Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

Jacqueline A. Pongracic; Rémi Gagnon; Gordon Sussman; Dareen Siri; Roxanne C. Oriel; Terri F. Brown-Whitehorn; Todd D. Green; Dianne E. Campbell; Sara Anvari; William E. Berger; J. Andrew Bird; Edmond S. Chan; Amarjit Cheema; R. Sharon Chinthrajah; Hey Jin Chong; Paul J. Dowling; Stanley M. Fineman; David M. Fleischer; Erika Gonzalez-Reyes; Edwin H. Kim; Bruce J. Lanser; Andrew MacGinnitie; Hemalini Mehta; Daniel Petroni; Ned Rupp; Lynda C. Schneider; Amy M. Scurlock; Lawrence D. Sher; Wayne G. Shreffler; Sayantani B. Sindher; Allan Stillerman; Robert Wood; William H. Yang; Timothée Bois; Hugh A. Sampson; Philippe Bégin

doi:10.1016/j.jaip.2021.11.017

Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

Jacqueline A. Pongracic^*, Rémi Gagnon, Gordon Sussman, Dareen Siri, Roxanne C. Oriel, Terri F. Brown-Whitehorn, Todd D. Green, Dianne E. Campbell, Sara Anvari, William E. Berger, J. Andrew Bird, Edmond S. Chan, Amarjit Cheema, R. Sharon Chinthrajah, Hey Jin Chong, Paul J. Dowling, Stanley M. Fineman, David M. Fleischer, Erika Gonzalez-Reyes, Edwin H. KimBruce J. Lanser, Andrew MacGinnitie, Hemalini Mehta, Daniel Petroni, Ned Rupp, Lynda C. Schneider, Amy M. Scurlock, Lawrence D. Sher, Wayne G. Shreffler, Sayantani B. Sindher, Allan Stillerman, Robert Wood, William H. Yang, Timothée Bois, Hugh A. Sampson, Philippe Bégin

^*Corresponding author for this work

Pediatrics

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

36 Scopus citations

Abstract

Background: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children. Objective: To examine the safety of VP250 in children, using a study design approximating potential real-world use. Methods: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported. Results: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis. Conclusions: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.

Original language	English (US)
Pages (from-to)	1864-1873.e10
Journal	Journal of Allergy and Clinical Immunology: In Practice
Volume	10
Issue number	7
DOIs	https://doi.org/10.1016/j.jaip.2021.11.017
State	Published - Jul 2022

Keywords

Children
Desensitization
Epicutaneous immunotherapy (EPIT)
Food allergy
Immunotherapy
Peanut allergy
Real-world setting

ASJC Scopus subject areas

Immunology and Allergy

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10.1016/j.jaip.2021.11.017

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Pongracic, J. A., Gagnon, R., Sussman, G., Siri, D., Oriel, R. C., Brown-Whitehorn, T. F., Green, T. D., Campbell, D. E., Anvari, S., Berger, W. E., Bird, J. A., Chan, E. S., Cheema, A., Chinthrajah, R. S., Chong, H. J., Dowling, P. J., Fineman, S. M., Fleischer, D. M., Gonzalez-Reyes, E., ... Bégin, P. (2022). Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results. Journal of Allergy and Clinical Immunology: In Practice, 10(7), 1864-1873.e10. https://doi.org/10.1016/j.jaip.2021.11.017

@article{73a34a8d37de4ae0a9b48e5c92ffc0cd,

title = "Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results",

abstract = "Background: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children. Objective: To examine the safety of VP250 in children, using a study design approximating potential real-world use. Methods: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported. Results: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis. Conclusions: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.",

keywords = "Children, Desensitization, Epicutaneous immunotherapy (EPIT), Food allergy, Immunotherapy, Peanut allergy, Real-world setting",

author = "Pongracic, {Jacqueline A.} and R{\'e}mi Gagnon and Gordon Sussman and Dareen Siri and Oriel, {Roxanne C.} and Brown-Whitehorn, {Terri F.} and Green, {Todd D.} and Campbell, {Dianne E.} and Sara Anvari and Berger, {William E.} and Bird, {J. Andrew} and Chan, {Edmond S.} and Amarjit Cheema and Chinthrajah, {R. Sharon} and Chong, {Hey Jin} and Dowling, {Paul J.} and Fineman, {Stanley M.} and Fleischer, {David M.} and Erika Gonzalez-Reyes and Kim, {Edwin H.} and Lanser, {Bruce J.} and Andrew MacGinnitie and Hemalini Mehta and Daniel Petroni and Ned Rupp and Schneider, {Lynda C.} and Scurlock, {Amy M.} and Sher, {Lawrence D.} and Shreffler, {Wayne G.} and Sindher, {Sayantani B.} and Allan Stillerman and Robert Wood and Yang, {William H.} and Timoth{\'e}e Bois and Sampson, {Hugh A.} and Philippe B{\'e}gin",

note = "Funding Information: This study was supported in part by UL1TR001422 from the National Center for Advancing Translational Sciences and National Institutes of Health (NIH). 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.Conflicts of interest: S. Anvari received grants from DBV Technologies during the conduct of the study and grants from the US National Institute of Allergy and Infectious Diseases (NIAID) and Aimmune Therapeutics outside of the submitted work. P. B{\'e}gin reports personal fees from Novartis, Pfizer, Sanofi, ALK, and Aralez, as well as grants from DBV Technologies related to the submitted work and grants from Regeneron and Sanofi outside the submitted work. W. E. Berger is the Medical Director and National Spokesperson for Allergy and Asthma Network. J. A. Bird reports research support from DBV Technologies during the conduct of this study, research support from National Institutes of Health (NIH)-NIAID, Genentech, Astellas, Aimmune Therapeutics, DBV Technologies, and Food Allergy Research and Education (FARE) outside the submitted work, and consulting fees from FARE, Pharm-Olam International Ltd, Pfizer Pharmaceuticals, Aimmune Therapeutics, Prota Therapeutics, Allergy Therapeutics, Ltd, AllerGenis, Abbott Nutrition International, DBV Technologies, and Novartis. T. F. Brown-Whitehorn reported receiving grants and personal fees from DBV Technologies. D. 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. E. S. Chan has received research support from DBV Technologies; has been a member of advisory boards for Pfizer, Pediapharm, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi Genzyme, Bausch Health, and Avir Pharma; is a member of the health care advisory board for Food Allergy Canada; and was colead of the CSACI oral immunotherapy guidelines. A. Cheema reports receiving grants for clinical research from Merck, AstraZeneca, Novartis, GSK, Amgen, Sanofi, DBV Technologies, and Aimmune Therapeutics, as well as consulting fees/honoraria for participation in speaker bureaus and advisory boards from ALK-Abell{\'o}, GSK, AstraZeneca, and Merc. R. S. Chinthrajah reports grants from NIAID, Consortium for Food Allergy Research (CoFAR), Aimmune Therapeutics, DBV Technologies, Astellas, and Regeneron; and is an advisory member for Alladapt, Genentech, Novartis, and Sanofi. H. J. Chong reports receiving consultancy fees from Horizon. P. J. Dowling has presently or in the recent past conducted clinical research with the following companies: Merck, Aimmune Therapeutics, Sanofi, and DBV Technologies. S. M. Fineman has participated in research for Aimmune Therapeutics, DBV Technologies, and BioCryst, and has participated on speaker bureaus for Takeda. D. M. Fleischer received research support to his institution from Aimmune Therapeutics and DBV Technologies; is a member of Medical Advisory Board for the Food Allergy & Anaphylaxis Connection Team, Medical Advisory Council for the National Peanut Board, the Adverse Reactions to Food Committee (former chair 2017-2019) for the American Academy of Allergy, Asthma & Immunology, and Food Allergy Committee for the American College of Allergy, Asthma and Immunology; has received royalties from UpToDate; and is a consultant to AllerGenis, Aquestive, Aravax, Danone, DBV Technologies, Genentech, Intrommune, Nasus, and Nurture Inc (Happy Family Organics). T. D. Green and T. Bois are employees of DBV Technologies. E. H. Kim reports personal fees from DBV Technologies, Aimmune Therapeutics, AllerGenis, Ukko Inc, Vibrant America, Allakos, Kenota Health, and Duke Clinical Research Institute, and grants from FARE and Wallace Research Foundation outside the submitted work. B. J. Lanser reports grants and personal fees from Aimmune Therapeutics, grants from DBV Technologies and Regeneron, personal fees from Allergenis, Hycor, GSK, and Genentech, and is a member of the NIH/NIAID-sponsored CoFAR. J. A. Pongracic reports receiving research funding from DBV Technologies and Aimmune Therapeutics and honorarium from Medscape, consulting fees from DBV Technologies, and participating in advisory boards for DBV Technologies and Regeneron and clinical advisory boards for FARE. H. A. Sampson receives consulting fees from DBV Technologies, Siolta Therapeutics, and N-Fold Therapeutics, and received stock options from DBV Technologies. L. C. Schneider reports grants from DBV Technologies, Genentech, and Aimmune Therapeutics during the conduct of the study; personal fees from FARE Medical Advisory Board and Abbvie; and grants from Regeneron Pharmaceuticals outside the submitted work. A. M. Scurlock reports grant support to her institution from NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and FARE. She reports clinical medical advisory board membership with DBV Technologies. W. 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 scientific advisory board. S. B. Sindher receives grants from NIAID, CoFAR, Regeneron, DBV Technologies, Aimmune Therapeutics, Novartis, and Sanofi. G. Sussman is an advisory board member for Novartis, Aralez, CSL Behring, and Sanofi; he reports 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 has participated in clinical trials (PI) for Novartis, GSK, Genentech, DBV Technologies, Aimmune, CSL Behring, Astrazeneca, Stallergenes, Merck, Pfizer, Dyax, Biocryst, Greencross, Kendrion, Leo Pharma, Regeneron, Sanofi, Blueprint, ALK, Amgen, and Cliantha. R. Wood reported receiving grants from the NIH, DBV Technologies, Aimmune Therapeutics, Astellas, HAL Allergy, Sanofi, and Regeneron. W. H. Yang has received fees for CHE from CSL Behring, Shire/Takeda, Sanofi, Novartis, Merck, and AstraZeneca; has received fees for advisory boards from CSL Behring, BioCryst, Shire/Takeda, Pharming, Novartis, Sanofi/Genzyme, and Merck; and has received research grants from CSL Behring, Shire/Takeda, BioCryst, Pharming, Pharvaris, Sanofi, Novartis, GSK, Regeneron, Galderma, Glenmark, Dermira, Amgen, AnaptysBio, AstraZeneca, DBV Technologies, Aimmune Therapeutics, EliLily, Genentec, Roche, and Pfizer. E. Gonzalez-Reyes has participated in the speaker bureau for Teva Pharmaceuticals (Digihaler Technology [2021-present]). A. MacGinnitie has been a consultant for DBV Technologies and received grant support (through his institution) from DBV Technologies, Novartis, and Aimmune Therapeutics. D. Petroni has participated in the speaker bureau for AstraZeneca and has been a consultant for HollisterStier. N. Rupp received funding from DBV Technologies, the sponsor, as remuneration for his participation as principal investigator carrying out duties defined by the clinical trial protocol for the REAL LIfe Use and Safety of EPIT (REALISE) trial; is active in the conduction of clinical trials with a number of different sponsors across multiple indications; and has received funding for his services on the speaker panel for dupilumab as sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. D. Siri is the owner, CEO/CMO, of Midwest Allergy Sinus Asthma Food Allergy Center for Treatment; has been a consultant for Aimmune Therapeutics/Nestl{\'e}; has participated in the speaker bureau for Aimmune Therapeutics/Nestl{\'e}; has participated in clinical research for Aimmune Therapeutics/Nestl{\'e}, Alladapt Immunotherapeutics, and DBV Technologies; and reports stock in DBV Technologies. The rest of the authors declare that they have no relevant conflicts of interest. Funding Information: This study was supported in part by UL1TR001422 from the National Center for Advancing Translational Sciences and National Institutes of Health (NIH). 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. Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2022",

month = jul,

doi = "10.1016/j.jaip.2021.11.017",

language = "English (US)",

volume = "10",

pages = "1864--1873.e10",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "Elsevier",

number = "7",

}

Pongracic, JA, Gagnon, R, Sussman, G, Siri, D, Oriel, RC, Brown-Whitehorn, TF, Green, TD, Campbell, DE, Anvari, S, Berger, WE, Bird, JA, Chan, ES, Cheema, A, Chinthrajah, RS, Chong, HJ, Dowling, PJ, Fineman, SM, Fleischer, DM, Gonzalez-Reyes, E, Kim, EH, Lanser, BJ, MacGinnitie, A, Mehta, H, Petroni, D, Rupp, N, Schneider, LC, Scurlock, AM, Sher, LD, Shreffler, WG, Sindher, SB, Stillerman, A, Wood, R, Yang, WH, Bois, T, Sampson, HA & Bégin, P 2022, 'Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results', Journal of Allergy and Clinical Immunology: In Practice, vol. 10, no. 7, pp. 1864-1873.e10. https://doi.org/10.1016/j.jaip.2021.11.017

TY - JOUR

T1 - Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children

T2 - REALISE Randomized Clinical Trial Results

AU - Pongracic, Jacqueline A.

AU - Gagnon, Rémi

AU - Sussman, Gordon

AU - Siri, Dareen

AU - Oriel, Roxanne C.

AU - Brown-Whitehorn, Terri F.

AU - Green, Todd D.

AU - Campbell, Dianne E.

AU - Anvari, Sara

AU - Berger, William E.

AU - Bird, J. Andrew

AU - Chan, Edmond S.

AU - Cheema, Amarjit

AU - Chinthrajah, R. Sharon

AU - Chong, Hey Jin

AU - Dowling, Paul J.

AU - Fineman, Stanley M.

AU - Fleischer, David M.

AU - Gonzalez-Reyes, Erika

AU - Kim, Edwin H.

AU - Lanser, Bruce J.

AU - MacGinnitie, Andrew

AU - Mehta, Hemalini

AU - Petroni, Daniel

AU - Rupp, Ned

AU - Schneider, Lynda C.

AU - Scurlock, Amy M.

AU - Sher, Lawrence D.

AU - Shreffler, Wayne G.

AU - Sindher, Sayantani B.

AU - Stillerman, Allan

AU - Wood, Robert

AU - Yang, William H.

AU - Bois, Timothée

AU - Sampson, Hugh A.

AU - Bégin, Philippe

N1 - Funding Information: This study was supported in part by UL1TR001422 from the National Center for Advancing Translational Sciences and National Institutes of Health (NIH). 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.Conflicts of interest: S. Anvari received grants from DBV Technologies during the conduct of the study and grants from the US National Institute of Allergy and Infectious Diseases (NIAID) and Aimmune Therapeutics outside of the submitted work. P. Bégin reports personal fees from Novartis, Pfizer, Sanofi, ALK, and Aralez, as well as grants from DBV Technologies related to the submitted work and grants from Regeneron and Sanofi outside the submitted work. W. E. Berger is the Medical Director and National Spokesperson for Allergy and Asthma Network. J. A. Bird reports research support from DBV Technologies during the conduct of this study, research support from National Institutes of Health (NIH)-NIAID, Genentech, Astellas, Aimmune Therapeutics, DBV Technologies, and Food Allergy Research and Education (FARE) outside the submitted work, and consulting fees from FARE, Pharm-Olam International Ltd, Pfizer Pharmaceuticals, Aimmune Therapeutics, Prota Therapeutics, Allergy Therapeutics, Ltd, AllerGenis, Abbott Nutrition International, DBV Technologies, and Novartis. T. F. Brown-Whitehorn reported receiving grants and personal fees from DBV Technologies. D. 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. E. S. Chan has received research support from DBV Technologies; has been a member of advisory boards for Pfizer, Pediapharm, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi Genzyme, Bausch Health, and Avir Pharma; is a member of the health care advisory board for Food Allergy Canada; and was colead of the CSACI oral immunotherapy guidelines. A. Cheema reports receiving grants for clinical research from Merck, AstraZeneca, Novartis, GSK, Amgen, Sanofi, DBV Technologies, and Aimmune Therapeutics, as well as consulting fees/honoraria for participation in speaker bureaus and advisory boards from ALK-Abelló, GSK, AstraZeneca, and Merc. R. S. Chinthrajah reports grants from NIAID, Consortium for Food Allergy Research (CoFAR), Aimmune Therapeutics, DBV Technologies, Astellas, and Regeneron; and is an advisory member for Alladapt, Genentech, Novartis, and Sanofi. H. J. Chong reports receiving consultancy fees from Horizon. P. J. Dowling has presently or in the recent past conducted clinical research with the following companies: Merck, Aimmune Therapeutics, Sanofi, and DBV Technologies. S. M. Fineman has participated in research for Aimmune Therapeutics, DBV Technologies, and BioCryst, and has participated on speaker bureaus for Takeda. D. M. Fleischer received research support to his institution from Aimmune Therapeutics and DBV Technologies; is a member of Medical Advisory Board for the Food Allergy & Anaphylaxis Connection Team, Medical Advisory Council for the National Peanut Board, the Adverse Reactions to Food Committee (former chair 2017-2019) for the American Academy of Allergy, Asthma & Immunology, and Food Allergy Committee for the American College of Allergy, Asthma and Immunology; has received royalties from UpToDate; and is a consultant to AllerGenis, Aquestive, Aravax, Danone, DBV Technologies, Genentech, Intrommune, Nasus, and Nurture Inc (Happy Family Organics). T. D. Green and T. Bois are employees of DBV Technologies. E. H. Kim reports personal fees from DBV Technologies, Aimmune Therapeutics, AllerGenis, Ukko Inc, Vibrant America, Allakos, Kenota Health, and Duke Clinical Research Institute, and grants from FARE and Wallace Research Foundation outside the submitted work. B. J. Lanser reports grants and personal fees from Aimmune Therapeutics, grants from DBV Technologies and Regeneron, personal fees from Allergenis, Hycor, GSK, and Genentech, and is a member of the NIH/NIAID-sponsored CoFAR. J. A. Pongracic reports receiving research funding from DBV Technologies and Aimmune Therapeutics and honorarium from Medscape, consulting fees from DBV Technologies, and participating in advisory boards for DBV Technologies and Regeneron and clinical advisory boards for FARE. H. A. Sampson receives consulting fees from DBV Technologies, Siolta Therapeutics, and N-Fold Therapeutics, and received stock options from DBV Technologies. L. C. Schneider reports grants from DBV Technologies, Genentech, and Aimmune Therapeutics during the conduct of the study; personal fees from FARE Medical Advisory Board and Abbvie; and grants from Regeneron Pharmaceuticals outside the submitted work. A. M. Scurlock reports grant support to her institution from NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and FARE. She reports clinical medical advisory board membership with DBV Technologies. W. 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 scientific advisory board. S. B. Sindher receives grants from NIAID, CoFAR, Regeneron, DBV Technologies, Aimmune Therapeutics, Novartis, and Sanofi. G. Sussman is an advisory board member for Novartis, Aralez, CSL Behring, and Sanofi; he reports 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 has participated in clinical trials (PI) for Novartis, GSK, Genentech, DBV Technologies, Aimmune, CSL Behring, Astrazeneca, Stallergenes, Merck, Pfizer, Dyax, Biocryst, Greencross, Kendrion, Leo Pharma, Regeneron, Sanofi, Blueprint, ALK, Amgen, and Cliantha. R. Wood reported receiving grants from the NIH, DBV Technologies, Aimmune Therapeutics, Astellas, HAL Allergy, Sanofi, and Regeneron. W. H. Yang has received fees for CHE from CSL Behring, Shire/Takeda, Sanofi, Novartis, Merck, and AstraZeneca; has received fees for advisory boards from CSL Behring, BioCryst, Shire/Takeda, Pharming, Novartis, Sanofi/Genzyme, and Merck; and has received research grants from CSL Behring, Shire/Takeda, BioCryst, Pharming, Pharvaris, Sanofi, Novartis, GSK, Regeneron, Galderma, Glenmark, Dermira, Amgen, AnaptysBio, AstraZeneca, DBV Technologies, Aimmune Therapeutics, EliLily, Genentec, Roche, and Pfizer. E. Gonzalez-Reyes has participated in the speaker bureau for Teva Pharmaceuticals (Digihaler Technology [2021-present]). A. MacGinnitie has been a consultant for DBV Technologies and received grant support (through his institution) from DBV Technologies, Novartis, and Aimmune Therapeutics. D. Petroni has participated in the speaker bureau for AstraZeneca and has been a consultant for HollisterStier. N. Rupp received funding from DBV Technologies, the sponsor, as remuneration for his participation as principal investigator carrying out duties defined by the clinical trial protocol for the REAL LIfe Use and Safety of EPIT (REALISE) trial; is active in the conduction of clinical trials with a number of different sponsors across multiple indications; and has received funding for his services on the speaker panel for dupilumab as sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. D. Siri is the owner, CEO/CMO, of Midwest Allergy Sinus Asthma Food Allergy Center for Treatment; has been a consultant for Aimmune Therapeutics/Nestlé; has participated in the speaker bureau for Aimmune Therapeutics/Nestlé; has participated in clinical research for Aimmune Therapeutics/Nestlé, Alladapt Immunotherapeutics, and DBV Technologies; and reports stock in DBV Technologies. The rest of the authors declare that they have no relevant conflicts of interest. Funding Information: This study was supported in part by UL1TR001422 from the National Center for Advancing Translational Sciences and National Institutes of Health (NIH). 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. Publisher Copyright: © 2021 The Authors

PY - 2022/7

Y1 - 2022/7

N2 - Background: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children. Objective: To examine the safety of VP250 in children, using a study design approximating potential real-world use. Methods: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported. Results: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis. Conclusions: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.

AB - Background: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children. Objective: To examine the safety of VP250 in children, using a study design approximating potential real-world use. Methods: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported. Results: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis. Conclusions: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.

KW - Children

KW - Desensitization

KW - Epicutaneous immunotherapy (EPIT)

KW - Food allergy

KW - Immunotherapy

KW - Peanut allergy

KW - Real-world setting

UR - http://www.scopus.com/inward/record.url?scp=85123728757&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85123728757&partnerID=8YFLogxK

U2 - 10.1016/j.jaip.2021.11.017

DO - 10.1016/j.jaip.2021.11.017

M3 - Article

C2 - 34848381

AN - SCOPUS:85123728757

SN - 2213-2198

VL - 10

SP - 1864-1873.e10

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

IS - 7

ER -

Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

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