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Treatment with the monoclonal antibody omalizumab allows nearly a third of multi-food allergic children to consume full portions of allergens like peanuts, milk, eggs, or wheat without severe reactions, according to a study published in JAMA Pediatrics. Conducted by researchers at Stanford University, the research compares omalizumab against oral immunotherapy, finding that the injectable biologic treatment offers a higher completion rate and fewer adverse events that force patients to stop therapy.
Clinical Comparison of Omalizumab and Oral Immunotherapy
Food allergies affect roughly 8 to 10 percent of children and adults, according to background data in the study. Traditional management often relies on oral immunotherapy, which exposes patients incrementally to increasing amounts of an allergen to build desensitization. Alternatively, omalizumab—an anti-immunoglobulin E monoclonal antibody that received FDA approval in 2024 to protect against accidental exposure to small amounts of food allergens—blocks allergic reactions by targeting IgE antibodies before they bind to immune cells.
To evaluate how the two approaches perform in patients with multiple food allergies, Stanford researchers recruited 117 children with a mean age of seven years. Every participant was allergic to peanuts and at least two other foods, which included milk, eggs, wheat, cashews, hazelnuts, and walnuts. Eligibility required participants to show dose-limiting symptoms during oral food challenges at cumulative protein thresholds of 144 mg or less for peanuts, and 444 mg or less for other allergens.
The trial split participants into two tracks: one group received a full year of omalizumab monotherapy, while the other group received eight weeks of omalizumab followed by multi-food oral immunotherapy for the remainder of the year. The study applied a strict success metric, requiring children to consume a full portion of three distinct trigger foods by the end of the intervention.
Trial Results and Treatment Tolerability
Children receiving omalizumab alone demonstrated significantly higher completion rates than those undergoing oral immunotherapy, which triggered more side effects that caused participants to drop out. After one year, 36 percent of the participants in the omalizumab monotherapy group successfully tolerated full portions of three target foods. By comparison, only 19 percent of the children in the oral immunotherapy group reached that benchmark.
Furthermore, the data showed that omalizumab was superior in achieving a cumulative tolerated dose or more across two or more foods, as well as for several individual allergens.
“We demonstrated that there is more than one way to safely live with food allergies,” said Sharon Chinthrajah, a professor of medicine and pediatrics at Stanford who contributed to the research. Chinthrajah noted that these findings give physicians the data needed to tailor treatment plans to individual patient goals, observing that while some patients want to permanently incorporate allergen foods into their daily diets, others primarily seek reliable protection against accidental exposures.
Frequently Asked Questions
What is omalizumab and how does it work for food allergies?
Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody. It neutralizes free IgE antibodies in the blood and interstitial fluid, preventing them from triggering the chain reaction that leads to an allergic response when a patient encounters an allergen.
How was success measured in the Stanford study?
Researchers defined treatment success as a participant’s ability to consume a full serving of three different foods that previously triggered their allergies, without experiencing a dose-limiting reaction.
Why did more patients stop oral immunotherapy compared to omalizumab?
According to the study findings, oral immunotherapy produced a higher frequency of adverse side effects, which led more participants to discontinue the treatment protocol compared to the omalizumab monotherapy group.
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