ObjectiveTo determine the efficacy of omalizumab in patients (12~75 years of age) with severe allergic asthma, and guide its clinical application. MethodsDatabases, including Pubmed, Web of Science and Embase, were searched to collect randomized controlled trials (RCTs).Data were extracted, and the quality of included RCTs was assessed by two reviewers, followed by meta-analyses using Review Manage 5.1 software. ResultsMeta-analyses of ten included RCTs showed that, compared with placebo, omalizumab reduced the rate of exacerbation per patient during both stable-steroid phase [RR=0.56, 95% CI(0.42, 0.75), P < 0.000 1] and steroid-reduction phase for patients with severe asthma [RR=0.53, 95% CI(0.48, 0.60), P < 0.000 01], reduced the number of patients experienced at least one exacerbation [RR=0.71, 95% CI(0.61, 0.84), P < 0.000 01], and significantly reduced the dosage of beclomethasone dipropionate (≥50%) [RR=1.51, 95% CI(1.24, 1.84), P < 0.001].Omalizumab significantly improved asthma-related quality of life [RR=1.25, 95% CI(1.13, 1.38), P < 0.000 01], albeit no indications of omalizumab reducing the rate of emergency visits [RR=0.63, 95% CI(0.28, 1.44), P < 0.001]. ConclusionThe addition of omalizumab to standard asthma therapy reduces asthma exacerbations, decreases inhaled corticosteroid and rescue medication use, and improves the quality of life in severe asthma patients.