Mount Sinai researchers—leading the largest clinical trial on peanut allergy desensitization—have concluded that a skin patch that gradually exposes the body to small amounts of peanut allergen appears to be safe and effective, and holds promise as a potential treatment for peanut allergies.
Research results from the Phase IIb clinical trial were presented at the 2015 American Academy of Allergy, Asthma & Immunology by Hugh A. Sampson, MD, Dean for Translational Biomedical Research and Director of the Jaffe Food Allergy Institute at Kravis Children’s Hospital at Mount Sinai, who served as the Co-Principal Investigator of the study. Dr. Sampson is also Professor of Pediatrics, and Immunology, at Icahn School of Medicine at Mount Sinai.
According to Dr. Sampson, the prevalence of peanut allergy in the United States has grown to more than 2 percent of the pediatric population. It is the most common food allergy and can lead to severe allergic reaction and death, even in trace amounts.
Specifically, researchers evaluated the Viaskin® peanut patch, a product being developed by the French biotech firm DBV Technologies, which funded the study. In a practice known as epicutaneous immunotherapy, the patch introduces allergenic proteins into the skin to cells that present peanut protein and take it to regulatory cells in local lymph nodes. “It appears to educate the cells to turn off allergic reaction,” says Dr. Sampson.
The study enlisted 221 volunteers, ages 6 to 55, from North America and Europe, to determine reaction thresholds: how much peanut protein it took to elicit an allergic reaction. Researchers next randomly selected subjects to wear a Viaskin® peanut patch coated with a dose of 0, 50, 100, or 250 micrograms of peanut protein.
After one year, the participants’ reaction thresholds were again tested. The study found the 250-microgram patch was the most effective: 50 percent of those wearing the high-dose patch were able to tolerate consuming at least 10 times their pre-treatment dose, or one gram of peanut protein (equal to roughly four peanuts), with no adverse reactions. “Our work has demonstrated that we may be able to provide low-level protection for patients, to the extent that they will no longer have to fear activities like birthday parties or dining out at a restaurant where there may be an accidental exposure to peanuts, and they wouldn’t have to worry about processed foods with ‘May contain peanuts’ labels,” says Dr. Sampson.
The patch also represents an advance over oral immunotherapy, which requires patients to ingest increasing amounts of allergic food to increase tolerance. “Virtually everyone has reactions during the course of their oral immunotherapy,” says Dr. Sampson. Adverse reactions typically manifest as itchy mouth, swelling of the lips and tongue, and/or stomachaches; and 5 percent to 20 percent require treatment for more severe reactions.
The U.S. Food and Drug Administration (FDA) has fast-tracked continuing study of the patch and plans to launch a Phase III trial this fall, the final hurdle before submitting the product for FDA approval.
Dr. Sampson is an unpaid member of DBV Technologies’ Scientific Advisory Board.