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

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Journal of Infection and Public Health Pub Date : 2025-06-18 DOI:10.1016/j.jiph.2025.102873

Othman AlOmeir , Ahmad H. Alhowail , Syed Imam Rabbani , Syed Mohammed Basheeruddin Asdaq , Rafiulla Gilkaramenthi , Abida Khan , Mohd Imran , Tafadzwa Dzinamarira

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引用次数: 0

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.

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托珠单抗治疗COVID-19的安全性和有效性：不良反应和治疗结果的系统评估

虽然COVID-19已从大流行转变为地方性流行，但对其持续性并发症的管理仍然面临重大临床挑战。托珠单抗是世界卫生组织（世卫组织）批准用于严重COVID-19治疗的白介素-6受体拮抗剂，仍然是一种关键的治疗干预措施。该系统评估提供了tocilizumab安全性和有效性的全面评估，为临床决策提供信息。方法利用MeSH术语和布尔运算符对多个数据库（PubMed、SCOPUS、WoS、BIOSIS）进行穷举检索，识别相关研究。使用风险偏倚2 （RoB 2）工具严格评估方法学价值。研究结果的统计分析采用单因素方差分析、Mann-Whitney U检验和Pearson相关系数(r)（95% %置信区间）来量化不良反应和治疗结果。结果对涵盖不同人口统计学人群（年龄≥2岁，男女）的9项研究的分析建立了tocilizumab的明确安全性。治疗与轻度不良反应(恶心、腹泻、头痛、疲劳；r = 0.62,95 % CI = 0.59-0.71)和中度不良反应(震颤、排尿困难、情绪变化；r = 0.54,95 % CI = 0.47-0.60)。更令人担忧的是严重的不良反应，包括肝胆功能障碍和超敏感反应（r = 0.36,95 % CI = 0.32-0.41），以及罕见但严重的急性肝衰竭（r = 0.18,95 % CI = 0.15-0.22）。值得注意的是，尽管有这样的安全性，tocilizumab在改善COVID-19症状方面表现出显著的治疗效果（P <； 0.01），特别是在合并细胞因子风暴综合征的病例中。结论本研究证实了tocilizumab作为COVID-19并发症有价值的治疗药物的地位，同时强调了由于其潜在的重大不良反应，明智的患者选择和警惕监测的必要性。研究结果强调了治疗前筛查、遵守禁忌症和持续的药物警戒对优化风险-收益比的重要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Infection and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH -INFECTIOUS DISEASES

CiteScore

13.10

自引率

1.50%

发文量

203

审稿时长

96 days

期刊介绍： The Journal of Infection and Public Health, first official journal of the Saudi Arabian Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences and the Saudi Association for Public Health, aims to be the foremost scientific, peer-reviewed journal encompassing infection prevention and control, microbiology, infectious diseases, public health and the application of healthcare epidemiology to the evaluation of health outcomes. The point of view of the journal is that infection and public health are closely intertwined and that advances in one area will have positive consequences on the other. The journal will be useful to all health professionals who are partners in the management of patients with communicable diseases, keeping them up to date. The journal is proud to have an international and diverse editorial board that will assist and facilitate the publication of articles that reflect a global view on infection control and public health, as well as emphasizing our focus on supporting the needs of public health practitioners. It is our aim to improve healthcare by reducing risk of infection and related adverse outcomes by critical review, selection, and dissemination of new and relevant information in the field of infection control, public health and infectious diseases in all healthcare settings and the community.