Introduction of allergenic foods after treatment with omalizumab

J Allergy Clin Immunol. 2025 Aug;156(2):394-405. doi: 10.1016/j.jaci.2025.05.014. Epub 2025 May 28.

Abstract

Background: Omalizumab has been shown to increase reaction thresholds to allergenic foods during treatment. Little is known about its potential to permit introduction of allergenic foods.

Objective: The aim of this study was to examine introduction of allergenic foods after stopping treatment with omalizumab.

Methods: The first 60 participants completing OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants) stage 1 entered a 24-week open label extension, followed by entry into protocol stage 3, which could include dietary consumption (DC) of retail allergenic foods, rescue oral immunotherapy, or allergen avoidance, depending on the results of the final food challenges and participant preferences.

Results: A total of 60 participants were included (58% male, median age 8.5 years, age range 1-20 years). The study foods included peanut (n = 60), cashew (n = 28), egg (n = 27), milk (n = 25), walnut (n = 23), wheat (n = 9), and hazelnut (n = 8). Of the initial treatment plans, 82% included DC. DC success was defined as a median daily consumption of at least 300 mg of food protein over 12 months, with the data analyzed in quarterly intervals. Overall, greater success was observed for milk, egg, or wheat (61%-70%) than for peanut or tree nuts (38%-56%). Allergenic food consumption generally declined over time, except in the cases of wheat, with greater variability in median consumption for egg and milk relative to nuts. Reduced consumption appeared to be related to both symptoms and patient preference. The only predictor of DC success was a higher screening challenge threshold. Adverse events included episodes of anaphylaxis, epinephrine use, and 2 diagnoses of eosinophilic esophagitis related to DC.

Conclusions: In this first study of introduction of retail food following omalizumab treatment, most participants were able to introduce allergenic foods in a dietary form, although adverse reactions did occur and many participants returned to avoidance.

Keywords: Omalizumab; anti-IgE; food allergy.

MeSH terms

  • Adolescent
  • Adult
  • Allergens* / immunology
  • Anti-Allergic Agents* / therapeutic use
  • Child
  • Child, Preschool
  • Desensitization, Immunologic* / methods
  • Female
  • Food Hypersensitivity* / immunology
  • Food Hypersensitivity* / therapy
  • Humans
  • Infant
  • Male
  • Omalizumab* / therapeutic use
  • Young Adult

Substances

  • Omalizumab
  • Allergens
  • Anti-Allergic Agents