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The oral immunotherapy in children 1 to 3 years of age with peanut allergy has been shown to be effective in achieving desensibilización to this food in most of them and the remission of allergy by a fifth, according to the results of a clinical trial funded by the National Institutes of Health (NIH, for its acronym in English) called IMPACT and published in
The Lancet.
Immunotherapy consisted of a daily oral dose of peanut flour for 2.5 years. Remission was defined as the ability to eat 5 grams of peanut protein, equivalent to 1.5 tablespoons of peanut butter, without having an allergic reaction six months later to complete immunotherapy.
Younger children and those who started the trial with lower levels of peanut-specific antibodies were more likely to achieve remission.
“The landmark results of the IMPACT trial suggest a window of opportunity in early childhood to induce remission of peanut allergy through oral immunotherapy,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID). ), which is part of NIH. «
Almost 150 children from 1 to 3 years old participated in the IMPACT trial at five academic medical centers in the United States. Only children who had an allergic reaction after eating half a gram of peanut protein (about 1.5 peanuts) or less were eligible to participate in the study. They were randomly assigned to receive either peanut protein-containing flour or a similar-appearing placebo flour. The flours were mixed with foods such as applesauce or pudding to help mask their taste. No one except a pharmacist and a dietitian knew who received peanut flour or placebo flour until all the data was collected and the study visits were over.
Over a 30-week period, children in the treatment group took daily doses that were gradually increased until they reached 2 grams of peanut protein, equivalent to about six peanuts. The children then continued to consume their daily dose of peanut flour or placebo for two more years.
The children then received gradually increasing doses of peanut protein up to a cumulative maximum of 5 grams. They then stopped treatment and avoided peanuts for six months. Finally, the participants underwent a repeated food challenge with 5 grams of peanut protein, equivalent to about 16 peanuts. Those who did not have an allergic reaction during the challenge were then fed 8 grams of peanut butter, equivalent to 2 tablespoons, on a different day to confirm that they could eat peanuts without having an allergic reaction.
At the end of the treatment period, 71% of the children who had received peanut flour were desensitized to this food, compared to only 2% of those who had received placebo flour. Desensitization was defined as being able to eat 5 grams of peanut protein during the first oral food challenge without having an allergic reaction. After six months of avoiding peanuts after treatment, 21% of the children who had received peanut flour could eat 5 grams of peanut protein during the second oral food challenge without having an allergic reaction and thus were in remission. In contrast, only 2% of the children who had received placebo flour were in remission at that time.
The researchers found that lower levels of peanut-specific immunoglobulin E antibodies at the start of the trial and being younger were factors that predicted whether a child would achieve remission. In an analysis done after the researchers were able to view the study data, they found an inverse relationship between age at the start of the trial and remission, with 71% of 1-year-olds, 35% of 2-year-olds years and 19% of 3-year-olds experiencing remission.
Although almost all children who received peanut flour had at least one dose-related reaction during treatment, most were mild to moderate in severity. .