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1. Significantly more patients in the bimekizumab group than placebo reported improved clinical response at week 16.

2. Treatment-related adverse events were infrequent with one fatality across both treatment groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Hidradenitis suppurativa (HiS) is a chronic inflammatory disease with limited therapeutic options. Bimekizumab, a monoclonal IgG1 antibody that inhibits interleukin (IL)-17F and IL-17A, has shown potential in treating this condition. This randomized controlled trial aimed to assess the safety and efficacy of bimekizumab in patients with moderate-to-severe HiS. The primary outcome of this study was achieving a HiS clinical response of at least 50% (HiSCR50) at week 16, while the key secondary outcome was the safety profile. According to study results, bimekizumab significantly improved HiSCR50 rates compared to placebo.

Click to read the study in The Lancet

Relevant Reading: Brepocitinib, Zimlovisertib, and Ropsacitinib in Hidradenitis Suppurativa

In-depth [randomized controlled trial]: Between Feb 19, 2020, and Oct 27, 2021, 778 patients were assessed for eligibility across 176 sites in Europe, USA, Canada, Asia, and Australia. Included were patients ≥ 18 years with moderate-to-severe HiS. Altogether, 333 patients (104 in bimekizumab every 2 weeks to week 16 then every 4 weeks to week 48, 98 in bimekizumab every 2 weeks to week 48, 87 in bimekizumab every 4 weeks to week 48, and 44 in placebo to week 16 then bimekizumab every 2 weeks to week 48) were included in the final analysis. The primary outcome of HiSCR50 at week 16 was significantly higher in the bimekizumab groups compared to control (48% vs. 29% in trial I, odds ratio [OR] 2.23, 97.5% confidence interval [CI] 1.16-4.31, p=0.0060 and 52% vs. 32% in trial II, OR 2.29, 97.5% CI 1.22-4.29, p=0.0032). Treatment related adverse events were uncommon (8% in trial I and 5% in trial II) and included hidradenitis, candidiasis, and headache. Only 1 death was reported overall. Findings from this study suggest that bimekizumab is a well-tolerated and effective treatment option for patients with moderate-to-severe hidradenitis suppurativa.

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