Omalizumab Pretreatment Associated With Increased Dose Tolerance Among Patients With Food Allergies
Key Takeaways:
- Omalizumab improved patient tolerance: In total, 193 two-dose initiation challenges took place during the study, with patients having tolerance for 181 (94%) challenges after receiving omalizumab pretreatment.
- Omalizumab streamlined oral immunotherapy (OIT) protocols: Traditional OIT procedures include multistep dose escalations, but the majority of patients began OIT at target maintenance dosing.
- Omalizumab was not associated with increased toxicity: The safety profile of omalizumab pretreatment was manageable, with 40% of patients reporting any kind of adverse event (AE) and only 2 patients discontinuing treatment.
For patients with multiple food allergies, standard OIT protocols require multistep dose escalations as well as frequent up-dosing visits. These procedures create a significant treatment burden on patients.
Study Methods and Outcomes
Researchers at Children’s Hospital of Philadelphia (CHOP) conducted a study to assess the effect of omalizumab pretreatment on patients with food allergies. The primary aim was to determine if an omalizumab-facilitated OIT protocol could allow patients to skip up-dosing and begin direct OIT at maintenance.
The study included 100 children and adults treated at CHOP who received omalizumab-facilitated OIT between July 2024 and October 2025. After 8 weeks of omalizumab (Xolair) pretreatment, patients underwent 2-dose initiation challenges for each target food.
The study’s primary outcome was tolerance of the initiation challenge without dose-limiting symptoms. Patients with tolerance initiated OIT at maintenance.
Omalizumab Pretreatment Increased Tolerance of Allergen Dosing
The study included 193 initiation challenges, 181 (94%) of which patients had tolerance after a median of 12 weeks of omalizumab pretreatment.
Among the 100 patients in the study, 97 (97%) began daily dosing for at least 1 food. Within this group, 81 (84%) patients initiated OIT at target dosing for all foods.
Omalizumab Safety Profile
Researchers found that omalizumab pretreatment had a tolerable safety profile that was consistent with other omalizumab regimens. Thirty-nine (40%) patients reported some kind of AE, the most common being abdominal pain (23%) and oral pruritus (13%).
Treatment discontinuation was uncommon, experienced by only 2 patients during the study period who discontinued due to AEs.
Implications for Managed Care
These findings highlight how omalizumab-facilitated OIT protocols could increase dosing tolerance among patients with food allergies, streamlining the treatment process while managing drug toxicity.
The study’s authors said, “This approach may reduce treatment burden while maintaining an acceptable safety profile.”
References
- Shannon CM, Kennedy KL, Lee J, Hanna E, Spergel J, Cianferoni A. Omalizumab-facilitated oral immunotherapy with direct initiation at maintenance dosing for most foods. Ann Allergy Asthma Immunol. 2026;S1081-1206(26):00384-4. doi:10.1016/j.anai.2026.07.031
- Derman C. Omalizumab-facilitated OIT enables maintenance dosing in food allergy. HCP Live. Published August 8, 2026. Accessed August 13, 2026. https://www.hcplive.com/view/omalizumab-facilitated-oit-maintenance-dosing-food-allergy
