Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis

TY - JOUR

T1 - Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management

T2 - A Rapid Evidence Assessment and Meta-Analysis

AU - Turner, Paul J.

AU - Patel, Nandinee

AU - Ballmer-Weber, Barbara K.

AU - Baumert, Joe L.

AU - Blom, W. Marty

AU - Brooke-Taylor, Simon

AU - Brough, Helen

AU - Campbell, Dianne E.

AU - Chen, Hongbing

AU - Chinthrajah, R. Sharon

AU - Crevel, René W.R.

AU - Dubois, Anthony E.J.

AU - Ebisawa, Motohiro

AU - Elizur, Arnon

AU - Gerdts, Jennifer D.

AU - Gowland, M. Hazel

AU - Houben, Geert F.

AU - Hourihane, Jonathan O.B.

AU - Knulst, André C.

AU - La Vieille, Sébastien

AU - López, María Cristina

AU - Mills, E. N.Clare

AU - Polenta, Gustavo A.

AU - Purington, Natasha

AU - Said, Maria

AU - Sampson, Hugh A.

AU - Schnadt, Sabine

AU - Södergren, Eva

AU - Taylor, Stephen L.

AU - Remington, Benjamin C.

N1 - Funding Information: This research was funded in part by a UK Medical Research Council Clinician Scientist award to PJT (reference MR/K010468/1). NP and PJT are supported through the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. The views expressed in this article are those of the authors and do not necessarily reflect those of the NHS, NIHR, the UK Departments of Health, Livsmedelsverket (Swedish Food Agency) or Health Canada. Funding Information: This research was funded in part by a UK Medical Research Council Clinician Scientist award to PJT (reference MR/K010468/1). NP and PJT are supported through the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. The views expressed in this article are those of the authors and do not necessarily reflect those of the NHS, NIHR, the UK Departments of Health, Livsmedelsverket (Swedish Food Agency) or Health Canada.Conflicts of interest: P. J. Turner reports personal fees from Aimmune Therapeutics, DBV Technologies, Allergenis, UK Food Standards Agency, and ILSI Europe; grants from NIHR/Imperial BRC, UK Medical Research Council, UK Food Standards Agency, End Allergies Together, and Jon Moulton Charity Trust, outside the submitted work. J. L. Baumert reports personal fees from Neogen Corporation, outside the submitted work. W. M. Blom reports grants from the Dutch Governmental TNO Research Cooperation Funds during the conduct of the study. S. Brooke-Taylor reports personal fees from the Allergen Bureau of Australia and New Zealand, outside the submitted work. H. Brough declares speaker fees from DBV Technologies and Sanofi, and research grants from NIH (NAIAD), DBV Technologies, and Aimmune Therapeutics. D. E. Campbell is employed by DBV Technologies, and reports personal fees from Allergenis and Westmead Fertility Centre and grants from National Health and Medical Research Council of Australia, outside the submitted work. R. S. Chinthrajah reports grants from NIAID, CoFAR, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, FARE, and Stanford Maternal and Child Health Research Institute (MCHRI); other support from Alladapt Therapeutics, Novartis, Genentech, Sanofi, Allergenis, and Nutricia, outside the submitted work. R. W. R. Crevel reports personal fees from Unilever Pensions, Food Allergy Research and Resource Program (University of Nebraska), Syngenta PLC, Upfield R&D BV, Zoetis LLC, Exponent Ltd, Fermentalg SA, CEV SA, and ILSI-Europe, and other support from EAACI, outside the submitted work. M. Ebisawa reports personal fees from DBV Technologies, Mylan, and ARS Pharmaceuticals, outside the submitted work. J. O. B. Hourihane receives research funding from NCRC Ireland, City of Dublin Skin and Cancer Hospital, Temple St Hospital Foundation, Clemens von Pirquet Foundation, Aimmune Therapeutics, DBV Technologies, and Johnson & Johnson. He is an advisory board member for Aimmune Therapeutics, and receives speaker fees from DBV Technologies. He is a board member of the Irish Association of Allergy and Immunology and the Irish Food Allergy Network, which receive unrestricted grants and logistical support from industry sources for educational activities. E. N. C. Mills reports grants and other support from Reacta Biotech Ltd, grants from the European Food Safety Authority, Food Standards Agency, and other support from the Biotechnology and Biological Sciences Research Council, Medical Research Council, and Innovate UK, outside the submitted work. In addition, Dr Mills has a patent on blinding of allergens in foods for oral food challenges pending, and was a founder director of Reacta Biotech and a member of the board until November 2019; she owns founder shares in the company. M. Said is Chief Executive Officer for Allergy & Anaphylaxis Australia, which reports grants from Bulla Family Dairy, Freedom Foods, Nestle, NSW Food Authority, Mondelez, Nutricia, Abbott, and Sweet William, and nonfinancial support from Nuts for Life, outside the submitted work. H. A. Sampson reports grants from Immune Tolerance Network, NIAID/NIH, personal fees and other support from N-Fold Therapeutics and DBV Technologies, and personal fees from Siolta Therapeutics, outside the submitted work. S. Schnadt is employed by Deutscher Allergie- und Asthmabund e.V. (DAAB), a patient organization which has received industry support. E. S?dergren was employed by the Swedish Food Agency (SFA) during the initial drafting of this manuscript, and is now employed by ThermoFisher Scientific. S. L. Taylor reports funding for research and industry outreach activities related to food allergens received from a consortium of more than 100 food processing companies. B. C. Remington reports grants, personal fees, and nonfinancial support from DBV Technologies; nonfinancial support from ILSI Europe, outside the submitted work; and is an adjunct faculty member of the University of Nebraska. The rest of the authors declare that they have no relevant conflicts of interest. Funding Information: Conflicts of interest: P. J. Turner reports personal fees from Aimmune Therapeutics, DBV Technologies, Allergenis, UK Food Standards Agency, and ILSI Europe; grants from NIHR / Imperial BRC , UK Medical Research Council , UK Food Standards Agency , End Allergies Together , and Jon Moulton Charity Trust , outside the submitted work. J. L. Baumert reports personal fees from Neogen Corporation, outside the submitted work. W. M. Blom reports grants from the Dutch Governmental TNO Research Cooperation Funds during the conduct of the study. S. Brooke-Taylor reports personal fees from the Allergen Bureau of Australia and New Zealand, outside the submitted work. H. Brough declares speaker fees from DBV Technologies and Sanofi, and research grants from NIH (NAIAD), DBV Technologies, and Aimmune Therapeutics. D. E. Campbell is employed by DBV Technologies, and reports personal fees from Allergenis and Westmead Fertility Centre and grants from National Health and Medical Research Council of Australia , outside the submitted work. R. S. Chinthrajah reports grants from NIAID , CoFAR , Aimmune Therapeutics , DBV Technologies , Astellas , Regeneron , FARE , and Stanford Maternal and Child Health Research Institute (MCHRI); other support from Alladapt Therapeutics , Novartis , Genentech , Sanofi , Allergenis , and Nutricia , outside the submitted work. R. W. R. Crevel reports personal fees from Unilever Pensions, Food Allergy Research and Resource Program (University of Nebraska), Syngenta PLC, Upfield R&D BV, Zoetis LLC, Exponent Ltd, Fermentalg SA, CEV SA, and ILSI-Europe, and other support from EAACI , outside the submitted work. M. Ebisawa reports personal fees from DBV Technologies, Mylan, and ARS Pharmaceuticals, outside the submitted work. J. O. B. Hourihane receives research funding from NCRC Ireland , City of Dublin Skin and Cancer Hospital , Temple St Hospital Foundation , Clemens von Pirquet Foundation , Aimmune Therapeutics , DBV Technologies , and Johnson & Johnson . He is an advisory board member for Aimmune Therapeutics, and receives speaker fees from DBV Technologies. He is a board member of the Irish Association of Allergy and Immunology and the Irish Food Allergy Network, which receive unrestricted grants and logistical support from industry sources for educational activities. E. N. C. Mills reports grants and other support from Reacta Biotech Ltd , grants from the European Food Safety Authority , Food Standards Agency , and other support from the Biotechnology and Biological Sciences Research Council , Medical Research Council , and Innovate UK , outside the submitted work. In addition, Dr Mills has a patent on blinding of allergens in foods for oral food challenges pending, and was a founder director of Reacta Biotech and a member of the board until November 2019; she owns founder shares in the company. M. Said is Chief Executive Officer for Allergy & Anaphylaxis Australia, which reports grants from Bulla Family Dairy , Freedom Foods , Nestle , NSW Food Authority , Mondelez, Nutricia , Abbott , and S weet William , and nonfinancial support from Nuts for Life, outside the submitted work. H. A. Sampson reports grants from Immune Tolerance Network , NIAID / NIH , personal fees and other support from N-Fold Therapeutics and DBV Technologies , and personal fees from Siolta Therapeutics, outside the submitted work. S. Schnadt is employed by Deutscher Allergie- und Asthmabund e.V. (DAAB), a patient organization which has received industry support. E. Södergren was employed by the Swedish Food Agency (SFA) during the initial drafting of this manuscript, and is now employed by ThermoFisher Scientific. S. L. Taylor reports funding for research and industry outreach activities related to food allergens received from a consortium of more than 100 food processing companies. B. C. Remington reports grants, personal fees, and nonfinancial support from DBV Technologies ; nonfinancial support from ILSI Europe, outside the submitted work; and is an adjunct faculty member of the University of Nebraska. The rest of the authors declare that they have no relevant conflicts of interest. Publisher Copyright: © 2021 The Authors Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2022/1

Y1 - 2022/1

N2 - Regional and national legislation mandates the disclosure of “priority” allergens when present as an ingredient in foods, but this does not extend to the unintended presence of allergens due to shared production facilities. This has resulted in a proliferation of precautionary allergen (“may contain”) labels (PAL) that are frequently ignored by food-allergic consumers. Attempts have been made to improve allergen risk management to better inform the use of PAL, but a lack of consensus has led to variety of regulatory approaches and nonuniformity in the use of PAL by food businesses. One potential solution would be to establish internationally agreed “reference doses,” below which no PAL would be needed. However, if reference doses are to be used to inform the need for PAL, then it is essential to characterize the hazard associated with these low-level exposures. For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals, but a similar level of evidence is lacking for other priority allergens. We present the results of a rapid evidence assessment and meta-analysis for the risk of anaphylaxis to a low-level allergen exposure for priority allergens. On the basis of this analysis, we propose that peanut can and should be considered an exemplar allergen for the hazard characterization at a low-level allergen exposure.

AB - Regional and national legislation mandates the disclosure of “priority” allergens when present as an ingredient in foods, but this does not extend to the unintended presence of allergens due to shared production facilities. This has resulted in a proliferation of precautionary allergen (“may contain”) labels (PAL) that are frequently ignored by food-allergic consumers. Attempts have been made to improve allergen risk management to better inform the use of PAL, but a lack of consensus has led to variety of regulatory approaches and nonuniformity in the use of PAL by food businesses. One potential solution would be to establish internationally agreed “reference doses,” below which no PAL would be needed. However, if reference doses are to be used to inform the need for PAL, then it is essential to characterize the hazard associated with these low-level exposures. For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals, but a similar level of evidence is lacking for other priority allergens. We present the results of a rapid evidence assessment and meta-analysis for the risk of anaphylaxis to a low-level allergen exposure for priority allergens. On the basis of this analysis, we propose that peanut can and should be considered an exemplar allergen for the hazard characterization at a low-level allergen exposure.

KW - Anaphylaxis

KW - Eliciting dose

KW - Food allergy

KW - Precautionary allergen labeling

KW - Reference dose

KW - Threshold

UR - http://www.scopus.com/inward/record.url?scp=85114693574&partnerID=8YFLogxK

U2 - 10.1016/j.jaip.2021.08.008

DO - 10.1016/j.jaip.2021.08.008

M3 - Article

AN - SCOPUS:85114693574

SN - 2213-2198

VL - 10

SP - 59

EP - 70

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

IS - 1

ER -