Offering peace of mind: Peanut immunotherapy clinical trials at Lurie Children’s

Families of children with food allergies are constantly on high alert. Meticulous avoidance of the child’s allergen is their daily reality. Allergies to multiple foods demand even more attention in efforts to keep the child from ingesting even miniscule amounts of allergens.

Unfortunately, accidental exposure to a food allergen is all too common and it can lead to severe, potentially fatal reactions. It can happen from eating food cooked or processed on shared equipment with the allergen, and it can occur in just about any setting, from playground to school to birthday parties.

So far, there is no cure for food allergies. The vigilance required to keep a child with food allergies safe is a huge emotional burden on the entire family. To boost safety and mitigate some of this stress, research has focused on reducing the risk of severe allergic reactions from accidental exposure.

This is the strategy behind the two FDA-approved treatments that are now available – an oral immunotherapy for peanut allergy (Palforzia) and an injectable medication (Xolair/omalizumab) for multiple food allergies. While neither of these treatments allows carefree eating, some of the worry about unintentional ingestion of the allergen is diminished.

“The two approved treatments for food allergies are an exciting step forward, but they are not perfect, which is why we continue to pursue research into more effective and convenient treatment options,” said Elizabeth Lippner, MD, an allergist who heads the food allergy clinical trials program at Ann & Robert H. Lurie Children’s Hospital of Chicago and is an Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “Clinical trials are bringing innovative new therapies for youths with food allergies, and we at Lurie Children’s are happy to offer our patients opportunities to receive the latest treatments.”

One of the ongoing studies at Lurie Children’s is a multinational Phase 3 randomized clinical trial for children 4-7 years of age who are allergic to peanuts. The study is testing the safety and effectiveness of peanut immunotherapy using a skin patch coated with peanut protein (also known as the Viaskin patch). It works by desensitizing kids to peanuts, starting with a tiny dose that is gradually increased, and it tends to be better tolerated and easier to manage than daily oral immunotherapy.

The peanut patch came close to FDA approval but was turned down because it was not sticky enough and easily fell off, which interfered with effectiveness. Now a better patch has been developed, and a recent Phase 3 clinical trial produced positive results in toddlers (1-3 years of age). Lurie Children’s also participated in that trial, which was published in the New England Journal of Medicine.

Another clinical trial at Lurie Children’s is also an immunotherapy for peanut allergy, but this one uses a tablet that dissolves under the tongue to desensitize patients with increasing doses of peanut. It is in an earlier stage of clinical research (Phase 1) and is recruiting participants 18-25 years of age to evaluate tolerability, safety, and effectiveness. Part 3 of this Phase 1 trial is about to start at Lurie Children’s and it will recruit children, adolescents, and adults (ages 4-25 years).

“All forms of immunotherapy are intended to keep the child safe in cases of accidental exposure, which helps to alleviate anxiety for families,” said Abigail Lang, MD, MSCI, an allergist and researcher with the food allergy clinical trials program at Lurie Children’s and Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “Strict avoidance of the food allergen is still required as these therapies are not cures for food allergies. The biggest benefit of immunotherapy is minimizing the risk of severe or potentially life-threatening reactions, offering families greater peace of mind.”

For more information about food allergy studies at Lurie Children’s, please call 312.227.6474 or 888.573.1833, or email allergystudy@luriechildrens.org.