Initial trial results have shown that a wearable patch, which delivers small amounts of peanut protein, can protect children and young adults with peanut allergies from the effects of accidental ingestion or exposure.
The findings come from the first year of an ongoing trial of a treatment called epicutaneous immunotherapy or EPIT, which is being conducted by the Consortium of Food Allergy Research (CoFAR).
A total of 74 peanut-allergic individuals were enrolled, aged 4 – 25 years, and assigned to either a high-dose (250mg peanut protein), low-dose (100mg peanut protein), or placebo patch. Baseline peanut tolerance was tested with a supervised oral food challenge with peanut-containing food. The study involved the patients applying a new EPIT patch each day to their arm or between their shoulder blades.
Results show that after one year, 46% of the low-dose and 48% of the high-dose group achieved treatment success, which was defined as the ability to consume at least 10 times more peanut protein than he or she was able to before starting EPIT. The placebo group had a treatment success rate of 12%.
Greater treatment effects were seen among children aged 4 to 11 years, with significantly less effect in participants aged 12 years and older. No serious reactions were reported apart from mild skin reactions such as itching or rash at the site of application.
“Epicutaneous immunotherapy aims to engage the immune system in the skin to train the body to tolerate small amounts of allergen, whereas other recent advances have relied on an oral route that appears difficult for approximately 10 to 15 percent of children and adults to tolerate,” said Daniel Rotrosen, MD, director of the National Institute of Allergy and Infectious Diseases’ Division of Allergy, Immunology and Transplantation.
The plan is to keep the participants in the study for a total of two and a half years. After the first year all participants in the EPIT group have begun using the high-dose daily patches. Additional studies in larger groups of children are needed before the therapy could be approved for wider use.
The patches used in the trial are developed and provided by the DBV Technologies under the trade name Viaskin.
For more information visit niaid.nih.gov.