Bimekizumab Poised to Tackle Unmet HS Treatment Needs

Bimekizumab (Bimzelx; UCB) is a dual IL-17A and IL-17F inhibitor with current indications to treat moderate to severe plaque psoriasis, active psoriatic arthritis, active nonradiographic axial spondyloarthritis, and active ankylosing spondylitis. A supplemental biologics license application (sBLA) was submitted to the FDA in April for moderate to severe hidradenitis suppurativa (HS). Data from the BE HEARD I (NCT04242446) and II (NCT04242498) trials support the sBLA, and the late-breaking 2-year data were presented at the recent European Academy of Dermatology and Venereology (EADV) Congress, along with results from the open-label extension study.

In this discussion with Amit Garg, MD, founding chair, Department of Dermatology, Northwell Health, he explains the significance of these latest data and how bimekizumab will help to address unmet treatment needs among patients who have HS.

Garg is also senior vice president for the dermatology service line at Northwell Health, where he specializes in treating patients with inflammatory and autoimmune diseases, including HS, and is a professor in the Center for Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, at Northwell Health.

This interview has been lightly edited for clarity.

Transcript

How does bimekizumab address unmet needs in hidradenitis suppurativa?

HS is an inflammatory disease. It is a chronic disease. It has a very high symptom burden and physical burden, and we believe it to be, in fact, a progressive disease that gets worse over time if it's inadequately treated. We believe the prevalence is highest in people who are aged 20 to 40 years. Within that, women are affected at least twice, maybe 3 times as common as men. We also know that, at least in the United States, Black Americans are disproportionately affected by the disease.

Let me just take a little bit of a step back and talk about unmet needs for patients with hidradenitis [suppurativa]. We did a study called the global VOICE survey, and in that study, HS patients from all around the world told us that treatment for HS represents their greatest unmet need. Up to half of them told us that they were dissatisfied with their HS treatment. And they also told us that treatment with a biologic was associated, in fact, with greater satisfaction with treatment.

So since both IL-17A and IL-17F are highly expressed in lesional skin of HS patients, and given that bimekizumab inhibits both IL-17A and IL-17F, approval of this medication would offer patients with moderate to severe HS a new and unique mechanism of action to address the symptom burden and the physical burden that we see in HS.

Can you provide an overview of the BE HEARD I and II trials?

The BE HEARD I and II trials were phase 3 studies that evaluated efficacy and safety of bimekizumab in over 1000 moderate to severe HS patients. Overall, the studies showed that there were higher responder rates that were observed in bimekizumab vs placebo patients in both trials. And across both trials, approximately half of patients receiving bimekizumab achieved a high score of 50 primary end point, which was at 16 weeks. In fact, those responses were either maintained or even increased to week 48. And at week 48, there were approximately 40% and 30% of patients with moderate to severe disease who achieved either a high score 90 or a high score 100, respectively. And there were no new safety signals that were observed in either of the BE HEARD trials.

What do the latest data reveal about the efficacy and safety of bimekizumab?

At this year's EADV meeting in 2024, the 2-year bimekizumab data from the BE HEARD I and II trials and the open-label extension were presented. And that's important because these were the first long-term data presented for any IL-17 inhibitor out to 96 weeks. From these data, we learned that both efficacy and health-related quality of life outcomes were maintained through 2 years of treatment.

And there were no new safety signals. So safety over 2 years was consistent with findings from the BE HEARD I and II trials, as well as with studies of bimekizumab across all of the other indications it has.