Efficacy and safety of bimekizumab in moderate to severe hidradenitis suppurativa: A phase 2, double-blind, placebo-controlled randomized clinical trial
JAMA Nov 23, 2021
Glatt S, Jemec GBE, Forman S, et al. - Researchers investigated the efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin 17A and 17F, in patients with moderate to severe hidradenitis suppurativa (HS).
A double-blind, placebo-controlled, phase 2 randomized clinical trial.
A total of 90 patients with HS (73 completed the trial) were randomized 2:1:1 to receive bimekizumab (640 mg at week 0, 320 mg every 2 weeks), placebo, or reference arm adalimumab (160 mg at week 0, 80 mg at week 2, and 40 mg every week for weeks 4-10).
The proportion of participants with a 50% or greater decrease from baseline in the total abscess and inflammatory nodule count, with no rise in abscess or draining fistula count (Hidradenitis Suppurativa Clinical Response [HiSCR]) at week 12, was assessed as the prespecified primary efficacy variable.
Proportion achieving a modified HiSCR with 75% reduction of HiSCR criteria (HiSCR75) or a modified HiSCR with 90% reduction of HiSCR criteria (HiSCR90), change in Patient’s Global Assessment of Pain, and Dermatology Life Quality Index total scores, were the exploratory variables.
Participants with HS showed clinically meaningful and consistent improvements across all assessed outcome measures in correlation with receiving bimekizumab vs placebo.
Two of 46 bimekizumab-treated participants (4%) and two of 21 placebo-treated participants (10%) experienced serious adverse event occurrences.
Findings overall suggest bimekizumab as valuable in treating HS, with the potential to achieve deep responses in clinical outcome measures.
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