Journal
CLINICAL AND EXPERIMENTAL ALLERGY
Volume 39, Issue 6, Pages 788-797Publisher
WILEY-BLACKWELL PUBLISHING, INC
DOI: 10.1111/j.1365-2222.2009.03214.x
Keywords
anti-IgE; omalizumab; safety; tolerability
Categories
Funding
- Novartis and Genentech
- MRC [G19/34] Funding Source: UKRI
- Medical Research Council [G19/34] Funding Source: researchfish
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Omalizumab (Xolair((R))) is a recombinant humanized monoclonal anti-IgE antibody with proven efficacy in patients with moderate-to-severe and severe persistent allergic (IgE-mediated) asthma. To review clinical study data to assess the safety profile of omalizumab. 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. 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. 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.
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