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

David M. Fleischer; Wayne G. Shreffler; Dianne E. Campbell; Todd D. Green; Sara Anvari; Amal Assa'ad; Philippe Bégin; Kirsten Beyer; J. Andrew Bird; Terri Brown-Whitehorn; Aideen Byrne; Edmond S. Chan; Amarjit Cheema; Sharon Chinthrajah; Hey Jin Chong; Carla M. Davis; Lara S. Ford; Rémi Gagnon; Matthew Greenhawt; Jonathan O.B. Hourihane; Stacie M. Jones; Edwin H. Kim; Lars Lange; Bruce J. Lanser; Stephanie Leonard; Vera Mahler; Andreas Maronna; Anna Nowak-Wegrzyn; Roxanne C. Oriel; Michael O'Sullivan; Daniel Petroni; Jacqueline A. Pongracic; Susan L. Prescott; Lynda C. Schneider; Peter Smith; Doris Staab; Gordon Sussman; Robert Wood; William H. Yang; Romain Lambert; Aurélie Peillon; Timothée Bois; Hugh A. Sampson

doi:10.1016/j.jaci.2020.06.028

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

David M. Fleischer^*, Wayne G. Shreffler, Dianne E. Campbell, Todd D. Green, Sara Anvari, Amal Assa'ad, Philippe Bégin, Kirsten Beyer, J. Andrew Bird, Terri Brown-Whitehorn, Aideen Byrne, Edmond S. Chan, Amarjit Cheema, Sharon Chinthrajah, Hey Jin Chong, Carla M. Davis, Lara S. Ford, Rémi Gagnon, Matthew Greenhawt, Jonathan O.B. HourihaneStacie M. Jones, Edwin H. Kim, Lars Lange, Bruce J. Lanser, Stephanie Leonard, Vera Mahler, Andreas Maronna, Anna Nowak-Wegrzyn, Roxanne C. Oriel, Michael O'Sullivan, Daniel Petroni, Jacqueline A. Pongracic, Susan L. Prescott, Lynda C. Schneider, Peter Smith, Doris Staab, Gordon Sussman, Robert Wood, William H. Yang, Romain Lambert, Aurélie Peillon, Timothée Bois, Hugh A. Sampson

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

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.

Original language	English (US)
Pages (from-to)	863-874
Number of pages	12
Journal	Journal of Allergy and Clinical Immunology
Volume	146
Issue number	4
DOIs	https://doi.org/10.1016/j.jaci.2020.06.028
State	Published - Oct 2020
Externally published	Yes

Keywords

EPIT
Peanut allergy
desensitization
eliciting dose
epicutaneous immunotherapy
food allergy
immunotherapy
sustained unresponsiveness

ASJC Scopus subject areas

Immunology and Allergy
Immunology

Access to Document

10.1016/j.jaci.2020.06.028

Cite this

Fleischer, D. M., Shreffler, W. G., Campbell, D. E., Green, T. D., Anvari, S., Assa'ad, A., Bégin, P., Beyer, K., Bird, J. A., Brown-Whitehorn, T., Byrne, A., Chan, E. S., Cheema, A., Chinthrajah, S., Chong, H. J., Davis, C. M., Ford, L. S., Gagnon, R., Greenhawt, M., ... 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, 146(4), 863-874. https://doi.org/10.1016/j.jaci.2020.06.028

@article{a4fd240178bc49db80896ad654b19a7b,

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

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.",

keywords = "EPIT, Peanut allergy, desensitization, eliciting dose, epicutaneous immunotherapy, food allergy, immunotherapy, sustained unresponsiveness",

author = "Fleischer, {David M.} and Shreffler, {Wayne G.} and Campbell, {Dianne E.} and Green, {Todd D.} and Sara Anvari and Amal Assa'ad and Philippe B{\'e}gin and Kirsten Beyer and Bird, {J. Andrew} and Terri Brown-Whitehorn and Aideen Byrne and Chan, {Edmond S.} and Amarjit Cheema and Sharon Chinthrajah and Chong, {Hey Jin} and Davis, {Carla M.} and Ford, {Lara S.} and R{\'e}mi Gagnon and Matthew Greenhawt and Hourihane, {Jonathan O.B.} and Jones, {Stacie M.} and Kim, {Edwin H.} and Lars Lange and Lanser, {Bruce J.} and Stephanie Leonard and Vera Mahler and Andreas Maronna and Anna Nowak-Wegrzyn and Oriel, {Roxanne C.} and Michael O'Sullivan and Daniel Petroni and Pongracic, {Jacqueline A.} and Prescott, {Susan L.} and Schneider, {Lynda C.} and Peter Smith and Doris Staab and Gordon Sussman and Robert Wood and Yang, {William H.} and Romain Lambert and Aur{\'e}lie Peillon and Timoth{\'e}e Bois and Sampson, {Hugh A.}",

note = "Funding Information: The study was sponsored by DBV Technologies. Disclosure of potential conflict of interest: Todd D. Green, Romain Lambert, Aur?lie Peillon, and Timoth?e Bois are employees of DBV Technologies. Dianne E. Campbell is a part-time employee of DBV Technologies and reported receiving grant support from National Health and Medical Research Council of Australia and personal fees from Allergenis, Westmead Fertility Centre, and Financial Markets Foundation for Children. Hugh A. Sampson is a part-time employee of DBV Technologies and reported receiving consultancy fees from N-Fold Therapeutics, grant funding from the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID), and royalties from Elsevier. Sara Anvari reported receiving grants from DBV Technologies during the conduct of the study and grants from the US NIAID and Aimmune Therapeutics outside of the submitted work. Amal Assa'ad reported receiving research grants from Aimmune, DBV Technologies, Astellas, Sanofi, and Regeneron. Philippe B?gin 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. Kirsten Beyer reported receiving grants from DBV Technologies during the conduct of the study; outside the submitted work she reported grants and personal fees from Aimmune Therapeutics and ALK-Abell?, as well as personal fees from Allergopharma, Bencard, DBV Technologies, and Mabylon AG. J. Andrew Bird reported receiving grants from DBV Technologies related to this submission and personal fees from DBV Technologies outside of the submitted work; the following potential conflicts of interest are outside of the submitted work: grants, personal fees, and nonfinancial support from Aimmune Therapeutics, personal fees from Food Allergy Research and Education, personal fees and nonfinancial support from American College of Allergy, Asthma and Immunology, grants from Nestle Health Sciences, personal fees from Nutricia North America, personal fees from Pharm-Olam International LTD, personal fees and other from Pfizer Pharmaceuticals, personal fees from Prota Therapeutics, personal fees from Allergy Therapeutics, Ltd, grants from NIH-NIAID, grants from Novartis, personal fees from AllerGenis, personal fees from Abbott Nutrition International. Terri Brown-Whitehorn reported receiving grants and personal fees from DBV Technologies. Edmond S. Chan has received research support from DBV Technologies, has been a member of advisory boards for Pfizer, Pediapharm, Leo Pharma, Kaleo, DBV, is a member of the health care advisory board for Food Allergy Canada, was an expert panel and coordinating committee member of the NIAID-sponsored Guidelines for Peanut Allergy Prevention, and is co-lead of the Canadian Society of Allergy and Clinical Immunity oral immunotherapy guidelines. Sharon Chinthrajah received grants from NIAID, Consortium of Food Allergy Research, Aimmune, DBV Technologies, Astellas, AnaptysBio, Novartis, and Regeneron and personal fees from Novartis, Genentech, Allergenis, Before Brands, and Alladapt. Hey Jin Chong reported receiving consultancy fees from Horizon. Carla M. Davis reported research contract funding from DBV Technologies, Regeneron Pharmaceuticals, and Aimmune Therapeutics, and she is a consultant for Moonlight Therapeutics. David M. Fleischer reported receiving research support to his institution from DBV Technologies and Aimmune Therapeutics; served on the clinical medical advisory board with DBV Technologies; served as a consultant for DBV Technologies, AllerGenis, Aquestive Therapeutics, Aravax, Genentech, Nasus, and Intrommune Therapeutics; received honorarium for lectures from DBV Technologies; and received royalties from UpToDate. Matthew Greenhawt reported grant support (5K08HS024599-02) from the Agency for Healthcare Research and Quality; serving as an expert panel and coordinating committee member of the NIAID-sponsored Guidelines for Peanut Allergy Prevention; has served as a consultant for the Canadian Transportation Agency, Thermo Fisher, Intrommune, and Aimmune Therapeutics; serving as a member of physician/medical advisory boards for Aimmune Therapeutics, DBV Technologies, Sanofi/Genzyme, Genentech, GlaxoSmithKline, Nutricia, Kal?o Pharmaceutical, Nestl?, Aquestive Therapeutics, Allergy Therapeutics, AllerGenis, Aravax, Prota Therapeutics, and Monsanto; serving as a member of the scientific advisory council for the National Peanut Board; received honorarium for lectures from Thermo Fisher, Aimmune Therapeutics, DBV Technologies, BEFORE Brands, multiple state allergy societies, the American College of Allergy, Asthma and Immunology, the European Academy of Allergy and Clinical Immunology; serving as an associate editor for the Annals of Allergy, Asthma & Immunology; and serving as a member of the Joint Taskforce on Allergy Practice Parameters. Jonathan O'B. Hourihane reported receiving research funding and consultancy fees from Aimmune Corporation, and research funding from Johnson & Johnson. Stacie M. Jones reported serving as a member of the Research Advisory Board for Food Allergy Research and Education (FARE) and Scientific Advisory Board for Aimmune Therapeutics and receiving consultation fees for US Food and Drug Advisory Committee for Aimmune Therapeutics; grant funding from NIAID Consortium for Food Allergy Research and Immune Tolerance Network; and clinical trials funding from Aimmune Therapeutics, DBV Technologies, Genentech, Regeneron, Sanofi, and Astellas, Inc. Edwin H. Kim reported clinical medical advisory board membership with DBV Technologies; consultancy with Aimmune Therapeutics, DBV Technologies, AllerGenis, Allakos, Ukko, and Vibrant America; and receiving grant support to his institution from the NIH/NIAID, National Center for Complementary and Integrative Health, FARE, and the Wallace Research Foundation. Lars Lange reported receiving consulting and lecturer fees from DBV Technologies. Bruce J. Lanser reported grants and personal fees from Aimmune Therapeutics; grants from DBV Technologies and Regeneron; personal fees from Allergenis, Hycor, GlaxoSmithKline (GSK), and Genentech, outside the submitted work; and serving as a member of the NIH/NIAID-sponsored Consortium of Food Allergy Research. Stephanie Leonard reported receiving grants from DBV Technologies and Aimmune Therapeutics; grants and personal fees as a member of the medical advisory board of FARE; and consulting fees for work with LabCorp outside the submitted work. Vera Mahler became an employee of the Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany, after participation as investigator in the trial; measures are in place for unbiased marketing authorization procedures. Anna Nowak-Wegrzyn reported receiving research grants from DBV Technologies, Astellas Pharma, NIH/NIAID Immune Tolerance Network, and Nutricia Danone; serving as a member of the Data Monitoring Committee for the clinical trials of dupilumab for peanut allergy and has served on the advisory board for Genentech regarding omalizumab for food allergy as mono or combined therapy; authored topics for UpToDate; and serving as the deputy editor for the Annals of Allergy, Asthma and Immunology. Daniel 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. Susan L. Prescott reported receiving research grants from DBV Technologies related to this submission; outside the submitted work she received speaker fees from Danone Nutricia and Swisse and consultancy fees from Bayer and Sanofi. Jacqueline A. Pongracic reported receiving research funding from DBV Technologies and Aimmune Therapeutics and honorarium from Medscape, and participating on the independent data monitoring committee for Regeneron and clinical advisory boards for FARE. Lynda C. Schneider reported serving as a researcher or consultant for DBV Technologies, Regeneron Pharmaceuticals, Pfizer, AbbVie, and Aimmune and receiving funding for an investigator-initiated study from Genentech. Wayne G. Shreffler reported receiving personal fees and research funding from DBV Technologies during the conduct of the study and grants from Sanofi, the NIH, and FARE and personal fees from Aimmune Therapeutics for serving on the scientific advisory board. Gordon Sussman reported serving as an advisory board member for Novartis, Aralez, CSL Behring, and Sanofi; receiving grant or honorarium from Novartis, Aralez, Pediapharm, GSK, Genentech, DBV Technologies, Aimmune, CSL Behring, AstraZeneca, Stallergenes, Merck, Pfizer, Dyax, Biocryst, Greencross, Kendrion, Shire, Leopharma, Regeneron, and mdBriefCase; and participating in clinical trials (principal investigator) for Novartis, GSK, Genentech, DBV Technologies, Aimmune, CSL Behring, AstraZeneca, Stallergenes, Merck, Pfizer, Dyax, Biocryst, Greencross, Kendrion, Leo Pharma, Regeneron, Sanofi, Blueprint, ALK-Abell?, Amgen, and Cliantha. Robert Wood reported receiving grants from the NIH, DBV Technologies, Aimmune Therapeutics, Astellas, HAL Allergy, Sanofi, and Regeneron. William H. Yang reported receiving speaker fees from CSL Behring, Takeda (Shire), Novartis, Merck, and AstraZeneca; being a member of the advisory board for CSL Behring, Takeda (Shire), Novartis, Sanofi, Merck, and AstraZeneca; receiving research grants from CSL Behring, Takeda (Shire), Pharming, BioCryst, Novartis, Regeneron, Glenmark, AnaptysBio, Dermira, Genentec, Galderma, Pfizer, and Roche. The rest of the authors declare that they have no relevant conflicts of interest. Publisher Copyright: {\textcopyright} 2020 The Authors",

year = "2020",

month = oct,

doi = "10.1016/j.jaci.2020.06.028",

language = "English (US)",

volume = "146",

pages = "863--874",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Mosby Inc.",

number = "4",

}

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, JOB, 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, '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, vol. 146, no. 4, pp. 863-874. https://doi.org/10.1016/j.jaci.2020.06.028

Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children : PEOPLE 3-year results. / Fleischer, David M.; Shreffler, Wayne G.; Campbell, Dianne E. et al.

In: Journal of Allergy and Clinical Immunology, Vol. 146, No. 4, 10.2020, p. 863-874.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children

T2 - PEOPLE 3-year results

AU - Fleischer, David M.

AU - Shreffler, Wayne G.

AU - Campbell, Dianne E.

AU - Green, Todd D.

AU - Anvari, Sara

AU - Assa'ad, Amal

AU - Bégin, Philippe

AU - Beyer, Kirsten

AU - Bird, J. Andrew

AU - Brown-Whitehorn, Terri

AU - Byrne, Aideen

AU - Chan, Edmond S.

AU - Cheema, Amarjit

AU - Chinthrajah, Sharon

AU - Chong, Hey Jin

AU - Davis, Carla M.

AU - Ford, Lara S.

AU - Gagnon, Rémi

AU - Greenhawt, Matthew

AU - Hourihane, Jonathan O.B.

AU - Jones, Stacie M.

AU - Kim, Edwin H.

AU - Lange, Lars

AU - Lanser, Bruce J.

AU - Leonard, Stephanie

AU - Mahler, Vera

AU - Maronna, Andreas

AU - Nowak-Wegrzyn, Anna

AU - Oriel, Roxanne C.

AU - O'Sullivan, Michael

AU - Petroni, Daniel

AU - Pongracic, Jacqueline A.

AU - Prescott, Susan L.

AU - Schneider, Lynda C.

AU - Smith, Peter

AU - Staab, Doris

AU - Sussman, Gordon

AU - Wood, Robert

AU - Yang, William H.

AU - Lambert, Romain

AU - Peillon, Aurélie

AU - Bois, Timothée

AU - Sampson, Hugh A.

N1 - Funding Information: The study was sponsored by DBV Technologies. Disclosure of potential conflict of interest: Todd D. Green, Romain Lambert, Aur?lie Peillon, and Timoth?e Bois are employees of DBV Technologies. Dianne E. Campbell is a part-time employee of DBV Technologies and reported receiving grant support from National Health and Medical Research Council of Australia and personal fees from Allergenis, Westmead Fertility Centre, and Financial Markets Foundation for Children. Hugh A. Sampson is a part-time employee of DBV Technologies and reported receiving consultancy fees from N-Fold Therapeutics, grant funding from the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID), and royalties from Elsevier. Sara Anvari reported receiving grants from DBV Technologies during the conduct of the study and grants from the US NIAID and Aimmune Therapeutics outside of the submitted work. Amal Assa'ad reported receiving research grants from Aimmune, DBV Technologies, Astellas, Sanofi, and Regeneron. Philippe B?gin 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. Kirsten Beyer reported receiving grants from DBV Technologies during the conduct of the study; outside the submitted work she reported grants and personal fees from Aimmune Therapeutics and ALK-Abell?, as well as personal fees from Allergopharma, Bencard, DBV Technologies, and Mabylon AG. J. Andrew Bird reported receiving grants from DBV Technologies related to this submission and personal fees from DBV Technologies outside of the submitted work; the following potential conflicts of interest are outside of the submitted work: grants, personal fees, and nonfinancial support from Aimmune Therapeutics, personal fees from Food Allergy Research and Education, personal fees and nonfinancial support from American College of Allergy, Asthma and Immunology, grants from Nestle Health Sciences, personal fees from Nutricia North America, personal fees from Pharm-Olam International LTD, personal fees and other from Pfizer Pharmaceuticals, personal fees from Prota Therapeutics, personal fees from Allergy Therapeutics, Ltd, grants from NIH-NIAID, grants from Novartis, personal fees from AllerGenis, personal fees from Abbott Nutrition International. Terri Brown-Whitehorn reported receiving grants and personal fees from DBV Technologies. Edmond S. Chan has received research support from DBV Technologies, has been a member of advisory boards for Pfizer, Pediapharm, Leo Pharma, Kaleo, DBV, is a member of the health care advisory board for Food Allergy Canada, was an expert panel and coordinating committee member of the NIAID-sponsored Guidelines for Peanut Allergy Prevention, and is co-lead of the Canadian Society of Allergy and Clinical Immunity oral immunotherapy guidelines. Sharon Chinthrajah received grants from NIAID, Consortium of Food Allergy Research, Aimmune, DBV Technologies, Astellas, AnaptysBio, Novartis, and Regeneron and personal fees from Novartis, Genentech, Allergenis, Before Brands, and Alladapt. Hey Jin Chong reported receiving consultancy fees from Horizon. Carla M. Davis reported research contract funding from DBV Technologies, Regeneron Pharmaceuticals, and Aimmune Therapeutics, and she is a consultant for Moonlight Therapeutics. David M. Fleischer reported receiving research support to his institution from DBV Technologies and Aimmune Therapeutics; served on the clinical medical advisory board with DBV Technologies; served as a consultant for DBV Technologies, AllerGenis, Aquestive Therapeutics, Aravax, Genentech, Nasus, and Intrommune Therapeutics; received honorarium for lectures from DBV Technologies; and received royalties from UpToDate. Matthew Greenhawt reported grant support (5K08HS024599-02) from the Agency for Healthcare Research and Quality; serving as an expert panel and coordinating committee member of the NIAID-sponsored Guidelines for Peanut Allergy Prevention; has served as a consultant for the Canadian Transportation Agency, Thermo Fisher, Intrommune, and Aimmune Therapeutics; serving as a member of physician/medical advisory boards for Aimmune Therapeutics, DBV Technologies, Sanofi/Genzyme, Genentech, GlaxoSmithKline, Nutricia, Kal?o Pharmaceutical, Nestl?, Aquestive Therapeutics, Allergy Therapeutics, AllerGenis, Aravax, Prota Therapeutics, and Monsanto; serving as a member of the scientific advisory council for the National Peanut Board; received honorarium for lectures from Thermo Fisher, Aimmune Therapeutics, DBV Technologies, BEFORE Brands, multiple state allergy societies, the American College of Allergy, Asthma and Immunology, the European Academy of Allergy and Clinical Immunology; serving as an associate editor for the Annals of Allergy, Asthma & Immunology; and serving as a member of the Joint Taskforce on Allergy Practice Parameters. Jonathan O'B. Hourihane reported receiving research funding and consultancy fees from Aimmune Corporation, and research funding from Johnson & Johnson. Stacie M. Jones reported serving as a member of the Research Advisory Board for Food Allergy Research and Education (FARE) and Scientific Advisory Board for Aimmune Therapeutics and receiving consultation fees for US Food and Drug Advisory Committee for Aimmune Therapeutics; grant funding from NIAID Consortium for Food Allergy Research and Immune Tolerance Network; and clinical trials funding from Aimmune Therapeutics, DBV Technologies, Genentech, Regeneron, Sanofi, and Astellas, Inc. Edwin H. Kim reported clinical medical advisory board membership with DBV Technologies; consultancy with Aimmune Therapeutics, DBV Technologies, AllerGenis, Allakos, Ukko, and Vibrant America; and receiving grant support to his institution from the NIH/NIAID, National Center for Complementary and Integrative Health, FARE, and the Wallace Research Foundation. Lars Lange reported receiving consulting and lecturer fees from DBV Technologies. Bruce J. Lanser reported grants and personal fees from Aimmune Therapeutics; grants from DBV Technologies and Regeneron; personal fees from Allergenis, Hycor, GlaxoSmithKline (GSK), and Genentech, outside the submitted work; and serving as a member of the NIH/NIAID-sponsored Consortium of Food Allergy Research. Stephanie Leonard reported receiving grants from DBV Technologies and Aimmune Therapeutics; grants and personal fees as a member of the medical advisory board of FARE; and consulting fees for work with LabCorp outside the submitted work. Vera Mahler became an employee of the Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Langen, Germany, after participation as investigator in the trial; measures are in place for unbiased marketing authorization procedures. Anna Nowak-Wegrzyn reported receiving research grants from DBV Technologies, Astellas Pharma, NIH/NIAID Immune Tolerance Network, and Nutricia Danone; serving as a member of the Data Monitoring Committee for the clinical trials of dupilumab for peanut allergy and has served on the advisory board for Genentech regarding omalizumab for food allergy as mono or combined therapy; authored topics for UpToDate; and serving as the deputy editor for the Annals of Allergy, Asthma and Immunology. Daniel 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. Susan L. Prescott reported receiving research grants from DBV Technologies related to this submission; outside the submitted work she received speaker fees from Danone Nutricia and Swisse and consultancy fees from Bayer and Sanofi. Jacqueline A. Pongracic reported receiving research funding from DBV Technologies and Aimmune Therapeutics and honorarium from Medscape, and participating on the independent data monitoring committee for Regeneron and clinical advisory boards for FARE. Lynda C. Schneider reported serving as a researcher or consultant for DBV Technologies, Regeneron Pharmaceuticals, Pfizer, AbbVie, and Aimmune and receiving funding for an investigator-initiated study from Genentech. Wayne G. Shreffler reported receiving personal fees and research funding from DBV Technologies during the conduct of the study and grants from Sanofi, the NIH, and FARE and personal fees from Aimmune Therapeutics for serving on the scientific advisory board. Gordon Sussman reported serving as an advisory board member for Novartis, Aralez, CSL Behring, and Sanofi; receiving grant or honorarium from Novartis, Aralez, Pediapharm, GSK, Genentech, DBV Technologies, Aimmune, CSL Behring, AstraZeneca, Stallergenes, Merck, Pfizer, Dyax, Biocryst, Greencross, Kendrion, Shire, Leopharma, Regeneron, and mdBriefCase; and participating in clinical trials (principal investigator) for Novartis, GSK, Genentech, DBV Technologies, Aimmune, CSL Behring, AstraZeneca, Stallergenes, Merck, Pfizer, Dyax, Biocryst, Greencross, Kendrion, Leo Pharma, Regeneron, Sanofi, Blueprint, ALK-Abell?, Amgen, and Cliantha. Robert Wood reported receiving grants from the NIH, DBV Technologies, Aimmune Therapeutics, Astellas, HAL Allergy, Sanofi, and Regeneron. William H. Yang reported receiving speaker fees from CSL Behring, Takeda (Shire), Novartis, Merck, and AstraZeneca; being a member of the advisory board for CSL Behring, Takeda (Shire), Novartis, Sanofi, Merck, and AstraZeneca; receiving research grants from CSL Behring, Takeda (Shire), Pharming, BioCryst, Novartis, Regeneron, Glenmark, AnaptysBio, Dermira, Genentec, Galderma, Pfizer, and Roche. The rest of the authors declare that they have no relevant conflicts of interest. Publisher Copyright: © 2020 The Authors

PY - 2020/10

Y1 - 2020/10

N2 - 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.

AB - 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.

KW - EPIT

KW - Peanut allergy

KW - desensitization

KW - eliciting dose

KW - epicutaneous immunotherapy

KW - food allergy

KW - immunotherapy

KW - sustained unresponsiveness

UR - http://www.scopus.com/inward/record.url?scp=85089355764&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85089355764&partnerID=8YFLogxK

U2 - 10.1016/j.jaci.2020.06.028

DO - 10.1016/j.jaci.2020.06.028

M3 - Article

C2 - 32659313

AN - SCOPUS:85089355764

SN - 0091-6749

VL - 146

SP - 863

EP - 874

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 4

ER -

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

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