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March 4, 2024 – Kathy N. has had food allergies since childhood. It started with eggs, an allergy that she shared with her mother, and gradually evolved to include walnuts, pecans, and garlic. With few options other than avoidance, Kathy, a 61-year-old consultant from Northern Virginia, has relied on over-the-counter allergy medications. “I’ve basically self-medicated my entire life,” she said. “If I’m going out to dinner, I take a bunch of drugs so I know that I’m going to live through the meal.”
Kathy’s experience is getting more common; food allergies affect as many as 1 in 10 U.S. adults and up to 8% of U.S. children, 30% to 86% of whom are allergic to more than one thing. But there may be a glimmer of hope; the FDA just approved a medication called Xolair for reducing the risk of potentially life-threatening allergic reactions (anaphylaxis) after accidental exposure.
Xolair is a drug with a long track record. It has been used for over 20 years for treating asthma in children as young as 6, for chronic allergies to cold temperatures, and for chronic nasal stuffiness with polyps in adolescents and adults.
“It’s also safe in pregnancy, and has been shown to not be associated with cancer, which was an initial concern way back,” said Thomas Casale, MD, director of the Division of Allergy and Immunology at the University of South Florida in Tampa, and chief medical adviser for the nonprofit Food Allergy Research & Education.
But, he said, side effects such as pain where you get the shot and fever are common.
“If it’s the right circumstances and the right patient, I wouldn’t hesitate to use it,” he said.
Xolair’s approval comes at an important time.
“There’s a large unmet need,” said Robert Wood, MD, director of the Eudowood Division of Pediatric Allergy, Immunology, and Rheumatology at Johns Hopkins Children’s Center in Baltimore. “The treatment strategies that we’ve used are to avoid the food and carry around emergency medications in the event of a reaction.”
That’s not the best approach, he said, as “accidental reactions are very common.”
Risk Reduction
There are nine major food allergens, five of which (peanuts, tree nuts, milk, wheat, and eggs) were recently included in a study that aimed to determine if Xolair is an effective, safe treatment in children as young as age 1 and adults as old as 55. The study, which enrolled 180 people with a history of peanut and at least two other food allergies, compared 16 to 20 weeks of Xolair shots to placebo shots.
After being assigned to either group, the researchers did a food challenge to learn if participants could eat at least 600 milligrams of peanut protein (1/16th tablespoon) without having moderate to severe symptoms like whole-body hives, coughing, or vomiting. The participants were then exposed to increasing doses of cashews, milk, eggs, walnuts, hazelnuts, or wheat.
“Eighty to 85% had very clear protection against the risk from accidental exposure,” said Wood, who also led the study.
Almost half were able to tolerate a dose equal to roughly 25 peanuts. During the study, 69% of the people taking Xolair were also able to safely consume just over 1,000 milligrams of two foods combined, and 47%, three combined – more than most daily accidental exposures.
Food for Thought
Xolair is expected by many in allergy research and clinical communities to usher in a new era of how food allergies are managed – welcome news for the millions of people who are forced to tread lightly around food.
Though Xolair might be an important addition to the allergy toolbox, it is not a panacea. The drug reduces the risk of severe allergic reactions but does not entirely prevent them. Roughly 14% of patients in the clinical study had reactions after exposure to certain foods.
What’s more, patients using Xolair are advised to continue to avoid allergen exposures whenever possible and continue to have an EpiPen on hand in case of an emergency. Also, the first three drug injections must be given in the doctor’s office so patients can be monitored in case of an emergency reaction. (Roughly 75% of emergency reactions will occur with the first three doses, Casale said.)
There’s also the issue of price, which, according to a spokesperson for biotechnology company Genentech, ranges from an estimated $2,900 monthly for children to $5,000 for adults, depending on the dose, the total amount of protein antibodies (immunoglobulin or IgE, produced when exposed to allergens) in the blood, and how often (2 to 4 weeks) shots are needed.
Still, life with food allergies is already difficult, and the traditional way to deal with them is far less than ideal.
“Having to adhere to a diet and fear of having a reaction every day your child leaves for school does cause many families an extraordinary amount of stress and anxiety, where their quality of life is significantly impaired,” Wood said. “There’s knowledge in the public about peanut allergy, but if you have a severe reaction to milk or egg or wheat, the family essentially cannot eat outside their home.”
“It’s very anxiety-producing,” said Emily Goodstein, a 40-year Washington, DC, consultant and mother of a 3-year old who is allergic to cashews, pistachios, and eggs.
“Obviously, I am very careful with what she eats, but it’s hardest in situations when we’re at a vegan or vegetarian restaurant; that’s where there’s often lots of cashew stuff hanging out.”
The sudden death of a New York-based doctor after a meal at a Disney World restaurant last year reinforces that dangers often lurk in any type of restaurant, even if steps are taken to ensure proper safeguards are in place. In this situation, the doctor had been assured by the restaurant staff that certain foods could be prepared allergy-free, and she had also used an epinephrine (EpiPen) device. Still, the medical examiner’s report showed that she had been exposed to higher levels of dairy and nuts, which caused a severe allergic reaction and death.
Ultimately, the decision to try Xolair may not be as simple as a conversation with a doctor and health insurer. Price aside (Genentech does offer patient assistance for people who meet certain qualifications), health disparities are as pervasive in allergies as they are in other disease conditions. Studies show that non-Hispanic Black children have higher rates of food allergies, multiple food allergies, severe reactions, and food allergy-related visits to the emergency room, compared to White children.
The same disparities may exist in Black adults, although evidence is limited. And, for underserved communities, many of whom exist in food deserts and rely on food banks, the ability to access safe, unadulterated foods can be difficult.
Cautiously optimistic, patients like Kathy N. and parents like Goodstein say that they are curious enough to keep an eye on Xolair but not quite willing to take the plunge, at least not yet. For others, the drug might be a welcome safety net that allows them and their children to live more freely and with less fear of accidentally being exposed to a dangerous food allergen.
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