BE HEARD Trials Highlight Efficacy of Bimekizumab in Hidradenitis Suppurativa

On November 20, the FDA approved bimekizumab (Bimzelx; UCB Pharma) for use in patients with moderate to severe hidradenitis suppurativa.¹ Chris Sayed, MD, dermatologist and a professor at the University of North Carolina at Chapel Hill Department of Dermatology, was an investigator with the BE HEARD I and II trials, which provided the data the FDA used as the basis for this approval.

This newest approval is the fifth overall for the anti–IL-17A, IL-17F, and IL-17AF humanized immunoglobulin G1 monoclonal antibody, with indications granted for psoriatic arthritis, nonradiographic axial spondyloarthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis since October 2023.^2,3

Here, Sayed delves into how bimekizumab helps to fill treatment gaps for patients living with hidradenitis suppurativa and what the open-label extension trial is seeking to accomplish.

This transcript has been lightly edited for clarity.

Transcript

How does this dual IL-17A/IL-17F inhibitor help to address unmet clinical needs in patients with hidradenitis suppurativa?

Bimekizumab is unique to other drugs that are currently on the market because it affects a couple of types of IL-17. There are other IL-17 antagonists that are out there that mostly have tried to go after and block IL-17A, which is very important in conditions like psoriasis and other inflammatory diseases, but there's another type of IL-17 called IL-17F. And while it's not sort of as potent at causing inflammation, there's just so much of it around that if you don't block it, you tend to see continued inflammation in those patients.

So by blocking both A and F, you get a more complete blockade of the type of inflammation that drives these kinds of conditions, and in some instances, that seems to translate into improvement in symptoms overall. So, there seems to be increasing efficacy of the IL-17A and F antagonists compared to those that block IL-17A alone. That won't necessarily be across the board, but the overall trend seems to be in that direction.

Can you provide an overview of the BE HEARD I and II trials that provided the data for this approval?

BE HEARD I [NCT04242446] and BE HEARD II [NCT04242498] are the 2 large trials were designed in pretty much an identical way to try to understand how well we treat HS with something like bimekizumab and also what the safety of that medication is in those patients who have HS.

The nice thing is that it showed very good efficacy. It used pretty good methods that are tried and true from other trials to look at how patients responded over time, and in particular, they used a higher benchmark. Most studies have used a 50% reduction in inflammatory lesions as a rough estimate of how well patients are doing. This study looked at 75% reduction. So it set a higher bar and showed that many patients hit that standard, and it clearly differentiated itself from a placebo—so control where there was no active treatment being used at all.

I think the most important thing that I get out of these studies is that it looks like things continued to improve or at least remain stable for those patients over a long period of time. So more than just 16 weeks, over the course of a year and 2 years, you saw that there was continued improvement throughout the course for many of those patients. And so many stayed in the trial for 2 years despite the fact they're having to go back so often, and it's such a burden to be in a trial. That shows me that just a lot of patients see these really deep responses. That's what's important—not these partial responses, but when patients feel like they really had a major disease reduction or maybe even feel like relatively clear as time has passed.

Can you discuss the open-label extension study evaluating bimekizumab in patients previously enrolled in BE HEARD I and II?

An open label extension is always a great opportunity to understand how well a drug works as more time passes and to make sure that it remains safe as more time passes. All those patients who completed the initial study phase of bimekizumab for HS were allowed the chance to continue it longer to try to understand will their response continue to be maintained over time That's where we've seen some of the data already. So week 96 data, patients who were on it for nearly 2 years have been reported out now.

And that's what, again, I think is one of the most impressive things about this drug, is the number of patients who stay on that long and how well they tend to respond. If anything, there seems to be a slow trend toward continued improvement where those patients who were 50% and 75% better in those first few months start to achieve these deeper benchmarks of being 90% and 100% better.

I think it was about 40% of patients who stayed in the trial over a 2-year period had what's called a high score 100 [HiSCR100]. That means they had no abscesses and no inflammatory nodules. That's a huge shift and something that I think a lot of patients have trouble feeling like it's even possible to achieve that at a certain point. But it's pretty clear that there is a significant subset of patients that have these really deep and sustained responses, which is highly encouraging.

References

1. Shaw M. FDA approves bimekizumab in hidradenitis suppurativa. AJMC®. Novenmber 20, 2024. Accessed November 25, 2024. https://www.ajmc.com/view/fda-approves-bimekizumab-in-hidradenitis-suppurativa

2. McNulty R. FDA approves bimekizumab for psoriatic arthritis, nonradiographic axspa, ankylosing spondylitis. AJMC®. September 23, 2024. Accessed November 20, 2024. https://www.ajmc.com/view/fda-approves-bimekizumab-for-psoriatic-arthritis-non-radiographic-axspa-ankylosing-spondylitis

3. Bimzelx approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. News release. UCB Pharma. October 18, 2023. Accessed November 20, 2024. https://www.ucb.com/stories-media/press-releases/article/bimzelxr-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis