Clinical Efficacy and Safety Profile of Bimekizumab in Psoriasis: A Systematic Review and Meta-analysis of Randomized...

Bimekizumab, a monoclonal antibody that simultaneously neutralizes interleukin (IL)-17A and IL-17F, may offer therapeutic advantages over other biologics for the treatment of psoriasis. With the availability of head-to-head randomized controlled trials (RCTs) and ongoing concerns regarding inflammatory bowel disease (IBD), further evaluation of its efficacy and safety is warranted.

This meta-analysis assessed the efficacy and safety of bimekizumab relative to placebo and active biologic comparators. RCTs comparing bimekizumab with placebo or other targeted biologics in adult patients with psoriasis were systematically identified from PubMed, Embase, and CENTRAL. Efficacy outcomes included Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA). Safety outcomes included total and serious treatment-emergent adverse events (TEAEs) and specific TEAEs of interest, such as infections and IBD. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using Mantel-Haenszel fixed- or random-effects models based on heterogeneity.

Twelve RCTs involving 4,812 patients met the inclusion criteria. Bimekizumab significantly outperformed placebo for PASI75 (RR = 12.11), PASI90 (RR = 19.72), PASI100 (RR = 20.43), and IGA 0/1 (RR = 23.34) (all p < 0.001), and was superior to active comparators-including adalimumab, ustekinumab, and secukinumab-for PASI75 (RR = 2.11), PASI90 (RR = 1.55), PASI100 (RR = 2.11), and IGA 0/1 (RR = 1.53) (all p < 0.05). Although the overall incidence remained low, total TEAE risk was higher versus placebo (RR = 1.17, p = 0.03) but comparable with active controls; serious TEAEs did not differ significantly across comparisons. Risks of oral candidiasis (RR = 7.88 vs placebo; RR = 9.59 vs comparators, both p < 0.001) and nasopharyngitis (RR = 1.61 vs placebo, p = 0.01) were elevated, whereas no signal of severe systemic or organ- specific toxicity, including IBD, was detected.

This meta-analysis highlights that bimekizumab offers substantial therapeutic benefit in psoriasis, with robust and consistent efficacy across dosing regimens, baseline disease severity, and treatment durations. The results strengthen the mechanistic rationale that dual IL-17A and IL-17F inhibition provides additive advantages beyond single-cytokine blockade.

Bimekizumab demonstrated superior efficacy to both placebo and other biologics, with particularly strong effects in achieving complete clearance (PASI100). Its safety profile was acceptable, with increased but generally low-incidence risks of oral candidiasis and nasopharyngitis, and no evidence of excess serious TEAEs. Although no excess IBD signal was observed, this finding should be interpreted with caution, as the assessment of IBD risk was limited by relatively short follow-up durations and the exclusion of patients with IBD in most trials.