Omalizumab-Facilitated Oral Immunotherapy with Direct Initiation at Maintenance Dosing for Most Foods

Existing clinical oral immunotherapy (OIT) protocols require multistep initial dose escalations and frequent up-dosing visits. Omalizumab increases tolerated doses of food allergens and may enable direct initiation at low maintenance doses.

To characterize outcomes associated with an omalizumab-facilitated OIT protocol designed to enable direct initiation at maintenance dosing for most foods.

We conducted a prospective cohort study of 100 children and young adults who initiated omalizumab-facilitated OIT between July 2024 and October 2025. After at least 8 weeks of omalizumab pretreatment, patients underwent a two-dose initiation challenge. If tolerated, daily dosing was initiated at maintenance for most foods, with abbreviated up-dosing for the remaining foods. The primary outcome was tolerance of the initiation challenge without dose-limiting symptoms.

AFTER A MEDIAN OF 12 WEEKS (IQR: 9.5 - 15.8) of omalizumab pretreatment, patients tolerated 181 of 193 initiation challenges (94%). Ninety-seven patients (97%) initiated daily dosing for at least one food and 81 (84%) started at target doses for all foods. During median follow-up of 27.6 weeks (IQR: 18.1 - 41.1), 39 patients (40%) reported any adverse event, most commonly abdominal pain (23%) or oral pruritus (13%). Two patients discontinued therapy due to adverse events. Among those who met criteria for omalizumab discontinuation, median treatment duration was 26.3 weeks (IQR: 20.7 - 36.4).

In this cohort, a short course of omalizumab facilitated direct initiation at maintenance dosing for most foods. Most patients successfully initiated therapy at target doses, and treatment discontinuation was uncommon. This approach may reduce treatment burden while maintaining an acceptable safety profile.