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Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study

BACKGROUND: Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. METHODS: We performed a retrospective study on severe COVID-19 patient...

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Autores principales: Campochiaro, Corrado, Della-Torre, Emanuel, Cavalli, Giulio, De Luca, Giacomo, Ripa, Marco, Boffini, Nicola, Tomelleri, Alessandro, Baldissera, Elena, Rovere-Querini, Patrizia, Ruggeri, Annalisa, Monti, Giacomo, De Cobelli, Francesco, Zangrillo, Alberto, Tresoldi, Moreno, Castagna, Antonella, Dagna, Lorenzo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Federation of Internal Medicine. Published by Elsevier B.V. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242960/
https://www.ncbi.nlm.nih.gov/pubmed/32482597
http://dx.doi.org/10.1016/j.ejim.2020.05.021
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author Campochiaro, Corrado
Della-Torre, Emanuel
Cavalli, Giulio
De Luca, Giacomo
Ripa, Marco
Boffini, Nicola
Tomelleri, Alessandro
Baldissera, Elena
Rovere-Querini, Patrizia
Ruggeri, Annalisa
Monti, Giacomo
De Cobelli, Francesco
Zangrillo, Alberto
Tresoldi, Moreno
Castagna, Antonella
Dagna, Lorenzo
author_facet Campochiaro, Corrado
Della-Torre, Emanuel
Cavalli, Giulio
De Luca, Giacomo
Ripa, Marco
Boffini, Nicola
Tomelleri, Alessandro
Baldissera, Elena
Rovere-Querini, Patrizia
Ruggeri, Annalisa
Monti, Giacomo
De Cobelli, Francesco
Zangrillo, Alberto
Tresoldi, Moreno
Castagna, Antonella
Dagna, Lorenzo
author_sort Campochiaro, Corrado
collection PubMed
description BACKGROUND: Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. METHODS: We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up. RESULTS: 65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups. CONCLUSIONS: At day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.
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spelling pubmed-72429602020-05-22 Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study Campochiaro, Corrado Della-Torre, Emanuel Cavalli, Giulio De Luca, Giacomo Ripa, Marco Boffini, Nicola Tomelleri, Alessandro Baldissera, Elena Rovere-Querini, Patrizia Ruggeri, Annalisa Monti, Giacomo De Cobelli, Francesco Zangrillo, Alberto Tresoldi, Moreno Castagna, Antonella Dagna, Lorenzo Eur J Intern Med Original Article BACKGROUND: Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. METHODS: We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up. RESULTS: 65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups. CONCLUSIONS: At day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials. European Federation of Internal Medicine. Published by Elsevier B.V. 2020-06 2020-05-22 /pmc/articles/PMC7242960/ /pubmed/32482597 http://dx.doi.org/10.1016/j.ejim.2020.05.021 Text en © 2020 European Federation of Internal Medicine. Published by Elsevier B.V. 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
Campochiaro, Corrado
Della-Torre, Emanuel
Cavalli, Giulio
De Luca, Giacomo
Ripa, Marco
Boffini, Nicola
Tomelleri, Alessandro
Baldissera, Elena
Rovere-Querini, Patrizia
Ruggeri, Annalisa
Monti, Giacomo
De Cobelli, Francesco
Zangrillo, Alberto
Tresoldi, Moreno
Castagna, Antonella
Dagna, Lorenzo
Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
title Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
title_full Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
title_fullStr Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
title_full_unstemmed Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
title_short Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
title_sort efficacy and safety of tocilizumab in severe covid-19 patients: a single-centre retrospective cohort study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242960/
https://www.ncbi.nlm.nih.gov/pubmed/32482597
http://dx.doi.org/10.1016/j.ejim.2020.05.021
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