TOPLINE

A brief course of omalizumab enabled most children and young adults with food allergies to start oral immunotherapy (OIT) directly at low maintenance doses for most food allergens.

METHODOLOGY

• Researchers conducted a prospective cohort study involving 100 children and young adults (median age, 9 years; 67% male) initiating omalizumab-facilitated OIT for one or more food allergens between 2024 and 2025 at a pediatric tertiary referral center in Philadelphia.
• Patients received omalizumab pretreatment for at least 8 weeks, with the dose determined by body weight and the total serum immunoglobulin E levels measured at baseline.
• After pretreatment, patients underwent a two-dose oral food challenge for each food allergen, with a maximum dose of approximately 100-400 mg of protein per allergen; patients who tolerated the maximum dose began daily dosing at 100 mg for cashews and 200-400 mg for other foods (peanuts, tree nuts, sesame, eggs, wheat, and milk).
• Target maintenance doses were 200-400 mg for peanuts, tree nuts, and sesame and 2000-4000 mg for wheat, eggs, and milk, with abbreviated updosing at intervals of 2 weeks or more when required.
• The primary outcome was tolerance of the maximum dose of each food without dose-limiting symptoms during the initiation challenge; secondary outcomes included the incidence and severity of adverse events.

TAKEAWAY

• After omalizumab pretreatment for a median of 12 weeks, patients tolerated the maximum dose without dose-limiting symptoms in 94% of initiation challenges, including 93% of challenges involving peanuts, tree nuts, sesame, eggs, wheat, and milk.
• Overall, 89% of the patients who underwent an initiation challenge for a single food allergen began daily dosing at the target dose for that food allergen, and 72% of patients who underwent initiation challenges for two or more food allergens began daily dosing at the target dose for each food allergen challenged.
• During daily dosing, 40% of the patients reported experiencing an adverse event — most commonly abdominal pain or oral pruritus — over a median follow-up of 27.6 weeks; 6% of the patients received epinephrine, and only 2% discontinued therapy due to adverse events.
• Among patients who discontinued omalizumab, the median treatment duration was 26.3 weeks, and it ranged from 23.7 weeks for single-food therapy to 31.8 weeks for multifood therapy.

IN PRACTICE

“Collectively, these protocol modifications reduced the median number of visits to reach maintenance for peanut, most tree nuts, and sesame from 10-11 visits under our standard protocol to 1-2 visits under our omalizumab-facilitated protocol,” the authors of the study wrote.

SOURCE

Colleen M. Shannon, MD, MPH, Children’s Hospital of Philadelphia, Philadelphia, was the corresponding author of the study, which was published online on August 5 in Annals of Allergy, Asthma & Immunology.

LIMITATIONS

The study lacked a baseline oral food challenge to confirm ongoing clinical reactivity, had no comparison group, and used a single-center design with a predominantly male, White population, all of which may have limited generalizability. Additionally, patients self-selected between standard and omalizumab-facilitated protocols, introducing potential selection bias.

DISCLOSURES

The study was supported by the Children’s Hospital of Philadelphia Gail Slap Department of Pediatrics Fellowship Endowment Award. One author reported receiving research funding from the National Institutes of Health, Novartis, Regeneron, and Sanofi.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.