Deriving individual threshold 1 doses from clinical food challenge data for 2 population risk assessment of food allergens
File(s)Deriving threshold doses from FC JACI 2019.pdf (1.01 MB)
Accepted version
Author(s)
Turner, Paul
Type
Journal Article
Abstract
Background: Food allergies are a significant public health issue and the only effective management option currently available is strict avoidance of all foods containing the allergen. In view of the practical impossibility to limit risks to zero, quantitative allergen risk assessment and management strategies are needed. Objective: To develop appropriate methods for informing population-based risk assessments and risk management programs to benefit all stakeholders, but particularly food allergic individuals. Methods: Individual thresholds for food allergens (maximum tolerable doses and minimum eliciting doses) can ideally be established through double-blind, placebo-controlled food challenges (DBPCFCs). If DBPCFC data is not available, data from widely used “open” food challenges (OFCs) using pre-defined objective criteria can also provide useful data regarding minimum eliciting doses. For more than 20 years, the Netherlands Organisation for Applied Scientific Research (TNO) and The Food Allergy Research and Resource Program (FARRP) at the University of Nebraska-Lincoln have been
collecting individual maximum tolerable doses and minimum eliciting doses that produce objective symptoms from published and unpublished clinical data to better refine knowledge regarding the sensitivity of the population to food allergens. Results: In this paper we provide in depth insights into the methodology applied by TNO and FARRP to derive individual maximum tolerable doses and minimum eliciting doses for objective symptoms from clinical food challenge data. Over 90 examples for determining the individual allergic thresholds are presented. Conclusion: With the methodology presented in this paper, we aim to stimulate harmonization and transparency in quantitative food allergen risk assessment and risk management programs, encouraging their wider adoption.
collecting individual maximum tolerable doses and minimum eliciting doses that produce objective symptoms from published and unpublished clinical data to better refine knowledge regarding the sensitivity of the population to food allergens. Results: In this paper we provide in depth insights into the methodology applied by TNO and FARRP to derive individual maximum tolerable doses and minimum eliciting doses for objective symptoms from clinical food challenge data. Over 90 examples for determining the individual allergic thresholds are presented. Conclusion: With the methodology presented in this paper, we aim to stimulate harmonization and transparency in quantitative food allergen risk assessment and risk management programs, encouraging their wider adoption.
Date Issued
2019-11
Date Acceptance
2019-07-22
Citation
Journal of Allergy and Clinical Immunology, 2019, 144 (5), pp.1290-1309
ISSN
0091-6749
Publisher
Elsevier
Start Page
1290
End Page
1309
Journal / Book Title
Journal of Allergy and Clinical Immunology
Volume
144
Issue
5
Copyright Statement
© 2019 Elsevier Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/
Sponsor
Medical Research Council (MRC)
Identifier
https://www.sciencedirect.com/science/article/pii/S0091674919310930?via%3Dihub
Grant Number
MR/K010468/1
Subjects
Science & Technology
Life Sciences & Biomedicine
Allergy
Immunology
Food allergy
food challenge
double-blind
placebo-controlled food challenge
threshold
eliciting dose
risk assessment
risk management
decision-making process
no observed adverse effect level-lowest observed adverse effect level derivation
DOUBLE-BLIND
PEANUT
CHILDREN
DIAGNOSIS
EUROPE
Food allergy
decision-making process
double-blind, placebo-controlled food challenge
eliciting dose
food challenge
no observed adverse effect level–lowest observed adverse effect level derivation
risk assessment
risk management
threshold
1107 Immunology
Allergy
Publication Status
Published
Date Publish Online
2019-08-22