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dc.contributor.authorFleischer, DM
dc.contributor.authorShreffler, WG
dc.contributor.authorCampbell, DE
dc.contributor.authorGreen, TD
dc.contributor.authorAnvari, S
dc.contributor.authorAssa'ad, A
dc.contributor.authorBégin, P
dc.contributor.authorBeyer, K
dc.contributor.authorBird, JA
dc.contributor.authorBrown-Whitehorn, T
dc.contributor.authorByrne, A
dc.contributor.authorChan, ES
dc.contributor.authorCheema, A
dc.contributor.authorChinthrajah, S
dc.contributor.authorChong, HJ
dc.contributor.authorDavis, CM
dc.contributor.authorFord, LS
dc.contributor.authorGagnon, R
dc.contributor.authorGreenhawt, M
dc.contributor.authorHourihane, JOB
dc.contributor.authorJones, SM
dc.contributor.authorKim, EH
dc.contributor.authorLange, L
dc.contributor.authorLanser, BJ
dc.contributor.authorLeonard, S
dc.contributor.authorMahler, V
dc.contributor.authorMaronna, A
dc.contributor.authorNowak-Wegrzyn, A
dc.contributor.authorOriel, RC
dc.contributor.authorO'Sullivan, M
dc.contributor.authorPetroni, D
dc.contributor.authorPongracic, JA
dc.contributor.authorPrescott, SL
dc.contributor.authorSchneider, LC
dc.contributor.authorSmith, P
dc.contributor.authorStaab, D
dc.contributor.authorSussman, G
dc.contributor.authorWood, R
dc.contributor.authorYang, WH
dc.contributor.authorLambert, R
dc.contributor.authorPeillon, A
dc.contributor.authorBois, T
dc.contributor.authorSampson, HA
dc.date.accessioned2020-08-04T05:11:27Z
dc.date.available2020-08-04T05:11:27Z
dc.date.issued2020
dc.identifier.issn0091-6749
dc.identifier.doi10.1016/j.jaci.2020.06.028
dc.identifier.urihttp://hdl.handle.net/10072/396160
dc.description.abstractBackground: We previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT™) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250μg) in a 12-month randomized controlled study (PEPITES) of peanut-allergic children aged 4-11 years. Objective: To assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) open-label extension PEOPLE study. Methods: Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250μg, subjects who had received DBV712 250μg in PEPITES underwent Month-36 double-blind, placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment. Results: 198 (93%) of 213 eligible subjects who had received DBV712 250μg in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36. At Month 36, 51.8% (73/141) of subjects reached an eliciting dose (ED) of ≥1000 mg, compared with 40.4% (57/141) at Month 12. 75.9% (107/141) demonstrated increased ED compared to baseline. 13.5% (19/141) tolerated the full DBPCFC of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. 18 subjects underwent an optional SU assessment; 14/18 (77.8%) maintained an ED of ≥1000 mg at Month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%). Conclusion: These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherElsevier BV
dc.relation.ispartofjournalJournal of Allergy and Clinical Immunology
dc.subject.fieldofresearchImmunology
dc.subject.fieldofresearchcode1107
dc.subject.keywordsDesensitization
dc.subject.keywordsEliciting Dose
dc.subject.keywordsEpicutaneous Immunotherapy (EPIT)
dc.subject.keywordsFood Allergy
dc.subject.keywordsImmunotherapy
dc.titleLong-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationFleischer, et al., Long-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results., Journal of Allergy and Clinical Immunology, 2020
dcterms.dateAccepted2020-06-24
dcterms.licensehttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.date.updated2020-08-04T03:10:18Z
dc.description.versionPublished
gro.rights.copyright© The Author(s) 2020. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International (CC BY-NC-ND 4.0) License, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorSmith, Peter K.


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