A new study has shown that children with peanut allergies can safely build tolerance by gradually ingesting store-bought, home-measured peanut butter over 18 months. Researchers found that 100% of children who could initially tolerate at least half a peanut were able to consume up to three tablespoons of peanut butter without an allergic reaction. This breakthrough treatment strategy may offer a solution for the approximately half of children with peanut allergies who are already able to tolerate small amounts of peanuts.
The trial, funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), was published today in NEJM Evidence. The findings are especially important for children with high-threshold peanut allergies, who were excluded from previous food allergy treatment trials. These children, who could tolerate at least half a peanut but still need treatment, have lacked options until now.
“We’re excited to show that a simple, accessible therapy could provide significant benefits for children with high-threshold peanut allergies and their families,” said Dr. Jeanne Marrazzo, director of NIAID.
Current FDA-approved food allergy treatments primarily target children with low-threshold peanut allergies, who cannot tolerate even small amounts of peanuts. These treatments aim to reduce the likelihood of reactions to accidental peanut exposure. However, the 800,000 children in the U.S. with high-threshold peanut allergies have been left without alternatives. This study tests whether a low-cost, practical treatment could help these children tolerate more peanut protein.
The trial involved 73 children aged 4 to 14, with a nearly 60% representation of white participants, 19% Asian, 1.4% Black, and 22% mixed-race. The children were randomly assigned to either the treatment or avoidance group. Those in the treatment group began by consuming 1/8 teaspoon of peanut butter daily, gradually increasing the dose every eight weeks under medical supervision until they reached one tablespoon.
None of the children in the ingestion group required epinephrine to treat severe allergic reactions during home dosing, and only one child needed epinephrine during a supervised visit. After completing the treatment regimen, the children participated in an oral food challenge to determine how much peanut butter they could tolerate. All 32 children in the ingestion group successfully tolerated up to 9 grams of peanut protein, equivalent to three tablespoons of peanut butter. In contrast, only three children in the avoidance group could tolerate this amount, with three others showing some improvement.
Although the study took place during the COVID-19 pandemic, with some families avoiding indoor visits, the results were still striking. Using statistical techniques to account for missing data, researchers found that 100% of the ingestion group tolerated at least two doses more than they could at the start of the study, compared to 21% in the avoidance group.
Following the treatment, 86.7% of children in the ingestion group maintained tolerance to 9 grams of peanut protein after 16 weeks of weekly peanut consumption, followed by eight weeks of avoidance. In total, 68.4% of the ingestion group achieved sustained unresponsiveness to peanuts, compared to only 8.6% in the avoidance group.
These promising results suggest that this gradual ingestion method could offer long-term benefits for children with peanut allergies. The researchers are now interested in exploring whether the same approach could work for other food allergens.
The trial was led by Dr. Scott H. Sicherer and Dr. Julie Wang at the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai Kravis Children’s Hospital in New York. Dr. Sicherer is the director of the Institute and a professor of pediatric allergy and immunology, while Dr. Wang is a professor at the Institute specializing in pediatric allergy and immunology.
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