A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to small amounts of peanuts, cashews, milk and eggs, researchers reported Sunday.
The drug, Xolair, has already been approved by the Food and Drug Administration For adults and children over 1 year old with food allergies. It is the first treatment to dramatically reduce the risk of serious reactions, such as anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock, after accidental exposures to various food allergens.
He researchers study results about children and adolescents, presented at the annual conference of the American Academy of Allergy, Asthma and Immunology in Washington, were published in The New England Journal of Medicine.
“For a certain population of patients with food allergies, this drug will be life-changing,” said Dr. Robert A. Wood, first author of the paper and director of the Eudowood Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.
“If you have a severe allergy to milk or eggs, or something that wasn’t even part of this study, like garlic or mustard, you will never be able to eat in a restaurant,” Dr. Wood said.
“There is also the fear and anxiety that you walk with every day,” he added. “I have many patients who are teenagers and have never been allowed to eat in a restaurant. The family has never been on a plane for fear of allergies.”
The prevalence of food allergies has increased over the past 20 years, although it is not clear why. About 5.5 million American children and 13.6 million adults have food allergies, and many are allergic to more than one food.
Nearly half of people with food allergies have experienced a serious, life-threatening reaction. Food allergies are the cause of about 30,000 emergency department visits a year.
Dr. Ann Marqueling and Dr. Kevin Wang, of Palo Alto, California, have a five-year-old son, Liam, with multiple food allergies, who participated in the trial.
They have not been told whether their child was randomly assigned to receive the drug or dummy injections. But by the end of the treatment phase, she showed more tolerance to small amounts of eggs, peanuts and tree nuts, they said. They think they gave him Xolair.
“It’s been very liberating for us, but it’s also liberating for him: We’re not watching like a hawk everywhere because of accidental exposures,” Dr. Wang said. “We remain vigilant, but not indecisive. Instead of being on red alert, we are on yellow or orange alert.”
“We felt more comfortable letting him run around and explore,” Dr. Marqueling said. “We’ll let him be a boy.”
But while some hailed the approval of Xolair as a breakthrough, experts warned it was far from a perfect solution. The medication reduces the risk of a reaction to small amounts of an allergen, but life-threatening episodes are still possible. Patients should still scrupulously avoid foods that may trigger a reaction.
The medication is not easy to take and is administered by injection every two to four weeks. Many people, especially children, do not like injections and are afraid of needles. And for Xolair to be effective, patients must take it regularly.
Only one other medication, Palforzia, is approved to reduce severe reactions, but it is only for people with a peanut allergy. It is an oral immunotherapy regimen that works by gradually exposing children to small amounts of peanut protein until they can safely eat the equivalent of two peanuts. Those taking Palforzia should also continue to avoid peanuts.
The Xolair study, funded largely by the National Institute of Allergy and Infectious Diseases, was the type considered the gold standard in medicine: a double-blind, randomized, placebo-controlled clinical trial.
It was carried out at 10 medical centers in the United States and included 177 children and adolescents between the ages of 1 and 17, all of whom were allergic to peanuts and at least two other foods, including cashew, milk, egg, walnut, wheat and hazelnut.
To be included, they had to have an allergic reaction to 100 milligrams or less of peanut protein (less than half a peanut) and to 300 milligrams or less of two other foods from a list that included milk and eggs, among others.
Participants were randomly assigned to receive injections of Xolair or a placebo every two to four weeks for 16 to 20 weeks. (Dosing frequency was based on individual characteristics, including weight.)
After completing the treatment phase, participants were tested to see if they could tolerate trace amounts of food allergens. Of the 118 participants who received the drug, 79, or 67 percent, were able to tolerate up to 600 milligrams of peanut protein in a single dose, equivalent to just over half a teaspoon of peanut butter, or about two and a half peanuts. . without serious symptoms.
Only four of 59 participants who received the placebo injections, or 7 percent, were able to do so.
Levels of protection varied by food: 41 percent of cashew allergy sufferers who received the drug had no reactions when they ate up to 1,000 milligrams of cashews, for example, compared with 3 percent of those in the comparison group. with placebo.
Two-thirds of those with milk allergies who took the drug could tolerate up to 1,000 milligrams of milk protein, compared with 10 percent of those in the placebo group.
More than two-thirds of people with egg allergies tolerated up to 1,000 milligrams of egg protein if they had been given the drug, while no one in the placebo group could do so. All findings were statistically significant.
Xolair is a synthetic antibody that targets immunoglobulin E (IgE), which is produced by the body’s immune system and causes allergic reactions.
The drug binds to IgE, acting “like a sponge that absorbs everything,” said Dr. Sharon Chinthrajah, lead author of the paper and interim director of the Sean N. Parker Center for Allergy and Asthma Research at the University of California. Stanford.
Although the drug has been approved for other uses for two decades, Genentech did not study whether Xolair could be beneficial against severe food allergies until approached by the National Institute of Allergy and Infectious Diseases’ Food Allergy Research Consortium, which provided funding. to the company in 2017, a spokeswoman for the institute said.
Dr. Larry Tsai, global head of product development for respiratory diseases, allergies and infectious diseases at Genentech, which developed Xolair with Novartis, emphasized that the drug was not intended to cure allergies and does not do so.
But, he added, it may be helpful for someone like his own college-going daughter, who has multiple food allergies and is concerned about accidental exposure at a cafe or restaurant.
“My daughter can easily avoid eating a lobster or a handful of peanuts,” Dr. Tsai said. “What’s more concerning is if she goes out to lunch with friends and eats a sandwich that turned out to have been cut with a knife that had previously been used to spread peanut butter and wasn’t washed properly, and she ends up in a hospital. That is a fear that patients live with.”