Safety and tolerability of omalizumab

Summary Background Omalizumab (Xolair®) is a recombinant humanized monoclonal anti‐IgE antibody with proven efficacy in patients with moderate‐to‐severe and severe persistent allergic (IgE‐mediated) asthma. Objective To review clinical study data to assess the safety profile of omalizumab. Methods We analysed the safety of omalizumab using data from completed clinical studies (up to 1 year) involving more than 7500 patients with asthma, rhinitis or related conditions and up to 4 years in one study of patients with severe allergic asthma, as well as post‐marketing safety data. Analysis focuses on the risk of immune‐system effects, hypersensitivity reactions, malignant neoplasia, parasitic infections and thrombocytopenia. Results Omalizumab exhibited a good safety and tolerability profile that was maintained up to 4 years in one study. The incidence of anaphylaxis was 0.14% in omalizumab‐treated patients and 0.07% in control patients. No omalizumab‐treated patient developed measurable anti‐omalizumab antibodies. Post‐marketing, based on estimated exposure of 57 300 patients (June 2003–December 2006), the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients. Current clinical trial data do not support an increased risk of malignant neoplasia or thrombocytopenia with omalizumab. Conclusion Data indicate that the proven efficacy of add‐on omalizumab in patients with moderate‐to‐severe or severe allergic asthma is accompanied by a favourable safety and tolerability profile.