Bimekizumab produces rapid, clinically meaningful responses in hidradenitis suppurativa
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Key takeaways:
- The group receiving bimekizumab every 2 weeks in both trials met the primary outcome.
- The group receiving bimekizumab every 4 weeks in BE HEARD II also achieved the primary outcome.
Patients treated with bimekizumab for moderate to severe hidradenitis suppurativa exhibited rapid and clinically meaningful responses that were maintained up to 48 weeks, according to new data published in The Lancet.
“Even with the substantial progress we have made, hidradenitis suppurativa (HS) is very challenging to treat,” Alexa B. Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, professor of dermatology at Harvard Medical School and lead investigator of the study, told Healio. “We have only a few rigorously tested therapies to work with and gaps to achieving the highest levels of efficacy on regular basis.”
Bimekizumab (Bimzelx, UCB), an interleukin-17F and IL-17A inhibitor that is currently approved for the treatment of psoriasis, may be a promising treatment for HS. In two identically designed phase 3 trials, BE HEARD I and BE HEARD II, Kimball and colleagues evaluated the efficacy and safety of bimekizumab in this indication.
Patients aged 18 years or older with moderate to severe HS in both BE HEARD I (n = 505) and BE HEARD II (n = 509) were randomly assigned to receive either subcutaneous bimekizumab 320 mg twice weekly; bimekizumab 320 mg twice weekly to week 16, then every 4 weeks to week 48; bimekizumab 320 mg every 4 weeks to week 48; or placebo to week 16, then bimekizumab 320 mg twice weekly.
The primary outcome was a 50% reduction in total abscess and inflammatory nodule count from baseline without any increase in abscess or draining tunnel count, also known as HiSCR50, by week 16.
Results showed that the group receiving bimekizumab every 2 weeks in both trials met the primary outcome. Higher responder rates were observed in the bimekizumab groups, with 48% achieving HiSCR50 vs. 29% in the placebo group in BE HEARD I (OR = 2.23; 97.5% CI, 1.16-4.31). Similarly, 52% of the bimekizumab group reached HiSCR50 vs. 32% of placebo in BE HEARD II (OR = 2.29; 97.5% CI, 1.22-4.29).
Additionally, 54% of the group receiving bimekizumab every 4 weeks in BE HEARD II achieved HiSCR50 vs. 32% of placebo (OR = 2.42; 97.5% CI, 1.22-4.8). According to the study, all primary endpoint responses were maintained through week 48.
Among those treated with bimekizumab, 8% in BE HEARD I and 5% in BE HEARD II experienced serious treatment-emergent adverse events over 48 weeks. One death from congestive heart failure was reported in the group receiving bimekizumab every 2 weeks in BE HEARD I; however, investigators ruled that it was unrelated to treatment.
While no new safety signals were observed, patients reported that the most common adverse events were coronavirus infection and diarrhea in BE HEARD I and oral candidiasis and headache in BE HEARD II.
“The field of HS is changing rapidly, with new options available and other advances on the horizon,” Kimball told Healio. “These data demonstrated that bimekizumab can be used to successfully treat HS and provide relief for patients.”
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