From wheal to wellness: efficacy and safety of ligelizumab in chronic spontaneous urticaria: a systematic review and meta-analysis.

Chronic spontaneous urticaria (CSU) is characterized by persistent hives and itching that lasts longer than six weeks. Ligelizumab, a humanized monoclonal antibody specifically targeting IgE, has emerged as a promising option for managing CSU. This study evaluates the effectiveness and safety of ligelizumab for this debilitating condition. A comprehensive literature search was conducted at PubMed, Cochrane Library, Google Scholar, and ClinicalTrials.gov to identify relevant studies published until December 2024. The review included randomized controlled trials that compared ligelizumab with a placebo. Our meta-analysis of 2581 patients found that ligelizumab significantly improves outcomes in chronic spontaneous urticaria. A dose-dependent response was observed, with 24 mg being non-superior to placebo. Doses of 72 mg significantly reduced Itch Severity Score (MD: - 3.54; 95% CI - 4.36 to - 2.73; P < 0.00001), Urticaria Activity Score (UAS7) (MD: - 9.79; 95% CI - 10.65 to - 8.93; P < 0.00001),  provided complete UAS7 response (UAS7 = 0) (OR: 7.30; 95% CI 2.99 to 17.83; P < 0.0001), and Angioedema free weeks (MD: 2.22; 95% CI 1.63 to 2.82; P < 0.00001), with further improvements noted at the 120 mg dose. Statistically significant results were also observed for the Dermatological Life Quality Index and Hives Severity Score. No significant adverse effects were reported with ligelizumab 72 mg, but very mild adverse effects were discovered with the 120 mg dose. Ligelizumab, at doses of 72 mg and 120 mg, effectively manages CSU by reducing symptoms and improving overall quality of life compared to placebo, although 120 mg Ligelizumab is associated with mild Adverse Events.