American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis
Open accessAbstract
The American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma and Immunology Executive Committees formed the Omalizumab Joint Task Force with the purpose of reviewing the Genentech Xolair (omalizumab) clinical trials and postmarketing surveillance data on anaphylaxis and anaphylactoid reactions. Using the definition of anaphylaxis proposed at a 2005 multidisciplinary symposia, the Omalizumab Joint Task Force concluded that 35 patients had 41 episodes of anaphylaxis associated with Xolair (omalizumab) administration between June 1, 2003, and December 31, 2005. With 39,510 patients receiving Xolair (omalizumab) during the same period of time, this would correspond to an anaphylaxis-reporting rate of 0.09% of patients. Of those 36 events for which the time of reaction was known, 22 (61%) reactions occurred in the first 2 hours after one of the first 3 doses. Five (14%) of the events after the fourth or later doses occurred within 30 minutes. Considering the timing of these 36 events, an observation period of 2 hours for the first 3 injections and 30 minutes for subsequent injections would have captured 75% of the anaphylactic reactions. The OJTF report provides recommendations for physicians who prescribe Xolair (omalizumab) on (1) the suggested wait periods after administration and (2) patient education regarding anaphylaxis.
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Omalizumab has been associated with anaphylactic reactions in 0.09% to 0.2% of patients, and monitoring for 30 minutes after administration is recommended.
“Finally, omalizumab has been associated with anaphylactic reactions in 0.09% to 0.2% of patients, with current recommendations to monitor patients for 30 minutes following administration.1742,1743”
From International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (2018) · cites this paper as [1742]
The Incidence section reports an anaphylaxis-reporting rate of 0.09% and cites product information reporting anaphylaxis in at least 0.2% of patients. The OJTF Conclusions and Recommendations section recommends 30 minutes of observation only after the first three injections; it recommends two hours for those initial injections. The claim omits that distinction. (LLM, conf=0.93)
Experimental — accuracy not yet measuredThe estimated rate of systemic reaction from a pollen-food allergy is 10%, and the estimated rate of anaphylaxis is 1.7% to 10%.
“The estimated rate of systemic reaction from a pollen-food allergy is 10% and the estimated rate of anaphylaxis is 1.7% to 10%.1742,1919,1920”
From International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (2018) · cites this paper as [1742]
The 'Incidence of potential Xolair (omalizumab) anaphylactic reactions' section reports a 0.09% anaphylaxis-reporting rate for patients receiving omalizumab, not rates associated with pollen-food allergy. Searches for pollen-food allergy, systemic reactions, and the claimed percentages found no passage addressing those estimates. Page numbers were not available in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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- Authors
- Cox, L., Platts-Mills, T. A. E., Finegold, I., Schwartz, L. B., Simons, F. E. R., & Wallace, D. V.
- Affiliations
- Nova Southeastern University (US)
- St. Luke's-Roosevelt Hospital Center (US)
- Virginia Commonwealth University (US)
- University of Manitoba (CA)
- Corresponding author
- Cox, Linda
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2007-12
- Volume
- 120
- Issue
- 6
- Pages
- 1373-1377
- ISSN
- 0091-6749 (ISSN-L)
- OpenAlex
- W2010946738
- Cited by
- 295
- References
- 14
- Citations by year
- 2026: 6 · 2025: 15 · 2024: 6 · 2023: 13 · 2022: 10 · 2021: 13 · 2020: 26 · 2019: 21 · 2018: 10 · 2017: 15 · 2016: 16 · 2015: 14 · 2014: 18 · 2013: 10 · 2012: 12
- FWCI
- 15.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- GlaxoSmithKline
- Sanofi
- Teva Pharmaceutical Industries
- National Institutes of Health
- Genentech
- Topics
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- omalizumab, anaphylaxis, anaphylactoid reactions, drug hypersensitivity, post-marketing surveillance, clinical trial safety, patient education, prescribing recommendations
- MeSH terms
- Academies and Institutes, Omalizumab, Allergy and Immunology, Anaphylaxis, Antibodies, Anti-Idiotypic, Antibodies, Monoclonal, Asthma, Humans, United States, Anti-Allergic Agents, Anti-Asthmatic Agents, Advisory Committees, Antibodies, Monoclonal, Humanized
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