First multicenter rigorous clinical trial yields promising results
(NEW YORK –October 30, 2018) – 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.”
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 integrated delivery system encompassing seven hospital campuses, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai’s vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The System includes approximately 6,600 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools”, aligned with a U.S. News & World Report’s “Honor Roll” Hospital, it is ranked as a leading medical school for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report’s “Honor Roll” of top U.S. hospitals; it is one of the nation’s top 20 hospitals in Cardiology/Heart Surgery, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in six other specialties in the 2018-2019 “Best Hospitals” issue. Mount Sinai’s Kravis Children’s Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 11th nationally for Ophthalmology and 44th for Ear, Nose, and Throat, while Mount Sinai Beth Israel, Mount Sinai St. Luke’s and Mount Sinai West are ranked regionally. For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.