Cooper Megan H, Christensen Paul A, Salazar Eric, Perez Katherine K, Graviss Edward A, Nguyen Duc, Musser James M, Huang Howard J, Liebl Michael G
Department of Pharmacy, Houston Methodist Hospital, Houston, Texas, USA.
Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas, USA.
Open Forum Infect Dis. 2021 Oct 8;8(11):ofab512. doi: 10.1093/ofid/ofab512. eCollection 2021 Nov.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread globally and cause significant morbidity and mortality. Antispike protein monoclonal antibody (mAb) therapy has been shown to prevent progression to severe coronavirus disease 2019 (COVID-19). The objective of this study was to report the outcomes of high-risk, SARS-CoV-2-positive patients infused with 1 of the 3 mAb therapies available through Food and Drug Administration Emergency Use Authorization (EUA).
A total of 4328 SARS-CoV-2-positive patients who satisfied EUA criteria for eligibility for receiving mAb therapy were infused with bamlanivimab or the combination therapies bamlanivimab-etesevimab or casirivimab-imdevimab from November 22, 2020, to May 31, 2021, at 6 infusion clinics and multiple emergency departments within the 8 Houston Methodist Hospitals in Houston, Texas. The primary outcome of hospital admission within 14 and 28 days postinfusion was assessed relative to a propensity score-matched cohort, matched based on age, race/ethnicity, median income by zip code, body mass index, comorbidities, and positive polymerase chain reaction date. Secondary outcomes included intensive care unit admission and mortality.
A total of 2879 infused patients and matched controls were included in the analysis, including 1718 patients infused with bamlanivimab, 346 patients infused with bamlanivimab-etesevimab, and 815 patients infused with casirivimab-imdevimab. Hospital admission and mortality rates were significantly decreased overall in mAb-infused patients relative to matched controls. Among the infused cohort, those who received casirivimab-imdevimab had a significantly decreased rate of admission relative to the other 2 mAb therapy groups (adjusted risk ratio,0.51; =.001).
Treatment with bamlanivimab, bamlanivimab-etesevimab, or casirivimab-imdevimab significantly decreased the number of patients who progressed to severe COVID-19 disease and required hospitalization.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）继续在全球传播，导致大量发病和死亡。抗刺突蛋白单克隆抗体（mAb）疗法已被证明可预防进展为重症冠状病毒病2019（COVID-19）。本研究的目的是报告通过美国食品药品监督管理局紧急使用授权（EUA）获得的三种mAb疗法之一输注的高危SARS-CoV-2阳性患者的治疗结果。
2020年11月22日至2021年5月31日期间，在德克萨斯州休斯顿的8家休斯顿卫理公会医院的6家输液诊所和多个急诊科，共有4328名符合EUA标准且有资格接受mAb治疗的SARS-CoV-2阳性患者接受了巴瑞替尼单抗或联合疗法巴瑞替尼单抗-依替塞韦单抗或卡西瑞维单抗-依德维单抗的输注。相对于倾向评分匹配队列，评估输注后14天和28天内入院的主要结局，该队列根据年龄、种族/族裔、邮政编码中位数收入水平、体重指数、合并症和聚合酶链反应阳性日期进行匹配。次要结局包括重症监护病房入院率和死亡率。
共有2879名输注患者和匹配对照纳入分析，其中1718名患者接受巴瑞替尼单抗输注，346名患者接受巴瑞替尼单抗-依替塞韦单抗输注，815名患者接受卡西瑞维单抗-依德维单抗输注。与匹配对照相比，接受mAb输注的患者总体入院率和死亡率显著降低。在输注队列中，接受卡西瑞维单抗-依德维单抗的患者相对于其他两个mAb治疗组入院率显著降低（调整风险比，0.51；P=.001）。
巴瑞替尼单抗、巴瑞替尼单抗-依替塞韦单抗或卡西瑞维单抗-依德维单抗治疗显著减少了进展为重症COVID-19疾病并需要住院治疗的患者数量。
