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dc.contributor.authorFleischer, DM
dc.contributor.authorGreenhawt, M
dc.contributor.authorSussman, G
dc.contributor.authorBégin, P
dc.contributor.authorNowak-Wegrzyn, A
dc.contributor.authorPetroni, D
dc.contributor.authorBeyer, K
dc.contributor.authorBrown-Whitehorn, T
dc.contributor.authorHebert, J
dc.contributor.authorHourihane, JOB
dc.contributor.authorCampbell, DE
dc.contributor.authorLeonard, S
dc.contributor.authorChinthrajah, RS
dc.contributor.authorSmith, P
dc.contributor.authoret al.
dc.date.accessioned2020-04-06T04:06:59Z
dc.date.available2020-04-06T04:06:59Z
dc.date.issued2019
dc.identifier.issn0098-7484
dc.identifier.doi10.1001/jama.2019.1113
dc.identifier.urihttp://hdl.handle.net/10072/392967
dc.description.abstractImportance: There are currently no approved treatments for peanut allergy. Objective: To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among peanut-allergic children. Design, Setting, and Participants: Phase 3, randomized, double-blind, placebo-controlled trial conducted at 31 sites in 5 countries between January 8, 2016, and August 18, 2017. Participants included peanut-allergic children (aged 4-11 years [n = 356] without a history of a severe anaphylactic reaction) developing objective symptoms during a double-blind, placebo-controlled food challenge at an eliciting dose of 300 mg or less of peanut protein. Interventions: Daily treatment with peanut patch containing either 250 μg of peanut protein (n = 238) or placebo (n = 118) for 12 months. Main Outcomes and Measures: The primary outcome was the percentage difference in responders between the peanut patch and placebo patch based on eliciting dose (highest dose at which objective signs/symptoms of an immediate hypersensitivity reaction developed) determined by food challenges at baseline and month 12. Participants with baseline eliciting dose of 10 mg or less were responders if the posttreatment eliciting dose was 300 mg or more; participants with baseline eliciting dose greater than 10 to 300 mg were responders if the posttreatment eliciting dose was 1000 mg or more. A threshold of 15% or more on the lower bound of a 95% CI around responder rate difference was prespecified to determine a positive trial result. Adverse event evaluation included collection of treatment-emergent adverse events (TEAEs). Results: Among 356 participants randomized (median age, 7 years; 61.2% male), 89.9% completed the trial; the mean treatment adherence was 98.5%. The responder rate was 35.3% with peanut-patch treatment vs 13.6% with placebo (difference, 21.7% [95% CI, 12.4%-29.8%; P <.001]). The prespecified lower bound of the CI threshold was not met. TEAEs, primarily patch application site reactions, occurred in 95.4% and 89% of active and placebo groups, respectively. The all-causes rate of discontinuation was 10.5% in the peanut-patch group vs 9.3% in the placebo group. Conclusions and Relevance: Among peanut-allergic children aged 4 to 11 years, the percentage difference in responders at 12 months with the 250-μg peanut-patch therapy vs placebo was 21.7% and was statistically significant, but did not meet the prespecified lower bound of the confidence interval criterion for a positive trial result. The clinical relevance of not meeting this lower bound of the confidence interval with respect to the treatment of peanut-allergic children with epicutaneous immunotherapy remains to be determined.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherAmerican Medical Association
dc.relation.ispartofconferencename2018 World Allergy and Asthma Congress of the European Academy of Allergy and Clinical Immunology and World Allergy Organization
dc.relation.ispartofconferencetitleJAMA - Journal of the American Medical Association
dc.relation.ispartofdatefrom2018-05-26
dc.relation.ispartofdateto2018-05-30
dc.relation.ispartoflocationMunich, Germany
dc.relation.ispartofpagefrom946
dc.relation.ispartofpageto955
dc.relation.ispartofissue10
dc.relation.ispartofvolume321
dc.subject.fieldofresearchImmunology
dc.subject.fieldofresearchMedical and Health Sciences
dc.subject.fieldofresearchcode1107
dc.subject.fieldofresearchcode11
dc.titleEffect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion among Children with Peanut Allergy: The PEPITES Randomized Clinical Trial
dc.typeConference output
dc.type.descriptionE1 - Conferences
dcterms.bibliographicCitationFleischer, DM; Greenhawt, M; Sussman, G; Bégin, P; Nowak-Wegrzyn, A; Petroni, D; Beyer, K; Brown-Whitehorn, T; Hebert, J; Hourihane, JOB; Campbell, DE; Leonard, S; Chinthrajah, RS; Smith, P;et al., Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion among Children with Peanut Allergy: The PEPITES Randomized Clinical Trial, JAMA - Journal of the American Medical Association, 2019, 321 (10), pp. 946-955
dc.date.updated2020-04-06T04:02:47Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© 2019 American Medical Association (AMA). The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.
gro.hasfulltextFull Text
gro.griffith.authorSmith, Peter K.


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