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dc.contributor.authorTrøseid, Marius
dc.contributor.authorArribas, José R.
dc.contributor.authorAssoumou, Lambert
dc.contributor.authorHolten, Aleksander Rygh
dc.contributor.authorPoissy, Julien
dc.contributor.authorTerzic, Vida
dc.contributor.authorMazzaferri, Fulvia
dc.contributor.authorBaño, Jesús Rodríguez
dc.contributor.authorEustace, Joe
dc.contributor.authorHites, Maya
dc.contributor.authorJoannidis, Michael
dc.contributor.authorPaiva, José-Artur
dc.contributor.authorReuter, Jean
dc.contributor.authorPüntmann, Isabel
dc.contributor.authorPatrick-Brown, Thale Dawn
dc.contributor.authorWesterheim, Elin
dc.contributor.authorNezvalova-Henriksen, Katerina
dc.contributor.authorBeniguel, Lydie
dc.contributor.authorDahl, Tuva Børresdatter
dc.contributor.authorBouscambert, Maude
dc.contributor.authorHalanova, Monika
dc.contributor.authorPéterfi, Zoltán
dc.contributor.authorTsiodras, Sotirios
dc.contributor.authorRezek, Michael
dc.contributor.authorBriel, Matthias
dc.contributor.authorÜnal, Serhat
dc.contributor.authorSchlegel, Martin
dc.contributor.authorAder, Florence
dc.contributor.authorLacombe, Karine
dc.contributor.authorAmdal, Cecilie Delphin
dc.contributor.authorRodrigues, Serge
dc.contributor.authorTonby, Kristian
dc.contributor.authorGaudet, Alexandre
dc.contributor.authorHeggelund, Lars
dc.contributor.authorMootien, Joy
dc.contributor.authorJohannessen, Asgeir
dc.contributor.authorMøller, Jannicke Horjen
dc.contributor.authorPollan, Beatriz Diaz
dc.contributor.authorTveita, Anders Aune
dc.contributor.authorKildal, Anders Benjamin
dc.contributor.authorRichard, Jean-Christophe
dc.contributor.authorDalgard, Olav
dc.contributor.authorSimensen, Victoria Charlotte
dc.contributor.authorBaldé, Aliou
dc.contributor.authorde Gastines, Lucie
dc.contributor.authordel Álamo, Marta
dc.contributor.authorAydin, Burç
dc.contributor.authorLund-Johansen, Fridtjof
dc.contributor.authorTrabaud, Mary-Anne
dc.contributor.authorDiallo, Alpha
dc.contributor.authorHalvorsen, Bente
dc.contributor.authorRøttingen, John-Arne
dc.contributor.authorTacconelli, Evelina
dc.contributor.authorYazdanpanah, Yazdan
dc.contributor.authorOlsen, Inge Christoffer
dc.contributor.authorCostagliola, Dominique
dc.contributor.authorStudy Group, EU-SolidAct
dc.date.accessioned2023-02-10T12:10:28Z
dc.date.available2023-02-10T12:10:28Z
dc.date.issued2023-01-10
dc.description.abstractBackground Baricitinib has shown efcacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifcally on severe/critical COVID, including vaccinated participants.<p> <p>Methods Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/ critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures. <p>Results Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modifed intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49–69) years, 77% were male and 35% had received at least one dose of SARS-CoV2 vaccine. There were 21 deaths at day 60 in each group, 15.1% in the baricitinib group and 15.4% in the placebo group (adjusted absolute diference and 95% CI −0.1% [−8·3 to 8·0]). In sensitivity analysis censoring observations after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose), proportions of death were 5.8% versus 8.8% (−3.2% [−9.0 to 2.7]), respectively. There were 148 serious adverse events in 46 participants (33.1%) receiving baricitinib and 155 in 51 participants (37.5%) receiving placebo. In subgroup analyses, there was a potential interaction between vaccination status and treatment allocation on 60-day mortality. In a subsequent post hoc analysis there was a signifcant interac‑ tion between vaccination status and treatment allocation on the occurrence of serious adverse events, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib. Vaccinated partici‑ pants were on average 11 years older, with more comorbidities. <p>Conclusion This clinical trial was prematurely stopped for external evidence and therefore underpowered to con‑ clude on a potential survival beneft of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these fnd‑ ings warrant further investigation in other trials and real-world studies.en_US
dc.identifier.citationTrøseid M, Arribas, Assoumou, Holten AR, Poissy J, Terzic, Mazzaferri, Baño, Eustace J, Hites M, Joannidis M, Paiva J, Reuter, Püntmann, Patrick-Brown J.H., Westerheim, Nezvalova-Henriksen K, Beniguel, Dahl TB, Bouscambert M, Halanova, Péterfi, Tsiodras S, Rezek, Briel M, Ünal, Schlegel, Ader F, Lacombe K, Amdal CD, Rodrigues, Tonby K, Gaudet A, Heggelund L, Mootien, Johannessen A, Møller J, Pollan, Tveita A, Kildal AB, Richard J, Dalgard O, Simensen VC, Baldé, de Gastines, del Álamo, Aydin, Lund-Johansen F, Trabaud, Diallo A, Halvorsen BE, Røttingen J, Tacconelli E, Yazdanpanah Y, Olsen IC, Costagliola D, Study Group. Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID‑19 (Bari‑SolidAct): a randomised, double‑blind, placebo‑controlled phase 3 trial. Critical Care. 2023;27(9)en_US
dc.identifier.cristinIDFRIDAID 2104449
dc.identifier.doi10.1186/s13054-022-04205-8
dc.identifier.issn1364-8535
dc.identifier.issn1466-609X
dc.identifier.urihttps://hdl.handle.net/10037/28531
dc.language.isoengen_US
dc.publisherBMCen_US
dc.relation.journalCritical Care
dc.relation.projectIDinfo:eu-repo/grantAgreement/EC/H2020/101015736/EU/European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases/EU-RESPONSE/en_US
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleEfficacy and safety of baricitinib in hospitalized adults with severe or critical COVID‑19 (Bari‑SolidAct): a randomised, double‑blind, placebo‑controlled phase 3 trialen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's license is described as Attribution 4.0 International (CC BY 4.0)