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Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials.
Br J Clin Pharmacol. 2022 05; 88(5):1955-1963.BJ

Abstract

AIMS

Tocilizumab has emerged as an important therapy in treating patients with coronavirus disease (COVID-19). Our purpose was to evaluate the efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19.

METHODS

We searched a variety of sources from 1 January 2020 to 5 May 2021. All randomized controlled trials that reported tocilizumab efficacy as a primary agent in COVID-19 patients were considered. RCTs had to include mortality events, incidence of mechanical ventilation and serious adverse events. Two reviewers were independently responsible for data extraction. Assessment of bias and certainty of evidence was carried out using the Cochrane Risk of Bias Tool and GRADE methodology. RR for mortality events was evaluated using a fixed-effects model.

RESULTS

A total of 6837 patients were included from 10 RCTs, of which nine were peer-reviewed. Pooled risk ratio (RR) for all-cause mortality in patients with tocilizumab administration was RR = 0.88 (95% CI: 0.81-0.95, P = .0009). RR for incidence of mechanical ventilation at 28-30 days was 0.79 (95% CI: 0.71-0.88). Serious adverse events (SAE) with tocilizumab use were associated with lower RR (RR = 0.91, 95% CI: 0.76-1.09) but the certainty of evidence was downgraded to moderate due to serious risk of bias.

CONCLUSION

In COVID-19 patients with moderate to critical COVID-19, use of tocilizumab reduces all-cause mortality and progression to mechanical ventilation. This efficacy was not associated with higher number of serious adverse events.

Authors+Show Affiliations

Faculty of Medicine, University of Prishtina, Prishtina, Kosova.Faculty of Medicine, University of Prishtina, Prishtina, Kosova. Clinic of Endocrinology, University Clinical Centre of Kosova, Prishtina, Kosova.Faculty of Medicine, University of Prishtina, Prishtina, Kosova. Clinic of Reumatology, University Clinical Centre of Kosova, Prishtina, Kosova.Clinic of Endocrinology, University Clinical Centre of Kosova, Prishtina, Kosova.Clinic of Cardiology, University Clinical Centre of Kosova, Prishtina, Kosova.Faculty of Medicine, University of Prishtina, Prishtina, Kosova. Clinic of Anesthesiology and Intensive Care, University Clinical Centre of Kosova, Prishtina, Kosova.

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

34713921

Citation

Vela, Driton, et al. "Efficacy and Safety of Tocilizumab Versus Standard Care/placebo in Patients With COVID-19; a Systematic Review and Meta-analysis of Randomized Clinical Trials." British Journal of Clinical Pharmacology, vol. 88, no. 5, 2022, pp. 1955-1963.
Vela D, Vela-Gaxha Z, Rexhepi M, et al. Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials. Br J Clin Pharmacol. 2022;88(5):1955-1963.
Vela, D., Vela-Gaxha, Z., Rexhepi, M., Olloni, R., Hyseni, V., & Nallbani, R. (2022). Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials. British Journal of Clinical Pharmacology, 88(5), 1955-1963. https://doi.org/10.1111/bcp.15124
Vela D, et al. Efficacy and Safety of Tocilizumab Versus Standard Care/placebo in Patients With COVID-19; a Systematic Review and Meta-analysis of Randomized Clinical Trials. Br J Clin Pharmacol. 2022;88(5):1955-1963. PubMed PMID: 34713921.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials. AU - Vela,Driton, AU - Vela-Gaxha,Zana, AU - Rexhepi,Mjellma, AU - Olloni,Rozafa, AU - Hyseni,Violeta, AU - Nallbani,Rajmonda, Y1 - 2021/11/30/ PY - 2021/10/04/revised PY - 2021/05/27/received PY - 2021/10/19/accepted PY - 2021/10/30/pubmed PY - 2022/4/13/medline PY - 2021/10/29/entrez KW - COVID-19 KW - meta-analysis KW - randomized clinical trial KW - tocilizumab SP - 1955 EP - 1963 JF - British journal of clinical pharmacology JO - Br J Clin Pharmacol VL - 88 IS - 5 N2 - AIMS: Tocilizumab has emerged as an important therapy in treating patients with coronavirus disease (COVID-19). Our purpose was to evaluate the efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19. METHODS: We searched a variety of sources from 1 January 2020 to 5 May 2021. All randomized controlled trials that reported tocilizumab efficacy as a primary agent in COVID-19 patients were considered. RCTs had to include mortality events, incidence of mechanical ventilation and serious adverse events. Two reviewers were independently responsible for data extraction. Assessment of bias and certainty of evidence was carried out using the Cochrane Risk of Bias Tool and GRADE methodology. RR for mortality events was evaluated using a fixed-effects model. RESULTS: A total of 6837 patients were included from 10 RCTs, of which nine were peer-reviewed. Pooled risk ratio (RR) for all-cause mortality in patients with tocilizumab administration was RR = 0.88 (95% CI: 0.81-0.95, P = .0009). RR for incidence of mechanical ventilation at 28-30 days was 0.79 (95% CI: 0.71-0.88). Serious adverse events (SAE) with tocilizumab use were associated with lower RR (RR = 0.91, 95% CI: 0.76-1.09) but the certainty of evidence was downgraded to moderate due to serious risk of bias. CONCLUSION: In COVID-19 patients with moderate to critical COVID-19, use of tocilizumab reduces all-cause mortality and progression to mechanical ventilation. This efficacy was not associated with higher number of serious adverse events. SN - 1365-2125 UR - https://www.unboundmedicine.com/medline/citation/34713921/Efficacy_and_safety_of_tocilizumab_versus_standard_care/placebo_in_patients_with_COVID_19 L2 - https://doi.org/10.1111/bcp.15124 DB - PRIME DP - Unbound Medicine ER -