In the U.S., the FDA has approved the biologic drug Xolair to avert serious reactions in case of accidental food allergen consumption. But now an Italian study suggests the potential of omalizumab (or Xolair) as a food allergy treatment could extend well beyond that.
Researchers at a Rome hospital clinic enrolled 65 children with severe asthma and a history of food anaphylaxis. After one year on Xolair, they found a remarkable 40 (or 62 percent) of these highly allergic kids could eat a diet free of restrictions.
Another 17 kids (26 percent) were desensitized to smaller amounts of their allergens. All patients could tolerate trace amounts, meaning they no longer needed to avoid foods with allergen warning labels.
The children, ages 6 to 18, all had severe asthma. To take part in the study, they also needed to have anaphylactic allergies to one or more food allergens. The allergens included peanut, tree nuts, fish, egg, milk or wheat. (Oral food challenges were done to confirm the allergies.)
After four months of omalizumab shots, the children passed 66 percent of oral food challenges at the highest dosage of protein. For baked milk, that was 3,300 milligrams and for egg, 4,300 mg (about one egg). For peanut, the high dose was 2,900 mg (7 to 9 peanuts).
Another 24 percent of food challenges showed partial desensitization and increased how much allergen the children could safely consume. However, in 10 percent of food challenges, there was no improvement in the reactivity threshold.
Xolair Kids: Eating Freely or Small Amounts
There were three sets of oral food challenges at four-month intervals over the year. When kids in the study passed challenges, physicians encouraged them to eat the foods at home in the tolerated amounts.
“Omalizumab can increase the threshold of reactivity to the culprit food and then allow the introduction of the foods,” says lead study author Dr. Stefania Arasi. The pediatric allergist with the Pediatric Hospital Bambino Gesu notes: “Some can have a full portion.”
Fewer than 6 percent experienced minor allergic reactions while eating the tolerated amounts at home.
Quality of life scores reported by parents and teens related to social, emotional and physical functioning also improved with Xolair.
First Approved for Multiple Allergies
In Europe, omalizumab, which was developed by manufacturers Genentech and Novartis, is approved to treat moderate to severe asthma. However, it is not yet approved as a food allergy treatment.
In February 2024, the U.S. Food and Drug Administration approved Xolair to reduce allergic reactions from accidental food exposures in adults and children ages 1 and up with one or more food allergies.
The U.S. approval was based on the OUtMATCH study. That Phase 3 trial compared Xolair shots every two or four weeks to placebo shots in patients aged 1 to 17 years old. They were allergic to peanuts and at least two of: milk, egg, wheat, cashew, hazelnut and walnut.
After four months, food challenges tested how much participants could consume. OUtMATCH results showed 68 percent of patients receiving Xolair shots could tolerate at least 600 mg of peanut protein, or 2½ peanuts. About 66 percent could tolerate about 1,000 mg of milk or 2 tablespoons. Sixty-seven percent could tolerate 1,000 mg of egg (a quarter of an egg), and 42 percent could tolerate the same amount of cashews (about 3½ nuts).
OUtMATCH data do indicate that more than 50 percent of patients could likely safely eat larger serving sizes without reacting, Dr. Robert Wood told the American College of Allergy, Asthma and Immunology (ACAAI) allergists’ meeting in Boston.
The medication provides “protection against reactions to small accidental exposures in the vast majority of patients. But maybe the more important aspect is that most patients can actually tolerate serving size portions of the food they’re allergic to,” he said.
Wood, the director of pediatric allergy and immunology at Johns Hopkins School of Medicine, is the co-principal investigator on the OUtMATCH study, funded by the National Institutes of Health.
Wood stressed that U.S. patients taking Xolair are still advised to avoid their allergens due to variability in individual responses.
More OUtMATCH Data Coming
The OUtMATCH study is ongoing. The next stage (Stage 2) will compare desensitization outcomes from Xolair alone versus multi-food oral immunotherapy (OIT) alongside omalizumab shots.
Participants will take omalizumab for eight weeks before starting OIT, and then for another eight weeks during OIT. Researchers hope to see whether Xolair accelerates OIT dose escalation or enables a higher maintenance dose. Wood says Stage 2 is complete, and results will be released in February 2025.
A third stage will explore whether Xolair enables patients to incorporate allergenic foods into their regular diet. “It’s a really fun part of the study, Wood told the allergists’ meeting. “Can you actually start eating the food after you’ve been treated with omalizumab or multi-food OIT?”
Arasi suggests her team’s hopeful findings may preview the outcomes of OUtMATCH’s third stage.
Who Should Consider Xolair?
Arasi says patients who have multiple allergic conditions that affect their quality of life stand to benefit the most from Xolair.
The children in the Italian study had severe food allergies that had led to at least one prior anaphylactic reaction. They also experienced frequent asthma flares and wheezing despite using high-dose inhaled corticosteroids. Seventy-four percent had allergic rhinitis, and 29 percent had eczema.
On Xolair, children saw improvements in lung function and a significant drop in food allergy reactions, including anaphylaxis. They have all remained on the treatment.
At the ACAAI meeting, Wood also noted that a “side benefit” of biologic medications such as Xolair is that a single medication can treat more than one allergic condition.
“You may not only achieve protection for your food allergy, but also better control of your asthma or allergic rhinitis with the use of a single drug,” he says. Although not a primary recommendation for eczema, research has shown omalizumab can help with allergic rhinitis and eczema.
Xolair: Investigating Why Results Vary
Xolair shots are administered every two or four weeks, and can often be done at home. This flexibility may help patients avoid “rigid protocols” of OIT, which usually requires clinic visits for updosing, a daily dosing schedule and post-consumption rest periods, Arasi says.
While the Italian study is hopeful news, there is more to be learned about Xolair for food allergies. For instance, this study did not include children younger than age 6.
Researchers also found differences in desensitization rates among foods. All children with wheat and cod allergy achieved full desensitization, but those with hazelnut and peanut allergy showed lower success rates. Researchers noted the small sample size could influence these differences.
Future research is planned to explore why some children respond poorly to Xolair, Arasi says.
Related Reading:
Allergic Living’s Xolair and Food Allergy FAQ
Xolair OUtMATCH Study: Dr. Wood Presents to Allergists
FDA Approves Palforzia for Toddlers with Peanut Allergy
