Dataset Information

Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials.

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.

SUBMITTER: Vela D

PROVIDER: S-EPMC8653234 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials.

Vela Driton D Vela-Gaxha Zana Z Rexhepi Mjellma M Olloni Rozafa R Hyseni Violeta V Nallbani Rajmonda R

British journal of clinical pharmacology 20211130 5

<h4>Aims</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 34713921

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Project description:BackgroundWe aimed to evaluate the efficacy and safety of biologic agents targeting three main cytokines, that is, nerve growth factor (NGF), interleukin-1 (IL-1), and tumor necrosis factor-α (TNF-α), for osteoarthritis (OA) treatment.MethodsDatabases (PubMed, Embase, and Cochrane Library) and ClinicalTrials.gov were systematically searched for randomized placebo-controlled trials (RCTs) of biologic agents from inception to November 15, 2020. The outcomes were the mean change in pain, function scores, and the risk of adverse effects (AEs).ResultsOut of the 28 studies with 29 RCTs (8555 individuals) included, biologic agents were superior to placebo in pain relief (standardized mean difference [SMD] = 0.28, 95% confidence interval [CI] = 0.17-0.38, p < 0.001) and function improvement (SMD = 0.30, 95% CI = 0.18-0.43, p < 0.001). The incidence of any AEs (risk ratio [RR] = 1.09, 95% CI = 1.05-1.14, p < 0.001) and discontinuations due to AEs (RR = 1.39, 95% CI = 1.05-1.83, p = 0.021) were higher following treatment with biologic agents while no significant difference was found in serious AEs. Subgroup analyses showed that NGF inhibitors provided superior pain relief (SMD = 0.36, 95% CI = 0.26-0.47, p < 0.001) and function improvement (SMD = 0.41, 95% CI = 0.30-0.51, p < 0.001), whereas IL-1 inhibitors and TNF-α inhibitors did not. Meanwhile, NGF inhibitors increased the incidence of any AEs (RR = 1.12, 95% CI = 1.07-1.17, p < 0.001) and discontinuations due to AEs (RR = 1.48, 95% CI = 1.07-2.06, p = 0.018). IL-1 inhibitors and TNF-α inhibitors showed no difference in safety compared with placebo.ConclusionsThe efficacy and safety of biologic agents vary by mechanism of action. NGF inhibitors can relieve OA-related pain and improve function but involve safety concerns. IL-1 inhibitors and TNF-α inhibitors are relatively safe options but with limited efficacy.

Project description:BackgroundMany recent trials have investigated the long-term efficacy and safety of endarterectomy versus stenting in treating patients with carotid artery stenosis. We aimed to determine the long-term comparative efficacy and safety of both procedures by pooling this evidence in a meta-analysis.MethodsWe searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published until May 6, 2016. Randomized controlled trials, which reported outcomes of interest with a median follow-up of at least 4-year, were included.ResultsEight trials involving 7005 patients and 41824 patient-years of follow-up were included. In terms of the periprocedural outcomes, stenting was associated with a lower risk of myocardial infarction (OR: 0.51; 95% CI: 0.33 to 0.80; P = 0.003) but a higher risk of death or stroke (the composite endpoint, OR: 1.76; 95% CI: 1.38 to 2.25; P < 0.0001), a result that was primarily driven by minor stroke (OR: 2.19; 95% CI: 1.59 to 3.01; P < 0.0001), less so by periprocedural death (OR: 1.68; 95% CI: 0.82 to 3.44; P = 0.16) and major stroke (OR: 1.41; 95% CI: 0.95 to 2.09; P = 0.09). In terms of the long-term outcomes, stenting was associated with a higher risk of stroke (OR 1.45; 95% CI: 1.22 to 1.73; P < 0.0001) and the composite outcome of death or stroke (OR 1.25; 95% CI: 1.05 to 1.48; P = 0.01). No difference was found in long-term all-cause mortality between stenting and endarterectomy (OR: 1.09; 95% CI: 0.95 to 1.26; P = 0.21) and restenosis (OR: 1.48 (95% CI: 0.93 to 2.35; P = 0.10). No evidence of significant heterogeneity was found in any of the analyses.ConclusionsCarotid endarterectomy was found to be superior to stenting for short- and long-term outcomes, although endarterectomy was associated with a higher risk of periprocedural myocardial infarction. Carotid endarterectomy should be offered as the first choice for carotid stenosis at present, however, more evidence is needed because rapid progress in concurrent devices and medical treatments is being made.

Dataset Information

Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials.

Aims

Methods

Results

Conclusion

Publications

Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials.

Similar Datasets

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