Improvements in quality of life in children following epicutaneous immunotherapy (EPIT) for peanut allergy in the PEPITES and PEOPLE studies
dc.contributor.author | DunnGalvin, Audrey | |
dc.contributor.author | Fleischer, David M. | |
dc.contributor.author | Campbell, Dianne E. | |
dc.contributor.author | Hourihane, Jonathan O'B. | |
dc.contributor.author | Green, Todd D. | |
dc.contributor.author | Sampson, Hugh A. | |
dc.contributor.author | Greenhawt, Matthew | |
dc.date.accessioned | 2022-09-12T16:48:58Z | |
dc.date.available | 2022-09-12T16:48:58Z | |
dc.date.issued | 2021-01-06 | |
dc.date.updated | 2022-09-12T15:53:13Z | |
dc.description.abstract | Background: 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.status | Peer reviewed | en |
dc.description.version | Published Version | en |
dc.format.mimetype | application/pdf | en |
dc.identifier.citation | DunnGalvin, 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.2020.08.015 | en |
dc.identifier.doi | 10.1016/j.jaip.2020.08.015 | en |
dc.identifier.eissn | 2213-2198 | |
dc.identifier.endpage | 224 | en |
dc.identifier.issued | 1 | en |
dc.identifier.journaltitle | Journal of Allergy and Clinical Immunology: In Practice | en |
dc.identifier.startpage | 216 | en |
dc.identifier.uri | https://hdl.handle.net/10468/13591 | |
dc.identifier.volume | 9 | en |
dc.language.iso | en | en |
dc.publisher | Elsevier 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.2020.08.015 216 | en |
dc.rights.uri | https://www.creativecommons.org/licenses/by-nc-nd/4.0/ | en |
dc.subject | Peanut | en |
dc.subject | Food allergy | en |
dc.subject | Food allergy quality of life | en |
dc.subject | Epicutaneous immunotherapy | en |
dc.subject | Immunotherapy | en |
dc.subject | FAQLQ | en |
dc.subject | Patient-centered outcomes | en |
dc.title | Improvements in quality of life in children following epicutaneous immunotherapy (EPIT) for peanut allergy in the PEPITES and PEOPLE studies | en |
dc.type | Article (peer-reviewed) | en |
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