How much is too much? Threshold dose distributions for five food allergens

Ballmer-Weber B., Fernandez-Rivas M., Beyer K., Defernez M., Sperrin M., Mackie A. R., Salt L. J., Hourihane J., Asero R., Belohlavkova S., Kowalski M., de Blay F., Papadopoulos N. G., Clausen M., Knulst A. C., Roberts G. C., Popov T., Sprikkelman A. B., Dubakiene R., Vieths S., van Ree R., Crevel R. W., Mills E. C. N.. (2015)

Journal of Allergy and Clinical Immunology, 135, 964-971

Background: Precautionary labelling is used to warn consumers of the presence of unintended allergens but the lack of agreed allergen thresholds can result in confusion and risk taking by food allergic individuals. The lack of data on threshold doses below which individuals are unlikely to react is preventing the development of evidence-based allergen management strategies that are understood by clinician and patient alike. Objective: To define threshold dose distributions for five major allergenic foods in the European population. Methods: Food allergic subjects were drawn from the EuroPrevall birth cohort, community survey and outpatient clinic study and invited to undergo a food challenge. Low dose, double-blind, placebo-controlled, food challenges were undertaken using commercially available food ingredients (peanut, hazelnut, celery, fish and shrimp) blinded into common matrices. Dose distributions were modelled using interval censoring survival analysis with three parametric approaches. Results: Of the five foods used for challenge, four gave similar dose distributions with estimated doses eliciting reactions in 10% of the allergic population (ED10) ranging from 1.6 to 10.1 mg protein for hazelnut, peanut and celery with overlapping 95% confidence intervals. ED10 values for fish were somewhat higher (27.3 mg protein) although the confidence intervals were wide and overlapping between fish and the plant foods. Shrimp gave radically different dose distributions with an ED10 of 2.5g protein. Conclusion: An evidence base has been developed which will support development of reference doses and action levels for allergens in foods below which only the most sensitive individuals may react.

Journal of Allergy and Clinical Immunology, 135, 964-971

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