The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies

Background: Among the several therapeutic options assessed for the treatment of coronavirus disease 2019 (COVID-19), tocilizumab (TCZ), an antagonist of the interleukine-6 receptor, has emerged as a promising therapeutic choice, especially for the severe form of the disease. Proper synthesis of the...

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Autores principales:	Alberto Enrico Maraolo, Anna Crispo, Michela Piezzo, Piergiacomo Di Gennaro, Maria Grazia Vitale, Domenico Mallardo, Luigi Ametrano, Egidio Celentano, Arturo Cuomo, Paolo A. Ascierto, Marco Cascella
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	COVID-19 pneumonia tocilizumab SARS-CoV-2 COVID-19 meta-analysis trial sequential analysis Medicine R
Acceso en línea:	https://doaj.org/article/40df4318293449579a3b4392e929bcbd
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spelling	oai:doaj.org-article:40df4318293449579a3b4392e929bcbd2021-11-11T17:34:21ZThe Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies10.3390/jcm102149352077-0383https://doaj.org/article/40df4318293449579a3b4392e929bcbd2021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/4935https://doaj.org/toc/2077-0383Background: Among the several therapeutic options assessed for the treatment of coronavirus disease 2019 (COVID-19), tocilizumab (TCZ), an antagonist of the interleukine-6 receptor, has emerged as a promising therapeutic choice, especially for the severe form of the disease. Proper synthesis of the available randomized clinical trials (RCTs) is needed to inform clinical practice. Methods: A systematic review with a meta-analysis of RCTs investigating the efficacy of TCZ in COVID-19 patients was conducted. PubMed, EMBASE, and the Cochrane COVID-19 Study Register were searched up until 30 April 2021. Results: The database search yielded 2885 records; 11 studies were considered eligible for full-text review, and nine met the inclusion criteria. Overall, 3358 patients composed the TCZ arm, and 3131 the comparator group. The main outcome was all-cause mortality at 28–30 days. Subgroup analyses according to trials’ and patients’ features were performed. A trial sequential analysis (TSA) was also carried out to minimize type I and type II errors. According to the fixed-effect model approach, TCZ was associated with a better survival odds ratio (OR) (0.84; 95% confidence interval (CI): 0.75–0.94; I<sup>2</sup>: 24% (low heterogeneity)). The result was consistent in the subgroup of severe disease (OR: 0.83; 95% CI: 0.74–0.93; I<sup>2</sup>: 53% (moderate heterogeneity)). However, the TSA illustrated that the required information size was not met unless the study that was the major source of heterogeneity was omitted. Conclusions: TCZ may represent an important weapon against severe COVID-19. Further studies are needed to consolidate this finding.Alberto Enrico MaraoloAnna CrispoMichela PiezzoPiergiacomo Di GennaroMaria Grazia VitaleDomenico MallardoLuigi AmetranoEgidio CelentanoArturo CuomoPaolo A. AsciertoMarco CascellaMDPI AGarticleCOVID-19 pneumoniatocilizumabSARS-CoV-2COVID-19meta-analysistrial sequential analysisMedicineRENJournal of Clinical Medicine, Vol 10, Iss 4935, p 4935 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 pneumonia tocilizumab SARS-CoV-2 COVID-19 meta-analysis trial sequential analysis Medicine R
spellingShingle	COVID-19 pneumonia tocilizumab SARS-CoV-2 COVID-19 meta-analysis trial sequential analysis Medicine R Alberto Enrico Maraolo Anna Crispo Michela Piezzo Piergiacomo Di Gennaro Maria Grazia Vitale Domenico Mallardo Luigi Ametrano Egidio Celentano Arturo Cuomo Paolo A. Ascierto Marco Cascella The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies
description	Background: Among the several therapeutic options assessed for the treatment of coronavirus disease 2019 (COVID-19), tocilizumab (TCZ), an antagonist of the interleukine-6 receptor, has emerged as a promising therapeutic choice, especially for the severe form of the disease. Proper synthesis of the available randomized clinical trials (RCTs) is needed to inform clinical practice. Methods: A systematic review with a meta-analysis of RCTs investigating the efficacy of TCZ in COVID-19 patients was conducted. PubMed, EMBASE, and the Cochrane COVID-19 Study Register were searched up until 30 April 2021. Results: The database search yielded 2885 records; 11 studies were considered eligible for full-text review, and nine met the inclusion criteria. Overall, 3358 patients composed the TCZ arm, and 3131 the comparator group. The main outcome was all-cause mortality at 28–30 days. Subgroup analyses according to trials’ and patients’ features were performed. A trial sequential analysis (TSA) was also carried out to minimize type I and type II errors. According to the fixed-effect model approach, TCZ was associated with a better survival odds ratio (OR) (0.84; 95% confidence interval (CI): 0.75–0.94; I<sup>2</sup>: 24% (low heterogeneity)). The result was consistent in the subgroup of severe disease (OR: 0.83; 95% CI: 0.74–0.93; I<sup>2</sup>: 53% (moderate heterogeneity)). However, the TSA illustrated that the required information size was not met unless the study that was the major source of heterogeneity was omitted. Conclusions: TCZ may represent an important weapon against severe COVID-19. Further studies are needed to consolidate this finding.
format	article
author	Alberto Enrico Maraolo Anna Crispo Michela Piezzo Piergiacomo Di Gennaro Maria Grazia Vitale Domenico Mallardo Luigi Ametrano Egidio Celentano Arturo Cuomo Paolo A. Ascierto Marco Cascella
author_facet	Alberto Enrico Maraolo Anna Crispo Michela Piezzo Piergiacomo Di Gennaro Maria Grazia Vitale Domenico Mallardo Luigi Ametrano Egidio Celentano Arturo Cuomo Paolo A. Ascierto Marco Cascella
author_sort	Alberto Enrico Maraolo
title	The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies
title_short	The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies
title_full	The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies
title_fullStr	The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies
title_full_unstemmed	The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies
title_sort	use of tocilizumab in patients with covid-19: a systematic review, meta-analysis and trial sequential analysis of randomized controlled studies
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/40df4318293449579a3b4392e929bcbd
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The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies

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