New Patch Shows Promise Against Peanut Allergies

The patch, which seems particularly effective in young children, "trains" the immune system to tolerate higher doses of peanut protein with no reported major side effects.

Maureen Kingsley

An ongoing clinical trial of a wearable skin patch to treat life-threatening peanut allergy is looking promising at the one-year mark, particularly for young children, according to results published online on October 26 in the Journal of Allergy and Clinical Immunology.

The Phase II trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID; part of NIH) and conducted by the NIAID-funded Consortium of Food Allergy Research, has 74 participants across five sites nationwide undergoing epicutaneous immunotherapy (EPIT) in the form of the Viaskin peanut-protein-delivery patch, provided by biopharmaceutical company DBV Technologies (headquartered in France with a U.S. office in New York City).

During the first year, the participants, who range in age from 4 to 25 years, wore a high-dose patch (delivering 250 micrograms of peanut protein), a low-dose patch (delivering 100 micrograms of peanut protein), or a placebo patch. Each day they applied a new patch to their arm or between their shoulder blades.

At the end of the year, researchers assessed each participant's ability to consume at least 10 times more peanut protein than he or she was able to consume before starting EPIT. The low-dose and high-dose patches offered similar benefits, with 46% of the low-dose group and 48% of the high-dose group achieving treatment success, compared with 12% of the placebo group, according to an NIH press release. (Now that the first year of the trial has been completed, all participants are receiving the high-dose daily patches.)

The peanut patches also "induced immune responses similar to those seen with other investigational forms of immunotherapy for food allergy," NIH reported.

Investigators observed the most improvement among participants aged 4 to 11 years, suggesting that EPIT, which engages the immune system in the skin to teach the body to tolerate small amounts of an allergen, may be more effective when started early in childhood.

So far, the Viaskin-patch treatment appears safe and well tolerated with no major side effects, and nearly all of the trial participants have used it daily as directed. "The high adherence to the daily peanut-patch regimen suggests that the patch is easy to use, convenient, and safe," said Marshall Plaut, chief of the Food Allergy, Atopic Dermatitis and Allergic Mechanisms Section of NIAID's Division of Allergy, Immunology and Transplantation (DAIT). "The results of this study support further investigation of epicutaneous immunotherapy as a novel approach for peanut allergy treatment."

The main difference between EPIT via Viaskin patch and other recent innovations in food-allergy treatment is that other treatments are administered orally, which, according to DAIT director Daniel Rotrosen, "appears difficult for approximately 10 to 15% of children and adults to tolerate." With DBV Technologies' electrostatic Viaskin patch, the allergen is concentrated in the superficial layers of the skin, where it "activates the immune system by specifically targeting antigen-presenting cells without passage of the antigen into the bloodstream," according to the company.

The clinical trial is estimated to reach completion in December 2018; additional studies in larger groups of children are needed before EPIT can be approved for wider use.

DBV Technologies is also developing Viaskin patches for milk and egg allergies.

Maureen Kingsley is a contributor to Qmed. 

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[Image courtesy of DBV Technologies]