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Published on: October 25, 2018
Omalizumab for the Treatment of Multiple Food Allergies
Robert A Wood1, Alkis Togias1, Scott H Sicherer1
1From the Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore (R.A.W., J.D., K.M.), and the National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda (A.T., A.K.R.S., M.V., S.D.H., E.B., J.P., L.M.W.) - both in Maryland; the Division of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York (S.H.S., J.W., M.G.); the Division of Pediatric Allergy and Immunology and Food Allergy Center, Massachusetts General Hospital, Boston (W.G.S., D.P.); the University of North Carolina School of Medicine (E.H.K., C.A.K., M.K.) and Rho (A.C., C.M.H., N.H.R., N.Y.) - both in Chapel Hill; the University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock (S.M.J., A.M.S.); National Jewish Health, Denver (D.Y.M.L., B.J.L.); Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta (B.P.V., T.L.); the Department of Pediatrics, Division of Allergy and Immunology, University of Texas Southwestern Medical Center, Dallas (J.A.B., C.P.); the Division of Allergy and Immunology, Department of Pediatrics at Perelman School of Medicine at University of Pennsylvania, Philadelphia (J.M.S., T.B.-W.); Genentech-Roche, South San Francisco (A.I., J.O.), and Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Palo Alto (S.B.S., A.L., R.S.C.) - both in California; and Novartis Pharmaceuticals, East Hanover, NJ (M.L.-S., A.U.).
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. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT03881696.).
