The Efficacy and Safety of Remibrutinib in Patients with Chronic Spontaneous Urticaria: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Abstract Chronic spontaneous urticaria (CSU) often remains uncontrolled despite standard therapy. Bruton’s tyrosine kinase (BTK) inhibition has emerged as a novel therapeutic approach. A systematic review and meta-analysis were performed following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Electronic databases (Embase, Scopus, PubMed, and Cochrane) and ClinicalTrials.gov were searched from inception to June 1, 2025. Two randomized controlled trials (RCTs) were included (657 remibrutinib and 355 placebo). Remibrutinib significantly improved Urticaria Activity Score over 7 days (UAS7) at week 12 (standardized mean difference [SMD] 8.64; 95% confidence interval [CI] 6.98–10.29; P < 0.00001) and sustained improvement to week 24 (SMD 5.70; 95% CI 3.74–7.66). Complete response (UAS7 = 0) at week 12 was higher with remibrutinib (30.3%) versus placebo (9.0%) (odds ratio 4.53; 95% CI 3.02–6.80). Safety analysis showed no increase in serious adverse events. Remibrutinib demonstrates promising efficacy and acceptable safety in CSU. Longer-term studies are needed to assess durability and effects in subpopulations.