20 Jul Peanut Allergy: Three Year Study of Viaskin Immunotherapy Demonstrates Long Term Safety and Efficacy in Children
MedicalResearch.com Interview with:
Dr. Todd Green
Vice President of Clinical Development and Medical Affairs
MedicalResearch.com: What is the background for this study?
Response: The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg (DBV712). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE, which evaluates the eliciting dose (ED) after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC).
MedicalResearch.com: What are the main findings?
Response: In the study, approximately 3 out of 4 patients who completed 3 years of active treatment experienced an increase in their ED from baseline (month 0), showing a majority of patients benefited from the investigational therapy. Additionally, 78% maintained or improved the treatment effect observed at Month 12 following 2 additional years of therapy, and 51.8% achieved an ED of at least 1,000 mg peanut protein (about three peanuts); all patients were required to react to an ED of ≤300 mg in order to enter PEPITES.
A treatment effect was seen in a broad range of patients, including those with low baseline eliciting dose. The group who entered with an ED of ≤10 mg saw an average 22-fold increase over the treatment period (based on geometric mean ED). Consistent with the high rate of persistence of post-treatment effect reported in a previous clinical study, exploratory analyses in a subset of participants showed that 77.8% were able to maintain desensitization, according to predefined study definition, for a two-month period while off therapy and without peanut consumption.
The safety profile of DBV712 was consistent with that observed in the clinical program to date in over 1,000 patients. No treatment related serious adverse events (SAEs) were reported.
MedicalResearch.com: What should readers take away from your report?
Response: The PEOPLE trial represents the largest, long-term trial evaluating peanut allergy immunotherapy to date, with high compliance enabling extended study participation. Results from PEOPLE suggest long-term clinical benefit of DBV712 for at least three years.
Approximately 3 out of 4 patients who completed 3 years of active treatment experienced an increase in their ED from baseline (month 0), showing a majority of patients benefited from the investigational therapy. Increasing eliciting dose is important, as we know that caregivers are looking to protect children from accidental exposure, so we’re excited to see that patients are reaching high thresholds.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We believe this study is critical to supporting the long-term treatment effect of DBV712 and has potential implications for real world use, if approved. We also believe these results support the potential of DBV712 in offering long-term protection against the risk of reaction from accidental exposure and sustained desensitization.
Additionally, the PEOPLE study will assess the clinical benefit of DBV712 250 μg for up to five years. DBV has also conducted exploratory analyses investigating immune biomarkers that may reflect the impact of DBV712 on the immune system. The data suggest ongoing immunomodulatory effects of DBV712 and value of therapy beyond 12 months.
MedicalResearch.com: Is there anything else you would like to add?
Response: We believe these results support the potential of DBV712 in offering long-term protection against the risk of reaction from accidental exposure and sustained desensitization. Our mission has always been to deliver a safe, effective and enduring solution for children and families bearing the substantial burden of food allergy.
Vice President Clinical Development & Medical Affiars, DBV Technologies
Clinical Associate Professor of Pediatrics, Division of Allergy/Immunology, UPMC Children’s Hospital of Pittsburgh
Fleischer DM, Shreffler WG, Campbell DE, Green TD, Anvari S, Assa’ad A, Bégin P, Beyer K, Bird JA, Brown-Whitehorn T, Byrne A, Chan ES, Cheema A, Chinthrajah S, Chong H, Davis CM, Ford LS, Gagnon R, Greenhawt M, O’B Hourihane J, Jones SM, Kim EH, Lange L, Lanser BJ, Leonard S, Mahler V, Maronna A, Nowak-Wegrzyn A, Oriel RC, O’Sullivan M, Petroni D, Pongracic JA, Prescott SL, Schneider LC, Smith P, Staab D, Sussman G, Wood R, Yang WH, Lambert R, Peillon A, Bois T, Sampson HA, Long-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results, Journal of Allergy and Clinical Immunology (2020), doi: https://doi.org/10.1016/j.jaci.2020.06.028.
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