Efficacy and safety of omalizumab in patients with atopic dermatitis: A systematic review and meta-analysis

Abstract Background: Omalizumab is a recombinant humanized monoclonal antibody, which inhibits the occurrence of type 2 inflammatory response by reducing the serum-free immunoglobulin E (IgE) levels. Atopic dermatitis (AD) is a type 2 inflammatory response. However, the efficacy of omalizumab in treating AD remains controversial. Objectives: We aimed to assess the efficacy of omalizumab in the treatment of AD and therefore conducted a meta-analysis to obtain a more objective result. Methods: Seven databases were searched to identify relevant studies, which were subsequently subjected to quality assessment. RevMan5.4 software was used for meta-analysis (PROSPERO registered number: CRD42023476559). Results: A total of 25 studies involving 234 patients were included. The SCORing of AD, Eczema Area and Severity Index, and (Children’s) Dermatology Life Quality Index were all significantly decreased after omalizumab treatment, with mean difference = −23.27 (95% confidence interval [CI]: −30.96, −15.59) ( P < 0.05); −7.83 (95% CI: −14.37, −1.3) ( P < 0.05); −7.66 (95% CI: −9.65, −5.66) ( P < 0.05), respectively. Furthermore, as baseline IgE levels increased, the proportion of patients achieving an excellent response exhibited a declining trend. Conclusion: Omalizumab shows promise as a safe and moderately effective treatment for AD, particularly in patients with low IgE levels, elevated eosinophil counts, or positive autologous serum test results. Its efficacy may be influenced by baseline IgE levels, suggesting a need for individualized dosing strategies. Further large-scale randomized control trials are warranted to clarify its optimal use and identify ideal target populations.