Skin Patch Shows Promise for Treating Peanut Allergies

27 Oct 2016 --- A wearable patch that delivers small amounts of peanut protein through the skin has shown promise for treating children and young adults with peanut allergy, according to one-year results from an ongoing clinical trial.

The ongoing trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR) has published its one-year outcomes in the Journal of Allergy and Clinical Immunology.

The results of the study so far show that the technology has a greater effect when treating younger children, and appears to have less of an impact on participants aged 12 years and older.

Speaking to NutritionInsight, Marshall Plaut, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID) said, "There are some promising results from recent clinical trials for treatment of food allergy."

"The future does look better because of such results. However, the results of trials have demonstrated both strengths and weaknesses. It is to be hoped that future changes in approaches will increase the benefits and reduce the severity of side effects."

NIAID Director Anthony S. Fauci, M.D., also commented on the importance of the study, saying: “To avoid potentially life-threatening allergic reactions, people with peanut allergy must be vigilant about the foods they eat and the environments they enter, which can be very stressful.”

“One goal of experimental approaches such as epicutaneous immunotherapy is to reduce this burden by training the immune system to tolerate enough peanut to protect against accidental ingestion or exposure.”

CoFAR researchers at five study sites randomly assigned 74 peanut-allergic volunteers aged 4 to 25 years to treatment with either a high-dose (250 micrograms peanut protein), low-dose (100 micrograms peanut protein), or placebo patch.

The investigators assessed peanut allergy at the beginning of the study with a supervised, oral food challenge with peanut-containing food. The patches were developed and provided by the biopharmaceutical company DBV Technologies under the trade name Viaskin.

Each day, study participants applied a new patch to their arm or between their shoulder blades. After one 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 regimens offered similar benefits, with 46 percent of the low-dose group and 48 percent of the high-dose group achieving treatment success, compared with 12 percent of the placebo group.

In addition, the peanut patches induced immune responses similar to those seen with other investigational forms of immunotherapy for food allergy.

Investigators observed greater treatment effects among children aged 4 to 11 years, with significantly less effect in participants aged 12 years and older.

"This is an important and somewhat unexpected result," said Dr. Plaut, who is also chief of the Food Allergy, Atopic Dermatitis and Allergic Mechanisms Section in NIAID’s Division of Allergy, Immunology and Transplantation.

"It almost certainly tells us something about the differences in immune system in children vs. adults. We hope that understanding these differences will lead to improved treatment for both children and adults. However, because this concept that children are treated more effectively than adults is relatively new, we do not have follow-up studies yet, so we do not yet know why children respond better than adults."

Daniel Rotrosen, M.D., director of NIAID’s Division of Allergy, Immunology and Transplantation (DAIT), added, “The clinical benefit seen in younger children highlights the promise of this innovative approach to treating peanut allergy." 

“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.”

Nearly all of the study participants followed the EPIT regimen as directed. None reported serious reactions to the patch, although most experienced mild skin reactions, such as itching or rash, at the site of patch application.

“The high adherence to the daily peanut patch regimen suggests that the patch is easy-to-use, convenient and safe,” added Plaut.

“The results of this study support further investigation of epicutaneous immunotherapy as a novel approach for peanut allergy treatment.”

Additional studies in larger groups of children are needed before the therapy could be approved for wider use. After the first year, all participants began receiving high-dose daily patches, and they will continue in the study for a total of two and a half years of EPIT. 

by Hannah Gardiner