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Free Content Evaluation of daily patch application duration for epicutaneous immunotherapy for peanut allergy

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Background:

Epicutaneous immunotherapy is a potential novel immunotherapy that utilizes unique cutaneous immunologic properties. In a phase III, randomized, double-blind, placebo controlled clinical trial, an epicutaneous patch (DBV712) with 250 µg of peanut protein applied once daily for 12-months was statistically superior to placebo in desensitizing children with peanut allergy (ages 4‐11 years) (N = 356).

Objective:

To assess the relationship between the hours of daily application time and the efficacy of DBV712 250 µg.

Methods:

DBV712 250 µg was applied to 30 nonallergic volunteers for various durations from 2 to 24 hours and then assayed for residual peanut protein. Patch application data from the phase III clinical trial were analyzed post hoc according to prespecified responder rates and changes in the eliciting dose (ED), as measured by the geometric mean (GM) ED ratio (12 months/baseline).

Results:

Following application, there was a marked decrease in peanut protein on the patches from 2 to 12 hours. After 12 hours, the median peanut protein recovered was below quantification limits. The median daily patch application duration in subjects from the phase III clinical trial was 21.1 hours (DBV712 250 µg) and 22.4 hours (placebo). Ninety-five percent of the treated population achieved >10 hours per day mean application. Response rates and GM ED ratios were similar among subjects across a range of application durations; e.g., in those with a mean duration of >10 hours, the response rate was 36.6% and the GM ED ratio was 3.8, comparable with 42.6% and 4.0, respectively, in those with a mean duration of >20 hours. In DBV712 250 µg subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5‐34.0%]; p < 0.001).

Conclusion:

An evaluation of residual peanut protein on patches following application and post hoc analysis of phase III data strongly suggest that allergen delivery is attained with 12‐16 hours of daily patch application time, sufficient to drive clinically meaningful desensitization to peanut after 12 months.

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Keywords: Ara h 6; Epicutaneous immunotherapy (EPIT); desensitization; eliciting dose; food allergy; immunotherapy; peanut allergy; peanut residue; treatment duration

Document Type: Research Article

Affiliations: 1: From the Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado; 2: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; 3: University of North Carolina School of Medicine, Chapel Hill, North Carolina; 4: DBV Technologies, Montrouge, France; 5: Certara, Princeton, New Jersey; and

Publication date: July 1, 2020

This article was made available online on June 9, 2020 as a Fast Track article with title: "Evaluation of daily patch application duration for epicutaneous immunotherapy for peanut allergy".

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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma and by having the potential to directly impact the quality of patient care. AAP welcomes the submission of original works including peer-reviewed original research and clinical trial results. Additionally, as the official journal of the Eastern Allergy Conference (EAC), AAP will publish content from EAC poster sessions as well as review articles derived from EAC lectures.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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