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

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dc.contributor.author Hourihane, Jonathan O'B.
dc.contributor.author Allen, Katrina J.
dc.contributor.author Shreffler, Wayne G.
dc.contributor.author Dunn Galvin, Gillian
dc.contributor.author Nordlee, Julie A.
dc.contributor.author Zurzolo, Giovanni A.
dc.contributor.author Dunn Galvin, Audrey
dc.contributor.author Gurrin, Lyle C.
dc.contributor.author Baumert, Joseph L.
dc.contributor.author Taylor, Steve L.
dc.date.accessioned 2017-05-18T09:04:33Z
dc.date.available 2017-05-18T09:04:33Z
dc.date.issued 2017-02-24
dc.identifier.citation Hourihane, J. O. B., Allen, K. J., Shreffler, W. G., Dunngalvin, G., Nordlee, J. A., Zurzolo, G. A., Dunngalvin, A., Gurrin, L. C., Baumert, J. L. and Taylor, S. L. (2017) 'Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy', Journal of Allergy and Clinical Immunology, 139(5), pp. 1583-1590. doi:10.1016/j.jaci.2017.01.030 en
dc.identifier.volume 139 en
dc.identifier.issued 5 en
dc.identifier.startpage 1583 en
dc.identifier.endpage 1590 en
dc.identifier.issn 0091-6749
dc.identifier.uri http://hdl.handle.net/10468/3982
dc.identifier.doi 10.1016/j.jaci.2017.01.030
dc.description.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. en
dc.description.sponsorship Food Allergy Research & Resource Program, FARRP, United States (grant no. 1UL1TR001102-01) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier en
dc.rights © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier. This manuscript version is made available under the CC-BY-NC-ND 4.0 license. en
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.subject Eliciting dose en
dc.subject Food allergy related quality of life questionnaire en
dc.subject Single dose en
dc.subject Peanut thresholds en
dc.subject Oral food challenges en
dc.subject Voluntary Incidental Trace Allergen Labelling en
dc.subject Peanut Allergen Threshold Study en
dc.title Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Jonathan Hourihane, Paediatrics & Child Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: j.hourihane@ucc.ie en
dc.internal.availability Full text available en
dc.check.info Access to this article is restricted until 12 months after publication at the request of the publisher en
dc.check.date 2018-02-24
dc.date.updated 2017-05-18T08:53:44Z
dc.description.version Accepted Version en
dc.internal.rssid 395506547
dc.description.status Peer reviewed en
dc.identifier.journaltitle Journal of Allergy and Clinical Immunology en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress j.hourihane@ucc.ie en


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© 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier. This manuscript version is made available under the CC-BY-NC-ND 4.0 license. Except where otherwise noted, this item's license is described as © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.
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