RESUMO
This study was carried out to verify the evidence regarding the effectiveness and safety of sotrovimab in patients with COVID-19. This is a systematic review of randomized clinical trials retrieved from the PubMed, Embase, Scopus, Lilacs, and Cochrane Library databases. The risk of bias was measured using the Cochrane Risk and Bias Checklist (RoB 2). For the meta-analysis, RStudio Version 2024.04.2 software was used. The certainty of evidence was assessed using GRADE. The study protocol was registered in PROSPERO (CRD42022355786). A total of 1893 studies were identified and four were included in the study. The total population consisted of 5470 patients with COVID-19, 1921 (35%) in the sotrovimab group and 3549 (65%) in the control group (placebo or BRII-196 + BRII-198 or casirivimab + imdevimab or bamlanivimab + etesevimab, administered in a similar way to sotrovimab, in a single dose with a 60-min intravenous infusion). For the effectiveness outcome, three studies presented low risk and one high risk of bias, while for safety all presented high risk of bias. The meta-analysis showed no significant difference between the sotrovimab and control groups in terms of hospitalization rates (95% confidence interval (CI) - 2.10-0.51; p = 0 > 0.05), use of invasive mechanical ventilation (95% CI - 2.78-0.65; p = 0.35) and mortality (95% CI - 0.92-0.59; p = 0.39). However, sensitivity analysis showed that sotrovimab may be effective in reducing hospitalization rates compared to the control (IV = - 1.57; 95% CI - 2.41-0.73; p = 0.99). The use of sotrovimab in the treatment of patients with COVID-19 had no significant impact on mortality and need for mechanical ventilation and did not appear to be safer compared to controls. However, there was evidence of effectiveness in reducing the rate of hospitalization, although the certainty of the evidence is moderate and the risk of bias is high.
RESUMO
The use of biological immunotherapeutic drugs is one of the options currently being evaluated and employed to manage COVID-19, specifically monoclonal antibodies, which have shown benefit by regulating the excessive immune response seen in patients with severe infection, known as a cytokine storm. Tocilizumab has received particular importance for this clinical application, as has sarilumab. Both drugs share a substantial similarity in terms of pharmacodynamics, being inhibitors of the interleukin six receptor (IL-6Rα). Furthermore, sotrovimab, a neutralizing anti-SARS CoV-2 antibody, has gained the attention of the scientific community since it has recently been authorized under certain circumstances, positioning itself as a new therapeutic alternative in development. However, despite their clinical benefit, biological immunotherapies have the potential to generate life-threatening immune-related adverse events. Therefore it is essential to review their incidence, mechanism, and risk factors. This review aims to provide a comprehensive understanding of the safety of the biological immunotherapeutic drugs currently recommended for the treatment of COVID-19, provide a review of the known immune-mediated adverse events and explore the potential immune-related mechanisms of other adverse reactions.
RESUMO
The WHO Therapeutics and COVID-19: living guideline contains the Organization's most up-to-date recommendations for the use of therapeutics in the treatment of COVID-19. The latest version of this living guideline is available in pdf format (via the 'Download' button) and via an online platform, and is updated regularly as new evidence emerges. This twelfth version of the WHO living guideline now contains 19 recommendations. This latest update provides updated recommendations for remdesivir, addresses the use of combination therapy with corticosteroids, interleukin-6 (IL-6) receptor blockers and Janus kinase (JAK) inhibitors in patients with severe or critical COVID-19, and modifies previous recommendations for the neutralizing monoclonal antibodies sotrovimab and casirivimab-imdevimab in patients with non-severe COVID-19.