Mount Sinai Researchers Find Wheat Oral Immunotherapy to Be Therapeutic for Allergic Patients
First multicenter rigorous clinical trial yields promising results
In a major step towards understanding the safety and efficacy of wheat oral immunotherapy, Mount Sinai researchers report promising results from the first multicenter, rigorous clinical trial in the Journal of Allergy and Clinical Immunology.
The researchers said they had successfully induced desensitization in the majority of children enrolled. After 52 weeks of treatment, 52 percent of wheat-allergic children enrolled in the study were able to consume a cumulative dose of 4,443 mg of wheat protein, roughly the equivalent of one to two slices of bread, a hamburger bun, or a half-cup of cooked pasta, without encountering an adverse reaction.
Wheat is one of the five most common food allergens and represents a significant challenge for allergic children because of its prevalence in the American diet. A common ingredient in bread, pasta, pizza, and cakes, wheat is also a binding agent that is used in a surprising variety of foods such as cold cuts and ice creams.
Researchers at the Elliot and Roslyn Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai enrolled 46 wheat-allergic patients with a median age of 8.7 years to determine the efficacy and safety of oral immunotherapy for wheat. With oral immunotherapy, the patient is given an allergen in trace amounts that are gradually escalated in hopes of desensitizing the patient to the substance. Clinical trials conducted previously by Jaffe Food Allergy Institute researchers have yielded promising results, including a high rate (70-80 percent) of subjects reaching desensitization with an acceptable safety profile for foods such as cow milk, egg, and peanut.
Wheat allergic responses correlate to proteins present in the wheat. Therefore, to study the efficacy of oral immunotherapy, there needs to be a sufficient dose of protein. “Wheat contains relatively low amounts of protein compared to peanut or milk, making it a little more challenging to study. As a result, our young patients had to consume large quantities of wheat flour in order to ingest escalating doses of protein,” says Anna Nowak-Wegrzyn, MD, PhD, Professor of Pediatrics, Icahn School of Medicine at Mount Sinai, clinical researcher at the Jaffe Food Allergy Institute, and first author of the study.
“Overall, we were very pleased with the efficacy and safety of wheat oral immunotherapy for highly allergic patients,” says Dr. Nowak-Wegrzyn. “As a next step, we look forward to further studies to establish the optimal maintenance dose and duration of oral immunotherapy for our young patients.”
“While scientists studying food allergy therapies have made considerable progress over the past decade, wheat allergy has received limited attention, even though avoiding staple foods like wheat has been shown to significantly lower quality of life. This novel research, the first of its kind in the U.S., provides insights into an allergen that is not well understood and will likely impact future clinical trials,” said Lisa Gable, CEO of Food Allergy Research & Education, a funder of the study. “We are very pleased to have supported this study that finds wheat oral immunotherapy has a safety profile similar to OIT for other allergens and may be an option in the future for those living with wheat allergy.”
In addition to the Icahn School of Medicine at Mount Sinai, the study was conducted at Johns Hopkins University Children’s Medical Center, Stanford University Medical School, and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine.
The study was supported by Linda and Bill Friend and the Harris Family Foundation, Food Allergy Research & Education, Inc. (FARE), and Thermo Fisher Scientific.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.