Drug dramatically reduces kids’ life-threatening reactions to food allergen traces

FILE – This Feb. 20, 2015 photo shows an arrangement of peanuts in New York. A study published in the New England Journal of Medicine on Wednesday, May 10, 2023, finds an experimental skin patch shows promise to treat toddlers who are highly allergic to peanuts. (AP Photo/Patrick Sison, File)

An injectable drug used for decades to treat asthma substantially reduced potentially life-threatening reactions in children with an allergy who were exposed to trace amounts of peanuts, eggs, milk and cashew, according to new research. 

The Food and Drug Administration earlier this month approved omalizumab, marketed as Xolair, to treat severe food allergies in certain adults and children 1 year old or older. The injection is the first medicine to reduce allergic reactions to multiple foods following accidental exposure.  

The study was published Sunday in the New England Journal of Medicine and presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting. 

“The day-to-day life of patients with food allergy is consumed by fear of accidental exposure to food allergens,” Robert Wood, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, and the study’s primary author said in a statement. “Our findings have the potential to be very meaningful, and potentially even life changing, for people with food allergies.” 

According to the study, nearly 67 percent of participants who completed the antibody treatment— 79 of 118 treated children and adolescents— could consume the equivalent of 2.5 peanuts without a moderate or severe allergic reaction, up from less than half a peanut at the outset. 

The treatment yielded similar outcomes for egg, milk, wheat, cashew, walnut and hazelnut. 

In the study, investigators compared the effects of 16 to 20 weeks of Xolair injections every two to four weeks with placebo injections.  

The study enrolled 177 children aged 17 and younger with a history of peanut allergy and at least two other food allergies, including cashew, milk, egg, walnut, wheat and hazelnut. The subjects were randomly assigned to receive omalizumab or a placebo. 

The only other approved drug for food allergies is an oral immunotherapy regimen, or OIT, which involves daily ingestion of a specific food allergen in gradually increasing doses up to a maintenance amount.  

Currently, people with severe food allergies must avoid eating foods that may cause a reaction and have medications such as epinephrine on hand. Still, accidental exposures can be difficult to avoid, especially for children. People with food allergies and their caregivers need to maintain constant vigilance.  

People taking Xolair still need to avoid foods to which they are allergic. The treatment is not designed to allow patients to freely eat all foods; it only makes it so a higher level of the food is needed to cause an allergic reaction.  

“Although food avoidance remains critical, the findings reported today show that a medicine can help reduce the risk of allergic reactions to common foods and may provide protection from accidental exposure emergencies,” said Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases, a primary sponsor of the study.  

Food allergies affect up to 17 million children and adults in the U.S. More than 40 percent of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year.  

Tags drug approval fda food allergy

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