Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy - 27/09/17
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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.
Le texte complet de cet article est disponible en PDF.Key words : Eliciting dose, food allergy related quality of life questionnaire, single dose, peanut thresholds, oral food challenges, Voluntary Incidental Trace Allergen Labelling, Peanut Allergen Threshold Study
Abbreviations used : DBPCFC, ED, ED01, ED05, FAQL, FAQL-CF, FAQL-PF, OFC, PAL, PATS, sIgE, SPT
Plan
This project is funded by the Food Allergy Research & Resource Program (FARRP) and supported by grant no. 1UL1TR001102-01. |
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Disclosure of potential conflict of interest: J. O'B. Hourihane receives grant support from the Food Safety Authority and the National Children's Institute, Ireland; serves on the board for Aimmune Corporation; serves as a consultant for Aimmune Corporation; and receives payments for lectures from Thermo Fisher, Nutricia, and Servier. W. G. Shreffler receives grant support from the Food Allergy Research & Resource Program (FARRP); serves on the board for FARE; serves as a consultant for Sanofi; and receives grant support from Mead Johnson, Sanofi, Gerber Foundation, Aimmune, DBV, and the National Institute of Allergy and Infectious Diseases (NIAID). G. Dunngalvin receives grant support from the Food Safety Authority and the National Children's Institute. A. Dunngalvin receives grant support from the Food Safety Authority and the National Children's Institute, serves as a consultant for Aimmune Corporation, and receives payments for lectures from Nutricia and SafeFood Ireland. J. L. Baumert receives grant support from FARRP, serves as a consultant for DBV Technologies, and receives royalties from Neogen Corporation. S. L. Taylor receives grant support from FARRP and receives royalties from Neogen Corporation. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 139 - N° 5
P. 1583-1590 - mai 2017 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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