Efficacy and safety of Omalizumab in the treatment of CSU: a meta-analysis of a randomized controlled trial.

To systematically evaluate the efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria (CSU) through a meta-analysis. PubMed, Cochrane Library, and Embase databases were searched for randomized controlled trials (RCTs) comparing omalizumab with placebo in CSU. Two researchers independently screened studies, extracted data, and assessed quality. Efficacy outcomes, including the 7-day Urticaria Activity Score (UAS7), Itch Severity Score (ISS), hive count, and Dermatology Life Quality Index (DLQI), as well as safety outcomes (adverse event rates), were analyzed using RevMan 5.3 software across different doses (75, 150, 300, and 600 mg). Twelve RCTs involving 2,738 participants (2,090 in omalizumab groups, 648 in placebo) were included①Efficacy: The proportion of patients achieving UAS7 < 6 was significantly higher in the omalizumab group (OR = 3.29, 95% CI:1.16-9.38, P = 0.03), with the 300 mg dose showing optimal efficacy (OR = 7.60, 95% CI:5.44-10.62, P < 0.001).The 300 mg dose significantly reduced UAS7 (MD = 12.20, 95% CI:9.65-14.76), ISS (MD = 5.26, 95% CI:4.42-5.36), and hive count (MD = 6.83, 95% CI:5.73-7.94) compared to placebo (all P < 0.001).DLQI improvement was also greater with 300 mg (MD = 3.26, 95% CI:1.78-4.73, P < 0.0001).②Safety: Adverse events were more frequent in the omalizumab group (OR = 1.24, 95% CI:1.04-1.49, P = 0.02), though most were mild. Omalizumab effectively alleviates CSU symptoms and improves quality of life, with the 300 mg/month dose demonstrating optimal efficacy. Clinicians should prioritize this dose while monitoring short-term adverse effects. Further studies are needed to confirm long-term safety.