Abstract
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; I2: 24% (low heterogeneity)). The result was consistent in the subgroup of severe disease (OR: 0.83; 95% CI: 0.74–0.93; I2: 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.
Highlights
Introduction distributed under the terms andTocilizumab (TCZ) is a humanized monoclonal antibody that, via the binding to soluble and membrane interleukin (IL)-6 receptors, produces inhibition of the proinflammatory signals [1]
PubMed, EMBASE, and the Cochrane COVID-19 Study Register were searched up until 30 April 2021 for randomized clinical trials (RCTs) to investigate the efficacy of TCZ in COVID-19 patients
11 studies were considered eligible for full-text review, and nine met the inclusion criteria [22,23,24,25,26,27,28,29,30]
Summary
Tocilizumab (TCZ) is a humanized monoclonal antibody that, via the binding to soluble and membrane interleukin (IL)-6 receptors, produces inhibition of the proinflammatory signals [1] It is commonly used in several types of inflammatory arthritis, in Castleman’s syndrome, and in cytokine release syndrome secondary to chimeric antigen receptor T cell conditions of the Creative Commons. The precise pathogenesis of the coronavirus disease 2019 (COVID-19) pneumonia remains unsolved, evidence showed that within a complex cytokine storm scenario, SARS-CoV-2 provokes a dramatic increase in IL-6 levels [4]. Based on this evidence, it was suggested to use TCZ for improving the patients’ outcomes in COVID-19 pneumonia [5]. Proper synthesis of the available randomized clinical trials (RCTs) is needed to inform clinical practice
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