Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial
Vincent C. Marconi
,
Athimalaipet V Ramanan
,
Stephanie de Bono
,
Cynthia E Kartman
,
Venkatesh Krishnan
,
RAN LIAO
,
Maria Lucia B Piruzeli
,
Rita De Cassia Pellegrini
,
Anabela Cardoso
,
Sujatro Chakladar
,
Brenda Crowe
,
Paulo Reis
,
David H. Adams
,
E Wesley Ely
,
Mi Young Ahn
,
Miriam Akasbi
,
Jorge Alatorre Alexander
,
Javier David Altclas
,
Federico Ariel
,
Horacio Alberto Ariza
,
Chandrasekhar Atkar
,
Anselmo Bertetti
,
Meenakshi Bhattacharya
,
María Luisa Briones
,
Akshay Budhraja
,
Aaliya Burza
,
Adrian Camacho-Ortiz
,
Roberto Caricchio
,
Marcelo Casas
,
Valeria Cevoli Recio
,
Won Suk Choi
,
Emilia Cohen
,
Angel Comulada Rivera
,
PAUL COOK
,
Dora Patricia Cornejo Juarez
,
Daniel Carnevali
,
Luiz Fernando Degrecci Relvas
,
Jose Guillermo Dominguez Cherit
,
Todd Ellerin
,
Dmitry Enikeev
,
Suzana Erico Tanni Minamoto
,
Vicente Estrada
,
Elie Fiss
,
Motohiko Furuichi
,
Giovanni Luz Kleber
,
Jason D. Goldman
,
Omar González
,
Ivan Gordeev
,
Thomas Gruenewald
,
Victor Augusto Hamamoto Sato
,
Eun Young Heo
,
Jung Yeon Heo
,
Maria Hermida
,
Yuji Hirai
,
David Hutchinson
,
Claudio Iastrebner
,
Octavian Ioachimescu
,
Manish Jain
,
Maria Patelli Juliani Souza Lima
,
Akram Khan
,
Andreas E. Kremer
,
Thomas Lawrie
,
Mark Macelwee
,
Farah Madhani-Lovely
,
VINAY MALHOTRA
,
Michel Fernando Martínez Resendez
,
James McKinnell
,
Patrick Milligan
,
Cesar Minelli
,
Miguel Ángel Morán Rodríguez
,
Maria Leonor Parody
,
Priscila Paulin
,
Rita De Cassia Pellegrini
,
Priscilla Pemu
,
Ana Carolina Procopio Carvalho
,
Massimo Puoti
,
Joshua Purow
,
Mayur Ramesh
,
Alvaro Rea-Neto
,
Philip Robinson
,
Cristhieni Rodrigues
,
Gustavo Rojas‐Velasco
,
Jose Francisco Kerr Saraiva
,
Morton Scheinberg
,
Stefan Schreiber
,
Darío Scublinsky
,
Anete Sevciovic Grumach
,
Imad Shawa
,
Jesus Simon Campos
,
Nidhi Sofat
,
Mousumi Som
,
Christoph D. Spinner
,
Eduardo Sprinz
,
Roger Stienecker
,
Jose Suarez
,
Natsuo Tachikawa
,
Hasan Tahir
,
Brian Tiffany
,
Alexander Vishnevsky
,
Adilson Westheimer Cavalcante
,
Kapil Zirpe
Publication type: Journal Article
Publication date: 2021-12-01
scimago Q1
wos Q1
SJR: 6.788
CiteScore: 53.2
Impact factor: 32.8
ISSN: 22132600, 22132619
PubMed ID:
34480861
Pulmonary and Respiratory Medicine
Abstract
Baricitinib is an oral selective Janus kinase 1/2 inhibitor with known anti-inflammatory properties. This study evaluates the efficacy and safety of baricitinib in combination with standard of care for the treatment of hospitalised adults with COVID-19.In this phase 3, double-blind, randomised, placebo-controlled trial, participants were enrolled from 101 centres across 12 countries in Asia, Europe, North America, and South America. Hospitalised adults with COVID-19 receiving standard of care were randomly assigned (1:1) to receive once-daily baricitinib (4 mg) or matched placebo for up to 14 days. Standard of care included systemic corticosteroids, such as dexamethasone, and antivirals, including remdesivir. The composite primary endpoint was the proportion who progressed to high-flow oxygen, non-invasive ventilation, invasive mechanical ventilation, or death by day 28, assessed in the intention-to-treat population. All-cause mortality by day 28 was a key secondary endpoint, and all-cause mortality by day 60 was an exploratory endpoint; both were assessed in the intention-to-treat population. Safety analyses were done in the safety population defined as all randomly allocated participants who received at least one dose of study drug and who were not lost to follow-up before the first post-baseline visit. This study is registered with ClinicalTrials.gov, NCT04421027.Between June 11, 2020, and Jan 15, 2021, 1525 participants were randomly assigned to the baricitinib group (n=764) or the placebo group (n=761). 1204 (79·3%) of 1518 participants with available data were receiving systemic corticosteroids at baseline, of whom 1099 (91·3%) were on dexamethasone; 287 (18·9%) participants were receiving remdesivir. Overall, 27·8% of participants receiving baricitinib and 30·5% receiving placebo progressed to meet the primary endpoint (odds ratio 0·85 [95% CI 0·67 to 1·08], p=0·18), with an absolute risk difference of -2·7 percentage points (95% CI -7·3 to 1·9). The 28-day all-cause mortality was 8% (n=62) for baricitinib and 13% (n=100) for placebo (hazard ratio [HR] 0·57 [95% CI 0·41-0·78]; nominal p=0·0018), a 38·2% relative reduction in mortality; one additional death was prevented per 20 baricitinib-treated participants. The 60-day all-cause mortality was 10% (n=79) for baricitinib and 15% (n=116) for placebo (HR 0·62 [95% CI 0·47-0·83]; p=0·0050). The frequencies of serious adverse events (110 [15%] of 750 in the baricitinib group vs 135 [18%] of 752 in the placebo group), serious infections (64 [9%] vs 74 [10%]), and venous thromboembolic events (20 [3%] vs 19 [3%]) were similar between the two groups.Although there was no significant reduction in the frequency of disease progression overall, treatment with baricitinib in addition to standard of care (including dexamethasone) had a similar safety profile to that of standard of care alone, and was associated with reduced mortality in hospitalised adults with COVID-19.Eli Lilly and Company.For the French, Japanese, Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.
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Marconi V. C. et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial // The Lancet Respiratory Medicine. 2021. Vol. 9. No. 12. pp. 1407-1418.
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Marconi V. C. et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial // The Lancet Respiratory Medicine. 2021. Vol. 9. No. 12. pp. 1407-1418.
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@article{2021_Marconi,
author = {Vincent C. Marconi and Athimalaipet V Ramanan and Stephanie de Bono and Cynthia E Kartman and Venkatesh Krishnan and RAN LIAO and Maria Lucia B Piruzeli and Rita De Cassia Pellegrini and Anabela Cardoso and Sujatro Chakladar and Brenda Crowe and Paulo Reis and Xin Zhang and David H. Adams and E Wesley Ely and Mi Young Ahn and Miriam Akasbi and Jorge Alatorre Alexander and Javier David Altclas and Federico Ariel and Horacio Alberto Ariza and Chandrasekhar Atkar and Anselmo Bertetti and Meenakshi Bhattacharya and María Luisa Briones and Akshay Budhraja and Aaliya Burza and Adrian Camacho-Ortiz and Roberto Caricchio and Marcelo Casas and Valeria Cevoli Recio and Won Suk Choi and Emilia Cohen and Angel Comulada Rivera and PAUL COOK and Dora Patricia Cornejo Juarez and Daniel Carnevali and Luiz Fernando Degrecci Relvas and Jose Guillermo Dominguez Cherit and Todd Ellerin and Dmitry Enikeev and Suzana Erico Tanni Minamoto and Vicente Estrada and Elie Fiss and Motohiko Furuichi and Giovanni Luz Kleber and Jason D. Goldman and Omar González and Ivan Gordeev and Thomas Gruenewald and others},
title = {Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial},
journal = {The Lancet Respiratory Medicine},
year = {2021},
volume = {9},
publisher = {Elsevier},
month = {dec},
url = {https://doi.org/10.1016/S2213-2600(21)00331-3},
number = {12},
pages = {1407--1418},
doi = {10.1016/S2213-2600(21)00331-3}
}
Cite this
MLA
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Marconi, Vincent C., et al. “Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial.” The Lancet Respiratory Medicine, vol. 9, no. 12, Dec. 2021, pp. 1407-1418. https://doi.org/10.1016/S2213-2600(21)00331-3.