Sept. 17, 2013 | Researchers at the University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital are enrolling children ages 1-4 in a federally funded collaborative study of a possible new treatment for children with peanut allergy.
UAMS Department of Pediatrics Professor Stacie Jones, M.D, study co-chair, will work with colleagues in allergy and immunology research to conduct the study at UAMS and ACH, as well as at the University of North Carolina-Chapel Hill, Johns Hopkins University in Baltimore, Mount Sinai School of Medicine in New York and Stanford University in Stanford, Calif.
“Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children” will be the first major study to examine whether a therapeutic approach using oral immunotherapy can lead to durable lasting tolerance to peanuts among young, peanut-allergic children.
The study is sponsored by the National Institutes of Health-National Institute of Allergy and Infectious Disease-funded Immune Tolerance Network (ITN). Wesley Burks, M.D., chair of the University of North Carolina-Chapel Hill Department of Pediatrics, will lead the study with Jones.
A new aspect of this study is the very young patient population.
“The possibility of providing a therapy that can impact food allergy early in a patient’s life is not only exciting but may provide the best opportunity to make the disease go away,” Jones said.
Allergen immunotherapy administers an allergen under tight medical supervision to train a patient’s immune system so the patient will no longer have allergic reactions to that particular allergen. Oral immunotherapy for food allergies such as eggs, peanuts and milk, has shown promising results in several small studies.
In this randomized study, 144 peanut-allergic children will receive either peanut oral immunotherapy or a placebo. After 134 weeks of peanut consumption, the children will enter a six-month avoidance phase during which they will not consume peanuts.
There are two possible outcomes to allergen immunotherapy. In the first outcome, children may become desensitized as they take the daily, oral doses of the food allergen. In this case, participants would not experience an allergic reaction to the food during the study period but the adverse reaction would resume after the study is ended. The second possibility is for the development of tolerance, in which a participant can stop eating that particular food for a long time and afterward still be able to eat the food without having an allergic reaction.
To test for the latter possibility, after an extended period of receiving allergen immunotherapy during the study, the children will stop therapy for 6 months (during a period of dietary peanut avoidance), after which they will have a final peanut challenge to evaluate whether they have become tolerant to peanuts. 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 oral immunotherapy.
“No matter what the outcome, this study will improve our understanding of the disease and help us design the most effective treatment for the future,” Jones said.
The prevalence of peanut allergies in the United States has been increasing in the last few decades. It is estimated that peanut allergy affects 1 percent of the U.S. population. Although there is a spectrum of severity, peanut allergy can be extremely dangerous, even deadly. Only about 20 percent of patients with peanut allergy will outgrow their symptoms, and the only available treatment is avoiding peanuts, underscoring the need for improved options.
ITN is a research consortium sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The ITN develops and conducts clinical and mechanistic studies of immune tolerance therapies designed to prevent disease-causing immune responses, without compromising the natural protective properties of the immune system.
This study is receiving some additional support from the UAMS Translational Research Institute, which is providing Jones with dietary specialists who have developed food preparation procedures and are preparing food items for the study. The Translational Research Institute’s mission is to help accelerate research that will improve the health and health care of people in Arkansas and across the country. It was established with major funding from the National Institutes of Health (NIH) in 2009 and is one of 60 NIH Clinical and Translational Science Award (CTSA) recipients. The institute’s funding from NIH flows through the National Center for Advancing Translational Sciences (NCATS).