The Immune Tolerance Network’s (ITN’s) IMPACT Study, “Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children,” opened for enrollment today. This will be the first major study to examine whether oral immunotherapy can lead to durable, lasting tolerance to peanut among young peanut-allergic children. This study will be led by ITN investigator Wesley Burks, MD, Chair of the Department of Pediatrics at UNC Chapel Hill. Patients will be enrolled at UNC as well as at additional sites around the country including the University of Arkansas, Stanford University, Johns Hopkins Children’s Hospital and Mount Sinai Hospital.
In allergen immunotherapy a problematic allergen is administered under tight medical supervision to slowly train a patient’s immune system so they no longer have severe allergic reactions to a particular allergen. Oral immunotherapy (OIT), where the allergen is administered by mouth, is a route of delivery that in several small studies was able to decrease a patient’s sensitivity to an allergen, referred to as “desensitization.” With desensitization, as long as the patient continues oral doses of the food allergen, he or she will not have allergic reactions to the food. The question remains whether OIT is able to induce permanent changes so that a patient can safely consume that allergen without the need for continued, regimented consumption. The goal is to achieve clinical and immunological tolerance to peanut that persists after immunotherapy is stopped.
The IMPACT study will be a pivotal effort in determining OIT’s utility as a therapeutic strategy for inducing tolerance in young peanut-allergic patients. A novel aspect of this study is the very young patient population, children ages 1-4. “The best plan to possibly cause the disease to go away is to begin a treatment soon after the diagnosis,” said Dr. Burks. In this double-blind, placebo-controlled study, 144 peanut-allergic children will be randomized 2:1 to receive either peanut OIT or a placebo. After 134 weeks of peanut consumption the children will enter a 6 month avoidance phase during which they will not consume peanut. To test for tolerance, the children will have a final peanut challenge after the 6 month avoidance period to evaluate whether they have become tolerant to peanut.
In addition to the clinical endpoints, an equally important component of this study is the corresponding studies of immunologic markers, which could help predict which children can become tolerant during a course of OIT. “The mechanistic studies in the trial are designed to help us understand why the treatment does or does not work,” said Dr. Burks. “Either way the outcome will significantly improve our understanding of the disease and design the next type of treatment.”
For more information about the IMPACT study or to refer a patient, visit www.impactstudy.org.