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Key Points

Question  What is the effect of epicutaneous immunotherapy on reactivity to peanut protein ingestion in peanut-allergic children?

Finding  In this randomized clinical trial of 356 peanut-allergic children, the difference in treatment response rate (percentage of participants meeting a defined eliciting dose to peanut challenge) after 12 months of treatment with peanut-patch therapy, compared with placebo, was statistically significant (35.3% vs 13.6%), but did not meet a prespecified criterion (≥15% lower bound of the confidence interval) for a positive trial result.

Meaning  Epicutaneous immunotherapy induced a statistically significant response compared with placebo in peanut-allergic children, but the study did not meet a component of the primary outcome.

Abstract

Importance  There are currently no approved treatments for peanut allergy.

Objective  To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among peanut-allergic children.

Design, Setting, and Participants  Phase 3, randomized, double-blind, placebo-controlled trial conducted at 31 sites in 5 countries between January 8, 2016, and August 18, 2017. Participants included peanut-allergic children (aged 4-11 years [n = 356] without a history of a severe anaphylactic reaction) developing objective symptoms during a double-blind, placebo-controlled food challenge at an eliciting dose of 300 mg or less of peanut protein.

Interventions  Daily treatment with peanut patch containing either 250 μg of peanut protein (n = 238) or placebo (n = 118) for 12 months.

Main Outcomes and Measures  The primary outcome was the percentage difference in responders between the peanut patch and placebo patch based on eliciting dose (highest dose at which objective signs/symptoms of an immediate hypersensitivity reaction developed) determined by food challenges at baseline and month 12. Participants with baseline eliciting dose of 10 mg or less were responders if the posttreatment eliciting dose was 300 mg or more; participants with baseline eliciting dose greater than 10 to 300 mg were responders if the posttreatment eliciting dose was 1000 mg or more. A threshold of 15% or more on the lower bound of a 95% CI around responder rate difference was prespecified to determine a positive trial result. Adverse event evaluation included collection of treatment-emergent adverse events (TEAEs).

Results  Among 356 participants randomized (median age, 7 years; 61.2% male), 89.9% completed the trial; the mean treatment adherence was 98.5%. The responder rate was 35.3% with peanut-patch treatment vs 13.6% with placebo (difference, 21.7% [95% CI, 12.4%-29.8%; P< .001]). The prespecified lower bound of the CI threshold was not met. TEAEs, primarily patch application site reactions, occurred in 95.4% and 89% of active and placebo groups, respectively. The all-causes rate of discontinuation was 10.5% in the peanut-patch group vs 9.3% in the placebo group.

Conclusions and Relevance  Among peanut-allergic children aged 4 to 11 years, the percentage difference in responders at 12 months with the 250-μg peanut-patch therapy vs placebo was 21.7% and was statistically significant, but did not meet the prespecified lower bound of the confidence interval criterion for a positive trial result. The clinical relevance of not meeting this lower bound of the confidence interval with respect to the treatment of peanut-allergic children with epicutaneous immunotherapy remains to be determined.

Trial Registration  ClinicalTrials.gov Identifier: NCT02636699

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Article Information

Corresponding Author: David M. Fleischer, MD, Children’s Hospital Colorado, 13123 E 16th Ave, Box B518, Aurora, CO 80045 (david.fleischer@childrenscolorado.org).

Accepted for Publication: February 5, 2019.

Published Online: February 22, 2019. doi:10.1001/jama.2019.1113

Author Contributions: Drs Fleischer and Shreffler had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Fleischer, Sussman, Nowak-Wegrzyn, Green, Kim, Shreffler.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Fleischer, Greenhawt, Hourihane, Green, Smith, Yang, Kim, Lambert, Shreffler.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Fleischer, Sussman, Lambert.

Obtained funding: Pongracic, Yang, Chan, Lanser.

Administrative, technical, or material support: Fleischer, Nowak-Wegrzyn, Beyer, Campbell, Chong, Green, Smith, Yang, Chan, Bird, Schneider, Davis.

Supervision: Fleischer, Nowak-Wegrzyn, Beyer, Hourihane, Campbell, Wood, Cheema, Smith, Yang, Chan, Bird, Kim, Schneider.

Conflict of Interest Disclosures: Dr Fleischer reported receiving institutional research funding from DBV Technologies during the conduct of the study; receiving institutional research funding from Aimmune Therapeutics; serving as a consultant and receiving personal fees from DBV Technologies, Aimmune Therapeutics, Kaleo Pharmaceutical, INSYS Therapeutics, Abbott, and Nestle; and being an unpaid member of the scientific advisory council for the National Peanut Board and an unpaid member of clinical advisory boards for Food Allergy Research and Education and Food Allergy and Anaphylaxis Connectivity Team. Dr Greenhawt reported being supported by grant 5K08HS024599-02 from the US Agency for Healthcare Research and Quality; receiving personal fees from Sanofi, Symbiotix, Hybrid Health, ClinicalMind, and Vindico; serving as a consultant for the Canadian Transportation Agency, Thermo Fisher Scientific, Intrommune Therapeutics, and Aimmune Therapeutics; being a member of physician/medical advisory boards for Aimmune Therapeutics, DBV Technologies, Nutricia, Kaleo Pharmaceutical, Nestle, and Monsanto; being a member of the scientific advisory council for the National Peanut Board; receiving honoraria for lectures from Thermo Fisher Scientific, Before Brands, Kansas City Allergy Society, Northern California Allergy Society, Eastern Allergy Society, Florida Society of Allergy and Immunology, the American College of Allergy, Asthma, and Immunology, and the European Academy of Allergy and Clinical Immunology; serving as an associate editor for Annals of Allergy, Asthma, and Immunology; and being a member of the Joint Taskforce on Allergy Practice Parameters and the US National Institute of Allergy and Infectious Diseases (NIAID) Expert Panel on Peanut Allergy Prevention. Dr Sussman reported receiving grants from DBV Technologies during the conduct of the study and grants from DBV Technologies, Aimmune Therapeutics, Novartis, CSL Behring, AstraZeneca, Genentech, Stallergenes, Shire, Biocryst, GreenCross, and Regeneron outside the submitted work. Dr Bégin reported receiving grants through his institution from DBV Technologies during the conduct of the study and personal fees from Novartis, Aralez, and Pfizer and grants from Merck, Sanofi, and the Canadian Allergy, Asthma, and Immunology Foundation outside the submitted work. Dr Nowak-Wegrzyn reported receiving grants from the NIAID, DBV Technologies, Astellas Pharma, Sanofi Aventis, Aimmune Therapeutics, Nutricia, Nestle, Thermo Fisher Scientific, and the National Institutes of Health (NIH)/NIAID and personal fees from Merck and UpToDate outside the submitted work. Dr Beyer reported receiving grants from DBV Technologies during the conduct of the study; grants and personal fees from Aimmune Therapeutics; personal fees from Mabylon AG, Bencard, and Allergopharma; and grants and personal fees from ALK outside the submitted work. Dr Petroni reported receiving grants from DBV Technologies during the conduct of the study and grants from Aimmune, HAL Allergy, and Astellas outside the submitted work. Dr Brown-Whitehorn reported receiving grants and personal fees from DBV Technologies during the conduct of the study and outside the submitted work. Dr Hebert reported receiving grants from DBV Technologies during the conduct of the study and personal fees from GlaxoSmithKline, Merck, Novartis, Teva Pharmaceuticals, Shire, CSL Behring, and Sanofi outside the submitted work. Dr Hourihane reported receiving grants and personal fees from DBV Technologies during the conduct of the study and grants and personal fees from Aimmune Therapeutics; grants from City of Dublin Skin and Cancer Hospital Charity, National Children’s Research Centre Ireland, Food Allergy Research and Resource Program, and University of Nebraska, Lincoln; and personal fees from Nutricia outside the submitted work and serving as president of the Irish Association of Allergy and Immunology and chairman of the Irish Food Allergy Network. Dr Campbell reported receiving nonfinancial support and personal fees from DBV Technologies during the conduct of the study and grants from the National Health and Medical Research Council of Australia, the Allergy and Immunology Foundation of Australasia, and Nestle Health Science outside the submitted work. Dr Leonard reported receiving grants from DBV Technologies during the conduct of the study and grants from DBV Technologies and Aimmune Therapeutics; grants and personal fees as a member of the medical advisory board of Food Allergy Research and Education; and consulting fees for work with LabCorp outside the submitted work. Dr Chinthrajah reported receiving grants from DBV Technologies during the conduct of the study and grants from US NIAID, Aimmune Therapeutics, Astellas Pharma, and AnaptysBio and personal fees from Aimmune Therapeutics outside of the submitted work. Dr Pongracic reported receiving nonfinancial support and grants from DBV Technologies during the conduct of the study and grants and nonfinancial support from Food Allergy Research and Education; grants, personal fees, and nonfinancial support from Aimmune Therapeutics; personal fees and nonfinancial support from DBV Technologies; and nonfinancial support from Genentech/Novartis outside the submitted work. Dr Jones reported receiving personal fees from Food Allergy Research and Education, Aimmune Therapeutics, and EMMES Corporation and grants from DBV Technologies, Aimmune Therapeutics, Astellas Inc, Food Allergy Research and Education, and the NIAID outside the submitted work. Dr Lange reported receiving grants from DBV Technologies during the conduct of the study. Dr Wood reported receiving grants from the NIH and DBV Technologies during the conduct of the study and grants from Aimmune Therapeutics, Astellas, HAL Allergy, Sanofi, and Regeneron outside of the submitted work. Dr Prescott reported receiving personal fees from Sanofi Allergic Rhinitis Project Group, Swisse Scientific Advisory Panel, Danone Scientific Advisory Board, and Bayer Advisory board on micronutrients outside the submitted work. Dr Yang reported receiving grants from DBV Technologies during the conduct of the study and received grants from Aimmune Therapeutics, Shire, BioCryst, Novartis, CSL Behring, GlaxoSmithKline, AstraZeneca, Regeneron, Sanofi/Genzyme, Galderma, Pfizer, Genentech/Roche, Leo Pharma, Pharming, Stallergenes, and AnaptysBio and personal fees from Novartis, Shire, CSL Behring, and BioCryst outside the submitted work. Dr Chan reported receiving grants from DBV Technologies during the conduct of the study and personal fees from Pfizer and Aralez Pharmaceuticals and prior stock ownership in Aimmune Therapeutics outside the submitted work. Dr Assa’ad reported receiving grants from DBV Technologies during the conduct of the study and grants from Aimmune and Astellas outside the submitted work. Dr Assa’ad also had a patent to US 7,732,135 B2 issued, licensed, and with royalties paid. Dr Bird reported receiving grants and personal fees from DBV Technologies during the conduct of the study and personal fees and nonfinancial support from Food Allergy Research and Education and American College of Allergy, Asthma, and Immunology; grants from Nestle Health Sciences; personal fees from Nutricia North America, Foresite Capital Management, Medscape, Pfizer, and Pharm-Olam International LTD; grants, personal fees, and nonfinancial support from Aimmune Therapeutics; and other funding (meals) from Kaleo, Genentech, and GlaxoSmithKline outside the submitted work. Dr Kim reported receiving personal fees from DBV Technologies and Aimmune Therapeutics; nonfinancial support from Astellas Pharma, HAL Allergy; and grants from Food and Allergy Research and Education, the NIH, and the Wallace Foundation; and other funding from CSL Behring and Shire North American Group outside the submitted work and is a member of the clinical medical advisory board for DBV Technologies. Dr Schneider reported receiving grants from DBV Technologies during the conduct of the study; serving on the adjudication committee for Aimmune and receiving grants from Genentech and personal fees from Food Allergy Research and Education outside the submitted work. Dr Davis reported receiving grants from DBV Technologies during the conduct of the study and grants from the NIH, Aimmune Therapeutics, Regeneron, Mylan, Thermo Fisher, and Phadia; personal fees from DBV Technologies, Aimmune Therapeutics, Moonlight Therapeutics, and Food Allergy Research and Education; and other funding (contract) from Nutricia North America outside the submitted work. Dr Lanser reported receiving grants from DBV Technologies during the conduct of the study and personal fees from Mylan; grants and personal fees from Aimmune Therapeutics; and grants from the NIAID-sponsored Consortium for Food Allergy Research outside the submitted work. Dr Shreffler reported receiving personal fees and research funding from DBV Technologies during the conduct of the study and grants from Sanofi, the NIH, and Food Allergy Research and Education and personal fees from Aimmune Therapeutics scientific advisory board. Dr Green and Mr Lambert are employees of DBV Technologies. No other disclosures were reported.

Funding/Support: The study was sponsored by DBV Technologies and conducted under an Investigational New Drug application to the US FDA and Clinical Trial Approvals in Canada and European countries.

Role of the Funder/Sponsor: DBV Technologies was involved in the design and general oversight of the study but not in the collection and management of the data; analysis and interpretation of the data included contributions from DBV Technologies–employed and –contracted statisticians; and nonauthor contributors from DBV Technologies were involved in the preparation, review, approval, and decision to submit the manuscript for publication. DBV Technologies did not have the right or ability to veto the authors’ final decision to submit the manuscript for publication. All data were collected electronically, managed, analyzed, and locked by the contract research organization (Parexel International) prior to being released to the authors. An independent data and safety monitoring board oversaw the study conduct and reviewed blinded and unblinded adverse event data (Supplement 1). In addition, checks of data integrity were performed by DBV Technologies, which included site visits and site audits, as well as contract research organization oversight.

Meeting Presentations: This study was presented at the 2018 American Academy of Asthma, Allergy, & Immunology/World Allergy Organization Joint Congress, March 2-5, 2018, Orlando, Florida; the American College of Allergy, Asthma, and Immunology Annual Scientific Meeting, November 15-19, 2018, Seattle, Washington; the Food Allergy and Anaphylaxis Meeting, October 18-20, 2018, Copenhagen, Denmark; and the European Academy of Allergy and Clinical Immunology Congress, May 26-30, 2018, Munich, Germany.

Additional Contributions: Wenceslas Agbotounou, PhD, MBA, Pierre-Henri Benhamou, MD, and Laurent Martin, PharmD, MBA, were involved in the concept and design of the study and were compensated employees of DBV Technologies. Jean-Michel Germain, PhD, and Robin Mukherjee, PhD, were responsible for compilation of the manuscript and interpretation of data, and they were compensated employees of DBV Technologies. Courtney Evans, MA, Hannah Gilbert, MS, and Caitlin Clohessy, BA, of Children’s Hospital Colorado provided clinical research coordination and were not compensated. Tamara Griffin, BS, Melissa Westcott, BS, RN, CPN, and Nicole Hall, BS, RN, of Children’s Hospital Colorado provided clinical nursing support, and Lisa Hiers, MSN, Elizabeth Whitbeck, CPNP, and Jessica Moore, CPNP, of Children’s Hospital Colorado, University of Colorado Denver School of Medicine, provided subinvestigator support and were not compensated. Michael O’Sullivan, MBBS, FRACP, FRCPA, of University of Western Australia School of Paediatrics and Child Health, provided clinical support and was not compensated. Kate Bonehill, MBBS, Jody Thomson, NP, Richard Triggs, MBBS, Andrea Coe, and Clare Mahon, BAS, of Allergy Medical, Brisbane, Australia, contributed administrative and participant and/or ethical support and were compensated. Jennifer Connolly, RN, and June Considine, RN, of University College Cork, contributed clinical support and were compensated. Elizabeth Burke-Roberts, RN, MSN, NP-C, CCRN, and Tiffany Wang, MD, of Boston Children’s Hospital, provided patient care support and/or research assistance and were compensated. Andrew MacGinnitie, MD, PhD, of Boston Children’s Hospital, provided subinvestigator and patient care support, and was compensated. Hazelyn Torres, RPN, of Ottawa Allergy Research Corporation, provided data collection and material support and was compensated. Nicole Lee, MSc, Christopher Mill, MPH, Kelly Morrison, BScN, Linda Pringle, RN, BScN, and Tiffany Wong, MD, of British Columbia Children’s Hospital Research Hospital Institute, obtained data and provided material support and were not compensated. Lianne Soller, PhD, University of British Columbia, obtained data and provided material support and was compensated. Ingrid Baerg, RN, BSN, of British Columbia Children’s Hospital Research Hospital Institute, provided research nursing support and was compensated. Linette Milkovich, RN, and Susan Richey, BS, of Children’s Hospital of Pittsburgh of UPMC, provided research coordination and were not compensated. Kerstin Killer, MSc, Hélène Leroux, Dt. P, and Isabelle Boisvert of CHU Sainte-Justine, provided clinical research coordination and were compensated. Marie-Eve Lavergne, RN, Maryse Thibeault, RN, and Mélanie Desjardins, RN, of CHU Sainte-Justine, were research nurses and were compensated. Anne Des Roches, MD, Louis Paradis, MD, Kathryn Samaan, MD, FRCPC, Jonathan Lacombe-Barrios, MD, and François Graham, MD, MSc, FRCPC, of CHU Sainte-Justine, were coinvestigators and were not compensated. Administrative, technical, and material support was provided by Jo-Ann Elicia West, MSc, from Altizem, Boulogne, France, who was compensated. Editorial support was provided by IMPRINT Science, New York, New York, and was funded by DBV Technologies. Parexel International was the compensated contract research organization for the trial and was also responsible for monitoring all investigational sites, which included ensuring completeness and accuracy of data entries in the case report forms compared with participants’ source documents and adherence to compliance, good clinical practices, and applicable regulatory requirements. Parexel International was responsible for data management and statistical analyses, which included standard edit checks for data accuracy and consistency, as well as production of statistical outputs.

Data Sharing Statement: See Supplement 4.

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