Efficacy and safety of bimekizumab in moderate to severe hidradenitis suppurativa: A phase 2, double-blind, placebo-controlled randomized clinical trial
JAMA Aug 24, 2021
Glatt S, Jemec GBE, Forman S, et al. - Findings from this phase 2 randomized clinical trial support that dual inhibition of interleukin 17A and 17F by bimekizumab results in clinically meaningful improvements across all outcome measures, including stringent outcomes, in individuals with moderate to severe hidradenitis suppurativa (HS).
Researchers randomized 90 patients with HS (79 completed the trial) 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.
Following were the exploratory variables: the 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.
Clinically meaningful and consistent improvements were observed in participants receiving bimekizumab vs placebo across all assessed outcome measures.
Among bimekizumab-treated vs placebo-treated participants, 4% vs 10% had development of serious adverse events, respectively.
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