Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens - 05/11/19
, Katrina J. Allen, MD, PhD c, Barbara Ballmer-Weber, MD d, e, f, René W.R. Crevel, DIBT g, Anthony E.J. Dubois, MD, PhD h, Montserrat Fernández-Rivas, MD, PhD i, Matthew J. Greenhawt, MD, MBA, MSc j, Jonathan O'B. Hourihane, MD, DM k, Jennifer J. Koplin, PhD c, Astrid G. Kruizinga, MSc a, Thuy-My Le, MD, PhD l, Hugh A. Sampson, MD m, Wayne G. Shreffler, MD, PhD n, Paul J. Turner, MD, PhD o, p, Steve L. Taylor, PhD b, Geert F. Houben, PhD a, Benjamin C. Remington, PhD aAbstract |
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 of limiting risks to zero, quantitative allergen risk assessment and management strategies are needed.
Objective |
We sought to develop appropriate methods for informing population-based risk assessments and risk management programs to benefit all stakeholders but particularly patients with food allergy.
Methods |
Individual thresholds for food allergens (maximum tolerable doses and minimum eliciting doses) can ideally be established through double-blind, placebo-controlled food challenges. If double-blind, placebo-controlled food challenge data are not available, data from widely used open food challenges using predefined objective criteria can also provide useful data regarding minimum eliciting doses. For more than 20 years, the Netherlands Organisation for Applied Scientific Research and the Food Allergy Research and Resource Program 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individual maximum tolerable doses and minimum eliciting doses that produce objective symptoms from published and unpublished clinical data to better refine knowledge regarding the sensitivity of the population to food allergens.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 article we provide in-depth insights into the methodology applied by the Netherlands Organisation for Applied Scientific Research and Food Allergy Research and Resource Program to derive individual maximum tolerable doses and minimum eliciting doses for objective symptoms from clinical food challenge data. More than 90 examples for determining individual allergic thresholds are presented.
Conclusion |
With the methodology presented in this article, we aim to stimulate harmonization and transparency in quantitative food allergen risk assessment and risk management programs, encouraging their wider adoption.
Il testo completo di questo articolo è disponibile in PDF.Graphical abstract |
Key words : 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
Abbreviations used : DBPCFC, ED, LOAEL, NOAEL
Mappa
| This project was funded by The Dutch Ministry of Economic Affairs and the Food Allergy Research and Resource Program (FARRP) of the University of Nebraska. |
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| Disclosure of potential conflict of interest: J. Westerhout, W. M. Blom, A. G. Kruizinga, and G.F. Houben report grants from the Dutch Ministry of Economic Affairs and the Food Allergy Research and Resource Program (FARRP). B. Ballmer-Weber reports personal fees from Thermo Fisher. R. W. R. Crevel reports personal fees from Unilever PLC, FARRP, Syngenta, and Upfield Europe BV and reports travel support from COST Action Imparas FA1402, ILSI-Europe, the European Academy of Allergy and Clinical Immunology, and the University of Manchester. A. E. J. Dubois reports grants and personal fees from Aimmune and reports presentation support from ALK-Abelló. M. Fernández-Rivas reports grants from the European Commission and Spanish Government (MINECO, ISCIII) and reports personal fees from Aimmune, ALK-Abelló, Allergy Therapeutics Fundación SEAIC, HAL Allergy, Thermo Fisher Scientific, Schreiber foods, and DBV Technologies. M. J. Greenhawt reports grants from the Agency for Healthcare Research and Quality; reports travel support from the National Institute of Allergy and Infectious Diseases (NIAID); reports board membership fees from DBV Technologies, Aimmune Corporation, Sanofi, Kaleo, Nutricia, and Monsanto; reports consulting fees from the Canadian Transportation Agency and Intrommune Pharmaceutical; reports employment with the American College of Allergy, Asthma and Immunology; reports lecture fees from a number of allergy societies; and reports educational development fees from DBV Technologies and Aimmune. J. O'B. Hourihane reports grants and personal fees from Aimmune and DBV Technologies and reports grants from the City of Dublin Skin and Cancer Hospital. H. A. Sampson reports grants from the NIAID, Immune Tolerance Network, and National Institutes of Health/National Institute of Environmental Health Sciences; reports consultancy fees from N-Fold; reports employment with DBV Technologies; reports royalties from UpToDate and Elsevier; and reports stock options with DBV Technologies. P. J. Turner reports grants from the UK Medical Research Council; reports personal fees from the UK Food Standards Agency, DBV Technologies, and Aimmune; and reports travel support from Allergenis and ILSI Europe. B. C. Remington reports grants from the Dutch Ministry of Economic Affairs and FARRP, reports grants and personal fees from DBV Technologies, and reports travel support from ILSI Europe. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 144 - N° 5
P. 1290-1309 - novembre 2019 Ritorno al numero
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