Pharmacy Department, Beaumont Health, Dearborn, MI, USA.
Pharmacy Department, Henry Ford Health, Detroit, MI, USA.
J Intensive Care Med. 2023 Jun;38(6):511-518. doi: 10.1177/08850666231155822. Epub 2023 Feb 12.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoaV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic. In randomized clinical trials, patients who were treated with the anti-spike monoclonal antibody bamlanivimab had fewer COVID-19-related hospitalizations or emergency department (ED) visits than the control group. A retrospective cohort was assembled across a multisite healthcare system between November 20, 2020 and March 31, 2021. Ambulatory COVID-19 patients treated with bamlanivimab (n = 209) were propensity score matched without replacement (1:1) to a pool of 1024 eligible control patients who received similar care without bamlanivimab. The primary endpoint was all-cause mortality or admission at 30 days. Secondary endpoints included hospitalization, critical care admission, oxygenation requirements, and infusion-related reactions. Propensity score matching (PSM) analysis was used to assess the effect of bamlanivimab infusion on the composite endpoint and secondary endpoints. A total of n = 209 matched patients were included in each arm of the study. The absolute standardized difference () was calculated and indicated a balance between the groups. Almost all variables had a of less than 0.10, except for respiratory rate (RR) ( = -0.11). For the primary composite endpoint of the matched cohort, 10.1% (n = 21) of patients in the intervention group were hospitalized or deceased within 30-day postbamlanivimab infusion versus 27.8% (n = 58) in the control group (adjusted odds ratio [aOR]: 0.29, 95% confidence interval [CI]: 0.17 to 0.51, < .001). Patients with ambulatory COVID-19 who received bamlanivimab in the outpatient setting had a statistically significant reduction on the odds of admission postinfusion. Despite bamlanivimab's lack of efficacy on newer SARS-CoV-2 variants, this study demonstrates that neutralizing monoclonal antibodies can be effective against specific variants. If variant identification becomes a more accessible tool in outpatient centers or EDs, more targeted therapeutic options may be considered.
严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）是导致 2019 年冠状病毒病（COVID-19）大流行的罪魁祸首。在随机临床试验中，接受抗刺突单克隆抗体巴伦尼单抗治疗的患者与对照组相比，COVID-19 相关住院或急诊（ED）就诊的人数更少。在 2020 年 11 月 20 日至 2021 年 3 月 31 日期间，在一个多地点医疗保健系统中组建了一个回顾性队列。接受巴伦尼单抗治疗的门诊 COVID-19 患者（n=209）进行了无替换的倾向评分匹配（1:1），以匹配一组接受类似护理但未接受巴伦尼单抗治疗的 1024 名合格对照患者。主要终点是 30 天内全因死亡率或入院。次要终点包括住院、重症监护入院、氧合需求和输注相关反应。倾向评分匹配（PSM）分析用于评估巴伦尼单抗输注对复合终点和次要终点的影响。在研究的每个臂中，总共纳入了 n=209 例匹配患者。计算了绝对标准化差异（），并表明组间平衡。除呼吸频率（RR）（=−0.11）外，几乎所有变量的均小于 0.10。对于匹配队列的主要复合终点，干预组中 10.1%（n=21）的患者在接受巴伦尼单抗输注后 30 天内住院或死亡，而对照组中为 27.8%（n=58）（调整后的优势比[aOR]：0.29，95%置信区间[CI]：0.17 至 0.51， < 0.001）。在门诊环境中接受巴伦尼单抗治疗的有症状 COVID-19 患者，在输注后住院的可能性有统计学显著降低。尽管巴伦尼单抗对新型 SARS-CoV-2 变体没有疗效，但这项研究表明，中和单克隆抗体可以针对特定变体有效。如果变异识别成为门诊中心或 ED 中更易于获得的工具，那么可能会考虑更多有针对性的治疗选择。
