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Informing Risk Management for Patients With Cow's Milk Allergy Based on Threshold Dose Distributions Using Low-Dose Food Challenges

Katz, Y. (author), Melchior, M. (author), Elizur, A. (author), Nachshon, L. (author), Remington, B.C. (author), Leshno, M. (author)

Background: The safe consumption of foods depends on their allergen content in relation to patients’ lowest observed adverse effect level (LOAEL) and no observed adverse effect level (NOAEL), as well as other factors. In the case of milk, data on LOAEL and NOAEL are limited and conflicting. Objective: To determine the threshold dose distribution...

article 2023

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Reproducibility of food challenge to cow's milk: Systematic review with individual participant data meta-analysis

Turner, P.J. (author), Patel, N. (author), Campbell, D.E. (author), Sampson, H.A. (author), Maeda, M. (author), Katsunuma, T. (author), Westerhout, J. (author), Blom, W.M. (author), Baumert, J.L. (author), Houben, G.F. (author), Remington, B.C. (author)

Background: Cow's milk (CM) is an increasingly common cause of severe allergic reactions, but there is uncertainty with respect to severity of reactions at low-level CM exposure, as well as the reproducibility of reaction thresholds. Objective: We undertook an individual participant data (IPD) meta-analysis of studies reporting double-blind,...

article 2022

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Updated full range of Eliciting Dose values for Cow's milk for use in food allergen risk assessment

Blom, W.M. (author), Westerhout, J. (author), Baumert, J.L. (author), Meima, M.Y. (author), Turner, P.J. (author), Ebisawa, M. (author), Yanagida, N. (author), Remington, B.C. (author), Houben, G.F. (author)

Access to Eliciting Doses (ED) for allergens enables advanced food allergen risk assessment. Previously, the full ED range for 14 allergenic foods, including milk, and recommendations for their use were provided (Houben et al., 2020). Additional food challenge studies with cow's milk-allergic patients added 247 data points to the original...

article 2022

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Too high, too low: The complexities of using thresholds in isolation to inform precautionary allergen ('may contain') labels: editorial

Turner, P.J. (author), Baumert, J.L. (author), Beyer, K. (author), Brooke-Taylor, S. (author), Comberiati, P. (author), Crevel, R.W.R. (author), Gerdts, J.D. (author), Hazel G.M., (author), Houben, G.F. (author), Hourihane, J.O'B (author), Konstantinou, G.N. (author), La Vieille, S. (author), Moya, B. (author), Muraro, A. (author), Mills, E.N.C. (author), Patel, N. (author), Podestà, M. (author), Popping, B. (author), Reese, I. (author), Roberts, G. (author), Said, M. (author), Santos, A.F. (author), Schnadt, S. (author), Taylor, S.L. (author), Vlieg-Boerstra, B. (author), Remington, B.C. (author)

article 2022

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Allergen quantitative risk assessment within food operations: Concepts towards development of practical guidance based on an ILSI Europe workshop

Remington, B.C. (author), Baumert, J. (author), Blom, W.M. (author), Bucchini, L. (author), Buck, N. (author), Crevel, R. (author), de Mooij, F. (author), Flanagan, S. (author), Hindley, J. (author), Javed, B. (author), Stavropoulou, D.A. (author), van den Dungen, M.W. (author), van Ravenhorst, M. (author), Wang, S. (author), Walker, M. (author)

Quantitative risk assessment (QRA) for allergens exists in many different forms with different requirements placed on the risk assessor depending on the question that needs to be answered. An electronic workshop held in October 2020 and comprising representatives from a wide range of food allergy and allergen stakeholder groups identified that a...

article 2022

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

Turner, P.J. (author), Patel, N. (author), Ballmer-Weber, B.K. (author), Baumert, J.L. (author), Blom, W.M. (author), Brooke-Taylor, S. (author), Brough, H. (author), Campbell, D.E. (author), Chen, H. (author), Chinthrajah, R.S. (author), Crevel, R.W.R. (author), Dubois, A.E.J. (author), Ebisawa, M. (author), Elizur, A. (author), Gerdts, J.D. (author), Gowland, M.H. (author), Houben, G.F. (author), Hourihane, J.O.B. (author), Knulst, A.C. (author), La Vieille, S. (author), López, M.C. (author), Mills, E.N.C. (author), Polenta, G.A. (author), Purington, N. (author), Said, M. (author), Sampson, H.A. (author), Schnadt, S. (author), Södergren E., (author), Taylor, S.L. (author), Remington, B.C. (author)

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...

article 2022

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A systematic comparison of food intake data of the United States and the Netherlands for food allergen risk assessment

Meima, M.Y. (author), Blom, W.M. (author), Westerhout, J. (author), Kruizinga, A.G. (author), Remington, B.C. (author), Wheeler, M.W. (author), Houben, G.F. (author)

article 2021

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Methods to determine the risk of unintended allergen presence related to the dispersion of allergenic food particles in food production areas

Meima, M.Y. (author), Remington, B.C. (author), Blom, W.M. (author), Baumert, J.L. (author), Taylor, S.L. (author), Jeffery, B. (author), Robert, M.C. (author), Houben, G.F. (author), Lucas Luijckx, N.B. (author)

Allergenic food particles (typically ~0.5–5 mm) may unintentionally end up in food products during production and can pose a risk for the allergic consumer. A single particle can provoke allergic symptoms in an allergic consumer when the dose of allergenic protein exceeds minimal eliciting doses. However, there is a lack of fundamental knowledge...

article 2021

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Suitability of low-dose open food challenge data to supplement double-blind placebo-controlled data in generation of food allergen threshold dose distributions

Remington, B.C. (author), Westerhout, J. (author), Dubois, A.E.J. (author), Blom, W.M. (author), Kruizinga, A.G. (author), Taylor, S.L. (author), Houben, G.F. (author), Baumert, J.L. (author)

Food allergen threshold dose distributions are used in food allergen risk assessment to determine the level of risk within a food-allergic population to a defined exposure amount of allergenic food protein and to help inform allergen risk management decisions. There has been a long-standing interest in determining threshold dose distributions...

article 2021

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The population threshold for soy as an allergenic food – Why did the Reference Dose decrease in VITAL 3.0?

Taylor, S.L. (author), Houben, G.F. (author), Blom, W.M. (author), Westerhout, J. (author), Remington, B.C. (author), Crevel, R.W.R. (author), Brooke-Taylor, S. (author), Baumert, J.L. (author)

Background. Soy is globally recognized as a commonly allergenic food. The VITAL (Voluntary Incidental Trace Allergen Labeling) Scientific Expert Panel (VSEP) of the Allergen Bureau of Australia & New Zealand used data on minimal reactive doses in low-dose clinical challenges of soy-allergic individuals to elaborate and propose the first...

article 2021

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Using data from food challenges to inform management of consumers with food allergy: A systematic review with individual participant data meta-analysis

Patel, N. (author), Adelman, D.C. (author), Anagnostou, K. (author), Baumert, J.L. (author), Blom, W.M. (author), Campbell, D.E. (author), Chinthrajah, R.S. (author), Mills, E.N.C. (author), Javed, B. (author), Purington, N. (author), Remington, B.C. (author), Sampson, H.A. (author), Smith, A.D. (author), Yarham, R.A.R. (author), Turner, P.J. (author)

Background Eliciting doses (EDs) (eg, ED01 or ED05 values, which are the amounts of allergen expected to cause objective symptoms in 1% and 5% of the population with an allergy, respectively) are increasingly being used to inform allergen labeling and clinical management. These values are generated from food challenge, but the frequency of...

article 2021

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Updated population minimal eliciting dose distributions for use in risk assessment of 14 priority food allergens

Remington, B.C. (author), Westerhout, J. (author), Meima, M.Y. (author), Blom, W.M. (author), Kruizinga, A.G. (author), Wheeler, M.W. (author), Taylor, S.L. (author), Houben, G.F. (author), Baumert, J.L. (author)

Food allergy and allergen management are important global public health issues. In 2011, the first iteration of our allergen threshold database (ATDB) was established based on individual NOAELs and LOAELs from oral food challenge in roughly 1750 allergic individuals. Population minimal eliciting dose (EDp) distributions based on this dataset...

article 2020

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Full range of population Eliciting Dose values for 14 priority allergenic foods and recommendations for use in risk characterization

Houben, G.F. (author), Baumert, J.L. (author), Blom, W.M. (author), Kruizinga, A.G. (author), Meima, M.Y. (author), Remington, B.C. (author), Wheeler, M.W. (author), Westerhout, J. (author), Taylor, S.L. (author)

Previously, we published selected Eliciting Dose (ED) values (i.e. ED01 and ED05 values) for 14 allergenic foods, predicted to elicit objective allergic symptoms in 1% and 5%, respectively, of the allergic population (Remington et al., 2020). These ED01 and ED05 values were specifically presented and discussed in the context of establishing...

article 2020

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Risk of shared equipment in restaurants for consumers with peanut allergy: a simulation for preparing Asian foods: A simulation for preparing Asian foods

Remington, B.C. (author), Blom, W.M. (author), Bassa, B. (author), Koppelman, S.J. (author)

Allergic reactions to meals consumed outside the home are common and can be severe and sometimes fatal. Objective. To quantify the risk reduction potentially achieved by increasing an individual’s threshold sensitivity to peanut (such as by means of immunotherapy) in scenarios of peanut exposure through shared kitchen materials in a restaurant...

article 2020

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Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens

Westerhout, J. (author), Baumert, J.L. (author), Blom, W.M. (author), Allen, K.J. (author), Ballmer-Weber, B. (author), Crevel, R.W.R. (author), Dubois, A.E.J. (author), Fernández-Rivas, M. (author), Greenhawt, M.J. (author), Hourihane, J.O. (author), Koplin, J.J. (author), Kruizinga, A.G. (author), Le, T.M. (author), Sampson, H.A. (author), Shreffler, W.G. (author), Turner, P.J. (author), Taylor, S.L. (author), Houben, G.F. (author), Remington, B.C. (author)

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...

article 2019

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Sensitivity analysis to derive a food consumption point estimate for deterministic food allergy risk assessment

Blom, W.M. (author), Remington, B.C. (author), Baumert, J.L. (author), Bucchini, L. (author), Crépet, A. (author), Crevel, R.W.R. (author), Madsen, C.B. (author), Taylor, S.L. (author), Houben, G.F. (author), Kruizinga, A.G. (author)

One of the input parameters in food allergy risk assessment is the amount of a given food consumed at an eating occasion. There is no consensus on how to use food consumption data when assessing the risk from unintended allergen presence in food products. A sensitivity analysis was performed to establish the optimal food consumption estimate for...

article 2019

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Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy

Remington, B.C. (author), Krone, T. (author), Kim, E.H. (author), Bird, J.A. (author), Green, T.D. (author), Lack, G. (author), Fleischer, D.M. (author), Koppelman, S.J. (author)

Background: Peanut allergy is a generally persistent, sometimes life-threatening food allergy. With no treatments demonstrating the ability to cure a food allergy, the focus of drugs in development has been on providing a level of protection against accidental exposure reactions. However, no study has estimated the relative risk reduction of a...

article 2019

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Frequentist and Bayesian approaches for food allergen risk assessment: risk outcome and uncertainty comparisons

Birot, S. (author), Crépet, A. (author), Remington, B.C. (author), Madsen, C.B. (author), Kruizinga, A.G. (author), Baumert, J.L. (author), Brockhoff, P.B. (author)

Peer-reviewed probabilistic methods already predict the probability of an allergic reaction resulting from an accidental exposure to food allergens, however, the methods calculate it in different ways. The available methods utilize the same three major input parameters in the risk model: the risk is estimated from the amount of food consumed,...

article 2019

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The importance of reducing risk in peanut allergy: Current and future therapies

Shreffler, W.G. (author), Baumert, J.L. (author), Remington, B.C. (author), Koppelman, S.J. (author), Dinakar, C. (author), Fleischer, D.M. (author), Kim, E. (author), Tilles, S.A. (author), Spergel, J.M. (author)

article 2018

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Quantitative risk reduction through peanut immunotherapy: Safety benefits of an increased threshold in Europe

Remington, B.C. (author), Krone, T. (author), Koppelman, S.J. (author)

Background: The clinical relevance of increasing an allergic individual's peanut sensitivity threshold by immunotherapy, that is, eliciting dose (ED) to 300 or 1000 mg peanut protein, has not been previously characterized in a European population. In this study, we quantify the clinical benefits of an increased threshold of reaction following...

article 2018