Omalizumab (Xolair) desensitized more children with multiple food allergies, with fewer reactions, than oral immunotherapy, new research shows.
After one year of taking Xolair injections, 36 percent of children with three or more food allergies could consume at least 4 grams of each of their allergens. That’s a large amount – a full or nearly full serving of foods such as milk, eggs, peanut, wheat and tree nuts.
The results with these children were compared against those from a second treatment group, who also had multiple food allergies. That group was treated first with Xolair injections, then switched onto oral immunotherapy (OIT). Only 19 percent of children treated with Xolair-facilitated OIT reached that 4-gram threshold for each allergen.
Although OIT is known to build tolerance over time, it often triggers allergic reactions. The higher success rate in the Xolair-only group was largely due to fewer dropouts than in the OIT group, says lead study author Dr. Robert Wood. Wood is the director of pediatric allergy and immunology at Johns Hopkins Children’s Center.
“There were a large number of participants who were having reactions and stopped their treatment, and they were primarily in the OIT group,” Wood says. In oral immunotherapy, patients consume gradually increasing daily amounts of an allergen.
Among children and teens who completed the study, the desensitization rates were comparable across the groups. “If you can tolerate the OIT, the outcomes are very similar to what you would see with omalizumab,” he says.
This research is the second stage of the Phase 3 study, called OUtMATCH, of omalizumab in food allergies. “The goal of Stage 2 was to do a direct comparison of treating patients with multiple food allergies with omalizumab or multi-food OIT,” Wood says.
Head-to-head Matchup
OUtMATCH is a double-blinded, placebo-controlled study. Stage 1 found that after four months of Xolair injections, 67 percent of patients receiving Xolair could tolerate at least 600 milligrams of peanut protein, or 2½ peanuts, and about 66 percent could tolerate about 1,000 mg of milk (2 tablespoons). Other foods ranged from 67 percent for egg to 41 percent for cashew.
Those results led the U.S. Food and Drug Administration to approve Xolair in February 2024 to prevent allergic reactions from accidental exposures in adults and children. Xolair, given by injection every two or four weeks, is the first medication approved to treat multiple food allergies.
In this second stage of OUtMATCH, Wood and colleagues compared 117 children and teens. Regardless of which group they were in, all children received Xolair for 16 weeks. At the 9-week mark, half the children started OIT, while the others began placebo OIT.
Then, at 16 weeks, the kids in the OIT group switched to placebo injections, while the kids in the placebo OIT group continued to get Xolair injections. (Though no one knew which group they were in, this means one group was now receiving only Xolair. The other group was receiving only OIT.)
After 44 weeks, the participants took part in food challenges.
Although more patients in the Xolair group could eat at least 4 grams of three allergens, this was mostly due to the higher number of kids in the OIT group who dropped out because of allergic reactions.
About 88 percent of Xolair patients completed the trial, compared to just 51 percent in the OIT group. As for allergic reactions that led to discontinuing treatment, there were none in omalizumab group. That compared to 22 percent in the OIT group.
Xolair Injections Study: High Tolerance
Overall, there were no serious adverse events in the omalizumab group. In the OIT group, 30.5 percent experienced serious reactions. About 37 percent of those reactions required epinephrine, compared to 7 percent of reactions in kids receiving omalizumab.
This led researchers to conclude “omalizumab was superior to OIT in the treatment of multi-food allergy,” Wood says.
Wood notes that some participants in Stage 2 increased their tolerance to as high 8 grams for some of their foods. Other children reached the 4-gram threshold for one or two of their foods, but not all three. This study “really was setting quite a high bar” for tolerance, he says.
The study is the first head-to-head comparison of omalizumab and OIT. Wood presented it at the 2025 AAAAI / World Allergy Organization Joint Congress in San Diego in early March.
Stage 3: Introducing Foods
The continuing third stage of the OUtMATCH trial is exploring introducing allergenic foods into the diet with Xolair. Although Xolair is only approved to prevent reactions to small exposures, often patients can tolerate substantially more.
An Italian study found many children receiving Xolair injections could introduce foods into their diet.
In Stage 3 of OUtMATCH, the first 60 patients who passed oral food challenges after at least 24 weeks of omalizumab were encouraged to introduce safe amounts of their allergens into their diets. Safe amounts were based on food challenge results, and ranged from about 300 to 8,000 milligrams daily.
Most participants have introduced at least one allergen into their diets, says Dr. Jennifer Dantzer, this stage’s lead study author. The assistant professor of pediatrics at Johns Hopkins says some study graduates continued to avoid certain allergens. Others, meantime, have started OIT to increase their tolerance thresholds.
After one year, 61 to 70 percent of children and teens tolerated an average of more than 300 milligrams of milk, egg and wheat. Fewer, 38 to 56 percent, ate that amount of peanuts and tree nuts daily.
“Even though the Xolair was stopped, many were still able to keep the food in their diet,” she says. However, “adverse reactions did happen, including some episodes of anaphylaxis.”
Over a year, study graduates’ consumption of their allergens declined, with the exception of wheat. Researchers did expect this. “A lot of kids don’t like the taste of some of their allergens so they avoid eating it, and some people had symptoms,” Dantzer says.
These patients also had residual protection from Xolair at the start of the third stage. But Xolair’s protection against allergic reactions wears off about two months after shots are halted, she says.
What’s Next for Xolair Injections?
The full results from Stage 2 of OUtMATCH are expected to be published in late spring, while Stage 3 is ongoing. Some of the kids just starting Stage 3 will have completed OIT. So, they will have built up more tolerance to their allergens when Xolair is discontinued than these first kids had, says Dantzer.
But the early results “give us some initial information on using omalizumab in introducing foods into the diet. There are risks and benefits to this approach,” Dantzer says. “I’m definitely excited to see the results from the larger group.”
With Xolair, food-allergic children and adults may eventually have the option of eating certain foods and avoiding others, Wood says. Yet, they’d still benefit from having protection against accidental exposure to avoided foods.
In his practice, it’s common for food-allergic kids to want to eat milk and egg, but to prefer to continue to avoid nuts. Physicians need to discuss “with each individual family what are their goals, and make decisions together about what makes the most sense for that specific patient,” Wood says.
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