By: Sherry Coleman Collins, MS, RDN, LD
The world was all abuzz recently when the results of a study on the novel epicutaneous immunotherapy (aka EPIT or the “peanut patch”) to treat toddlers with peanut allergy was published in The New England Journal of Medicine called Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. The study was a randomized controlled trial including 362 patients 1-3 years of age and found that treatment with the patch resulted in 67% of children in the intervention group successfully achieving the primary end point (being able to eat substantially more peanut without reaction). Limitations of the study include exclusion of patients with a history of severe peanut anaphylaxis, lack of racial diversity among patients, the duration of treatment is not known and was not assessed in this study. This is still an experimental treatment available only in research settings and more research is needed. Epicutaneous immunotherapy is not a cure for peanut allergy, but may reduce the risk of anaphylaxis upon accidental ingestion of peanut containing foods.
National Peanut Board’s Sherry Coleman Collins (SCC), registered dietitian nutritionist and food allergy dietitian, interviewed the study’s primary investigator (PI) via email, Dr. Matthew Greenhawt (MG) of Children’s Hospital Colorado, to get the scoop on what this all means.
SCC: Dr. Greenhawt, thank you for taking the time to respond to my questions. Can you describe this study briefly?
MG: The EPITOPE study evaluated Viaskin Peanut in children ages 1 – 3 years of age. Viaskin Peanut is an investigational epicutaneous immunotherapy (EPIT) product, which uses the skin as a route to desensitize a patient to be less reactive to peanut. This is a daily therapy, worn between the shoulders on the back, which allows for non-oral peanut desensitization, which many parents find highly appealing. The study compared children randomized to 12 months of the investigational patch vs. children randomized to 12 months of a placebo patch. All children had to qualify for the study by reacting to 300mg or less of peanut in a double blind placebo controlled food challenge at the study start. To be considered responders after 12 months, the most reactive children at study start saw an increase in protection from having reactions triggered with 10mg of peanut protein or less (1/30 of a single peanut kernel) to at least 300mg (a single large peanut kernel), and those who had reactions triggered with 30-300mg peanut to start had to increase their protection to at least 1000mg(a little more than 3 large peanut kernels, or 4-5 peanut M&M candies).
SCC: It was really exciting to read that this study focused on toddlers. As a mom, I remember my friends who had toddlers with food allergies and they were so anxious. Can you talk a little about why early intervention (in this study 1-3 years of age) may be more effective than starting later (eg. 4-17 years approved for OIT)?
MG: Growing evidence from early introduction studies suggests that the allergic immune system is more modifiable early in life. Peanut allergy is commonly diagnosed very early in life, and fewer than 29% will naturally outgrow peanut allergy by age 6. There are currently no Food and Drug Administration (FDA) approved treatment options for toddlers under 4 years old. While this therapy is still under investigation and not approved by the FDA, it could one day fulfill a huge unmet medical need for children and their families in that a potential therapy would be available for very young children, and they could start this promptly after diagnosis, narrowing the time they live without having an active option to treat peanut allergy. This could provide an entirely different developmental paradigm for a family, who can proceed from a standpoint of being empowered by the protection the therapy offers, rather than fearing the consequences of not having protection from unintended ingestion.
SCC: Since OIT is already FDA-approved for peanut allergies, called Palforzia, how would an option of treatment using EPIT benefit those with peanut allergies? (I'm thinking that it has fewer side effects, better safety profile, but is there something else?)
MG: As a physician I can speak to the importance of having multiple options for both patients and caregivers. What works for one family may not work for another, with the best option being specific to what a family is seeking in terms of preference. Research has shown that many families prefer a non-oral option, and Viaskin Peanut may one day prove to be a viable choice for these individuals. Viaskin Peanut uses a novel approach called epicutaneous immunotherapy (EPIT), which is a route of desensitization that takes advantage of the skin being the largest immune organ in the body. Viaskin Peanut produces a level of protection utilizing much smaller doses of peanut protein compared to an oral therapy. EPIT is applied once a day, and the dose is rarely associated with systemic side effects. Moreover, the child’s activities do not need to be adjusted around the dose, and can even be applied when the child is ill, which is different than other therapies.
SCC: In those children who were successfully treated with EPIT, what is maintenance like for them?
MG: The patch is designed for daily wear and has been studied for up to 3 years in clinical trials. This is consistent with the length of treatment of other allergen immunotherapies, such as allergy shots for environmental allergies.
SCC: How does EPIT fit into the overall world of potential treatments for peanut allergies or even compared to the currently approved oral immunotherapy (OIT) for peanut allergies?
MG: EPIT is being studied as a non-oral, monotherapy option. Research has shown that many families prefer a non-oral option, and Viaskin Peanut may one day prove to be a viable choice for these individuals. Viaskin Peanut produces a level of protection utilizing much smaller doses of peanut protein compared to an oral therapy, the dose is rarely associated with systemic side effects, and the child’s activities do not need to be adjusted around the dose or the dose adjusted if the child is ill—all properties that are different than other therapies. Study in this age group is ongoing to understand if longer-term application of the patch continues to increase the amount of peanut required to provoke a reaction, and if children maintain protection if they stop wearing the patch after prolonged daily wear. While the safety profile for EPIT is highly reassuring, there are no studies that show that OIT is a superior therapy to EPIT that would justify the necessity of combining approaches in terms of either safety or efficacy.
SCC: Are there any trials looking at EPIT for other allergens besides peanut?
MG: A phase 2 trial for milk has been completed and is in the process of being submitted for publication.
SCC: What is the next step for the peanut patch (EPIT)?
MG: The FDA has requested additional safety data in order to get closer to 600 patients in the safety database. This is consistent with the FDA’s approach to Viaskin Peanut in 4 – 7-year-olds. As an investigator and clinician, I believe the EPITOPE study shows that a daily, non-oral epicutaneous therapy is a potentially viable option to provide safe and effective peanut allergy treatment. I have confidence that the forthcoming safety study will continue to build on the excellent safety profile demonstrated in EPITOPE, as part of a robust data package for the FDA that can support what we as clinicians and investigators hope is a timely decision to approve a much-needed product for this age range.
Matthew J. Greenhawt, M.D., M.B.A., M.S.c. — Dr. Greenhawt is Board-certified in pediatrics and allergy and immunology. He currently serves as an Assistant Professor of Pediatrics at the Children’s Hospital Colorado and the University of Colorado School of Medicine. He is the co-director of the Children’s Hospital Colorado Food Challenge Unit. He serves as a member of several national committees for both the American Academy of Allergy, Asthma, and Immunology and American College of Allergy, Asthma, and Immunology, and has served as an advisor on behalf of these organizations to the Centers for Disease Control Advisory Council on Immunization Practices pertaining to his work with influenza vaccine. He is the current chair of the Food Allergy Committee for the American College of Allergy, Asthma, and Immunology. He is a member of the Joint Task Force on Allergy Practice Parameters, and is also a member of the NIAID expert panel regarding food allergy prevention and the timing of infant feeding. Dr. Greenhawt is a member of National Peanut Board’s Food Allergy Education Advisory Council.