Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here?

Thomas Eiwegger; Katherine Anagnostou; Stefania Arasi; Philippe Bégin; Moshe Ben-Shoshan; Kirsten Beyer; Katharina Blumchen; Helen Brough; Jean Christoph Caubet; Edmond S. Chan; Meng Chen; Sharon Chinthrajah; Carla M. Davis; Anne Des Roches; George Du Toit; Arnon Elizur; Stephen J. Galli; Geir Håland; Karin Hoffmann-Sommergruber; Harold Kim; Donald Y.M. Leung; Andrew Long; Antonella Muraro; Ulugbek B. Nurmatov; Giovanni B. Pajno; Vanitha Sampath; Jamie Saxena; Sayantani Sindher; Julia Upton; Margitta Worm; Kari C. Nadeau

doi:10.1016/j.jaci.2019.10.021

Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here?

Thomas Eiwegger, Katherine Anagnostou, Stefania Arasi, Philippe Bégin, Moshe Ben-Shoshan, Kirsten Beyer, Katharina Blumchen, Helen Brough, Jean Christoph Caubet, Edmond S. Chan, Meng Chen, Sharon Chinthrajah, Carla M. Davis, Anne Des Roches, George Du Toit, Arnon Elizur, Stephen J. Galli, Geir Håland, Karin Hoffmann-Sommergruber, Harold KimDonald Y.M. Leung, Andrew Long, Antonella Muraro, Ulugbek B. Nurmatov, Giovanni B. Pajno, Vanitha Sampath, Jamie Saxena, Sayantani Sindher, Julia Upton, Margitta Worm, Kari C. Nadeau^*

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Editorial

13 Scopus citations

Original language	English
Pages (from-to)	1153-1156
Number of pages	4
Journal	Journal of Allergy and Clinical Immunology
Volume	145
Issue number	4
DOIs	https://doi.org/10.1016/j.jaci.2019.10.021
State	Published - Apr 2020

Funding

Funders	Funder number
ACAAI
Allergenis
American College of Allergy, Asthma and Immunology
Bencard Allergie, Allergopharma
Colorado Allergy and Asthma Society
Food Allergy Research & Education, End Allergies Together
Food Allergy and Anaphylaxis Program SickKids
Food Allergy and Anaphylaxis Program SickKids, and Innovation Funds Denmark
ForTra
Guidelines for Peanut Allergy Prevention
Naddisy Foundation
Reinhard Foundation
World Allergy Organization Center of Excellence
National Institutes of Health
National Heart, Lung, and Blood Institute
National Institute of Allergy and Infectious Diseases	U19AI104209, UM1AI130780
National Institute of Environmental Health Sciences
National Institute of Arthritis and Musculoskeletal and Skin Diseases	R01 AR067145, R01 AI125567, R01 AI32494, R01AR041256
National Center for Research Resources	UL1RR025780, 1UM2AI130836
U.S. Environmental Protection Agency
Boehringer Ingelheim
Pfizer	U19 AI117673, R01 AR41256
Astellas Pharma US
AstraZeneca
Genentech
Merck
Novartis
Sanofi
Stanford University
Canadian Allergy, Asthma and Immunology Foundation
Ontario Innovation Trust
CSL Behring
Australasian Society of Clinical Immunology and Allergy
Aimmune Therapeutics
Sean N. Parker Center for Allergy and Asthma Research, Stanford University
Fonds de Recherche du Québec - Santé
United States-Israel Binational Science Foundation	2017182
Austrian Science Fund
Shire
Horizon 2020
European Academy of Allergy and Clinical Immunology
Food Allergy Canada

Keywords

Food allergy
Institute for Clinical and Economic Review
US Food and Drug Administration Allergenic Products Advisory Committee
efficacy
management
peanut allergy
quality of life
safety
treatment

Access to Document

10.1016/j.jaci.2019.10.021

Cite this

Eiwegger, T., Anagnostou, K., Arasi, S., Bégin, P., Ben-Shoshan, M., Beyer, K., Blumchen, K., Brough, H., Caubet, J. C., Chan, E. S., Chen, M., Chinthrajah, S., Davis, C. M., Des Roches, A., Du Toit, G., Elizur, A., Galli, S. J., Håland, G., Hoffmann-Sommergruber, K., ... Nadeau, K. C. (2020). Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here? Journal of Allergy and Clinical Immunology, 145(4), 1153-1156. https://doi.org/10.1016/j.jaci.2019.10.021

@article{cf9d70cdb68a47cebee963c65ec1b9e6,

title = "Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here?",

keywords = "Food allergy, Institute for Clinical and Economic Review, US Food and Drug Administration Allergenic Products Advisory Committee, efficacy, management, peanut allergy, quality of life, safety, treatment",

author = "Thomas Eiwegger and Katherine Anagnostou and Stefania Arasi and Philippe B{\'e}gin and Moshe Ben-Shoshan and Kirsten Beyer and Katharina Blumchen and Helen Brough and Caubet, {Jean Christoph} and Chan, {Edmond S.} and Meng Chen and Sharon Chinthrajah and Davis, {Carla M.} and {Des Roches}, Anne and {Du Toit}, George and Arnon Elizur and Galli, {Stephen J.} and Geir H{\aa}land and Karin Hoffmann-Sommergruber and Harold Kim and Leung, {Donald Y.M.} and Andrew Long and Antonella Muraro and Nurmatov, {Ulugbek B.} and Pajno, {Giovanni B.} and Vanitha Sampath and Jamie Saxena and Sayantani Sindher and Julia Upton and Margitta Worm and Nadeau, {Kari C.}",

note = "Funding Information: Supported by the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Naddisy Foundation, Reinhard Foundation, and Food Allergy Research & Education.Disclosure of potential conflict of interest: T. Eiwegger received funding or has research contracts with DBV Technologies, ALK-Abell{\'o}, the Food Allergy and Anaphylaxis Program SickKids, and Innovation Funds Denmark and contributions to investigator-initiated oral immunotherapy (OIT) studies. K. Anagnostou has received research contracts with Aimmune Therapeutics and receives honoraria from the American College of Allergy, Asthma and Immunology (ACAAI) and the Colorado Allergy and Asthma Society (CAAS). P. B{\'e}gin received grants from Fonds de Recherche en Sant{\'e} du Qu{\'e}bec; the Canadian Allergy, Asthma and Immunology Foundation; DBV Technologies, Sanofi Genzyme; Merck; and Regeneron and personal fees from Aralez, Novartis, and ALK-Abell{\'o} outside the submitted work. M. Ben-Shoshan is a coinvestigator for Aimmune and currently involved in OIT studies. K. Beyer reports outside the submitted work grants and personal fees from Aimmune, Danone, and Infectopharm; personal fees from Bencard, Hycor, Mabylon AG, Mylan, and Nestle; and grants from ALK-Abell{\'o}, DBV Technologies, and Hipp. K. Blumchen received personal fees and nonfinancial support from Novartis; personal fees from HAL Allergy, Thermo Fisher, Bencard Allergie, Allergopharma, ALK-Abell{\'o}, DBV, Nestle, and Nutricia; grants and personal fees from Aimmune Therapeutics; and a grant from Hipp. H. Brough received serves on the UK Advisory Board for DBV Technologies and has received research support from Thermo Scientific. E. S. Chan has received grants from DBV Technologies; received personal fees from Pfizer, Kaleo, Pediapharm, and Leo Pharma; is co-lead of the Canadian Society of Allergy and Clinical Immunology (CSACI) oral immunotherapy (OIT) guidelines; is a member of the scientific advisory board for Food Allergy Canada; and was an expert panel and coordinating committee member of the National Institutes of Allergy and Infectious Diseases (NIAID)–sponsored Guidelines for Peanut Allergy Prevention. S. Chinthrajah received grant support from CoFAR NIAID, Aimmune, DBV Technologies, Astellas, AnaptysBio, Novartis, Regeneron, Stallergenes-Greer, and Boehringer Ingelheim and is a scientific advisory board member for Alladapt Immunotherapeutics. C. M. Davis is a coinvestigator for and has contracts with Aimmune Therapeutics, DBV Technologies, Regeneron, and Allakos and is on the scientific advisory board for DBV Technologies. A. Des Roches received grants from ALK-Abell{\'o} and personal fees from Novartis and ALK-Abell{\'o} outside the submitted work. G. Du Toit is a scientific advisory board member for Aimmune, is a coinvestigator on Aimmune-funded peanut immunotherapy trials, is a member for the UK Advisory Board for DBV Technologies; holds equity in DBV technologies; and is a lecturer at allergy symposia supported by Pharma companies, including Mylan and Aimmune. S. J. Galli received funding from National Institutes of Health (NIH) grants NIH/NIAID U19AI104209, NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) R01 AR067145, NIH/NIAID R01 AI125567, and NIH/NIAID R01 AI32494 and the United States–Israel Binational Foundation (grant 2017182). K. Hoffmann-Sommergruber received grants from the Austrian Science Fund and Horizon 2020 (cost action) and travel reimbursement from the European Academy of Allergy and Clinical Immunology (EAACI). H. Kim served as a speaker and/or advisor for ALK-Abell{\'o}, Aralez, Astra Zeneca, CSL Behring, Shire, Novartis, Pediapharm, Stallergenes, Kaleo, Sanofi, Pfizer, and Mylan. D. Y. M. Leung is chairman of the Aimmune Therapeutics DSMC; receives funding from NIH grants NIH/NIAMS R01 AR41256, NIH/NIAID U19 AI117673, NIH/ National Center for Research Resources (NCRR) UL1RR025780, NIH/NIAID UM1AI130780, and NIH/NIAID 1UM2AI130836 and consulted for Sanofi, Regeneron, Demira, and Novartis. A. Muraro received speaker's fees from DBV Technologies, Aimmune, and Nestl{\`e} Purina outside the submitted work. S. Sindher received grants from Aimmune, DBV Technologies, Sanofi, and Regeneron. J. Upton is a current or prior investigator for DBV Technologies, Aimmune, and Regeneron and is investigator lead on OIT studies (Food Allergy and Anaphylaxis Program SickKids), is on the advisory board Kaleo, is Food Allergy and Anaphylaxis Chair (CSACI), and is a member of the scientific advisory board for Food Allergy Canada. M. Worm reports grants and personal fees from Aimmune, Mylan, ALK-Abell{\'o}, DBV Technologies, Allergopharma, Regeneron, Sanofi, EliLilly, Stallergenes, Bencard, HAL, and Novartis outside the submitted work. K. Nadeau received grant support from the NIAID, Food Allergy Research & Education, End Allergies Together, AllerGenis, and Ukko; personal fees from Regeneron, AstraZeneca, ImmuneWorks, and Cour; research sponsorship from Novartis, Sanofi, Astellas, and Nestle; and research sponsorship for clinical trials from Genentech, Aimmune Therapeutics, DBV Technologies, AnaptysBio, Stallergenes-Greer, Regeneron, and Adare Pharmaceuticals and is a Data and Safety Monitoring Board member at Novartis and the National Heart, Lung, and Blood Institute (NHLBI); cofounded Before Brands, Alladapt Immunotherapeutics, and ForTra; is a grant awardee for the NIAID, NHLBI, National Institute of Environmental Health Sciences (NIEHS), and US Environmental Protection Agency (EPA); and is Director for Food Allergy Research & Education and the World Allergy Organization Center of Excellence. The rest of the authors declare that they have no relevant conflicts of interest.",

year = "2020",

month = apr,

doi = "10.1016/j.jaci.2019.10.021",

language = "אנגלית",

volume = "145",

pages = "1153--1156",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Elsevier Inc.",

number = "4",

}

Eiwegger, T, Anagnostou, K, Arasi, S, Bégin, P, Ben-Shoshan, M, Beyer, K, Blumchen, K, Brough, H, Caubet, JC, Chan, ES, Chen, M, Chinthrajah, S, Davis, CM, Des Roches, A, Du Toit, G, Elizur, A, Galli, SJ, Håland, G, Hoffmann-Sommergruber, K, Kim, H, Leung, DYM, Long, A, Muraro, A, Nurmatov, UB, Pajno, GB, Sampath, V, Saxena, J, Sindher, S, Upton, J, Worm, M & Nadeau, KC 2020, 'Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here?', Journal of Allergy and Clinical Immunology, vol. 145, no. 4, pp. 1153-1156. https://doi.org/10.1016/j.jaci.2019.10.021

Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here? / Eiwegger, Thomas; Anagnostou, Katherine; Arasi, Stefania et al.
In: Journal of Allergy and Clinical Immunology, Vol. 145, No. 4, 04.2020, p. 1153-1156.

Research output: Contribution to journal › Editorial

TY - JOUR

T1 - Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee

T2 - Where do we go from here?

AU - Eiwegger, Thomas

AU - Anagnostou, Katherine

AU - Arasi, Stefania

AU - Bégin, Philippe

AU - Ben-Shoshan, Moshe

AU - Beyer, Kirsten

AU - Blumchen, Katharina

AU - Brough, Helen

AU - Caubet, Jean Christoph

AU - Chan, Edmond S.

AU - Chen, Meng

AU - Chinthrajah, Sharon

AU - Davis, Carla M.

AU - Des Roches, Anne

AU - Du Toit, George

AU - Elizur, Arnon

AU - Galli, Stephen J.

AU - Håland, Geir

AU - Hoffmann-Sommergruber, Karin

AU - Kim, Harold

AU - Leung, Donald Y.M.

AU - Long, Andrew

AU - Muraro, Antonella

AU - Nurmatov, Ulugbek B.

AU - Pajno, Giovanni B.

AU - Sampath, Vanitha

AU - Saxena, Jamie

AU - Sindher, Sayantani

AU - Upton, Julia

AU - Worm, Margitta

AU - Nadeau, Kari C.

N1 - Funding Information: Supported by the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Naddisy Foundation, Reinhard Foundation, and Food Allergy Research & Education.Disclosure of potential conflict of interest: T. Eiwegger received funding or has research contracts with DBV Technologies, ALK-Abelló, the Food Allergy and Anaphylaxis Program SickKids, and Innovation Funds Denmark and contributions to investigator-initiated oral immunotherapy (OIT) studies. K. Anagnostou has received research contracts with Aimmune Therapeutics and receives honoraria from the American College of Allergy, Asthma and Immunology (ACAAI) and the Colorado Allergy and Asthma Society (CAAS). P. Bégin received grants from Fonds de Recherche en Santé du Québec; the Canadian Allergy, Asthma and Immunology Foundation; DBV Technologies, Sanofi Genzyme; Merck; and Regeneron and personal fees from Aralez, Novartis, and ALK-Abelló outside the submitted work. M. Ben-Shoshan is a coinvestigator for Aimmune and currently involved in OIT studies. K. Beyer reports outside the submitted work grants and personal fees from Aimmune, Danone, and Infectopharm; personal fees from Bencard, Hycor, Mabylon AG, Mylan, and Nestle; and grants from ALK-Abelló, DBV Technologies, and Hipp. K. Blumchen received personal fees and nonfinancial support from Novartis; personal fees from HAL Allergy, Thermo Fisher, Bencard Allergie, Allergopharma, ALK-Abelló, DBV, Nestle, and Nutricia; grants and personal fees from Aimmune Therapeutics; and a grant from Hipp. H. Brough received serves on the UK Advisory Board for DBV Technologies and has received research support from Thermo Scientific. E. S. Chan has received grants from DBV Technologies; received personal fees from Pfizer, Kaleo, Pediapharm, and Leo Pharma; is co-lead of the Canadian Society of Allergy and Clinical Immunology (CSACI) oral immunotherapy (OIT) guidelines; is a member of the scientific advisory board for Food Allergy Canada; and was an expert panel and coordinating committee member of the National Institutes of Allergy and Infectious Diseases (NIAID)–sponsored Guidelines for Peanut Allergy Prevention. S. Chinthrajah received grant support from CoFAR NIAID, Aimmune, DBV Technologies, Astellas, AnaptysBio, Novartis, Regeneron, Stallergenes-Greer, and Boehringer Ingelheim and is a scientific advisory board member for Alladapt Immunotherapeutics. C. M. Davis is a coinvestigator for and has contracts with Aimmune Therapeutics, DBV Technologies, Regeneron, and Allakos and is on the scientific advisory board for DBV Technologies. A. Des Roches received grants from ALK-Abelló and personal fees from Novartis and ALK-Abelló outside the submitted work. G. Du Toit is a scientific advisory board member for Aimmune, is a coinvestigator on Aimmune-funded peanut immunotherapy trials, is a member for the UK Advisory Board for DBV Technologies; holds equity in DBV technologies; and is a lecturer at allergy symposia supported by Pharma companies, including Mylan and Aimmune. S. J. Galli received funding from National Institutes of Health (NIH) grants NIH/NIAID U19AI104209, NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) R01 AR067145, NIH/NIAID R01 AI125567, and NIH/NIAID R01 AI32494 and the United States–Israel Binational Foundation (grant 2017182). K. Hoffmann-Sommergruber received grants from the Austrian Science Fund and Horizon 2020 (cost action) and travel reimbursement from the European Academy of Allergy and Clinical Immunology (EAACI). H. Kim served as a speaker and/or advisor for ALK-Abelló, Aralez, Astra Zeneca, CSL Behring, Shire, Novartis, Pediapharm, Stallergenes, Kaleo, Sanofi, Pfizer, and Mylan. D. Y. M. Leung is chairman of the Aimmune Therapeutics DSMC; receives funding from NIH grants NIH/NIAMS R01 AR41256, NIH/NIAID U19 AI117673, NIH/ National Center for Research Resources (NCRR) UL1RR025780, NIH/NIAID UM1AI130780, and NIH/NIAID 1UM2AI130836 and consulted for Sanofi, Regeneron, Demira, and Novartis. A. Muraro received speaker's fees from DBV Technologies, Aimmune, and Nestlè Purina outside the submitted work. S. Sindher received grants from Aimmune, DBV Technologies, Sanofi, and Regeneron. J. Upton is a current or prior investigator for DBV Technologies, Aimmune, and Regeneron and is investigator lead on OIT studies (Food Allergy and Anaphylaxis Program SickKids), is on the advisory board Kaleo, is Food Allergy and Anaphylaxis Chair (CSACI), and is a member of the scientific advisory board for Food Allergy Canada. M. Worm reports grants and personal fees from Aimmune, Mylan, ALK-Abelló, DBV Technologies, Allergopharma, Regeneron, Sanofi, EliLilly, Stallergenes, Bencard, HAL, and Novartis outside the submitted work. K. Nadeau received grant support from the NIAID, Food Allergy Research & Education, End Allergies Together, AllerGenis, and Ukko; personal fees from Regeneron, AstraZeneca, ImmuneWorks, and Cour; research sponsorship from Novartis, Sanofi, Astellas, and Nestle; and research sponsorship for clinical trials from Genentech, Aimmune Therapeutics, DBV Technologies, AnaptysBio, Stallergenes-Greer, Regeneron, and Adare Pharmaceuticals and is a Data and Safety Monitoring Board member at Novartis and the National Heart, Lung, and Blood Institute (NHLBI); cofounded Before Brands, Alladapt Immunotherapeutics, and ForTra; is a grant awardee for the NIAID, NHLBI, National Institute of Environmental Health Sciences (NIEHS), and US Environmental Protection Agency (EPA); and is Director for Food Allergy Research & Education and the World Allergy Organization Center of Excellence. The rest of the authors declare that they have no relevant conflicts of interest.

PY - 2020/4

Y1 - 2020/4

KW - Food allergy

KW - Institute for Clinical and Economic Review

KW - US Food and Drug Administration Allergenic Products Advisory Committee

KW - efficacy

KW - management

KW - peanut allergy

KW - quality of life

KW - safety

KW - treatment

UR - http://www.scopus.com/inward/record.url?scp=85075869296&partnerID=8YFLogxK

U2 - 10.1016/j.jaci.2019.10.021

DO - 10.1016/j.jaci.2019.10.021

M3 - ???researchoutput.researchoutputtypes.contributiontojournal.editorial???

C2 - 31678426

AN - SCOPUS:85075869296

SN - 0091-6749

VL - 145

SP - 1153

EP - 1156

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 4

ER -

Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here?

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