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Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial
OBJECTIVE: Randomized controlled trials comparing tocilizumab and baricitinib in patients with coronavirus disease 2019 (COVID-19) are needed. This was an open-label, randomized controlled trial aiming to address this unmet need. METHODS: To determine whether baricitinib was non-inferior to tocilizu...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9636985/ https://www.ncbi.nlm.nih.gov/pubmed/36273769 http://dx.doi.org/10.1016/j.cmi.2022.10.015 |
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author | Karampitsakos, Theodoros Papaioannou, Ourania Tsiri, Panagiota Katsaras, Matthaios Katsimpris, Andreas Kalogeropoulos, Andreas P. Malakounidou, Elli Zarkadi, Eirini Tsirikos, Georgios Georgiopoulou, Vasiliki Sotiropoulou, Vasilina Koulousousa, Electra Chourpiliadi, Charikleia Matsioulas, Apostolos Lagadinou, Maria Sampsonas, Fotios Akinosoglou, Karolina Marangos, Markos Tzouvelekis, Argyris |
author_facet | Karampitsakos, Theodoros Papaioannou, Ourania Tsiri, Panagiota Katsaras, Matthaios Katsimpris, Andreas Kalogeropoulos, Andreas P. Malakounidou, Elli Zarkadi, Eirini Tsirikos, Georgios Georgiopoulou, Vasiliki Sotiropoulou, Vasilina Koulousousa, Electra Chourpiliadi, Charikleia Matsioulas, Apostolos Lagadinou, Maria Sampsonas, Fotios Akinosoglou, Karolina Marangos, Markos Tzouvelekis, Argyris |
author_sort | Karampitsakos, Theodoros |
collection | PubMed |
description | OBJECTIVE: Randomized controlled trials comparing tocilizumab and baricitinib in patients with coronavirus disease 2019 (COVID-19) are needed. This was an open-label, randomized controlled trial aiming to address this unmet need. METHODS: To determine whether baricitinib was non-inferior to tocilizumab, we assessed whether the upper boundary of the two-sided 95% CI of the hazard ratio (HR) did not exceed 1.50. The primary outcome was mechanical ventilation or death by day 28. Secondary outcomes included time to hospital discharge by day 28 and change in WHO progression scale at day 10. RESULTS: We assigned 251 patients with COVID-19 and a PaO(2)(/)FiO(2) ratio of <200 to receive either tocilizumab (n = 126) or baricitinib (n = 125) plus standard of care. Baricitinib was non-inferior to tocilizumab for the primary composite outcome of mechanical ventilation or death by day 28 (mechanical ventilation or death for patients who received baricitinib, 39.2% [n = 49/125]; mechanical ventilation or death for patients who received tocilizumab, 44.4% [n = 56/126]; HR, 0.83; 95% CI, 0.56–1.21; p 0.001 for non-inferiority). Baricitinib was non-inferior to tocilizumab for the time to hospital discharge within 28 days (patients who received baricitinib- discharged alive: 58.4% [n = 73/125] vs. patients who received tocilizumab- discharged alive: 52.4% [n = 66/126]; HR, 0.85; 95% CI, 0.61–1.18; p < 0.001 for non-inferiority). There was no significant difference between the baricitinib and tocilizumab arms in the change in WHO scale at day 10 (0.0 [95% CI, 0.0–0.0] vs. 0.0 [95% CI, 0.0–1.0]; p 0.83). DISCUSSION: In the setting of this trial, baricitinib was non-inferior to tocilizumab with regards to the composite outcome of mechanical ventilation or death by day 28 and the time to discharge by day 28 in patients with severe COVID-19. |
format | Online Article Text |
id | pubmed-9636985 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-96369852022-11-07 Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial Karampitsakos, Theodoros Papaioannou, Ourania Tsiri, Panagiota Katsaras, Matthaios Katsimpris, Andreas Kalogeropoulos, Andreas P. Malakounidou, Elli Zarkadi, Eirini Tsirikos, Georgios Georgiopoulou, Vasiliki Sotiropoulou, Vasilina Koulousousa, Electra Chourpiliadi, Charikleia Matsioulas, Apostolos Lagadinou, Maria Sampsonas, Fotios Akinosoglou, Karolina Marangos, Markos Tzouvelekis, Argyris Clin Microbiol Infect Original Article OBJECTIVE: Randomized controlled trials comparing tocilizumab and baricitinib in patients with coronavirus disease 2019 (COVID-19) are needed. This was an open-label, randomized controlled trial aiming to address this unmet need. METHODS: To determine whether baricitinib was non-inferior to tocilizumab, we assessed whether the upper boundary of the two-sided 95% CI of the hazard ratio (HR) did not exceed 1.50. The primary outcome was mechanical ventilation or death by day 28. Secondary outcomes included time to hospital discharge by day 28 and change in WHO progression scale at day 10. RESULTS: We assigned 251 patients with COVID-19 and a PaO(2)(/)FiO(2) ratio of <200 to receive either tocilizumab (n = 126) or baricitinib (n = 125) plus standard of care. Baricitinib was non-inferior to tocilizumab for the primary composite outcome of mechanical ventilation or death by day 28 (mechanical ventilation or death for patients who received baricitinib, 39.2% [n = 49/125]; mechanical ventilation or death for patients who received tocilizumab, 44.4% [n = 56/126]; HR, 0.83; 95% CI, 0.56–1.21; p 0.001 for non-inferiority). Baricitinib was non-inferior to tocilizumab for the time to hospital discharge within 28 days (patients who received baricitinib- discharged alive: 58.4% [n = 73/125] vs. patients who received tocilizumab- discharged alive: 52.4% [n = 66/126]; HR, 0.85; 95% CI, 0.61–1.18; p < 0.001 for non-inferiority). There was no significant difference between the baricitinib and tocilizumab arms in the change in WHO scale at day 10 (0.0 [95% CI, 0.0–0.0] vs. 0.0 [95% CI, 0.0–1.0]; p 0.83). DISCUSSION: In the setting of this trial, baricitinib was non-inferior to tocilizumab with regards to the composite outcome of mechanical ventilation or death by day 28 and the time to discharge by day 28 in patients with severe COVID-19. European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. 2023-03 2022-10-20 /pmc/articles/PMC9636985/ /pubmed/36273769 http://dx.doi.org/10.1016/j.cmi.2022.10.015 Text en © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Original Article Karampitsakos, Theodoros Papaioannou, Ourania Tsiri, Panagiota Katsaras, Matthaios Katsimpris, Andreas Kalogeropoulos, Andreas P. Malakounidou, Elli Zarkadi, Eirini Tsirikos, Georgios Georgiopoulou, Vasiliki Sotiropoulou, Vasilina Koulousousa, Electra Chourpiliadi, Charikleia Matsioulas, Apostolos Lagadinou, Maria Sampsonas, Fotios Akinosoglou, Karolina Marangos, Markos Tzouvelekis, Argyris Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial |
title | Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial |
title_full | Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial |
title_fullStr | Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial |
title_full_unstemmed | Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial |
title_short | Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial |
title_sort | tocilizumab versus baricitinib in hospitalized patients with severe covid-19: an open label, randomized controlled trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9636985/ https://www.ncbi.nlm.nih.gov/pubmed/36273769 http://dx.doi.org/10.1016/j.cmi.2022.10.015 |
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