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Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial

dc.rights.licenseopenen_US
dc.contributor.authorVIERMYR, Hans-Kittil
dc.contributor.authorTONBY, Kristian
dc.contributor.authorPONZI, Erica
dc.contributor.authorTROUILLET-ASSANT, Sophie
dc.contributor.authorPOISSY, Julien
dc.contributor.authorARRIBAS, José R
dc.contributor.authorDYON-TAFANI, Virginie
dc.contributor.authorBOUSCAMBERT-DUCHAMP, Maude
dc.contributor.authorASSOUMOU, Lambert
dc.contributor.authorHALVORSEN, Bente
dc.contributor.authorTEKIN, Nuriye Basdag
dc.contributor.authorDIALLO, Alpha
dc.contributor.authorDE GASTINES, Lucie
dc.contributor.authorMUNTHE, Ludvig A
dc.contributor.authorMURPHY, Sarah Louise
dc.contributor.authorUELAND, Thor
dc.contributor.authorMICHELSEN, Annika E
dc.contributor.authorLUND-JOHANSEN, Fridtjof
dc.contributor.authorAUKRUST, Pål
dc.contributor.authorMOOTIEN, Joy
dc.contributor.authorDERVIEUX, Benjamin
dc.contributor.authorZERBIB, Yoann
dc.contributor.authorRICHARD, Jean-Christophe
hal.structure.identifierCentre de recherche Cardio-Thoracique de Bordeaux [Bordeaux] [CRCTB]
dc.contributor.authorPREVEL, Renaud
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMALVY, Denis
dc.contributor.authorTIMSIT, Jean-François
dc.contributor.authorPEIFFER-SMADJA, Nathan
dc.contributor.authorROUX, Damien
dc.contributor.authorPIROTH, Lionel
dc.contributor.authorAIT-OUFELLA, Hafid
dc.contributor.authorVIEIRA, Cesar
dc.contributor.authorDALGARD, Olav
dc.contributor.authorHEGGELUND, Lars
dc.contributor.authorMÜLLER, Karl Erik
dc.contributor.authorMØLLER, Jannicke Horjen
dc.contributor.authorKILDAL, Anders Benjamin
dc.contributor.authorSKOGEN, Vegard
dc.contributor.authorABALLI, Saad
dc.contributor.authorSJØBERG ØGAARD, Jonas Daniel
dc.contributor.authorDYRHOL-RIISE, Anne Ma
dc.contributor.authorTVEITA, Anders
dc.contributor.authorALIREZAYLAVASANI, Amin
dc.contributor.authorCOSTAGLIOLA, Dominique
dc.contributor.authorYAZDANPANAH, Yazdan
dc.contributor.authorOLSEN, Inge Christoffer
dc.contributor.authorDAHL, Tuva Børresdatter
dc.contributor.authorKARED, Hassen
dc.contributor.authorHOLTEN, Aleksander Rygh
dc.contributor.authorTRØSEID, Marius
dc.date.accessioned2025-01-29T13:23:51Z
dc.date.available2025-01-29T13:23:51Z
dc.date.issued2025-01-01
dc.identifier.issn2352-3964en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/204634
dc.description.abstractEnThe Bari-SolidAct randomized controlled trial compared baricitinib with placebo in patients with severe COVID-19. A post hoc analysis revealed a higher incidence of serious adverse events (SAEs) among SARS-CoV-2-vaccinated participants who had received baricitinib. This sub-study aimed to investigate whether vaccination influences the safety profile of baricitinib in patients with severe COVID-19. Biobanked samples from 146 participants (55 vaccinated vs. 91 unvaccinated) were analysed longitudinally for inflammation markers, humoral responses, tissue viral loads, and plasma viral antigens on days 1, 3, and 8. High-dimensional analyses, including RNA sequencing and flow cytometry, were performed on available samples. Mediation analyses were used to assess relationships between SAEs, baseline-adjusted biomarkers, and treatment-vaccination status. Vaccinated participants were older, more frequently hospitalized, had more comorbidities, and exhibited higher nasopharyngeal viral loads. Baricitinib treatment did not affect antibody responses or viral clearance, but reduced markers of T-cell and monocyte activation compared to placebo (sCD25, sCD14, sCD163, sTIM-3). Age, baseline levels of plasma viral antigen, and several inflammatory markers, as well as IL-2, IL-6, Neopterin, CXCL16, sCD14, and suPAR on day 8 were associated with the occurrence of SAEs. However, mediation analyses of markers linked to SAEs, baricitinib treatment, or vaccination status did not reveal statistically significant interactions between vaccination status and SAEs. This sub-study did not identify any virus- or host-related biomarkers significantly associated with the interaction between SARS-CoV-2 vaccination status and the safety of baricitinib. However, caution should be exercised due to the moderate sample size. EU Horizon 2020 (grant number 101015736).
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enHumans
dc.subject.enPurines
dc.subject.enSulfonamides
dc.subject.enAzetidines
dc.subject.enMale
dc.subject.enFemale
dc.subject.enPyrazoles
dc.subject.enMiddle Aged
dc.subject.enCOVID-19
dc.subject.enSARS-CoV-2
dc.subject.enCOVID-19 Drug Treatment
dc.subject.enAged
dc.subject.enViral Load
dc.subject.enCOVID-19 Vaccines
dc.subject.enVaccination
dc.subject.enAdult
dc.subject.enBiomarkers
dc.subject.enAntiviral Agents
dc.title.enSafety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial
dc.title.alternativeEBioMedicineen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.ebiom.2024.105511en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed39731852en_US
bordeaux.journalEBioMedicineen_US
bordeaux.page105511en_US
bordeaux.volume111en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
bordeaux.identifier.funderIDHorizon 2020en_US
bordeaux.import.sourcepubmed
hal.identifierhal-04919162
hal.version1
hal.date.transferred2025-01-29T13:23:58Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=EBioMedicine&rft.date=2025-01-01&rft.volume=111&rft.spage=105511&rft.epage=105511&rft.eissn=2352-3964&rft.issn=2352-3964&rft.au=VIERMYR,%20Hans-Kittil&TONBY,%20Kristian&PONZI,%20Erica&TROUILLET-ASSANT,%20Sophie&POISSY,%20Julien&rft.genre=article


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