Q&A: Alexa Kimball, MD, MPH, Talks BE HEARD Data for Hidradenitis Suppurativa

UCB recently announced that The Lancet has published the phase 3 trial results for bimekizumab (Bimzelx) in treating moderate to severe hidradenitis suppurativa (HS).¹

The publication covers data from the BE HEARD I and BE HEARD II trials, which involve over 1,000 participants and were randomized, double-blind, placebo-controlled studies conducted over 48 weeks to assess the safety and efficacy of bimekizumab.²

Alexa Kimball, MD, MPH, is a dermatologist, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and a professor at Harvard Medical School in dermatology. Kimball, a study investigator of the BE HEARD trials, recently spoke with Dermatology Times to discuss the significance of the BE HEARD I and II trial data and the potential implications of bimekizumab for patients with HS.

Q&A

Q: Can you explain the clinical significance of the BE HEARD I and II trials for bimekizumab in the treatment of moderate-to-severe HS?

A: We were very much anticipating, with enthusiasm, the data from this study. Certainly, we had seen the phase 2 programs have very robust efficacy results, and they really were recapitulated in the phase 3 program. The great news for HS patients, who are still very challenging to manage and get under good control, is that IL-17 inhibition clearly is effective in that population. Bimekizumab distinguishes itself from secukinumab in that inhibits IL-17 A and F, whereas secukinumab is really more targeted to IL-7A. There's no head-to-head study, of course, but the efficacy data for the bimekizuamb study is really very strong.

Q: In addition to efficacy, how did treatment with bimekizumab impact patient-reported outcomes and overall quality of life?

A: As we expect when patients do better clinically, they also see some improvements in other important measures like quality of life, and in pain. In hidradenitis suppurativa, pain in particular is an endpoint that's very important for us to watch, because that is one of the most disabling aspects of the disease. I'm pleased to see improvements for patients on all measures that accompany their improvement in what the physicians are assessing, as well.

Q: How do you foresee bimekizumab playing a role in treatment protocols for HS, and what should clinicians know or consider about this therapy?

A: The nice thing about having multiple approved therapies is that there are patients where different approaches are more appropriate and less appropriate, depending on comorbidities, preference, and other availability, as well. I think we'll see how this turns out in the clinical area, but I would certainly anticipate that bimekizumab, as one might anticipate based on the current data we have available, will be in the first line with the other biologics for moderate to severe HS.

Q: From your perspective, what are the biggest challenges currently facing clinicians in the treatment of HS, and how does bimekizumab address these challenges?

A: I think there are many problems as we approach HS today. One is just getting the patients to the right clinicians--how to manage it appropriately. The delay for diagnosis has classically been almost a decade long, at least anecdotally. You can kind of see it in the large studies as well, that the timeframe seems to be reducing, which is great. I now see patients who maybe got diagnosed 2 or 3 years ago getting in or earlier, whereas before, it was very extended.

The good news is: The patients are learning about it, and the doctors are learning about it. We're seeing patients get into experts a little earlier in the game. That's really critical in a disease where scarring and disfiguring disability can be a major issue. Then, it's making sure that enough clinicians who understand how to use these therapies are available, even within dermatology, and are comfortable with prescribing those. I think biologics, in general, have been are very straightforward to use. I remain optimistic that we'll see a continued increase in uptake through the dermatology community as they start to realize how actually straightforward it is to get patients on, and monitor their improvement, and monitor their safety. The other great news is that the pipeline is full for HS. We expect to continue to see some nice improvements, other therapies, and other options coming down the pipe.

Q: What other takeaways would you like clinicians to consider?

A: Overall, the biggest takeaway from all of this is: This is a great time for HS patients and for the clinicians who treat them. We now have proven therapies with strong records for both safety and efficacy that are really very straightforward to use, and that patients feel well while they're on them. It's a great time for patients to check in and for clinicians to continue to stay up to speed, because they can do a lot of good.

References

1. UCB announces publication in The Lancet of phase 3 BIMZELX (bimekizumab-bkzx) trials in moderate-to-severe hidradenitis suppurativa. News release. UCB. May 23, 2024. Accessed May 31, 2024. https://www.prnewswire.com/news-releases/ucb-announces-publication-in-the-lancet-of-phase-3-bimzelx-bimekizumab-bkzx-trials-in-moderate-to-severe-hidradenitis-suppurativa-302153768.html
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. The Lancet. May 22, 2024. https://doi.org/10.1016/S0140-6736(24)00101-6