Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

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.

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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