-line-up