Safety and Efficacy of Remibrutinib for Chronic Spontaneous Urticaria, a Systematic Review and Meta-analysis.

Background: Chronic spontaneous urticaria (CSU) is a burdensome condition marked by recurrent wheals and/or angioedema lasting over six weeks. Despite current treatments, many patients remain symptomatic. Remibrutinib, a selective Bruton's tyrosine kinase (BTK) inhibitor, is a promising therapy targeting mast cell degranulation.

Objective: To assess the efficacy and safety of remibrutinib versus placebo in CSU management.

Methods: A systematic review and meta-analysis following PRISMA guidelines was conducted. PubMed, Cochrane CENTRAL, and Google Scholar were searched for randomized controlled trials (RCTs) comparing remibrutinib to placebo. The primary outcome was change in Urticaria Activity Score over 7 days (UAS7). Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Analyses were performed using Review Manager (RevMan 5.4).

Results: Three RCTs were included. remibrutinib significantly reduced UAS7 scores compared to placebo (MD = -7.78, 95% CI: -10.24 to -5.32, p < 0.01) and improved disease control (RR = 2.16, 95% CI: 1.73-2.71, p < 0.00001) and absence of hives/itch (RR = 3.41, 95% CI: 2.32-5.03, p < 0.00001). No significant differences were found in overall AEs (RR = 1.05, p = 0.59) or SAEs (RR = 1.85, p = 0.37). However, infection risk was higher with remibrutinib, particularly for total infections (RR = 1.59, p < 0.00001) and upper respiratory infections (RR = 2.89, p = 0.009).

Conclusion: Remibrutinib significantly improves CSU symptoms and disease control. While generally safe, it may increase infection risk, notably upper respiratory tract infections. Further long-term studies are needed to confirm these findings.