A big question since Xolair was approved is whether it allows kids with food allergies to safely eat their allergenic foods. A new analysis finds that after six months on Xolair, most children with multiple food allergies could begin consuming their allergens.
However, there was a caveat. The study also found that after one year of eating the allergenic foods, both the amount and number of the foods the children ate declined.
The findings are from Stage 3 of the influential OUtMATCH trial, a double-blinded, placebo-controlled study.
Results from Stage 1 of the trial led to the Food and Drug Administration’s approval of Xolair (omalizumab) in 2024 as the first treatment for multiple food allergies. Currently, Xolair’s FDA approval is strictly for protection against accidental exposures.
The newly released Stage 3 results include the first 60 children who took the injection therapy for 24 to 48 weeks in Stage 1 of the trial and then an extension trial. The children, averaging 8½ years old, all had allergies to peanut and at least two other foods.
Following the extension trial, the children underwent food challenges to determine their tolerance levels. Patients had to tolerate at least 600 milligrams (mg) of their allergen to start dietary consumption. Most could tolerate much more, averaging 8 grams for most allergens.
After the Xolair shots were halted, the children entered Stage 3. Now they were encouraged to continue eating their allergic foods at home. They were given guidance on minimum and maximum daily amounts.
“The objective of this stage was to determine if allergenic foods could be safely introduced into the diet after stopping omalizumab, which is a new and unique approach,” says Dr. Jennifer Dantzer. The lead study author is an assistant professor of pediatrics at Johns Hopkins University.
After Xolair, Eating Declined Over Time
Initially, 95 percent of children who finished Xolair treatment began eating at least one their allergenic foods. About 68 percent (or 41 of 60) introduced all three. However, as time passed, these numbers dropped.
- One year later, 80 percent were still consuming at least one food. Only 58 percent were eating all three.
- 10 of 60 kids eventually stopped consuming all three of their allergenic foods.
- Two switched to oral immunotherapy for all three foods.
The decline was most significant for peanut and tree nuts. At Month 3, 92 percent of kids were eating at least 300 milligrams (mg) of peanut daily. By Month 12, that dropped to 56 percent. For cashew, 85 percent ate at least 300 mg daily at Month 3, dropping to 50 percent at Month 12.
Milk, egg and wheat consumption also dropped, but by less. For milk, 87 percent consumed it daily at Month 3, with 61 percent still doing so at Month 12.
Children also tended to eat a smaller amounts of their allergens over time. Wheat was the exception, with average daily intake rising over 12 months.
“The median amount for peanut and cashew was about the size of one nut, whereas for wheat the amount was in the range of a full serving size,” says Dantzer. The allergist shared her team’s Stage 3 findings at the AAAAI 2025 / World Allergy Congress meeting in San Diego.
While most participants kept allergens in their diets through the study follow-up, “reductions in dose were common, and some went back to avoidance,” Dantzer says.
After Xolair: Why Not Eating Allergens?
Reduced consumption appeared to be related to both symptoms and other factors, such as taste, aversion and preference, Dantzer says. “We found no clear relationship between symptoms and dietary consumption,” she says.
Children who continued eating their allergenic foods, or who were on a combination of dietary consumption and OIT, experienced a total of 17 episodes of anaphylaxis. Some were linked to dietary consumption and others to undertaking OIT.
Four children developed eosinophilic esophagitis (EoE) possibly related to introducing their allergens or to OIT.
Biologic Alone and Xolair Vs. OIT
The ongoing OUtMATCH trial includes children ages 1 to 17 who had allergies to peanuts and at least two of six other foods: milk, egg, cashew, hazelnut, walnut or wheat.
Xolair is an “anti-IgE” biologic, or lab-made antibody. People with food allergies produce IgE antibodies to their allergens, which then circulate in their blood. Xolair stops the IgE antibodies from binding to mast cells and basophils. Those are the immune system cells involved in setting off severe allergic reactions.
Stage 1 found that after four months of Xolair injections, 67 percent of patients could tolerate at least 600 milligrams of peanut protein, or 2½ peanuts. About 66 percent could tolerate about 1,000 mg of milk (2 tablespoons). Tolerance to other foods ranged from 67 percent for egg to 41 percent for cashew.
Stage 2 was a head-to-head comparison of omalizumab injections versus multi-allergen oral immunotherapy in 117 children. Researchers concluded that omalizumab was the preferred treatment because Xolair had fewer dropouts and adverse reactions.
However, some allergists have noted that the trial’s aggressive OIT protocol, which included high starting and high maintenance doses, may have contributed to the high rate of reactions.
Both Xolair and OIT have shown effectiveness in desensitizing children to their allergens.
The OUtMATCH study was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted at 10 sites across the U.S. by the Consortium for Food Allergy Research (CoFAR).
For food allergy, Xolair dosing is 75 mg to 600 mg, once every 2 or 4 weeks. The dose and frequency are determined by the IgE level in the blood and body weight.
Related Reading:
FDA Approves First Xolair Biosimilar (news release)
Allergists Advise Caution on Study’s Xolair Vs. OIT Findings
Peanut Allergy Patch Benefits Grew Over Time
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