CASRIVIMAB-IMDEVIMAB和SOTROVIMAB单克隆抗体治疗严重急性呼吸系统综合征冠状病毒2型感染高危患者的疗效:一项真实的经验

B. Tanriover, Abdulmecit Gungor, M. Al‐Obaidi, B. Thajudeen, R. Wong, I. Mansour, T. Zangeneh, K. Johnson, N. Low, Roshan Alam, Erik Alonso González, B. Sandikçi, S. Muruganpandian, G. Gupta, E. Bedrick, T. Saridogan, K. Mendoza
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Out of 109,788 adult patients who tested positive for COVID-19, the study cohort was split into patients who received Casirivimab-Imdevimab (Cas-Imd) (N=10,836; Delta-predominant period 6/2021-11/2021) and Sotrovimab (N=998; Omicron-predominant period 12/2021-1/2022) mAb compared to propensity-matched control groups (N=10,836 and N=998), respectively. Index date was the date of mAb administration or the date of positive COVID-19 testing. The primary and secondary outcomes were the incidence of composite outcome (all-cause hospitalization and/or mortality) and ICU admission at 30-days following index date, respectively. RESULTS: Compared to the propensity-matched untreated control cohort, the Cas-Imd mAb reduced the composite outcome (from 7.5% to 3.7%; difference: -3.8% [95% CI: (-4.4%, -3.2%)], p <0.01) regardless of their vaccination status, while Sotrovimab mAb did not (5.0% vs. 3.8%; difference: -1.2% [95% CI: (-3.1%, 0.7%)], p =0.22). 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引用次数: 1

摘要

背景:严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)可以逃避中和抗体,这引发了人们对抗刺突单克隆抗体(mAb)有效性的担忧。方法:本研究报告了Banner卫生保健系统的回顾性数据分析。在109788名新冠肺炎检测呈阳性的成年患者中,与倾向匹配的对照组(N=10836和N=998)相比,研究队列被分为分别接受Casirivimab-Imdevimab(Cas-Imd)(N=10836;Delta-加重期6/2021-11/2021)和Sotrovimab(N=998;Omicron-加重期12/2021-1/2022)mAb的患者。指标日期是mAb给药日期或新冠肺炎检测呈阳性的日期。主要和次要结果分别是综合结果(全因住院和/或死亡率)的发生率和指标日期后30天的ICU入院率。结果:与倾向匹配的未经治疗的对照队列相比,Cas-Imd-mAb降低了复合结果(从7.5%降低到3.7%;差异:-3.8%[95%CI:(-4.4%,-3.2%)],p<0.01),无论其疫苗接种状态如何,而Sotrovimab mAb没有(5.0%vs.3.8%;差异:-1.2%[95%CI:(-3.1%,0.7%)],p=0.22)。就次要结果而言,同样,与对照组相比,Cas-Imd-mAb在第一次住院期间减少了ICU入院人数(从1.5%到0.5%;差异:-1.0%[95%CI:(-1.3%,-0.7%)],p<0.01),而Sotrovimab mAb没有(0.9%对0.6%;差异:-0.3%[95%CI:(-1.2%,0.6%)],p=0.61),奥密克戎占主导地位的时期比德尔塔占主导地位时期的综合结果更低。结论:Cas-Imd-mAb对严重急性呼吸系统综合征冠状病毒2型德尔塔变异株有效,但sotrovimab在严重急性呼吸系冠状病毒2型奥密克戎显性期患者中缺乏疗效。
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EFFECTIVENESS OF CASIRIVIMAB-IMDEVIMAB AND SOTROVIMAB MONOCLONAL ANTIBODY TREATMENT AMONG HIGH-RISK PATIENTS WITH SARS-CoV-2 INFECTION: A REAL-WORLD EXPERIENCE
BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can evade neutralizing antibodies, raising concerns about the effectiveness of anti-spike monoclonal antibodies (mAb). METHODS: This study reports a retrospective data analysis in Banner Health Care System. Out of 109,788 adult patients who tested positive for COVID-19, the study cohort was split into patients who received Casirivimab-Imdevimab (Cas-Imd) (N=10,836; Delta-predominant period 6/2021-11/2021) and Sotrovimab (N=998; Omicron-predominant period 12/2021-1/2022) mAb compared to propensity-matched control groups (N=10,836 and N=998), respectively. Index date was the date of mAb administration or the date of positive COVID-19 testing. The primary and secondary outcomes were the incidence of composite outcome (all-cause hospitalization and/or mortality) and ICU admission at 30-days following index date, respectively. RESULTS: Compared to the propensity-matched untreated control cohort, the Cas-Imd mAb reduced the composite outcome (from 7.5% to 3.7%; difference: -3.8% [95% CI: (-4.4%, -3.2%)], p <0.01) regardless of their vaccination status, while Sotrovimab mAb did not (5.0% vs. 3.8%; difference: -1.2% [95% CI: (-3.1%, 0.7%)], p =0.22). In terms of the secondary outcome, similarly Cas-Imd mAb decreased ICU admission during the first hospitalization (from 1.5% to 0.5%; difference: -1.0% [95% CI: (-1.3%, -0.7%)], p <0.01) compared to the control group, whereas Sotrovimab mAb did not (0.9% vs. 0.6%; difference: -0.3% [95% CI: (-1.2%, 0.6%)], p =0.61). Comparing the periods, the Omicron-predominant period was associated with lower composite outcome than that during the Delta-predominant period. CONCLUSIONS: Cas-Imd mAb was effective against the SARS-CoV-2 Delta variant, however sotrovimab lacked efficacy in patients with SARS-CoV-2 Omicron-predominant period.
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