MedicalResearch.com Interview with:
Dr. Matthew Greenhawt
Director, Food Challenge and Research Unit
Children’s Hospital Colorado
MedicalResearch.com: What is the background for this study?
Response: In the US, nearly one million children suffer from a peanut allergy and severe reactions to food allergens are not uncommon – yet there is significant unmet need in the food allergy immunotherapy space, as there are no currently approved treatment options. That being said, we are encouraged by the efficacy and safety data, which support Viaskin Peanut as a convenient and well-tolerated potential treatment option for the peanut allergy.
In the pivotal Phase III clinical trial (PEPITES) just published in The Journal of the American Medical Association (JAMA), Viaskin Peanut – the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system – provided statistically significant desensitization in peanut-allergic children ages 4-11 years old. Patients who were treated with active therapy were more likely to have increased their eliciting dose to peanut (the amount of peanut protein ingested before an objective allergic reaction was seen during a double-blind, placebo-controlled food challenge) by a required amount as compared to patients treated with a placebo patch. The improvement suggests a reduced risk of allergic reaction to accidental peanut ingestion in the group treated with Viaskin Peanut, with no change seen in the placebo group.
MedicalResearch.com: What are the main findings?
Response: Key results showed that:
- Data from the PEPITES trial demonstrates that after 12 months of treatment, a statistically significant greater proportion of patients treated with Viaskin Peanut achieved a prespecified increase in the amount of peanut protein required to elicit an allergic reaction during the food challenge compared with placebo (treatment difference = 21.7%; 95% CI = 12.4% – 29.8%; p<0.001).
- In a post-hoc analysis, the majority of patients on Viaskin Peanut experienced an increased ED compared with the placebo group (62.6% in active vs. 28% in placebo) at 12 months.
- An additional post-hoc analysis showed that 53.1% of patients treated with Viaskin Peanut increased their baseline ED from ≤100 mg to ≥300 mg, compared to 19% in the placebo group.
- Based on independent quantitative risk modeling, it is believed that increasing the eliciting dose to at least 300mg is predicted to reduce the risk of an allergic reaction due to accidental exposure through various common food product categories by over 95%.
MedicalResearch.com: What should readers take away from your report?
Response: The data just published in JAMA support Viaskin Peanut as a safe, convenient, and well-tolerated potential option to desensitize peanut allergic children. Viaskin Peanut has demonstrated a favorable safety and tolerability profile, which is critical for patients that may be susceptible to potentially life-threatening allergic reactions.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Viaskin Peanut and its underlying technology is being evaluated to address significant unmet medical needs, and is presently being studied in 1-4 year olds for safety and efficacy. Topline results from a Phase II milk trial show statistically significant desensitization as well, and a Phase III study of epicutaneous therapy for milk allergy is forthcoming.
MedicalResearch.com: Is there anything else you would like to add?
Response: This is a very hopeful time for peanut-allergic children and their families, as there has been a greater increase in the understanding of peanut allergy and there are multiple treatment options working towards approval. This provides much needed hope that therapy will be available to improve the safety and quality of life of our patients. I look forward to seeing advancements in treatment to help families that so desperately need new options.
Dr. Greenhawt is supported by grant #5K08HS024599-02 from the Agency for Healthcare Research and Quality; served as a consultant for the Canadian Transportation Agency, Thermo Fisher, Intrommune, and Aimmune Therapeutics; is or has served as a member of physician/medical advisory boards for Aimmune Therapeutics, DBV Technologies, Nutricia, Kaleo, Nestle, Sanofi Genzyme, Genentech, Prota Therapeutics, Acquestive, Allergenis, and Monsanto; is a member of the scientific advisory council for the National Peanut Board; has received honoraria for lectures from Thermo Fisher, Before Brands, multiple state and local allergy societies, the American College of Allergy, Asthma, and Immunology, the European Academy of Allergy and Clinical Immunology; is an associate editor for the Annals of Allergy, Asthma, and Immunology; and is a member of the Joint Taskforce on Allergy Practice Parameters.
Fleischer DM, Greenhawt M, Sussman G, et al. Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial. JAMA. Published online February 22, 2019. doi:10.1001/jama.2019.1113
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