Food allergy, anaphylaxis, dermatology, and drug allergyDelayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma
Section snippets
Methods
We reviewed spontaneous adverse event reports submitted to the US Food and Drug Administration's Adverse Event Reporting System database and to the manufacturers of omalizumab from June 2003 to December 2006, as well as published cases in the literature.3, 4, 5 These data were voluntarily submitted to Adverse Event Reporting System, and no additional information was available. The estimated exposure to omalizumab over this period was about 57,300 patients. By using diagnostic criteria for
Results
We identified 124 cases of anaphylaxis to omalizumab (Table I). Eighty-three percent (101 of 121 cases with sex reported) of the patients were female, and the mean age was 43 years (range, 9-78 years). Thirty-nine percent (n = 48) of the cases were first-dose reactions. Approximately ⅓ (n = 44) occurred after the third dose or higher; in some of these cases, patients had been receiving omalizumab therapy for a year or more before the anaphylactic reaction. As reported, 89% (n = 110) displayed
Discussion
Anaphylaxis is commonly considered to be an immediate systemic response to an agent, with signs and symptoms occurring simultaneously or in rapid sequence. In certain situations, a biphasic response may be observed, with a second wave of symptoms presenting generally within 8 hours of the initial event. These 124 cases of omalizumab-induced anaphylaxis challenge the typical model of anaphylaxis and are noteworthy for cases with delayed onset and protracted progression of symptoms.
Delay in onset
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2020, Journal of Allergy and Clinical Immunology: In PracticeCitation Excerpt :More than half the cases of anaphylaxis to omalizumab occur less than 1 hour after medication administration. However, delayed reactions (>24 hours after the injection) and a protracted course, with symptoms progressively developing over the course of several hours, have been reported.506,507 Two patients with symptom onset more than 24 hours after the injection were rechallenged and both had recurrent reactions, strengthening the causality of omalizumab in these reactions.507
Disclosure of potential conflict of interest: The authors are employed by the US Food and Drug Administration.
The views expressed in this article are those of the authors and do not necessarily reflect the views or policies of the US Food and Drug Administration.