Omalizumab for the Treatment of Multiple Food Allergies

Robert A. Wood, Alkis Togias, Scott H. Sicherer, Wayne G. Shreffler, Edwin H. Kim, Stacie M. Jones, Donald Y.M. Leung, Brian P. Vickery, J. Andrew Bird, Jonathan M. Spergel, Ahmar Iqbal, Julie Olsson, Monica Ligueros-Saylan, Alkaz Uddin, Agustin Calatroni, Charmaine Marquis Huckabee, Nicole H. Rogers, Nancy Yovetich, Jennifer Dantzer, Kim MuddJulie Wang, Marion Groetch, David Pyle, Corinne A. Keet, Michael Kulis, Sayantani B. Sindher, Andrew Long, Amy M. Scurlock, Bruce J. Lanser, Tricia Lee, Christopher Parrish, Terri Brown-Whitehorn, Amanda K. Rudman Spergel, Maria Veri, Sanaz Daneshfar Hamrah, Erica Brittain, Julian Poyser, Lisa M. Wheatley, R. Sharon Chinthrajah

Research output: Contribution to journalArticlepeer-review

11 Scopus citations


BACKGROUND Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy. METHODS In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension. RESULTS Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group. CONCLUSIONS In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens.

Original languageEnglish
Pages (from-to)889-899
Number of pages11
JournalNew England Journal of Medicine
Issue number10
StatePublished - 7 Mar 2024


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