A National Institutes of Health-funded clinical experiment discovered that delivering peanut oral immunotherapy to extremely peanut-allergic children aged 1 to 3 years successfully desensitized most of them to peanut and produced remission of peanut allergy in one-fifth of them.
For 2.5 years, the immunotherapy comprised of a daily oral dosage of peanut flour. Six months after finishing immunotherapy, remission was defined as being able to ingest 5 grams of peanut protein, equivalent to 1.5 tablespoons of peanut butter, without experiencing an allergic reaction. The youngest children, as well as those who began the experiment with lower levels of peanut-specific antibodies, had the best chance of achieving remission. The findings of the IMPACT experiment were published in the journal The Lancet.
“The innovative 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, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. “We anticipate that the outcomes of this study will help to inform the development of treatment approaches that lessen the burden of peanut allergy in children.” The trial was sponsored and supported by the NIAID’s Immune Tolerance Network.
Peanut allergy affects roughly 2% of children in the United States, or nearly 1.5 million people aged 17 and under. The risk of a life-threatening allergic reaction to mistakenly consumed peanut is substantial for young children, the majority of whom will be peanut-allergic for the rest of their lives.
The innovative results of the IMPACT trial suggest a window of opportunity in early childhood to induce remission of peanut allergy through oral immunotherapy. We anticipate that the outcomes of this study will help to inform the development of treatment approaches that lessen the burden of peanut allergy in children.Anthony S. Fauci
The IMPACT trial authors reasoned that because oral immunotherapy has the capacity to influence the immune system, giving peanut oral immunotherapy to a child early in life, when the immune system is still forming, might modify a child’s immunological response to peanut. Two prior studies demonstrated that peanut oral immunotherapy may be safely administered to very young children and have a therapeutic effect.
The IMPACT trial included over 150 children aged one to three years old from five academic medical centers in the United States. Only children who experienced an allergic reaction to half a gram of peanut protein (approximately 1.5 peanuts) or less were eligible to participate in the trial. The youngsters were randomly allocated to receive either peanut protein flour or a placebo flour of identical appearance. To hide the taste of the flours, they were blended with foods such as applesauce or pudding. Except for a site pharmacist and a site dietitian, no one knew who received peanut flour or placebo flour until all of the data was collected and the research visits were completed.
The children in the treatment group consumed steadily increasing daily dosages of up to 2 grams of peanut protein, equivalent to around six peanuts, during a 30-week period. The children were subsequently given their daily amount of peanut or placebo flour for another two years.
The youngsters were then subjected to an oral food challenge in which they were given gradually increasing doses of peanut protein up to a total of 5 grams. They then discontinued treatment and abstained from peanuts for six months.
Finally, the youngsters were subjected to a second oral meal challenge with 5 grams of peanut protein, which is roughly comparable to 16 peanuts. Those who did not have an adverse reaction during the challenge were later administered 8 grams of peanut butter (equal to 2 tablespoons) on a different day to confirm that they could consume peanut without becoming allergic.
At the end of the treatment period, 71 percent of children who had received peanut flour had been desensitized to peanuts, compared to only 2 percent of those who had received placebo flour. Desensitization was defined as being able to eat 5 grams of peanut protein without experiencing an allergic reaction during the first oral meal challenge. After six months of peanut avoidance following treatment, 21% of children who had received peanut flour were able to ingest 5 grams of peanut protein during the second oral food challenge without experiencing an allergic reaction, indicating that they were in remission. In comparison, only 2% of the children who had received placebo flour were in remission at the time.
Lower levels of peanut-specific immunoglobulin E antibodies at the start of the experiment, as well as being younger, indicated whether a kid would achieve remission, according to the researchers. After the scientists had access to the research data, they discovered an inverse link between age at the start of the trial and remission, with 71% of the 1-year-olds, 35% of the 2-year-olds, and 19% of the 3-year-olds having remission.
Despite the fact that nearly all of the children who received peanut flour experienced at least one dose-related reaction throughout treatment, the majority of these reactions were mild to moderate in severity. During the 2.5-year therapy period, twenty-one children got the rescue medicine epinephrine for 35 mild responses to peanut flour.