Jafari Abarghan Yousef, Heiat Mohammad, Jahangiri Abolfazl, Hossein Peypar Mohammad, Abdorrashidi Mahdi, Tohidinia Amirmohammad, Salesi Mahmood, Tajik Shahrzad, Farzaneh Dehkordi Farnaz, Sedighian Hamid
Applied Microbiology Research Center, Biomedicine Technologies Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Clinical Sciences Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Int J Cardiol Heart Vasc. 2024 Aug 7;54:101483. doi: 10.1016/j.ijcha.2024.101483. eCollection 2024 Oct.
Monoclonal antibodies (mAbs) are currently under investigation as a potential therapeutic option for COVID-19. Clinical trials are examining their efficacy in lowering mortality rates and the requirement for mechanical ventilation (MV). It is necessary to conduct a thorough examination of current randomized controlled trials (RCTs) in order to provide more definitive evidence on their effectiveness for COVID-19 patients. This -analysis aims to analyze RCT results on the impact of three mAbs (Anakinra, Sarilumab, Tocilizumab) on COVID-19 patient outcomes.
The -analysis was conducted in accordance with the PRISMA guidelines. Eligible RCTs were conducted to evaluate the effectiveness of three mAbs in treating patients with COVID-19. These trials were identified by searching various databases up to April 1, 2024. In total, this -analysis incorporated 19 trials with a total of 8097 patients. Pooled relative risk and studies' heterogeneity were assessed by statistical analysis, which involved the use of fixed effects models and subgroup analysis.
The administration of mAbs (Tocilizumab, Sarilumab, and Anakinra) showed various results in the management of COVID-19 patients. While the overall pooled data did not reveal a significant reduction in the need for MV, the study found that the use of mAbs was associated with a decreased risk of clinical worsening (pooled relative risk: 0.75, 95 % CI [0.59, 0.94], p = 0.01) and an increased probability of discharging COVID-19 patients by day 28 or 29 (pooled relative risk: 1.17, 95 % CI [1.10, 1.26]). Notably, the subgroup analysis revealed that Tocilizumab had a significant effect in reducing the risk of clinical worsening compared to Sarilumab. Additionally, the analysis of mortality outcomes indicated that the administration of mAbs had the potential to decrease the overall risk of mortality over time (pooled RR: 0.90, 95 % CI [0.83, 0.97], p = 0.01).
In summary, our -analysis suggests that mAbs, particularly Tocilizumab, may play a valuable role in managing COVID-19 by reducing the risk of clinical worsening, improving hospital discharge rates, and decreasing mortality.
单克隆抗体(mAbs)目前正作为治疗新冠肺炎的一种潜在选择进行研究。临床试验正在检验其在降低死亡率和机械通气(MV)需求方面的疗效。有必要对当前的随机对照试验(RCT)进行全面审查,以便为其对新冠肺炎患者的有效性提供更确凿的证据。本分析旨在分析三项单克隆抗体(阿那白滞素、沙瑞鲁单抗、托珠单抗)对新冠肺炎患者预后影响的随机对照试验结果。
本分析按照PRISMA指南进行。开展符合条件的随机对照试验以评估三项单克隆抗体治疗新冠肺炎患者的有效性。通过检索截至2024年4月1日的各种数据库来识别这些试验。本分析总共纳入了19项试验,涉及8097名患者。通过统计分析评估合并相对风险和研究的异质性,其中包括使用固定效应模型和亚组分析。
单克隆抗体(托珠单抗、沙瑞鲁单抗和阿那白滞素)在新冠肺炎患者管理中呈现出不同结果。虽然总体合并数据未显示机械通气需求有显著降低,但研究发现使用单克隆抗体与临床恶化风险降低相关(合并相对风险:0.75,95%可信区间[0.59,0.94],p = 0.01),且在第28天或第29天让新冠肺炎患者出院的概率增加(合并相对风险:1.17,95%可信区间[1.10,1.26])。值得注意的是,亚组分析显示,与沙瑞鲁单抗相比,托珠单抗在降低临床恶化风险方面有显著效果。此外,死亡率结果分析表明,随着时间推移,使用单克隆抗体有可能降低总体死亡风险(合并相对风险:0.90,95%可信区间[0.83,0.97],p = 0.01)。
总之,我们的分析表明,单克隆抗体,尤其是托珠单抗,可能通过降低临床恶化风险、提高出院率和降低死亡率,在新冠肺炎管理中发挥重要作用。