Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy
| 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.date.updated | 2017-05-18T08:53:44Z | |
| 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.description.status | Peer reviewed | en |
| dc.description.version | Accepted Version | en |
| dc.format.mimetype | application/pdf | en |
| 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.doi | 10.1016/j.jaci.2017.01.030 | |
| dc.identifier.endpage | 1590 | en |
| dc.identifier.issn | 0091-6749 | |
| dc.identifier.issued | 5 | en |
| dc.identifier.journaltitle | Journal of Allergy and Clinical Immunology | en |
| dc.identifier.startpage | 1583 | en |
| dc.identifier.uri | https://hdl.handle.net/10468/3982 | |
| dc.identifier.volume | 139 | 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 |
