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Injectable Drug Xolair Resolves Dangerous Food Allergies In One-Third Of Kids

Medically reviewed by Carmen Pope, BPharm. Last updated on March 3, 2025.

By Dennis Thompson HealthDay Reporter

MONDAY, March 3, 2025 -- More than a third of food-allergic kids were able to eat full servings of their trigger foods after treatment with an injectable asthma drug, new clinical trial findings report.

In all, 36% of children treated with omalizumab (Xolair) for a year successfully ate full servings of allergy-triggering foods, according to phase 2 trial results presented Sunday at a meeting of the American Academy of Allergy, Asthma & Immunology in San Diego.

By comparison, only 19% of children could do the same when given a shorter round of omalizumab followed by months of oral immunotherapy, a treatment through which patients build tolerance by eating gradually increasing amounts of food allergens.

Further, early stage 3 results from the clinical trial found that children retained some resistance to food allergies even after they stopped taking omalizumab, researchers reported.

“This is the first time we’ve been able to directly compare these two treatments for multiple food allergies, and our study shows omalizumab was superior to oral immunotherapy,” principal investigator Dr. Robert Wood, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, said in a news release.

Food allergies are common, affecting 8% of U.S. children and 10% of adults, researchers said in background notes.

Omalizumab works by binding to the antibodies that promote allergic reactions, rendering them inactive, researchers said in background notes.

The drug has been on the market since 2003, first approved by the U.S. Food and Drug Administration (FDA) as a preventive treatment for allergic asthma, according to Drugs.com.

And based on early results from this clinical trial, the FDA approved omalizumab as a treatment for food allergies in adults and children as young as 1 year old, researchers said in background notes.

The stage 2 clinical trial involved 117 children with an average age of 7 who were allergic to peanuts and at least two other common food allergens -- milk, egg, cashew, wheat, walnut or hazelnut.

At week 44, the children were fed all three of their food allergens in amounts equivalent to about 20 peanuts or a half-cup of milk.

The lower results for children on oral immunotherapy were driven by the fact that more of these kids had to drop out of the study due to adverse reactions, researchers said.

About 88% of children treated with omalizumab finished the stage 2 trial, compared with 51% of those receiving oral immunotherapy, results show.

No children taking omalizumab experienced serious adverse reactions, compared with more than 30% of those treated with oral immunotherapy.

“We have demonstrated that there are multiple paths to living a safe life with food allergies,” senior researcher Dr. Sharon Chinthrajah, acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine, said in a news release.

“This study is very encouraging because it shows that we have treatment choices for our patients that are safe and not too burdensome,” she added.

Researchers at the AAAAI meeting also presented preliminary results from stage 3 of the clinical trial, which focused on the first 60 children in the study.

Stage 3 focused on different pathways that children with food allergies might take in real-world settings, after they’ve gained tolerance to trigger foods through omalizumab therapy.

Each of the children was assigned one of three strategies for each of their food allergens -- start eating the food, continue with oral immunotherapy or avoid the food.

These strategies were assigned based on how the kids responded to a food challenge following omalizumab treatment.

More than 80% of the plans began with the kids eating the foods to which they’d been allergic, results show.

The kids were then tracked for a year to see how they fared.

Preliminary results show that consumption of milk, egg and wheat had a greater success rate (61% to 70%) than peanuts and tree nuts (38% to 56%).

In most cases, kids ate declining amounts of their allergens during the follow-up period. Some adverse events occurred, including food reactions severe enough to require an epinephrine shot.

Stage 3 is ongoing, with completion expected this summer, researchers said.

“While the results of Stage 3 are still preliminary, the majority of the first 60 participants were able to successfully introduce allergenic foods into their diet after stopping omalizumab,” lead researcher Dr. Jennifer Dantzer, a pediatric allergist at Johns Hopkins Children’s Center, said in a news release.

“Omalizumab is currently approved in the U.S. for the reduction of allergic reactions that may occur with accidental exposures,” Dantzer said. “These results indicate that omalizumab may have additional uses that may be valuable for patients, but the potential risks should be recognized.”

Funding for the clinical trial came from Genentech, the maker of omalizumab.

Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Posted March 2025

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