Abstract
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory dermatosis with limited treatment options. This systematic review and meta-analysis aimed to evaluate the evidence regarding the use of bimekizumab for treating moderate-to-severe HS, focusing on its clinical efficacy, safety, and outcomes across different clinical parameters. METHODS: We followed the "preferred reporting items for systematic reviews and meta-analyses" (PRISMA) guidelines and performed a systematic search for trials that compared bimekizumab with a placebo in patients with moderate-to-severe HS. A comprehensive search of PubMed, Web of Science, Cochrane CENTRAL, and Embase was conducted up to April 2025. The primary outcome of efficacy was the percentage of patients who reached "HS Clinical Response 50" (HiSCR50), with secondary outcomes including HiSCR75, reduction in skin pain, and safety (evaluated by serious adverse events). Two reviewers independently assessed the risk of bias using the Cochrane risk-of-bias 2 tool. A fixed-effects model was used for meta-analysis. The study protocol was preregistered in PROSPERO (CRD420251025763). RESULTS: Three RCTs, encompassing 1218 participants, were included. Bimekizumab made it substantially more probable that the HiSCR50 would be reached (RR: 1.64; 95% CI [1.37-1.97]; P <.00001) than the placebo. Patients who received bimekizumab were also substantially more likely to achieve higher response levels, HiSCR75 (RR: 1.98; 95% CI [1.52-2.59]; P <.00001) and a considerable reduction in skin pain (RR: 2.29; 95% CI [1.54-3.42]; P <.0001). For all measures of efficacy, both the every-two-week and every-four-week dosage schedules were better than the placebo. The occurrence of serious adverse events did not differ significantly between the bimekizumab and placebo groups (RR: 2.34; 95% CI [0.80-6.79]; P = .12). CONCLUSION: The evidence, although derived from a limited number of trials, demonstrates the superiority of bimekizumab over placebo. For patients with moderate-to-severe HS, bimekizumab showed significantly improved outcomes compared to placebo in terms of enhancing clinical response and lessening skin pain. Although no statistically significant increase in serious adverse events was observed, a potential risk cannot be definitively ruled out given the numerical imbalance.