Miljanovic Danijela, Cirkovic Andja, Lazarevic Ivana, Knezevic Aleksandra, Cupic Maja, Banko Ana
Institute of Microbiology and Immunology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
Rev Med Virol. 2023 Jul;33(4):e2439. doi: 10.1002/rmv.2439. Epub 2023 Mar 16.
Until now, the treatment protocols for COVID-19 have been revised multiple times. The use and approval of therapeutic monoclonal antibodies (mAbs) for COVID-19 treatment represent exceptional achievements in modern science, technology and medicine. SARS-CoV-2 Omicron evasion of pre-existing immunity represents a serious public health problem nowadays. This systematic review with meta-analysis provided comprehensive and up-to-date evidence of the clinical efficacy of therapeutic anti-SARS-CoV-2 mAbs against Omicron subvariants in COVID-19 patients and included 10 articles. The prevalence of hospitalisation among Omicron-positive patients treated with anti-SARS-CoV-2 mAbs was 2.8% (89/3169) while it controls (Omicron-positive patients treated with other therapies) 11% (154/1371). There was a statistically significantly different number of hospitalisations between the two studied groups in favour of the anti-SARS-CoV-2 mAbs treated group. (OR = 0.56, 95% CI OR = 0.41-0.77, p < 0.001, respectively). Eight deaths (0.30%) out of 2619 Omicron-positive patients occurred in the anti-SARS-CoV-2 mAbs treated group, while in the control group (Omicron-positive patients treated with other therapies), 27 patients died out of 1401 (1.93%). There was a significantly different number of deaths between the two studied groups in favour of Omicron-positive patients treated with anti-SARS-CoV-2 mAbs (OR = 0.38, 95% CI OR = 0.17-0.85, p = 0.020). Using sotrovimab in treating Omicron-positive patients indicated a reduction of hospitalisation and mortality for 49% and 89% in favour of sotrovimab, respectively (OR = 0.51, 95% CI OR = 0.34-0.79, p = 0.002; OR = 0.11, 95% CI OR = 0.03-0.39, p = 0.001). We could only provide evidence of the positive impact in reducing hospitalisation and mortality rates when anti-SARS-CoV-2 mAbs were used to treat patients infected with Omicron variants BA.1 or BA.2 and not on other Omicron variants.
到目前为止，新冠病毒病（COVID-19）的治疗方案已经多次修订。治疗性单克隆抗体（mAbs）在COVID-19治疗中的应用和获批是现代科学、技术和医学的卓越成就。严重急性呼吸综合征冠状病毒2（SARS-CoV-2）奥密克戎变异株对既往免疫力的逃逸是当今一个严重的公共卫生问题。这项荟萃分析的系统评价提供了治疗性抗SARS-CoV-2单克隆抗体针对COVID-19患者中奥密克戎亚变体临床疗效的全面和最新证据，纳入了10篇文章。接受抗SARS-CoV-2单克隆抗体治疗的奥密克戎阳性患者的住院率为2.8%（89/3169），而其对照组（接受其他疗法治疗的奥密克戎阳性患者）为11%（154/1371）。两个研究组之间的住院人数在统计学上有显著差异，抗SARS-CoV-2单克隆抗体治疗组更具优势。（比值比[OR]=0.56，95%可信区间[CI]OR=0.41 - 0.77，p<0.001）。在接受抗SARS-CoV-2单克隆抗体治疗的2619例奥密克戎阳性患者中，有8例死亡（0.30%），而在对照组（接受其他疗法治疗的奥密克戎阳性患者）中，1401例中有27例死亡（1.93%）。两个研究组之间的死亡人数有显著差异，接受抗SARS-CoV-2单克隆抗体治疗的奥密克戎阳性患者更具优势（OR=0.38，95%CI OR=0.17 - 0.85，p=0.020）。使用索托维单抗治疗奥密克戎阳性患者显示住院率和死亡率分别降低了49%和89%，索托维单抗更具优势（OR=0.51，95%CI OR=0.34 - 0.79，p=0.002；OR=
