Oral food challenges after omalizumab treatment in the clinical setting

Published online March 6, 2026

The OUtMATCH study demonstrated omalizumab’s efficacy in increasing reaction thresholds to multiple foods in patients with IgE-mediated food allergy (FA), leading to its approval by the Food and Drug Administration for the treatment of FA in February 2024. This approval represents a significant milestone in FA treatment, and many patients have since initiated omalizumab for FA in clinical practice. However, real-world data remain limited.

In a recent study published in The Journal of Allergy and Clinical Immunology: In Practice, Tseng et al. examined the outcomes of oral food challenges (OFCs) among the first cohort of patients treated with omalizumab for FA at the Johns Hopkins Pediatric Allergy Clinic. The authors retrospectively reviewed 73 OFCs, mostly to milk, egg, and wheat, performed in 51 patients aged 1-23 years. OFCs were done after at least 4 months of omalizumab treatment. The amount of food protein successfully ingested during the OFC without dose-limiting symptoms, defined as the cumulative tolerated dose (CTD), was reported as the primary outcome. Additionally, the authors assessed adverse events related to OFCs, provider recommendations for home introduction of retail allergenic foods following OFCs, and predictors of successful OFC outcomes.

This study demonstrated a high proportion of successful OFCs, including many who tolerated serving size amounts (6000mg). The findings were similar to these in OUtMATCH but provide compelling evidence that omalizumab can be effectively translated to clinical practice. Allergic reactions during OFCs were common but mostly mild, with two receiving epinephrine. Dietary introduction of retail allergenic foods was permitted following 92% of OFCs, generally starting at 50% of the challenge CTD. Analysis of potential predictors found that successful outcomes were associated with higher baseline total IgE, every 2-week dosing versus every 4-week dosing, higher omalizumab dose per 4 weeks per weight, and lower allergen-specific IgE to total IgE ratio. Overall, this study shows that omalizumab can be effectively used for the treatment of food allergy in clinical settings and may enable the introduction of allergenic foods into the diet for most patients.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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Corresponding Author
Jennifer Dantzer, MD, MHS, Division of Pediatric Allergy, Immunology, and Rheumatology, Johns Hopkins University School of Medicine

First Author
Hao Tseng, MD, MSc, Division of Pediatric Allergy, Immunology, and Rheumatology, Johns Hopkins University School of Medicine