Single-dose oral challenges to validate eliciting doses in children with cow's milk allergy
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Background: There is increasing interest in the use of eliciting doses (EDs) to inform allergen risk management. The ED can be estimated from the distribution of threshold doses for allergic subjects undergoing food challenges within a specified population. Estimated ED05 values for cow's milk (the dose expected to cause objective allergic symptoms in 5% of the milk‐allergic population) range from 0.5 mg to 13.9 mg cow's milk protein. We undertook a single‐dose challenge study to validate a predicted ED05 for cow's milk of 0.5 mg protein.
Methods: Participants were recruited from 4 clinical centres. Predetermined criteria were used to identify patients reacting to 0.5 mg cow's milk protein (approximately 0.015 mL of fresh cow's milk). Children over 1 year underwent formal challenge to cow's milk to confirm clinical reactivity.
Results: 172 children (median age 6.0 (IQR 0.7‐11) years, 57% male) were included in this analysis. Twelve (7.0%, 95% CI 3.7%‐11.9%) children experienced objective symptoms that met the predetermined criteria. One participant had mild anaphylaxis that responded to a single dose of adrenaline, the remainder experienced only mild symptoms with no treatment required. We did not identify any baseline predictors of sensitization that were associated with objective reactivity to the single‐dose challenge using 0.5 mg cow's milk protein.
Conclusions: These data support an estimated ED05 for cow's milk of 0.5 mg protein. Values for ED05 above 0.5 mg for cow's milk protein proposed for allergen risk management need to be reviewed.
Methods: Participants were recruited from 4 clinical centres. Predetermined criteria were used to identify patients reacting to 0.5 mg cow's milk protein (approximately 0.015 mL of fresh cow's milk). Children over 1 year underwent formal challenge to cow's milk to confirm clinical reactivity.
Results: 172 children (median age 6.0 (IQR 0.7‐11) years, 57% male) were included in this analysis. Twelve (7.0%, 95% CI 3.7%‐11.9%) children experienced objective symptoms that met the predetermined criteria. One participant had mild anaphylaxis that responded to a single dose of adrenaline, the remainder experienced only mild symptoms with no treatment required. We did not identify any baseline predictors of sensitization that were associated with objective reactivity to the single‐dose challenge using 0.5 mg cow's milk protein.
Conclusions: These data support an estimated ED05 for cow's milk of 0.5 mg protein. Values for ED05 above 0.5 mg for cow's milk protein proposed for allergen risk management need to be reviewed.
Date Issued
2021-07
Date Acceptance
2021-02-17
Citation
Pediatric Allergy and Immunology, 2021, 32 (5), pp.1056-1065
ISSN
0905-6157
Publisher
John Wiley and Sons
Start Page
1056
End Page
1065
Journal / Book Title
Pediatric Allergy and Immunology
Volume
32
Issue
5
Copyright Statement
© 2021 The Authors. Pediatric Allergy and Immunology published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
License URL
Sponsor
Medical Research Council (MRC)
Commission of the European Communities
J P Moulton Charitable Foundation
Identifier
https://onlinelibrary.wiley.com/doi/10.1111/pai.13482
Grant Number
MR/K010468/1
656878
n/a
Subjects
Science & Technology
Life Sciences & Biomedicine
Allergy
Immunology
Pediatrics
cow&apos
s milk
eliciting dose
single‐
dose challenge
thresholds
Voluntary Incidental Trace Allergen Labelling (VITAL)
Voluntary Incidental Trace Allergen Labelling (VITAL)
cow's milk
eliciting dose
single-dose challenge
thresholds
1107 Immunology
1114 Paediatrics and Reproductive Medicine
1117 Public Health and Health Services
Allergy
Publication Status
Published
Date Publish Online
2021-02-20