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J Allergy Clin Immunol. 2017 May;139(5):1583-1590. doi: 10.1016/j.jaci.2017.01.030. Epub 2017 Feb 24.

Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy.

Author information

1
Paediatrics and Child Health, University College, Cork, Ireland. Electronic address: J.Hourihane@ucc.ie.
2
Murdoch Childrens Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Australia.
3
Food Allergy Centre and Centre for Immunology and Inflammatory Disease, and Massachusetts General Hospital/Harvard Medical School, Boston, Mass.
4
Paediatrics and Child Health, University College, Cork, Ireland; School of Applied Psychology, University College, Cork, Ireland.
5
Food Allergy Research and Resource Program, University of Nebraska, Lincoln, Neb.
6
Murdoch Childrens Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia; Centre for Chronic Disease, College of Health and Biomedicine, Victoria University, Melbourne, Australia.
7
Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.

Abstract

BACKGROUND:

Eliciting doses (EDs) of allergenic foods can be defined by the distribution of threshold doses for subjects within a specific population. The ED05 is the dose that elicits a reaction in 5% of allergic subjects. The predicted ED05 for peanut is 1.5 mg of peanut protein (6 mg of whole peanut).

OBJECTIVE:

We sought to validate the predicted peanut ED05 (1.5 mg) with a novel single-dose challenge.

METHODS:

Consecutive eligible children with peanut allergy in 3 centers were prospectively invited to participate, irrespective of previous reaction severity. Predetermined criteria for objective reactions were used to identify ED05 single-dose reactors.

RESULTS:

Five hundred eighteen children (mean age, 6.8 years) were eligible. No significant demographic or clinical differences were identified between 381 (74%) participants and 137 (26%) nonparticipants or between subjects recruited at each center. Three hundred seventy-eight children (206 male) completed the study. Almost half the group reported ignoring precautionary allergen labeling. Two hundred forty-five (65%) children experienced no reaction to the single dose of peanut. Sixty-seven (18%) children reported a subjective reaction without objective findings. Fifty-eight (15%) children experienced signs of a mild and transient nature that did not meet the predetermined criteria. Only 8 (2.1%; 95% CI, 0.6%-3.4%) subjects met the predetermined criteria for an objective and likely related event. No child experienced more than a mild reaction, 4 of the 8 received oral antihistamines only, and none received epinephrine. Food allergy-related quality of life improved from baseline to 1 month after challenge regardless of outcome (η2 = 0.2, P < .0001). Peanut skin prick test responses and peanut- and Ara h 2-specific IgE levels were not associated with objective reactivity to peanut ED05.

CONCLUSION:

A single administration of 1.5 mg of peanut protein elicited objective reactions in fewer than the predicted 5% of patients with peanut allergy. The novel single-dose oral food challenge appears clinically safe and patient acceptable, regardless of the outcome. It identifies the most highly dose-sensitive population with food allergy not otherwise identifiable by using routinely available peanut skin prick test responses or specific IgE levels, but this single-dose approach has not yet been validated for risk assessment of individual patients.

KEYWORDS:

Eliciting dose; Peanut Allergen Threshold Study; Voluntary Incidental Trace Allergen Labelling; food allergy related quality of life questionnaire; oral food challenges; peanut thresholds; single dose

PMID:
28238744
DOI:
10.1016/j.jaci.2017.01.030
[Indexed for MEDLINE]

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