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Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis

RECOVERY Collaborative Group; Horby, Peter W; Emberson, Jonathan R; Mafham, Marion; Campbell, Mark; Peto, Leon; Pessoa-Amorim, Guilherme; Spata, Enti; Staplin, Natalie; Lowe, Catherine; Chadwick, David R; Brightling, Christopher; Stewart, Richard; Collini, Paul; Ashish, Abdul; Green, Christopher A; Prudon, Benjamin; Felton, Tim; Kerry, Anthony; Baillie, J Kenneth; Buch, Maya H; Day, Jeremy N; Faust, Saul N; Jaki, Thomas; Jeffery, Katie; Juszczak, Edmund; Knight, Marian; Lim, Wei Shen; Montgomery, Alan; Mumford, Andrew; Rowan, Kathryn; Thwaites, Guy; Haynes, Richard; Landray, Martin J

Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis Thumbnail


Authors

RECOVERY Collaborative Group

Peter W Horby

Jonathan R Emberson

Marion Mafham

Mark Campbell

Leon Peto

Guilherme Pessoa-Amorim

Enti Spata

Natalie Staplin

Catherine Lowe

David R Chadwick

Christopher Brightling

Richard Stewart

Paul Collini

Abdul Ashish

Christopher A Green

Benjamin Prudon

Tim Felton

Anthony Kerry

J Kenneth Baillie

Maya H Buch

Jeremy N Day

Saul N Faust

Thomas Jaki

Katie Jeffery

Marian Knight

Wei Shen Lim

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Andrew Mumford

Kathryn Rowan

Guy Thwaites

Richard Haynes

Martin J Landray



Abstract

Background: We aimed to evaluate the use of baricitinib, a Janus kinase (JAK) 1–2 inhibitor, for the treatment of patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple possible treatments in patients hospitalised with COVID-19 in the UK. Eligible and consenting patients were randomly allocated (1:1) to either usual standard of care alone (usual care group) or usual care plus baricitinib 4 mg once daily by mouth for 10 days or until discharge if sooner (baricitinib group). The primary outcome was 28-day mortality assessed in the intention-to-treat population. A meta-analysis was done, which included the results from the RECOVERY trial and all previous randomised controlled trials of baricitinib or other JAK inhibitor in patients hospitalised with COVID-19. The RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936) and is ongoing. Findings: Between Feb 2 and Dec 29, 2021, from 10 852 enrolled, 8156 patients were randomly allocated to receive usual care plus baricitinib versus usual care alone. At randomisation, 95% of patients were receiving corticosteroids and 23% were receiving tocilizumab (with planned use within the next 24 h recorded for a further 9%). Overall, 514 (12%) of 4148 patients allocated to baricitinib versus 546 (14%) of 4008 patients allocated to usual care died within 28 days (age-adjusted rate ratio 0·87; 95% CI 0·77–0·99; p=0·028). This 13% proportional reduction in mortality was somewhat smaller than that seen in a meta-analysis of eight previous trials of a JAK inhibitor (involving 3732 patients and 425 deaths), in which allocation to a JAK inhibitor was associated with a 43% proportional reduction in mortality (rate ratio 0·57; 95% CI 0·45–0·72). Including the results from RECOVERY in an updated meta-analysis of all nine completed trials (involving 11 888 randomly assigned patients and 1485 deaths) allocation to baricitinib or another JAK inhibitor was associated with a 20% proportional reduction in mortality (rate ratio 0·80; 95% CI 0·72–0·89; p<0·0001). In RECOVERY, there was no significant excess in death or infection due to non-COVID-19 causes and no significant excess of thrombosis, or other safety outcomes. Interpretation: In patients hospitalised with COVID-19, baricitinib significantly reduced the risk of death but the size of benefit was somewhat smaller than that suggested by previous trials. The total randomised evidence to date suggests that JAK inhibitors (chiefly baricitinib) reduce mortality in patients hospitalised for COVID-19 by about one-fifth. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research.

Citation

RECOVERY Collaborative Group, Horby, P. W., Emberson, J. R., Mafham, M., Campbell, M., Peto, L., …Landray, M. J. (2022). Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet, 400(10349), 359-368. https://doi.org/10.1016/S0140-6736%2822%2901109-6

Journal Article Type Article
Acceptance Date Jul 15, 2022
Online Publication Date Jul 30, 2022
Publication Date Jul 30, 2022
Deposit Date Jul 29, 2022
Publicly Available Date Mar 28, 2024
Journal The Lancet
Print ISSN 0140-6736
Electronic ISSN 1474-547X
Peer Reviewed Peer Reviewed
Volume 400
Issue 10349
Pages 359-368
DOI https://doi.org/10.1016/S0140-6736%2822%2901109-6
Public URL https://nottingham-repository.worktribe.com/output/7545911
Publisher URL https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01109-6/fulltext

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