Bimekizumab reduces disease severity among patients with hidradenitis suppurativa
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Key takeaways:
- A greater proportion of patients treated with bimekizumab vs. placebo achieved the primary endpoint of HiSCR50.
- Safety signals of bimekizumab were consistent with previous studies.
New pooled results from the BE HEARD phase 3 trials show bimekizumab reduces disease severity in patients with moderate to severe hidradenitis suppurativa, according to a UCB press release.
The results were presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin.
“The burdens of hidradenitis suppurativa (HS) for people living with the skin disease are physical, social and emotional,” Jeffrey Stark, MD, vice president and U.S. head of medical immunology at UCB, told Healio. “UCB is committed to advancing the understanding of HS and addressing unmet needs of those living with this chronic, recurring, painful and debilitating inflammatory skin disease.”
The pooled data were drawn from the double-blind, placebo-controlled, multicenter, phase 3 trials BE HEARD I and BE HEARD II, which evaluated the efficacy of bimekizumab among patients with HS. The studies included an initial 16-week treatment period followed by a 32-week maintenance treatment period.
A total of 1,014 patients were randomly assigned to receive placebo initially followed by bimekizumab 320 mg once every 2 weeks (n = 146), bimekizumab 320 mg once every 4 weeks continuously (n = 288), bimekizumab 320 mg once every 2 weeks initially followed by once every 4 weeks (n = 292) or bimekizumab 320 mg once every 2 weeks continually (n = 288).
The primary endpoint was a 50 percent reduction from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50), according to the press release.
A greater proportion of patients treated with bimekizumab (range, 56.1% to 58%) vs. placebo (33.4%) achieved the primary endpoint at week 16. Nearly eight in 10 patients achieved HiSCR50 at week 48, and patients who switched from placebo to the study drug at week 16 saw similar results at week 48 as those who were on bimekizumab from baseline.
According to the press release, more than eight out of 10 patients across the bimekizumab groups with an abscess and inflammatory nodule count of 0, 1 or 2 at week 16 reported the same response at week 48.
Safety signals were consistent with previous studies, with 995 patients experiencing one or more treatment-emergent adverse event. Seven percent of bimekizumab-treated patients across treatment groups experienced serious treatment-emergent adverse events, according to the press release.
“From a regulatory perspective, UCB will submit supplemental applications for bimekizumab in the U.S. as soon as possible following its approval in moderate to severe plaque psoriasis,” Stark said.
As Healio previously reported, UCB is anticipating an FDA decision on its biologics license application for bimekizumab in the treatment of adults with moderate to severe plaque psoriasis this year.