Combination of omalizumab with allergen immunotherapy versus immunotherapy alone for allergic diseases: A meta‐analysis of randomized controlled trials

Abstract Background Allergen immunotherapy (AIT)‐associated adverse events (AEs) limit its usage in the management of allergic diseases. The monoclonal anti‐IgE antibody (omalizumab) and AIT have complementary actions. However, no consensus has been reached on whether their combination could exert superior efficacy and safety. Objective To evaluate whether the combination of AIT with omalizumab is superior to AIT alone in treating allergic diseases. Methods The MEDLINE/PubMed, Embase, Scopus and Cochrane Library databases were searched to identify randomized control trials (RCTs) reporting the outcomes of omalizumab combined with AIT (omalizumab + AIT) versus AIT alone. A random‐effect model was established to estimate outcomes with a 95% confidence interval (CI). Results A total of 11 eligible RCTs (involving 901 patients) were screened out for the meta‐analysis. According to a pooled analysis, omalizumab + AIT significantly increased the number of patients achieving the target maintenance dose (TMD) and sustained unresponsiveness (SU) to allergens (odds ratio [OR] = 2.43; 95% CI: 1.33–4.44; p = 0.004; I 2 = 35%, and OR = 6.77; 95% CI: 2.10–21.80; p = 0.001; I 2 = 36%, respectively). Similarly, individuals receiving the combination therapy reported significantly fewer episodes of severe systemic AEs than AIT alone (OR = 0.32; 95% CI: 0.18–0.59; p = 0.0003; I 2 = 0%). Meanwhile, the improvements in symptom severity score (mean difference [MD] = −0.26), rescue medication daily means score (MD = −0.14), and number of patients consuming epinephrine in AIT (OR = 0.20) were all more evident than those in AIT alone. Conclusion Omalizumab + AIT can significantly enhance the efficacy and safety of AIT by increasing TMD and SU to allergens, while decreasing severe systemic AEs.