‘A real game changer’: UNC is part of a groundbreaking food allergy study

By Jennifer Fernandez

Kristen Bush remembers the first time her firstborn suffered a severe allergic reaction.

Braylon was 7 months old, and he had just started eating solid foods. That night, it was a few pieces of one of those little puff cereals. About an hour later, Bush was nursing her son before bed.

“He just kept, like, choking and coughing and choking. And we were like, ‘What is going on?’” she recalled.

When she unzipped his onesie, Bush saw Braylon’s body was covered in hives. They used an Epipen that their pediatric allergist had given them as a precaution, then took him to the hospital where their baby boy was monitored for a few hours before going home.

Neither she nor her husband, Josh, has allergies. There’s no history of allergies in either of their families.

“In the beginning, it was a little bit hectic, I would say, and stressful,” Bush said about learning how to deal with her son’s food allergies.

She signed up Braylon, who’s now 5, for a study at UNC Chapel Hill that is aimed at helping kids and adults who are allergic to multiple foods. Braylon tested as allergic to peanuts, milk, wheat, eggs, tree nuts, sunflower and sesame.

Last year, the Food and Drug Administration approved the medicine used to treat Braylon during the study — co-authored by three UNC Chapel Hill researchers — to treat food allergies based on the study’s early-phase results. Their work showed that a treatment called omalizumab, which has helped asthma patients for more than two decades, could lessen — or even prevent — acute reactions to food allergies.

“As a parent of a kid who has allergies, it gives me peace of mind,” Bush said. “[It] also gives him a lot more food freedom.”

‘A real game changer’

“Omalizumab is going to be a real game changer when it comes to food allergy,” said Edwin Kim, chief of the Division of Pediatric Allergy and Immunology and director of the UNC Food Allergy Initiative at the UNC School of Medicine.

Kim worked on the study with colleagues Corinne Keet, professor of pediatrics and associate director of UNC Children’s Research Institute, and Mike Kulis, a pediatric allergy and immunology associate professor and member of UNC Children’s Research Institute. Researchers at Johns Hopkins and Stanford universities led the project. 

“This gives us something that we can offer in the clinic now that will provide a level of protection,” said Kim, who sees patients with allergies in his practice.

The patient must stay on the medication to benefit from the effects. And it’s an injection, which some people won’t like.

“It will help a lot of people out there, but it won’t be for everybody,” Kim said.

Some patients may decide to stay on the medication long term. For others, it might be for specific time periods. He’s seeing those decisions in his clinical practice.

“The people that have expressed probably the most interest are people that are experiencing transitions in their lives,” he said. 

He gave the example of a college student leaving home and learning to cook for themselves for the first time after having a parent supervise their food intake. Another example, he said, is when young children first attend school.

Allergies increasing in children

More than 33 million people in the U.S. have a serious and potentially life-threatening food allergy, according to Food Allergy Research & Education, a Virginia-based nonprofit. The group says that food allergy sends a patient to the emergency room every 10 seconds.

The number of children with at least one food allergy has been steadily growing, with 5.6 million children — nearly 8 percent — allergic to some type of food. That’s equal to one in 13 children, or about two per classroom.

So what causes an allergic reaction? When our bodies encounter a foreign substance, whether it’s a virus or a bacteria or a food molecule, pet dander or certain foods, specialized immune system cells known as B cells kick into action. The B cells produce proteins known as antibodies that target those foreign substances, surround it and help our bodies process it for removal. With an allergen, the body perceives it as a threat, flooding the system with antibodies and other chemicals, going into overdrive to attack the usually harmless substance.

This overreaction by the immune system leads to symptoms ranging from watery eyes and hives to breathing problems and even death when severe cases aren’t treated quickly. 

There’s no cure for allergies, although children often outgrow allergies to such protein-rich foods as milk, egg, wheat and soy. Children with allergies to peanuts, tree nuts and shellfish generally remain allergic into adulthood, research shows. 

Medication can help manage symptoms. Now omalizumab, which is sold under the brand name Xolair, can be used to lessen or avoid severe food allergies.

From asthma to food

Omalizumab is a monoclonal antibody — a lab-made protein that acts like an antibody. Monoclonal means these antibodies are cloned copies of a single antibody.

The U.S. Food and Drug Administration first approved omalizumab in 2003 to treat moderate to severe asthma. In 2014, the FDA expanded its use to treat hives and again in 2020 to treat chronic sinus inflammation. Last year, the agency approved omalizumab to be used for food allergies, based on preliminary data from the trial that involved Kim and the other UNC researchers.

“We’ve always suspected that it should work for food allergy,” Kim said. “It’s just we had to actually do the studies to prove it.”

In 2019, researchers began studying omalizumab’s use for food allergies with funding from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

UNC School of Medicine was one of 10 sites participating in the multi-stage trial that enrolled 177 children and three adults. Twenty-five North Carolina families participated.

Participants received injections every two to four weeks over a four- to five-month period. Nearly 67 percent who finished the full treatment could eat what amounted to two and a half peanuts without an allergic reaction, the university said in a news release. That was much higher than in the placebo group, where fewer than 7 percent could eat that much peanut protein without an allergic reaction.

It also represented a six-fold increase in how much peanut protein the participants could tolerate at the beginning of the trial.

The treatment increased the amount of peanut, tree nuts, egg, milk and wheat that children with multiple food allergies could consume without an allergic reaction.

“The way the medicine works is it grabs all of this allergic antibody, whether it’s for one food or all the foods, and gets rid of all of it,” Kim said. “But what’s important to keep in mind for patients is that it doesn’t get rid of the actual cells in the body that make those antibodies.

He explained that when patients stop the medication, B cells — which can remember foreign substances for years after encountering them — will make the antibody again. 

“Over a period of time, and we don’t know, maybe a couple of months, something like that, we anticipate that the allergy would come back,” he said.

Participating in the study

The families involved in the study were very committed, Kim said. The study kicked off in 2019, but was paused during the COVID-19 pandemic.

“Not a single parent, not a single family dropped out of the study when it restarted,” Kim said.

The Bush family spent two years going to Chapel Hill every two to four weeks. They live in Charlotte, so that’s a two-and-a-half hour drive each way.

Braylon participated in all three phases of the study. It started out with injections of the medicine. That evolved to oral immunotherapy, where he was given small amounts of the allergen to build up his tolerance. The final phase was transitioning into solid, everyday foods.

During the oral immunotherapy, Bush said they tried everything to entice Braylon to eat the small protein samples. They added it to applesauce or put sprinkles on it.

“But doing something every day and getting them to eat something every day was definitely a challenge,” she said.

Kim said the families went through a lot because they had to expose their children to foods that they knew would cause an allergic reaction.

“These kids … were having allergic reactions multiple times in the study to prove that this was working,” Kim said. “They stayed committed and helped to actually make this a reality for everybody else that’s out there.”

Social isolation

For children, food allergies can have a big impact on their ability to socialize. They even get bullied, teased or harassed over their allergies, research shows.

Parents often avoid going to restaurants or find one or two that they trust, Kim said. He said parents also may limit or avoid visits to friends’ homes. 

One study showed that more than a quarter of parents who were surveyed during food allergy appointments said their children do not participate in camp or sleepovers. Ten percent said they homeschool their children to avoid exposure to foods that trigger allergies.

About two in five students with food allergies have at least one allergic reaction while at school or a school-related activity, according to a recent report by the advocacy organization Food Allergy Research & Education. The group also said that about eight in 10 food allergy reactions in schools take place in the classroom.

Bush always has snacks with her when they go to parties or events in case Braylon can’t eat some of the food that’s there. That way he always has some special food just for him so he doesn’t feel left out.

She said their school has been great about letting her know when there are events coming up with food so that she can be prepared. 

Their family also makes sure to share information about allergies with people, including to not give food with kids unless you know they aren’t allergic to it.

In social gatherings, adults don’t think twice about encouraging a child to grab some food, Bush said.

“One of the first times we had been together with friends, I wanted to … slap a sticker and … a hat on [Braylon] that said … ‘I have allergies, do not feed me,’” she said.

Pushing science forward

More than a year after finishing his part in the study, Braylon can now better tolerate foods that once led to severe allergic reactions. He can have a slice of pizza or the occasional store-bought cupcake. That’s life-changing for a kid, Bush said.

“For him to be able to … go to a restaurant and not have a fear of … something happening, or us not having to be as strict with what he’s eating, has been a really exciting moment for our family,” she said.

While Braylon is no longer taking omalizumab, he must eat small amounts of the foods he is allergic to every day to maintain the tolerance he has built up. He gets a Reese’s Cup, some pretzels, and either a cheese stick or yogurt. He calls them his “allergy snacks.”

“He doesn’t understand the gravity of the situation, but it’s like, you helped science kind of push this forward,” Bush said.

National Geographic recently recognized the omalizumab study as one of the top medical breakthroughs in 2024, and the New England Journal of Medicine cited it among its list of studies that “stand out among the year’s most notable and impactful in clinical medicine” in 2024. 

“It makes me excited that we were able to be part of it and that [Braylon] played a role in making sure that it was studied properly and successfully,” Bush said. “I’m really proud of him for going through it.”

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