Safety of omalizumab in the treatment of moderate-to-severe bronchial asthma

Abstract

This review aimed to analyze national and international literature on the safety of omalizumab in the treatment of moderate-to-severe bronchial asthma. Omalizumab is one of the longest-standing monoclonal antibodies and the first available treatment option for severe allergic asthma in patients aged 6 years. Several randomized controlled studies have established its efficiency and safety, leading to its final registration more than 15 years ago. In most cases, long-term treatment with omalizumab is safe without increasing the risk of adverse reactions. However, over the years, a growing trend has been observed in several registrations of adverse events associated with the use of omalizumab. A review of the literature revealed a lack of long-term clinical monitoring data (over 2 years) in both patients aged 18 years and children. Long-term adverse reactions during omalizumab therapy are insufficiently examined and require more detailed analysis, despite reports of an association between omalizumab and some adverse events. Moreover, extremely few cases of adverse reactions to omalizumab were reported in the Russian Federation. Thus, further investigations of the safety profile of omalizumab and monitoring of its delayed adverse reactions are required.