UCB submitted a supplemental biologics license application for bimekuzimab (Bimzelyx) to the FDA in April for the drug’s approval in moderate to severe hidradenitis suppurativa (HS).
Speaking to the data that support UCB’s supplemental biologics license application for bimekuzimab (Bimzelyx) for the drug’s approval in moderate to severe hidradenitis suppurativa (HS), Amit Garg, MD, founding chair, Department of Dermatology, Northwell Health, stated, “These are patients that get their lives back, and that's a truly remarkable outcome...We don't get to say that often to patients.”
In part 2 of our interview with Garg, who is also senior vice president for the Dermatology Service line at Northwell Health and professor, Center for Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, at Northwell Health, he discusses the dual interleukin-17A and 17F inhibitor’s potential to dramatically change outcomes for patients.
The interview has been edited for clarity.
Transcript
How do the open-label extension data from the BE HEARD trial shape future long-term treatment strategies?
My takeaways from the open-label extension data [were] that through 96 weeks, bimekizumab showed both durability and consistency in the treatment of patients with moderate to severe HS. Both those outcomes are critically important to the management of a disease, as we discussed, that has a very high symptom burden, is chronic, and it's, again, likely to be progressive if it's not adequately treated. So, accordingly, then, the 96-week findings provide I think important direction to patients and to physicians in outlining a long-term treatment strategy for HS.
What key results from the trial might influence how clinicians prioritize patient-reported outcomes when considering bimekizumab?
One of the results that I was most impressed with related to bimekizumab was its effect on draining tunnels, which are amongst the most burdensome types of lesions for HS patients. So, when patients report their outcomes, oftentimes what they report is related to the burden of tunneling and the burden of that drainage and odor that results from the tunneling. In the long-term data, patients treated with bimekizumab had nearly a 75% reduction in their draining tunnel count at 2 years.
So, not surprisingly then, after 2 years of bimekizumab treatment, one-third of HS patients reported no effect at all on life from their disease. Simply put, these are patients that get their lives back, and that's a truly remarkable outcome for patients with moderate to severe hidradenitis suppurativa.We don't get to say that often to patients.
How might these findings also guide clinical decisions about transitioning patients to less frequent dosing while maintaining effective disease control?
There are a couple things to consider here. First off, for patients who are on weekly administration of a biologic, such as an [anti-]TNF [tumor necrosis factor-α] adalimumab, for example, particularly those who may be having an inadequate response to their treatment, they may soon have the option of switching to bimekizumab, which is a once-monthly administration—of course, pending approval by a regulatory agency.
We don't know yet what the FDA will say in terms of how it needs to be used, but one option that we, as clinicians, hope for is the ability to step up treatment so that if patients, for example, are on once-monthly dosing with bimekizumab, are doing well but could be doing better, we'd love the option to be able to go to twice-monthly dosing or every 2-week dosing, again, to try to get an improved or really an adequate response to the therapy.
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