Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results

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 HJ, Davis CM, Ford LS, Gagnon R, Greenhawt M, Hourihane JO, 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 (2020)

Publication Type: Journal article

Publication year: 2020

Journal

DOI: 10.1016/j.jaci.2020.06.028

Abstract

Background: The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). Objective: We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. Methods: Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment. Results: Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%). Conclusions: These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.

Authors with CRIS profile

Involved external institutions

DBV Technologies France (FR) University of Cincinnati United States (USA) (US) Charité - Universitätsmedizin Berlin Germany (DE) Massachusetts General Hospital United States (USA) (US) Baylor College of Medicine United States (USA) (US) The Children's Hospital at Westmead Australia (AU) University of Colorado Anschutz Medical Campus United States (USA) (US) University of British Columbia Canada (CA) Perth Children's Hospital Australia (AU) Centre hospitalier universitaire de Québec Canada (CA) Children's Hospital of Philadelphia United States (USA) (US) St.-Marien-Hospital Bonn Germany (DE) Boston Children's Hospital United States (USA) (US) University of Arkansas for Medical Sciences (UAMS) United States (USA) (US) Icahn School of Medicine at Mount Sinai United States (USA) (US) National Jewish Health United States (USA) (US) Ann & Robert H. Lurie Children's Hospital of Chicago United States (USA) (US) INFANT Research Centre Ireland (IE) University of North Carolina at Chapel Hill United States (USA) (US) University of California, San Diego United States (USA) (US) Stanford University United States (USA) (US) Temple Street Children's University Hospital / Children's Health Ireland (CHI) Ireland (IE) Johns Hopkins Hospital United States (USA) (US) Griffith University Australia (AU) Cheema Research Inc Canada (CA) University of Texas Southwestern Medical Center (UT Southwestern) United States (USA) (US) Université de Montréal Canada (CA) NYU Langone Medical Center United States (USA) (US) Seattle Allergy & Asthma Research Institute United States (USA) (US) University of Ottawa Canada (CA) Texas Children's Hospital United States (USA) (US) UPMC Children’s Hospital of Pittsburgh United States (USA) (US)

How to cite

APA:

Fleischer, D.M., Shreffler, W.G., Campbell, D.E., Green, T.D., Anvari, S., Assa'ad, A.,... Sampson, H.A. (2020). 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. https://dx.doi.org/10.1016/j.jaci.2020.06.028

MLA:

Fleischer, David M., et al. "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).

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