Drug can Reduce Harmful Reactions to Foods causing Allergy

A medication can make life safer for children with food allergies by preventing deadly allergic reactions to modest amounts of allergy-causing foods, according to a new study headed by Stanford School of Medicine researchers.

The study will be published on February 25 in the New England Journal of Medicine. The findings show that daily use of the medicine omalizumab may protect people against severe allergic reactions, such as trouble breathing, if they accidentally consume a small amount of a food to which they are allergic.

“I’m thrilled that we’ve developed a promising new treatment for people who are allergic to multiple foods. This new approach showed really great responses for many of the foods that trigger their allergies,” said the study’s senior author, Sharon Chinthrajah, MD, associate professor of medicine and pediatrics and acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine.

“Patients with food allergies face a daily risk of life-threatening reactions from accidental exposures,” stated the study’s chief author, Robert Wood, MD, professor of pediatrics at Johns Hopkins University School of Medicine. “The study showed that omalizumab can be a layer of protection against small, accidental exposures.”

Omalizumab, which was originally licensed by the FDA to treat conditions such as allergic asthma and persistent hives, binds to and inactivates antibodies that cause a variety of allergic diseases. On February 16, the FDA approved omalizumab to reduce the risk of allergic reactions to foods based on the findings of a new research.

All trial subjects had severe allergies to peanuts and at least two additional foods. After four months of monthly or biweekly omalizumab injections, two-thirds of the 118 people who received the medicine were able to safely consume tiny amounts of allergy-triggering foods. Notably, 38.4% of the study participants were under the age of six, which is a high risk group for unintentional consumption of allergy-triggering foods.

Allergies are frequent

Food allergies affect roughly 8% of children and 10% of adults in the United States. People with severe allergies should avoid all meals containing their allergy triggers, but common allergens like peanuts, milk, eggs, and wheat can be hidden in so many locations that attending parties and eating out can be difficult.

“Food allergies have significant social and psychological impacts, including the threat of allergic reactions upon accidental exposures, some of which can be life-threatening,” he stated. Families incur economic consequences for purchasing more expensive goods to avoid allergens, she added.

Oral immunotherapy, the most effective treatment for food allergies, involves patients ingesting tiny, progressively increasing quantities of allergy-triggering foods under the supervision of a specialist to build tolerance. However, oral immunotherapy can cause allergic reactions, and desensitization to allergens can take months or years. This approach is especially time-consuming for people who have many food allergies, as they are typically treated for one allergy at a time.

Patients who have been desensitized to an allergen must continue to eat it on a regular basis in order to preserve their tolerance to it, but people frequently loathe items they have previously been obliged to avoid.

“There is a real need for treatment that goes beyond vigilance and offers choices for our food allergic patients,” he said.

Omalizumab is an injectable antibody that binds to and deactivates all forms of immunoglobulin E, or IgE, the allergen found in the blood and on immune cells. So far, omalizumab appears to be effective in treating many food allergies at once.

“We think it should have the same impact regardless of what food it is,” Chinthrajah said.

Injections stave off severe reactions

The study included 177 children with at least three food allergies, including 38% aged one to five years, 37% aged six to eleven years, and 24% aged twelve and more. Skin-prick testing and food challenges confirmed participants’ severe food allergies; they reacted to fewer than 100 milligrams of peanut protein and less than 300 milligrams of the other foods.

Two-thirds of the patients were randomly assigned to get omalizumab injections, while one-third received an injected placebo; the injections were administered over 16 weeks. Medication doses were determined based on each participant’s body weight and IgE levels, with injections administered every two to four weeks, depending on the dose required. Participants were retested between weeks 16 and 20 to determine how much of each allergy-triggering food they may safely consume.

Upon re-testing, 79 patients (66.9%) who had taken omalizumab could tolerate at least 600 mg of peanut protein, equivalent to two or three peanuts, compared to only four patients (6.8%) who had received the placebo. A similar number of patients improved their reactivity to the other foods in the research.

Approximately 80% of patients receiving omalizumab were able to consume small amounts of at least one allergy-triggering meal without experiencing an allergic reaction; 69% of patients could consume small amounts of two allergenic foods; and 47% could consume tiny amounts of all three allergenic foods.

Omalizumab was safe and did not produce any side effects, except for a few small responses at the injection site. This is the first time its safety has been examined in youngsters as young as one.

More questions

The researchers stated that more research is needed to determine how omalizumab can help people with food allergies.

“We have a number of unanswered questions, including how long patients should take this medication. Have we permanently altered the immune system? What criteria predict who will respond most strongly?” Chinthrajah spoke. “We don’t know yet.”

The team is preparing studies to answer these and other concerns, such as determining the type of monitoring required to establish when a patient develops substantial tolerance to an allergy-triggering food.

According to Chinthrajah, many patients who have food allergies also have additional allergic disorders that omalizumab treats, such as asthma, allergic rhinitis (hay fever and allergies to environmental triggers such as mold, dogs or cats, or dust mites), or eczema. “One drug that could improve all of their allergic conditions is exactly what we’re hoping for,” she went on to say.

The medicine could be especially beneficial for young children with severe food allergies, she suggested, because they tend to put items in their mouths and may be unaware of the risks such allergies bring.

The medicine may also make it safer for community physicians to treat food allergy patients because it does not cause dangerous allergic reactions, as oral immunotherapy occasionally does. “This is something that our food allergy community has been waiting a long time for,” Chinthrajah said in a statement. “It’s an easy drug regimen to implement in a medical practice, and many allergists are already using this for other allergic conditions.”

More information: New England Journal of Medicine (2024). DOI: 10.1056/NEJMoa2312382

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