tetano
Editor, Senior Moderator
Br J Clin Pharmacol
. 2021 Oct 29.
doi: 10.1111/bcp.15124. Online ahead of print.
Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials
Driton Vela[SUP] 1 [/SUP], Zana Vela-Gaxha[SUP] 1 2 [/SUP], Mjellma Rexhepi[SUP] 1 3 [/SUP], Rozafa Olloni[SUP] 2 [/SUP], Violeta Hyseni[SUP] 4 [/SUP], Rajmonda Nallbani[SUP] 1 5 [/SUP]
Affiliations
Abstract
Aim: 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. RCTs had to include mortality events, incidence of mechanical ventilation, serious adverse events. 2 reviewers were independently responsible for data extraction. Assessment of bias and certainty of evidence was done by using The Cochrane Risk of Bias Tool and GRADE methodology. RR for mortality events was evaluated by using fixed-effects model.
Results: A total of 6837 patients were included from 10 RCTs, of which 9 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=0.0009). 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.
Keywords: COVID-19; meta-analysis; randomized clinical trial; tocilizumab.
. 2021 Oct 29.
doi: 10.1111/bcp.15124. Online ahead of print.
Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials
Driton Vela[SUP] 1 [/SUP], Zana Vela-Gaxha[SUP] 1 2 [/SUP], Mjellma Rexhepi[SUP] 1 3 [/SUP], Rozafa Olloni[SUP] 2 [/SUP], Violeta Hyseni[SUP] 4 [/SUP], Rajmonda Nallbani[SUP] 1 5 [/SUP]
Affiliations
- PMID: 34713921
- DOI: 10.1111/bcp.15124
Abstract
Aim: 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. RCTs had to include mortality events, incidence of mechanical ventilation, serious adverse events. 2 reviewers were independently responsible for data extraction. Assessment of bias and certainty of evidence was done by using The Cochrane Risk of Bias Tool and GRADE methodology. RR for mortality events was evaluated by using fixed-effects model.
Results: A total of 6837 patients were included from 10 RCTs, of which 9 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=0.0009). 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.
Keywords: COVID-19; meta-analysis; randomized clinical trial; tocilizumab.