January 7, 2019

UC Med Study Could Lead to First FDA-Approved Food Allergy Treatment

A recent study conducted at UChicago Medicine shows that exposing patients to escalating doses of peanut protein may reduce the severity of peanut allergies. The treatment used in the study, a peanut protein-derived immunotherapy drug known as AR101, will be reviewed by the Food and Drug Administration (FDA) in 2019; if approved, it will become the first FDA-backed food allergy treatment.

The study, led by interim Chief of Allergy and Immunology Christina Ciaccio, involved 554 European and North American participants between the ages of 4 to 55, who ingested varying amounts of peanut protein while under the effects of AR101.

The study’s participants received an ImmunoCAP blood test prior to participation in the study to ensure they were allergic to peanuts. Researchers only accepted patients with peanut-specific Immunoglobulin E levels of at least 0.35 kUA per liter.

Once a participant’s immune system adjusted, the dosage was increased until he or she could ingest one peanut with little to no allergic reaction. “We believe at this level of ingestion, one will be protected from most accidental ingestions,” Ciaccio wrote in an e-mail to The Maroon.

Although a tolerance build-up approach like the one used in this study has been the traditional treatment for pollen allergies for years, the standard of care for peanut allergies thus far has typically been a strict elimination diet and the use of rescue medications if peanuts are accidentally consumed. With supplementation of AR101, 62.7 percent of participants could eat the equivalent of about two peanuts without having an allergic reaction by the end of the study.

This does not mean, however, that participants can consume peanuts continuously, Ciaccio said. Rather, the intent behind the immunotherapy treatment trial is to reduce fatal allergic reactions and develop a safety net to improve the quality of life for those affected by this disease.

This landmark trial is the product of many years of deliberation and research. The first-noted instance of using such a method was in 1908, but clinical trials did not start until the 1990s. However, the trials conducted did not produce conclusive results, leaving the food allergy field with an unmet need for research.

“In 2011 a critical meeting with food allergy stakeholders took place which resulted in a consensus that OIT (oral immunotherapy) needed to be standardized,” Ciaccio told The Maroon. “As no pharmaceutical company was interested, the food allergy community started a company, now called Aimmune.”

Aimmune led the second and third trials for AR101. With their funding, UC Medicine has been able to work on using desensitization to reduce allergic reactions to various foods, not just peanuts.

“In fact, clinical trials are in the works for [allergies to] milk, eggs, and tree nuts, to name a few. We anticipate this to be just the beginning for food allerg[ies],” Ciaccio said. “We have several additional approaches in clinical trial currently and are very hopeful that we will see equally exciting results with others as well.”