Safety study of omalizumab use during pregnancy

Bronchial asthma (BA) is one of the important medical and social problems of modern society, the prevalence of which is increasing. According to the Ministry of Health of the Russian Federation, the prevalence of BA worldwide was 262 million people as of 2019, with the number of BA-related deaths accounting for 461,000. The prevalence of BA in pregnant women is 4-8%, with 40% of women experiencing worsening symptoms during pregnancy. Uncontrolled BA is also positively correlated with the risk of eclampsia, preterm birth, and low birthweight. A number of medications are used to manage exacerbations of BA and control symptoms, including omalizumab. Omalizumab is a humanized monoclonal antibody derived from recombinant DNA that binds to IgE, reducing its concentration and preventing the development of allergic reactions. Despite the proven efficacy of omalizumab in BA, data on the safety of omalizumab use in pregnant women and on the effect of omalizumab on fetal development are limited and controversial, and the appropriateness of omalizumab administration during pregnancy remains poorly understood. In this scientific review, we analyzed 5 studies aimed at investigating the efficacy and safety of omalizumab use during pregnancy.