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
| العنوان: | 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 |
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| المؤلفون: | Vincent C Marconi, Athimalaipet V Ramanan, Stephanie de Bono, Cynthia E Kartman, Venkatesh Krishnan, Ran Liao, Maria Lucia B Piruzeli, Jason D Goldman, Jorge Alatorre-Alexander, Rita de Cassia Pellegrini, Vicente Estrada, Mousumi Som, Anabela Cardoso, Sujatro Chakladar, Brenda Crowe, Paulo Reis, Xin Zhang, David H Adams, E Wesley Ely, Mi-Young Ahn, Miriam Akasbi, Javier David Altclas, Federico Ariel, Horacio Alberto Ariza, Chandrasekhar Atkar, Anselmo Bertetti, Meenakshi Bhattacharya, Maria 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, Carnevali Daniel, Luiz Fernando Degrecci Relvas, Jose Guillermo Dominguez Cherit, Todd Ellerin, Dmitry Enikeev, Suzana Erico Tanni Minamoto, Elie Fiss, Motohiko Furuichi, Kleber Giovanni Luz, Jason D. Goldman, Omar Gonzalez, 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 Angel Moran Rodriguez, Maria Leonor Parody, Priscila Paulin, 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, Dario Scublinsky, Anete Sevciovic Grumach, Imad Shawa, Jesus Simon Campos, Nidhi Sofat, Christoph D. Spinner, Eduardo Sprinz, Roger Stienecker, Jose Suarez, Natsuo Tachikawa, Hasan Tahir, Brian Tiffany, Alexander Vishnevsky, Adilson Westheimer Cavalcante, Kapil Zirpe |
| المساهمون: | Marconi, V, Ramanan, A, de Bono, S, Kartman, C, Krishnan, V, Liao, R, Piruzeli, M, Goldman, J, Alatorre-Alexander, J, de Cassia Pellegrini, R, Estrada, V, Som, M, Cardoso, A, Chakladar, S, Crowe, B, Reis, P, Zhang, X, Adams, D, Ely, E, Ahn, M, Akasbi, M, Altclas, J, Ariel, F, Ariza, H, Atkar, C, Bertetti, A, Bhattacharya, M, Briones, M, Budhraja, A, Burza, A, Camacho Ortiz, A, Caricchio, R, Casas, M, Cevoli Recio, V, Choi, W, Cohen, E, Comulada-Rivera, A, Cook, P, Cornejo Juarez, D, Daniel, C, Degrecci Relvas, L, Dominguez Cherit, J, Ellerin, T, Enikeev, D, Erico Tanni Minamoto, S, Fiss, E, Furuichi, M, Giovanni Luz, K, Gonzalez, O, Gordeev, I, Gruenewald, T, Hamamoto Sato, V, Heo, E, Heo, J, Hermida, M, Hirai, Y, Hutchinson, D, Iastrebner, C, Ioachimescu, O, Jain, M, Juliani Souza Lima, M, Khan, A, Kremer, A, Lawrie, T, Macelwee, M, Madhani-Lovely, F, Malhotra, V, Martinez Resendez, M, Mckinnell, J, Milligan, P, Minelli, C, Moran Rodriguez, M, Parody, M, Paulin, P, Pellegrini, R, Pemu, P, Procopio Carvalho, A, Puoti, M, Purow, J, Ramesh, M, Rea Neto, A, Robinson, P, Rodrigues, C, Rojas Velasco, G, Saraiva, J, Scheinberg, M, Schreiber, S, Scublinsky, D, Sevciovic Grumach, A, Shawa, I, Simon Campos, J, Sofat, N, Spinner, C, Sprinz, E, Stienecker, R, Suarez, J, Tachikawa, N, Tahir, H, Tiffany, B, Vishnevsky, A, Westheimer Cavalcante, A, Zirpe, K |
| المصدر: | The Lancet. Respiratory Medicine |
| بيانات النشر: | Elsevier Ltd., 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Asia, medicine.medical_treatment, Population, Placebo, Antiviral Agents, Corrections, Dexamethasone, Baricitinib, Double-Blind Method, Adrenal Cortex Hormones, Internal medicine, Clinical endpoint, medicine, Humans, education, Adverse effect, Mechanical ventilation, education.field_of_study, Sulfonamides, Alanine, business.industry, SARS-CoV-2, Hazard ratio, Absolute risk reduction, COVID-19, Odds ratio, Articles, South America, Adenosine Monophosphate, COVID-19 Drug Treatment, Europe, Treatment Outcome, Purines, North America, Azetidines, Pyrazoles, business |
| الوصف: | Summary Background 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. Methods 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 . Findings 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. Interpretation 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. Funding Eli Lilly and Company. Translations For the French, Japanese, Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section. |
| اللغة: | English |
| تدمد: | 2213-2619 2213-2600 0442-1027 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bf64edd09bbf67d7978734149d4c838aTest http://europepmc.org/articles/PMC8409066Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....bf64edd09bbf67d7978734149d4c838a |
| قاعدة البيانات: | OpenAIRE |
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Respiratory Medicine ) Array ( [Name] => Publisher [Label] => Publisher Information [Group] => PubInfo [Data] => Elsevier Ltd., 2021. ) Array ( [Name] => DatePubCY [Label] => Publication Year [Group] => Date [Data] => 2021 ) Array ( [Name] => Subject [Label] => Subject Terms [Group] => Su [Data] => <searchLink fieldCode="DE" term="%22Pulmonary+and+Respiratory+Medicine%22">Pulmonary and Respiratory Medicine</searchLink><br /><searchLink fieldCode="DE" term="%22Adult%22">Adult</searchLink><br /><searchLink fieldCode="DE" term="%22medicine%2Emedical%5Fspecialty%22">medicine.medical_specialty</searchLink><br /><searchLink fieldCode="DE" term="%22Asia%22">Asia</searchLink><br /><searchLink fieldCode="DE" term="%22medicine%2Emedical%5Ftreatment%22">medicine.medical_treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Population%22">Population</searchLink><br /><searchLink fieldCode="DE" term="%22Placebo%22">Placebo</searchLink><br /><searchLink fieldCode="DE" term="%22Antiviral+Agents%22">Antiviral Agents</searchLink><br /><searchLink fieldCode="DE" term="%22Corrections%22">Corrections</searchLink><br /><searchLink fieldCode="DE" term="%22Dexamethasone%22">Dexamethasone</searchLink><br /><searchLink fieldCode="DE" term="%22Baricitinib%22">Baricitinib</searchLink><br /><searchLink fieldCode="DE" term="%22Double-Blind+Method%22">Double-Blind Method</searchLink><br /><searchLink fieldCode="DE" term="%22Adrenal+Cortex+Hormones%22">Adrenal Cortex Hormones</searchLink><br /><searchLink fieldCode="DE" term="%22Internal+medicine%22">Internal medicine</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+endpoint%22">Clinical endpoint</searchLink><br /><searchLink fieldCode="DE" term="%22medicine%22">medicine</searchLink><br /><searchLink fieldCode="DE" term="%22Humans%22">Humans</searchLink><br /><searchLink fieldCode="DE" term="%22education%22">education</searchLink><br /><searchLink fieldCode="DE" term="%22Adverse+effect%22">Adverse effect</searchLink><br /><searchLink fieldCode="DE" term="%22Mechanical+ventilation%22">Mechanical ventilation</searchLink><br /><searchLink fieldCode="DE" term="%22education%2Efield%5Fof%5Fstudy%22">education.field_of_study</searchLink><br /><searchLink fieldCode="DE" term="%22Sulfonamides%22">Sulfonamides</searchLink><br /><searchLink fieldCode="DE" term="%22Alanine%22">Alanine</searchLink><br /><searchLink fieldCode="DE" term="%22business%2Eindustry%22">business.industry</searchLink><br /><searchLink fieldCode="DE" term="%22SARS-CoV-2%22">SARS-CoV-2</searchLink><br /><searchLink fieldCode="DE" term="%22Hazard+ratio%22">Hazard ratio</searchLink><br /><searchLink fieldCode="DE" term="%22Absolute+risk+reduction%22">Absolute risk reduction</searchLink><br /><searchLink fieldCode="DE" term="%22COVID-19%22">COVID-19</searchLink><br /><searchLink fieldCode="DE" term="%22Odds+ratio%22">Odds ratio</searchLink><br /><searchLink fieldCode="DE" term="%22Articles%22">Articles</searchLink><br /><searchLink fieldCode="DE" term="%22South+America%22">South America</searchLink><br /><searchLink fieldCode="DE" term="%22Adenosine+Monophosphate%22">Adenosine Monophosphate</searchLink><br /><searchLink fieldCode="DE" term="%22COVID-19+Drug+Treatment%22">COVID-19 Drug Treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Europe%22">Europe</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+Outcome%22">Treatment Outcome</searchLink><br /><searchLink fieldCode="DE" term="%22Purines%22">Purines</searchLink><br /><searchLink fieldCode="DE" term="%22North+America%22">North America</searchLink><br /><searchLink fieldCode="DE" term="%22Azetidines%22">Azetidines</searchLink><br /><searchLink fieldCode="DE" term="%22Pyrazoles%22">Pyrazoles</searchLink><br /><searchLink fieldCode="DE" term="%22business%22">business</searchLink> ) Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => Summary Background 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. Methods 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 . Findings 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. Interpretation 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. Funding Eli Lilly and Company. Translations For the French, Japanese, Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section. ) Array ( [Name] => Language [Label] => Language [Group] => Lang [Data] => English ) Array ( [Name] => ISSN [Label] => ISSN [Group] => ISSN [Data] => 2213-2619<br />2213-2600<br />0442-1027 ) Array ( [Name] => URL [Label] => Access URL [Group] => URL [Data] => <link linkTarget="URL" linkTerm="https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bf64edd09bbf67d7978734149d4c838a" linkWindow="_blank">https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bf64edd09bbf67d7978734149d4c838a</link><br /><link linkTarget="URL" linkTerm="http://europepmc.org/articles/PMC8409066" linkWindow="_blank">http://europepmc.org/articles/PMC8409066</link> ) Array ( [Name] => Copyright [Label] => Rights [Group] => Cpyrght [Data] => OPEN ) Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edsair.doi.dedup.....bf64edd09bbf67d7978734149d4c838a ) |
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|
| IllustrationInfo |