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Cited by 170Food Allergy and Anaphylaxis ResearchDrug-Induced Adverse ReactionsAsthma and respiratory diseases

Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma

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Limb, Susan L., Starke, Peter R., Lee, Charles E., Chowdhury, Badrul A.·2007·Journal of Allergy and Clinical Immunology
DOI 10.1016/j.jaci.2007.09.022
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Abstract

Background Risk of anaphylaxis is included in the prescribing information for omalizumab, but the nature of these reactions merits further elaboration.Objective To describe cases of anaphylaxis associated with omalizumab administration in patients with asthma.Methods We reviewed spontaneous postmarketing adverse event reports submitted to the US Food and Drug Administration's Adverse Event Reporting System database and to the manufacturers of omalizumab and cases published in the literature through December 2006. Diagnostic criteria for anaphylaxis outlined by the National Institute of Allergy and Infectious Diseases and the Food Allergy and Anaphylaxis Network were used to screen cases.Results One-hundred twenty-four cases of anaphylaxis associated with omalizumab administration in patients with asthma were identified. Many cases had a delayed onset of symptoms beyond 2 hours after dose administration. Many cases were also characterized by a protracted progression, with individual signs and symptoms of anaphylaxis staggered over hours. Review of the case reports did not reveal any predictive risk factors for the delayed onset or protracted progression of anaphylaxis.Conclusion Omalizumab-induced anaphylaxis may be characterized by a delayed onset and a protracted progression of symptoms.Clinical implications The unusual timing of anaphylaxis in these cases challenges our understanding of anaphylaxis. A delayed onset of symptoms and protracted progression of anaphylaxis should be taken into account when administering omalizumab.

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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 [1743]

    The Discussion (page unavailable) estimates anaphylaxis frequency at approximately 0.2% from postmarketing reports and 0.1% in premarketing trials, close to the claimed lower bound of 0.09%. The Results (page unavailable) say only about one-third of reactions began within 30 minutes; the passages found do not recommend 30 minutes of post-administration monitoring. (LLM, conf=0.87)

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  36. Correction With regard to the December 2007 article entitled ''Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma'' (J Allergy Clin Immunol 2007;120:1378-81), 2 errors appear in Table I. Under ''Time to onset,'' the correct percentage for the 30-to 60-minute range is 16%, not 26%. Under ''>24 h up to 4 d,'' the correct value for N (''No.'') is 6, not 5.

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Authors
Limb, S. L., Starke, P. R., Lee, C. E., & Chowdhury, B. A.
Affiliations
United States Food and Drug Administration (US)
Corresponding author
Limb, Susan L.
Venue
Journal of Allergy and Clinical Immunology
Publisher
Elsevier BV
Published
2007-12
Volume
120
Issue
6
Pages
1378-1381
ISSN
0091-6749 (ISSN-L)
DOI
10.1016/j.jaci.2007.09.022
OpenAlex
W2004147651
Cited by
170
References
17
Citations by year
2026: 1 · 2025: 6 · 2024: 2 · 2023: 7 · 2022: 6 · 2021: 8 · 2020: 9 · 2019: 14 · 2018: 3 · 2017: 10 · 2016: 7 · 2015: 7 · 2014: 8 · 2013: 7 · 2012: 8
FWCI
11.06
Type
journal article
Language
en
Update notices
erratum (2008-01-01)
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Allergy and Clinical Immunology (publishedVersion)
  • PubMed (publishedVersion)
  • UCLA - Biblioteca de Ciencias de la Salud (submittedVersion)
Topics
  • Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
  • Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
  • Health Sciences › Medicine › Physiology › Asthma and respiratory diseases
Keywords
omalizumab, anaphylaxis, delayed onset, asthma, drug hypersensitivity, adverse drug reactions, anti-IgE therapy, post-marketing surveillance
MeSH terms
Omalizumab, Adolescent, Adult, Aged, Anaphylaxis, Antibodies, Anti-Idiotypic, Antibodies, Monoclonal, Asthma, Child, Female, Humans, Male, Middle Aged, Time Factors, Disease Progression, Anti-Allergic Agents, Anti-Asthmatic Agents, Antibodies, Monoclonal, Humanized

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