For children with several food allergies, treatment goals can look very different. Some families primarily want protection from an accidental bite. Others hope their child may eventually be able to eat foods that once had to be strictly avoided.
A new clinical trial suggests both medication and oral immunotherapy can help some children tolerate meaningful amounts of multiple allergens. But ongoing treatment with omalizumab allowed more participants to complete the study and reach its demanding three-food goal than a strategy that transitioned from the medication to oral immunotherapy.
The findings do not mean the children’s allergies disappeared or that they could safely begin eating allergens without medical guidance. Participants were tested while receiving treatment, and only about one-third of those assigned to omalizumab met the full endpoint.
The study was published in JAMA Pediatrics and represents the second stage of a nationwide trial known as OUtMATCH. It received federal and industry support from the National Institutes of Health, Genentech and Novartis. The companies develop omalizumab, and Genentech supplied the medication. The funders participated in the study’s design and conduct, data collection and analysis, manuscript preparation and publication decision. Several authors also reported financial relationships with Genentech, Novartis and other allergy-drug developers.
Omalizumab, sold under the brand name Xolair, works by blocking immunoglobulin E, or IgE, an antibody involved in many allergic reactions. The U.S. Food and Drug Administration approved it in 2024 to reduce reactions caused by accidental exposure to one or more foods in people ages 1 and older with IgE-mediated food allergies.
That approval does not mean patients can intentionally begin eating foods that trigger their allergies. People taking omalizumab are still advised to avoid those foods and carry emergency medication.
The latest trial asked a more ambitious question: Could treatment raise tolerance enough for participants to eat full servings of several allergens during supervised food challenges?
The study included 117 participants, mostly children, with a median age of 7. All had peanut allergy and at least two other food allergies.
Participants first received omalizumab. They were then randomly assigned to continue the medication or transition to oral immunotherapy, a treatment that involves eating carefully measured, gradually increasing doses of allergenic foods.
At the end of the treatment period, researchers tested whether participants could consume at least 2,000 milligrams of protein from peanut and two other foods without a dose-limiting reaction. That amount was intended to resemble a full serving rather than the small traces involved in accidental exposure.
Among all participants originally assigned to each group, 36% of those who continued omalizumab met the three-food goal, compared with 19% of those assigned to oral immunotherapy. Similar proportions succeeded when researchers looked only at participants who completed their assigned treatment.
That distinction is central to understanding the results.
Omalizumab did not necessarily produce a stronger biological response than oral immunotherapy among children who could stay with either treatment. Its advantage came largely from the fact that many more participants were able to complete it.
About 88% of participants assigned to omalizumab finished treatment, compared with 51% of those assigned to oral immunotherapy. In the oral immunotherapy group, 15 participants stopped because of allergic reactions or other symptoms they could not tolerate. Others withdrew because they disliked the treatment foods or found participation too burdensome.
“For people who could comply with the combined treatment approach, they were as successful as the patients using omalizumab alone,” said Dr. Sharon Chinthrajah, the study’s senior author and a professor of medicine and pediatrics at Stanford Medicine.
Oral immunotherapy can be effective, but it requires a substantial daily commitment. Patients must regularly consume measured doses of the foods that trigger their allergies, even if they dislike those foods. Dosing can cause allergic reactions or gastrointestinal symptoms, and families may need to plan around activity restrictions and repeated medical appointments.
Discontinuing that treatment should not be interpreted as a lack of effort. A therapy can be difficult to sustain even when it works for those who complete it.
Omalizumab removes the need to eat allergens as treatment, but it brings other burdens. It requires repeated injections, may be expensive and may need to continue for protection to last. The study did not establish how long children would need treatment or whether the ability to tolerate full servings would remain after injections stopped.
“We have demonstrated that there are multiple paths to living a safe life with food allergies,” Chinthrajah said.
Those paths may reflect different family priorities.
A child who mainly needs greater protection against accidental exposure may have different treatment goals from one who strongly wants to add milk, egg, wheat or nuts back into daily meals. Families may also weigh concerns about injections, daily food dosing, side effects, cost, time and access differently.
The trial’s full endpoint was also intentionally difficult. Participants had to tolerate full servings of three separate allergens. Most children in both groups did not achieve that complete goal.
That does not necessarily mean treatment provided no benefit. Some participants may have become able to tolerate more of an allergen than they could before treatment or succeeded with one or two foods rather than all three. Even a higher reaction threshold could offer families reassurance around accidental exposure.
Still, the study should not be described as showing that one-third of children were cured.
Food-allergy treatment commonly produces desensitization, meaning a person can tolerate a larger amount of an allergen while therapy continues. That is different from lasting remission, in which protection remains after treatment is stopped.
The study also measured tolerance through medically supervised food challenges. Eating outside that controlled setting can introduce variables such as illness, exercise, changing portion sizes and uncertain ingredients.
Families should not test a child’s tolerance at home or intentionally introduce an allergen based on these findings. Treatment decisions and food challenges require guidance from an allergy specialist, and patients should continue following their emergency plans.
“This study is very encouraging because it shows that we have treatment choices for our patients that are safe and not too burdensome,” said Dr. Sayantani Sindher, a study co-author and clinical associate professor of medicine at Stanford.
The comparison also highlights why the most effective treatment on paper may not be the best option for every child. Benefits depend not only on whether a therapy can alter the allergic response, but also on whether a family can safely and realistically continue it.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences within the National Institutes of Health, as well as Genentech and Novartis. Genentech supplied omalizumab for the trial.
The funders participated in the design and conduct of the study, collection and analysis of data, manuscript preparation and the decision to submit the findings for publication. Numerous authors reported grants, consulting fees, employment, stock ownership or other relationships involving Genentech, Novartis and other companies developing food-allergy treatments. One author became a Sanofi employee after completing her primary contributions to the research.