Children with high-threshold peanut allergy can build a tolerance by consuming increasing amounts of peanut butter over 18 months, a groundbreaking study suggests. Unlike current FDA-approved treatments, which focus on preventing serious reactions from accidental exposure, this approach allowed 100 percent of participants in the treatment group to safely eat the equivalent of three tablespoons of peanut butter.

Simple peanut allergy solution?

Gradually increasing the daily dose of store-bought, home-prepared peanut butter over 18 months allowed 100 percent of peanut-allergic children (who could already tolerate at least half a peanut) to safely eat three tablespoons of peanut butter without a reaction, researchers report. This simple and easy treatment can help nearly half of children with peanut allergies, especially those who can already tolerate small amounts of peanuts but had no previous treatment options.

The study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health and published in NEJMEvidence, fills a gap in the field of allergy treatment.

New hope for high-threshold allergy sufferers

"Children with high-threshold peanut allergy were not able to participate in previous food allergy treatment trials, denying them the opportunity to explore treatment options," said NIAID Director Jeanne Marrazzo, MD, MPH. "Today's report focuses on this population and shows that a very safe and accessible treatment could liberate many of these children and their families."

Food allergy treatments currently approved by the Food and Drug Administration were tested in children with low-threshold peanut allergy, who cannot tolerate even half a peanut. The purpose of these treatments is to reduce the likelihood that children will react to small amounts of peanuts and be accidentally exposed to peanuts despite their efforts to avoid them. This approach is irrelevant to the approximately 800,000 U.S. children who may have high-threshold peanut allergy, so until the new report they had only one management strategy: avoid peanut exposure.

A game-changing experiment

To address this need, researchers tested whether a low-cost, convenient treatment strategy could help children with high-threshold peanut allergy tolerate more peanut protein. The mid-stage trial involved 73 children aged 4 to 14 years. According to parent or guardian reports, nearly 60% of the children were white, 19% Asian, 1.4% black and 22% multiracial. The research team randomly assigned the children to trial a new treatment strategy or to continue avoiding peanuts.

Researchers in the peanut intake group started with a minimum of 1/8 teaspoon of peanut butter per day. They gradually increase the dose every eight weeks, up to 1 tablespoon of peanut butter or the same amount of a different peanut product, such as peanut powder or candy. Dose increases were performed under medical supervision at the study site. No child in the peanut-ingestion group required epinephrine for severe allergic reactions while taking the medication at home, and only one child required epinephrine while taking the medication under the supervision of a research institution.

Promising results without major reactions

After undergoing the treatment regimen, the peanut-consuming children participated in an oral food challenge under careful supervision by the research team to see how much peanut butter they could eat without developing an allergic reaction. All 32 children who participated in the challenge were able to tolerate up to 9 grams of peanut protein, which is equivalent to 3 tablespoons of peanut butter. In contrast, only three of the 30 children in the avoidance group who received an oral food challenge at a similar time in the trial tolerated 9 grams of peanut protein. There were also three children in the avoidance group who tolerated the challenge dose at least two doses higher than what they tolerated at the start of the study.

The trial was conducted during the COVID-19 pandemic, when some families wanted to avoid close contact with others indoors, so some children did not return to the study site for an oral food challenge. Using a common statistical technique to calculate these missing challenge results, 100% of the intake group and 21% of the avoidance group were able to tolerate at least two doses greater than where they started.

Sustained tolerance after testing

Children in the peanut tolerance group tolerated 9 grams of peanut protein in an oral food challenge, consuming at least 2 tablespoons of peanut butter per week for 16 weeks and then avoiding peanuts completely for 8 weeks. At this time, they were asked to return to the study site for a final oral food challenge.

Of the 30 treated children who participated in the final challenge, 26 (86.7%) continued to tolerate 9 grams of peanut protein, indicating that they had achieved sustained nonresponse to peanuts. In the avoidance group, three children had no reaction after eating 9 grams of peanut protein in a previous challenge and are thought to have developed a natural tolerance to peanuts. The researchers analyzed these results and included all 73 children who started the trial (whether they participated in the final challenge or not) and found that 68.4% of children in the peanut intake group achieved sustained non-response, while only 8.6% of children in the avoidance group developed natural tolerance.

Based on these encouraging results, the researchers wanted to see if the same treatment strategy would work for other food allergens besides peanuts. Future follow-up studies are needed to determine the effectiveness of this therapy in inducing long-lasting tolerance to peanut.

Compiled from /ScitechDaily