Single dose oral challenges to validate eliciting doses in children with cow's milk allergy

Abstract

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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

“…In support of this, 0.5% to 0.6% of individuals developed anaphylaxis in response to an approximately ED 05 level of exposure in 2 prospective studies of patients with cow's milk allergy. 43,47 This rate was even lower for egg, wheat, and soy. 43 We were unable to undertake sensitivity analyses based on participant age (as these data were not available because of data confidentiality regulations).…”

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

“…ED 05 is the dose predicted to provoke reactions in 5% of the at‐risk allergic population). Notably, single‐dose challenges at an ED 05 level of exposure have been used to validate ED 05 values for peanut 10 and cow's milk 11 …”

“… 23 Maximum predicted rates for objective symptoms following exposure to 5 ppm allergen per 100 g and 250 g portion size estimated from Houben et al 23 Data relating to frequency of any symptoms estimated from the literature 10,11,23‐26 . Rates of anaphylaxis to ≤ED 05 exposures derived from Turner et al 26 …”

“…Up to 5% Data relating to frequency of any symptoms estimated from the literature. 10,11,[23][24][25][26] Rates of anaphylaxis to ≤ED 05 exposures derived from Turner et al 26 resulting action level would reflect the lowest amount of allergen in a small mouthful of food, which might cause a more dose-sensitive allergic individual to experience subjective symptoms. However, the use of a fixed food portion size (and hence a preset concentration) encountered significant criticism from consumers with food allergy, industry and government, for reasons including the following:…”

“…Notably, single-dose challenges at an ED 05 level of exposure have been used to validate ED 05 values for peanut 10 and cow's milk. 11 There have been attempts to improve the use of PAL through formal allergen risk assessment, 12 for example the Voluntary Incidental Trace Allergen Labelling (VITAL ® ) scheme established by the Allergen Bureau of Australia and New Zealand. 13 However, the current lack of international consensus over use of PAL has led to a variety of regulatory approaches and increasing inconsistency in how food businesses use PAL, even between different member states of the European Union (EU).…”