Secukinumab and Bimekizumab for Hidradenitis Suppurativa

The field of hidradenitis suppurativa (HS) is close to experiencing a surge of new drug development similar to that experienced by other chronic skin diseases, including atopic dermatitis and psoriasis, have experienced in the last decade. What’s more, many of the potential new agents are quite familiar to dermatologists already.

In the first segment of an interview with HCPLive during the Society for Dermatology Physician Assistants (SDPA) 2024 Summer Meeting, Jennifer L. Hsiao, MD, clinical associate professor at the Keck School of Medicine of USC, discussed the new era of drug development for HS—an ongoing series of US Food and Drug Administration (FDA) applications and pending approvals that started with the sign-off on secukinumab (Cosentyx), for the treatment of adults with moderate to severe HS, in October 2023. Secukinumab became only the second FDA-approved drug for HS after adalimumab back in 2015.

“I feel like for my patients, it really has meant that there's another biologic that's much easier to get my hands on,” Hsiao told HCPLive. “And when we think about just the dearth of FDA-approved therapies for HS, and we think about other chronic inflammatory skin conditions like psoriasis or atopic dermatitis, we know we have a long way to go. But certainly the fact that secukinumab is approved now is a huge deal.”

Later this year, the FDA will also decide on the application of bimekizumab-bkzx (Bimzelx) from UCB. A dual IL-17A and IL-17F pathway-targeting biologic, bimekizumab was associated with significantly improved odds of treated patients achieving 50% Hidradenitis Suppurativa Clinical Response (HiSCR50) versus placebo at 48 weeks in the company’s pivotal phase 3 trials, BE HEARD I and II.

“We haven't seen actual numbers that high, in terms of longevity and having HiSCR numbers of that proportion—of patients being able to achieve it,” Hsiao said. “So, I think that the data are also showing growth towards a better depth of response. And HiSCR75 was also looking good.”

Hsiao is additionally interested in the further development of Janus kinase (JAK) inhibitors for the treatment of HS—a drug class that she believes is approximately 1 - 2 years away from becoming an FDA-approved option. A pair of phase 3 trials will have been completed for JAK-1 selective inhibitor povorcitinib before the end of this year, and upadacitinib is currently in late-stage assessment as well.

“So, I think the top agents we're seeing are TNF alpha inhibitors, IL-17 and JAK inhibitors,” Hsiao said. “I just want to see more FDA approval so we have access for our patients. But certainly, seeing longevity of response and also better depth of response is also encouraging.”

Regarding the real-world rollout of therapies including secukinumab, Hsiao said the clinical benefit has been more pronounced than only improving patients’ HiSCRs and other physician-reported outcomes.

“Let's say they weren't a TNF alpha candidate, right?” Hsiao said. “So, they weren't able to get on that biologic for HS, but now it's easy to get their hands on secukinumab. And I have seen decreases in the number of flares that patients have, for example, and decrease in severity and duration of flare—and also improvements in pain, improvements in drainage.”

Hsiao remains hopeful the advancement of HS therapies reaches a level of such robust efficacy that positive, sustainable and safe response is practically assured for patients. It’s not yet a reality, but in a friendly tool like IL-17 and JAK inhibitors, dermatologists are treating the burdensome disease with greater and greater confidence.

“We've used it a lot for psoriasis, and so I think that having this class of agents available for HS in a more easily accessible way is very important,” Hsiao said.

References

1. ^{Kunzmann K. FDA Approves Secukinumab for Hidradenitis Suppurativa. HCPLive. Published October 31, 2024. https://www.hcplive.com/view/fda-approves-secukinumab-hidradenitis-suppurativa}
2. ^{Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-2519. doi:10.1016/S0140-6736(24)00101-6}