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

Authors

Paul J. Turner, National Heart & Lung Institute, Imperial College LondonFollow
Yvonne M. d'Art, University College Cork, Ireland
Bettina Duca, National Heart & Lung Institute, Imperial College London
Sophia A. Chastell, National Heart & Lung Institute, Imperial College London
Guadalupe Marco-Martin, Hospital Clinico San Carlos, Madrid
Rosialzira N. Vera-Berrios, Hospital Clinico San Carlos, Madrid
Olaya Alvarez, ARADyAL Research Network, Madrid
Raphaëlle Bazire, ARADyAL Research Network, Madrid
Pablo Rodríguez del Río, ARADyAL Research Network, Madrid
Marta Vazquez-Ortiz, National Heart & Lung Institute, Imperial College London
Joseph L. Baumert, University of Nebraska - LincolnFollow
Ronald van Ree, Amsterdam University Medical Centres
Clare E.N. Mills, University of Manchester
Montserrat Fernandez-Rivas, Hospital Clinico San Carlos, Madrid
Jonathan O.B. Hourihane, University College Cork, Ireland

ORCID IDs

Paul J. Turner https://orcid.org/0000-0001-9862-5161

Raphaëlle Bazire https://orcid.org/0000-0003-0079-3613

Marta Vazquez-Ortiz https://orcid.org/0000-0001-5493-6056

Jonathan O'B. Hourihane https://orcid.org/0000-0003-4997-9857

Document Type

Article

Date of this Version

2021

Citation

Pediatr Allergy Immunol. 2021;32:1056–1065.

DOI: 10.1111/pai.13482

Comments

This is an open access article under the terms of the Creative Commons Attribution License

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 hat 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.