For kids with allergies, a trace amount of a food substance can trigger deadly anaphylaxis within minutes of ingestion – the fear of which can be life altering for many families.
Researchers at Texas Children’s Hospital are looking to give hope to some of these families through a landmark peanut immunotherapy trial. Using a process known as desensitization where patients swallow tiny, increasing amounts of peanut over time, Dr. Carla Davis, a specialist in the Allergy and Immunology Section of the Department of Pediatrics at Baylor College of Medicine, will begin a trial this month that treats children with peanut allergy to help lower the risk of severe allergic reactions and eventually cause them to lose their allergy to peanuts. The study also will determine the mechanism by which the body develops tolerance, as well as measure the effect of viral infections on the ability of peanut allergic children to take peanut flour.
In Europe, a recent oral immunization trail (OIT) showed promise, and both the Consortium for Food Allergy Research and Stanford University are conducting studies in the U.S. But so far desensitization is not the standard of care, and no study has determined the mechanism by which the body develops tolerance. Davis’ plan to monitor how and why the immunotherapy works is revolutionary, and could help allergists ID patients who are good candidates for immunotherapy.
“No other immunotherapy trial in this area has used the state of the art laboratory testing of immune cells to improve the process of desensitization,” said Davis. “We believe the information gained from this trial will help make the process of desensitization faster and more efficient in the future.”
Davis and her team, in collaboration with Dr. Jordan Orange’s Center for Human Immunobiology and the Center for Cell and Gene Therapy, will be evaluating more than 25 markers of cells called lymphocytes, which are central to controlling immune responses. Patients will have blood drawn, and these markers will be evaluated by a process called flow cytometry. The markers will provide insight into how the immune system works to cause food allergy.
“Our study is evaluating clinical measures but in conjunction with the lymphocyte markers that will give us a better way to treat and potentially cure food allergy,” said Davis.
One in 13 U.S. children has a food allergy according to recent data from national organization FARE (Food Allergy Research and Education). This reflects a nearly 50 percent increase in childhood food allergies between 1997 and 2011, leading to 25 billion dollars per year in related health costs to treatment and diagnosis.
People can be allergic to any type of food, but eight foods account for nearly 90 percent of all allergic reactions to food in the U.S., with peanuts being the food that is most associated with life threatening food related anaphylaxis. More than 400,000 school-aged children in the United States have this allergy, according to the American College of Allergy, Asthma and Immunology.
“We chose this food (peanuts) to make the largest difference in safety for our patients,” said Davis.
Texas Children’s is the first center in the southwest region to have approval by the FDA to dispense peanut flour as an investigational new drug. The study will be funded by donations to the Food Allergy Program, with the majority of funds from a private group of individuals in the Food Allergy Advisory Group. Initially, 20 patients will be enrolled, with the potential to enroll hundreds more over the next three years, with the help of expanded funding.