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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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