Safety of omalizumab in children

Abstract

The purpose of the review is to analyze Russian and foreign literature sources on safety of using omalizumab in the treatment of moderate to severe bronchial asthma and chronic idiopathic urticaria in children. Omalizumab is one of the longest used monoclonal antibodies and the first available treatment option for severe atopic asthma in patients aged 6 years and older. Its efficacy and safety have been established in several randomized controlled trials, leading to its final registration over 15 years ago. In most cases, long-term treatment with omalizumab is safe and does not increase the risk of adverse reactions. However, over the years, there has been a trend towards an increase in the number of registrations of adverse reactions associated with the use of omalizumab. Long-term adverse reactions with omalizumab therapy are not sufficiently studied and require more detailed analysis, despite reports of an association between omalizumab and some adverse events. There are very few reports of adverse reactions when taking omalizumab in children in the Russian Federation. Further study of the safety of omalizumab and monitoring of its delayed adverse reactions is required.