Improvements in quality of life in children following epicutaneous immunotherapy (EPIT) for peanut allergy in the PEPITES and PEOPLE studies

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dc.contributor.authorDunnGalvin, Audrey
dc.contributor.authorFleischer, David M.
dc.contributor.authorCampbell, Dianne E.
dc.contributor.authorHourihane, Jonathan O'B.
dc.contributor.authorGreen, Todd D.
dc.contributor.authorSampson, Hugh A.
dc.contributor.authorGreenhawt, Matthew
dc.date.accessioned2022-09-12T16:48:58Z
dc.date.available2022-09-12T16:48:58Z
dc.date.issued2021-01-06
dc.date.updated2022-09-12T15:53:13Z
dc.description.abstractBackground: Food allergy quality of life (FAQL) is impaired in children with peanut allergy. Food Allergy Quality of Life Questionnaires (FAQLQs) provide disease-specific insight into the burden of peanut allergy and potential FAQL changes after peanut immunotherapy. Objective: To examine FAQL changes in children after treatment with epicutaneous immunotherapy for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). Methods: FAQL was prospectively measured using the FAQLQ parent proxy form (Food Allergy Quality of Life Questionnaire-Parent Proxy Form [FAQLQ-PF], for children aged ≤12 years) and child form (Food Allergy Quality of Life Questionnaire-Child Form [FAQLQ-CF], child rated if aged ≥8 years) during the 12-month double-blind, randomized, controlled Peanut EPIT Efficacy and Safety Study (PEPITES) trial and the initial 12 months of the open-label PEPITES Open Label Extension Study (PEOPLE) follow-up study. Data were analyzed for between-group differences after treatment unblinding. Results: FAQLQs from placebo participants (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment group participants (FAQLQ-PF: 209; FAQLQ-CF: 105) were analyzed. Twenty-four–month global FAQL scores (FAQLQ-PF/FAQLQ-CF) were significantly improved in the treatment group versus the placebo group (least squares mean, 0.34, P = .008, and 0.46, P = .023, respectively). At 24 months, there was significant FAQLQ-PF score improvement in participants initially randomized to treatment who met the efficacy primary end point (n = 74; least squares mean, 0.55; P < .001) and in participants with any eliciting dose increase (n = 127; least squares mean, 0.66; P < .001). FAQLQ-PF improvements were observed in social dietary limitations (P = .002), food-related anxiety (P = .029), and emotional impact (P = .048) domains. FAQLQ-CF improvements were observed in risk of accidental exposure (P = .002) and allergen avoidance (P = .04) domains. Nearly all outcomes met a nontreatment context minimal clinically important difference previously cited for FAQLQ. Conclusions: Epicutaneous immunotherapy treatment was observed to be associated with significant global and domain-specific FAQL improvement (FAQLQ-PF/FAQLQ-CF), largely driven by increases in eliciting dose, in children with peanut allergy.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationDunnGalvin, A., Fleischer, D. M., Campbell, D. E., Hourihane, J. O'B., Green, T. D., Sampson, H. A. and Greenhawt, M. (2021) 'Improvements in quality of life in children following epicutaneous immunotherapy (EPIT) for peanut allergy in the PEPITES and PEOPLE studies', Journal of Allergy and Clinical Immunology: In Practice, 9(1), pp. 216-224. doi: 10.1016/j.jaip.2020.08.015en
dc.identifier.doi10.1016/j.jaip.2020.08.015en
dc.identifier.eissn2213-2198
dc.identifier.endpage224en
dc.identifier.issued1en
dc.identifier.journaltitleJournal of Allergy and Clinical Immunology: In Practiceen
dc.identifier.startpage216en
dc.identifier.urihttps://hdl.handle.net/10468/13591
dc.identifier.volume9en
dc.language.isoenen
dc.publisherElsevier Inc.en
dc.rights© 2020, the Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). https://doi.org/10.1016/j.jaip.2020.08.015 216en
dc.rights.urihttps://www.creativecommons.org/licenses/by-nc-nd/4.0/en
dc.subjectPeanuten
dc.subjectFood allergyen
dc.subjectFood allergy quality of lifeen
dc.subjectEpicutaneous immunotherapyen
dc.subjectImmunotherapyen
dc.subjectFAQLQen
dc.subjectPatient-centered outcomesen
dc.titleImprovements in quality of life in children following epicutaneous immunotherapy (EPIT) for peanut allergy in the PEPITES and PEOPLE studiesen
dc.typeArticle (peer-reviewed)en
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