Therapy helps children with peanut allergies tolerate a few tablespoons of peanut butter

Press release

Monday February 10, 2025

Read moreNew strain of MPOX may increase risk of miscarriage

An NIH trial informs a potential treatment strategy for children who can already tolerate half a peanut or more.

NIAID

Consuming gradually increasing doses of store-bought peanut butter measured at home over about 18 months allowed 100 peanut-allergic children who could initially tolerate the equivalent of at least half a peanut to consume three tablespoons of peanut butter without an allergic reaction, the researchers report. This easy-to-implement treatment strategy could potentially address an unmet need for about half of peanut-allergic children who can already tolerate the equivalent of at least half a peanut, considered a high threshold. The findings come from a trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health and published today in the journal NEJM Evidence.

“Children with high-threshold peanut allergy have been unable to participate in previous food allergy treatment trials, leaving them without 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 form of therapy could be liberating for many of these children and their families.”

Food allergy treatments currently approved by the Food and Drug Administration were tested on children with low-threshold peanut allergies, who cannot tolerate even half a peanut. These treatments are designed to reduce the likelihood of a reaction to a small amount of peanut despite efforts to avoid it, as might occur in the event of accidental exposure. This approach is irrelevant for the estimated 800,000 U.S. children likely to have a high-threshold peanut allergy, leaving them with only one management strategy before the new report: peanut avoidance.

To address this need, researchers tested whether an inexpensive and practical treatment strategy could help children with high-threshold peanut allergy tolerate significantly more peanut protein than they already did. The mid-stage trial enrolled 73 children ages 4 to 14. According to parent or guardian reports, nearly 60 of the children were White, 19 were Asian, 1.4 were Black, and 22 were of mixed ethnicities. The study team randomly assigned the children to either test the new treatment strategy or continue to avoid peanuts.

Those in the peanut group started with a minimum daily dose of 1/8 teaspoon of peanut butter. They gradually increased their dose every eight weeks to 1 tablespoon of peanut butter or an equivalent amount of another peanut product, such as peanut flour or candy. Dose increases took place under medical supervision at the study site. None of the children in the peanut group required epinephrine to treat severe allergic reactions during home dosing, and only one child required epinephrine during a supervised dosing visit at the study site.

After completing the treatment, the peanut-eating children participated in an oral challenge test carefully supervised by the study team to see how much peanut butter they could eat without an allergic reaction. All 32 children who participated in the test were able to tolerate the maximum amount of 9 grams of peanut protein, the equivalent of 3 tablespoons of peanut butter. In contrast, only three of the 30 children in the avoidance group who underwent the oral challenge test after a similar length of time in the trial were able to tolerate 9 grams of peanut protein. Three other children in the avoidance group tolerated a challenge dose at least two doses higher than the amount they could tolerate at the beginning of the study.

The trial took place during the COVID-19 pandemic, and some families preferred to avoid close contact with others indoors at that time, so some children did not return to the study site for the oral challenge test. Using a standard statistical technique to account for missing test results, 100 % in the ingestion group and 21 % in the avoidance group tolerated at least two doses higher than they could tolerate at baseline.

Children in the peanut group who could tolerate 9 grams of peanut protein during the oral challenge consumed at least 2 tablespoons of peanut butter per week for 16 weeks and then completely avoided peanuts for eight weeks. At that point, they were asked to return to the study site for a final oral challenge.

Twenty-six of the 30 treated children (86.7 %) who participated in the final test continued to tolerate 9 grams of peanut protein, indicating that they had achieved lasting peanut insensitivity. The three children in the avoidance group who could eat 9 grams of peanut protein without reacting to the previous test were considered to have developed natural peanut tolerance. Analyzing these results and including the 73 children who began the trial, whether or not they participated in the final test, the researchers found that 68.4 % in the peanut ingestion group achieved lasting insensitivity, while only 8.6 % in the avoidance group developed natural tolerance.

Based on these encouraging results, the researchers are interested in whether the same treatment strategy would work for food allergens other than peanuts. Further follow-up is needed to determine the therapy's effectiveness in inducing lasting peanut tolerance.

Scott H. Sicherer, MD, and Julie Wang, MD, led the trial, which took place at the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai Kravis Children's Hospital in New York City. Dr. Sicherer is the Director of the Institute and the Elliot and Roslyn Jaffe Professor of Pediatric Allergy and Immunology. He is also Chief of the Division of Allergy and Immunology in the Department of Pediatrics and Medical Director of the Clinical Research Unit at the ConduITS Institute for Translational Sciences at the Icahn School of Medicine at Mount Sinai. Dr. Wang is a Professor of Pediatric Allergy and Immunology at the Elliot and Roslyn Jaffe Food Allergy Institute.

Further information about the clinical trial, called the CAFETERIA study, is available at ClinicalTrials.gov under the study identifier NCT03907397.

NIAID conducts and supports research—at the NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets, and other NIAID-related materials are available at NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, comprises 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, studying the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health^®

###