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dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorALLOUCHERY, Marion
ORCID: 0000-0002-8261-9549
IDREF: 193082543
dc.contributor.authorTOMOWIAK, Cecile
dc.contributor.authorLOMBARD, Thomas
dc.contributor.authorPERAULT-POCHAT, Marie Christine
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
IDREF: 221043470
dc.date.accessioned2022-01-06T10:53:03Z
dc.date.available2022-01-06T10:53:03Z
dc.date.issued2021-10-28
dc.identifier.issn1663-9812 (Print) 1663-9812 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/124327
dc.description.abstractEnAs ibrutinib has become a standard of care in B-cell malignancies in monotherapy or in combination with other agents, definition of its safety profile appears essential. The aim of this study was to further characterize the safety profile of ibrutinib through the identification of potential safety signals in a large-scale pharmacovigilance database. All serious individual case safety reports (ICSRs) in patients aged >/=18 years involving ibrutinib suspected in the occurrence of serious adverse drug reactions or drug interacting from November 13th, 2013 to December 31st, 2020 were extracted from VigiBase, the World Health Organization global safety database. Disproportionality reporting was assessed using the information component (IC) and the proportional reporting ratio (PRR), with all other anticancer drugs used as the reference group. To mitigate the confounding of age, two subgroups were considered: patients aged<75 years and >/=75 years. A signal of disproportionate reporting (SDR) was defined if both IC and PRR were significant. A total of 16,196 ICSRs were included. The median age of patients was 72.9 years, 42.6% of ICSRs concerned patients aged >/=75 years, and 64.2% male patients. More than half (56.2%) of ICSRs resulted in hospitalization or prolonged hospitalization. Among 713 SDRs, 36 potential safety signals emerged in ibrutinib-treated patients, mainly ischemic heart diseases, pericarditis, uveitis, retinal disorders and fractures. All potential safety signals having arisen in this analysis may support patient care and monitoring of ongoing clinical trials. However, owing to the mandatory limitations of this study, our results need further confirmation using population-based studies.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enIbrutinib
dc.subject.enBruton’s tyrosine kinase inhibitor
dc.subject.enDrug safety
dc.subject.enAdverse drug reaction
dc.subject.enPharmacovigilance
dc.title.enSafety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database
dc.typeArticle de revueen_US
dc.identifier.doi10.3389/fphar.2021.769315en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34776981en_US
bordeaux.journalFrontiers in Pharmacologyen_US
bordeaux.page769315en_US
bordeaux.volume12en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03514429
hal.version1
hal.date.transferred2022-01-06T10:53:14Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=Frontiers%20in%20Pharmacology&amp;rft.date=2021-10-28&amp;rft.volume=12&amp;rft.spage=769315&amp;rft.epage=769315&amp;rft.eissn=1663-9812%20(Print)%201663-9812%20(Linking)&amp;rft.issn=1663-9812%20(Print)%201663-9812%20(Linking)&amp;rft.au=ALLOUCHERY,%20Marion&amp;TOMOWIAK,%20Cecile&amp;LOMBARD,%20Thomas&amp;PERAULT-POCHAT,%20Marie%20Christine&amp;SALVO,%20Francesco&amp;rft.genre=article


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