Safety and efficacy of tocilizumab in COVID-19 : a systematic evaluation of adverse effects and therapeutic outcomes

Abstract

BACKGROUND : While COVID-19 has transitioned from a pandemic to an endemic state, the management of its persistent complications continues to present substantial clinical challenges. Tocilizumab, an interleukin-6 receptor antagonist endorsed by the World Health Organization (WHO) for severe COVID-19 management, remains a critical therapeutic intervention. This systematic evaluation provides a comprehensive assessment of tocilizumab's safety and efficacy profile to inform clinical decision-making. METHODS : The study involved exhaustive search across multiple databases (PubMed, SCOPUS, WoS, BIOSIS) utilizing MeSH terms and Boolean operators to identify relevant studies. Methodological worthiness was rigorously evaluated utilizing the Risk of Bias 2 (RoB 2) tool. The statistical analysis of the findings incorporated one-way ANOVA, Mann-Whitney U tests, and Pearson's correlation coefficient (r) with 95 % confidence intervals to quantify adverse effects and therapeutic outcomes. RESULTS : The analysis of nine studies encompassing diverse demographic populations (ages ≥2 years, both sexes) established a clear safety profile for tocilizumab. The treatment demonstrated a statistically important association (P < 0.05) with mild adverse effects (nausea, diarrhea, headache, fatigue; r = 0.62, 95 % CI = 0.59–0.71) and moderate adverse effects (tremors, urinary difficulties, mood changes; r = 0.54, 95 % CI = 0.47–0.60). More concerning were the severe adverse effects, including hepatobiliary dysfunction and hypersensitivity reactions (r = 0.36, 95 % CI = 0.32–0.41), with rare but critical instances of acute liver failure (r = 0.18, 95 % CI = 0.15–0.22). Notably, despite this safety profile, tocilizumab exhibited significant therapeutic efficacy (P < 0.01) in ameliorating COVID-19 symptoms, particularly in cases complicated by cytokine storm syndrome. CONCLUSION : This study confirms tocilizumab's position as a valuable therapeutic agent for COVID-19 complications while highlighting the necessity for judicious patient selection and vigilant monitoring due to its potential for significant adverse effects. The findings underscore the importance of pre-treatment screening, adherence to contraindications, and ongoing pharmacovigilance to optimize risk-benefit ratios.