In a prospective cohort study of 100 children and young adults with multi-food allergy treated at Children's Hospital of Philadelphia, 94% of initiation challenges were tolerated after a median of 12 weeks of omalizumab (Xolair) pretreatment, allowing most patients to begin oral immunotherapy (OIT) directly at maintenance dosing.¹
Standard OIT protocols require multistep dose escalations and frequent in-office up-dosing visits, creating a substantial treatment burden for patients with multi-food allergy. Investigators evaluated whether a short course of omalizumab pretreatment could allow most patients to skip incremental up-dosing and begin OIT directly at maintenance.
Omalizumab-Facilitated OIT Study Design and Initiation Outcomes
Colleen Shannon, MD, MPH, from the Children’s Hospital of Philadelphia, and colleagues conducted a prospective cohort study of 100 children and young adults who initiated omalizumab-facilitated OIT between July 2024 and October 2025.¹ Patients received ≥ 8 weeks of omalizumab pretreatment before undergoing a 2-dose initiation challenge for each target food. If tolerated, daily OIT dosing began at maintenance for most foods, with abbreviated up-dosing reserved for the remaining foods.
Median omalizumab pretreatment duration was 12 weeks (interquartile range [IQR], 9.5-15.8 weeks). Patients tolerated 181 of 193 initiation challenges (94%), meeting the primary outcome of tolerance without dose-limiting symptoms. In total, 97 patients (97%) initiated daily dosing for ≥ 1 food, and 81 patients (84%) started at target maintenance doses across all foods in their regimen.
These findings indicate the omalizumab-facilitated protocol allowed most patients to bypass the incremental dose-escalation phase required by conventional OIT.
Safety and Follow-Up Outcomes With Omalizumab-Facilitated OIT
Frequently Asked Questions
What is omalizumab-facilitated OIT?
Omalizumab-facilitated OIT pairs a short course of omalizumab pretreatment with oral immunotherapy, raising the threshold for allergic reactions before food dosing begins.
How effective was direct initiation at maintenance dosing in this cohort?
Patients tolerated 94% (181 of 193) of initiation challenges after a median of 12 weeks of omalizumab pretreatment, and 84% started at target maintenance doses for all foods.
What safety signals were reported?
The most common adverse events were abdominal pain (23%) and oral pruritus (13%), with 2 patients discontinuing therapy because of adverse events.
During median follow-up of 27.6 weeks (IQR, 18.1-41.1 weeks), 39 patients (40%) reported ≥ 1 adverse event.¹ The most common events were abdominal pain, reported by 23% of patients, and oral pruritus, reported by 13%. In total, 2 patients discontinued OIT because of adverse events.
Among patients who met criteria for omalizumab discontinuation, median treatment duration was 26.3 weeks (IQR, 20.7-36.4 weeks). Investigators characterized the overall safety profile as acceptable, with treatment discontinuation uncommon across the cohort.
Abdominal pain and oral pruritus are commonly reported with OIT dose escalation, and their frequency in this cohort was consistent with expectations for a multi-food regimen. Omalizumab has an established safety profile across its approved indications, including IgE-mediated food allergy, moderate-to-severe asthma, chronic urticaria, and chronic rhinosinusitis with nasal polyps.² The low discontinuation rate observed here suggests the direct-to-maintenance approach did not introduce new tolerability concerns beyond those seen with standard OIT.
“This approach may reduce treatment burden while maintaining an acceptable safety profile,” investigators concluded.
A separate randomized trial found omalizumab produced significantly greater treatment success than omalizumab-facilitated multiallergen oral immunotherapy (MOIT) in patients with multifood allergy, per stage 2 results from the OUTMATCH trial.³ Among 117 participants with peanut allergy and ≥ 2 additional food allergies, omalizumab was superior to MOIT for the primary endpoint of cumulative tolerated dose in the intention-to-treat population (36% vs 19%; odds ratio, 2.6; 95% CI, 1.1-6.3; P =.03). This difference narrowed in the per-protocol population, reflecting a substantially higher discontinuation rate in the MOIT arm (49%) compared with omalizumab (12%).
MOIT also carried a heavier safety burden, with more serious adverse events (31% vs 0%), epinephrine-treated reactions (37% vs 7%), and events meeting anaphylaxis criteria (27% vs 2%) compared with omalizumab.³
"Both treatments can be effective, and both will provide protection from small exposures and even the ability to start eating the food directly," Robert A. Wood, MD, professor of pediatrics, Johns Hopkins University School of Medicine, told HCPLive.³ "The biggest difference we found was the side effects from oral immunotherapy were such a far larger group of patients really couldn't tolerate the therapy.”
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. Published online August 5, 2026. doi:10.1016/j.anai.2026.07.031
