Division of Infectious Diseases, Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan, USA.
School of Medicine, Wayne State University, Detroit, Michigan, USA.
J Clin Pharm Ther. 2022 Sep;47(9):1438-1443. doi: 10.1111/jcpt.13694. Epub 2022 May 28.
Anti-spike monoclonal antibodies (MAB) including bamlanivimab (BAM) and bamlanivimab/etesevimab (BAM/E) have shown reduced hospitalization rates for non-severe coronavirus disease 2019 (COVID-19) in clinical trials. Recent data have provided real-world hospitalization rates for high-risk patients treated with BAM, however, data on a similar cohort treated with BAM/E are lacking.
This retrospective cohort study evaluated outpatients ≥18 years with laboratory-confirmed mild/moderate COVID-19 who received MAB from 1 December 2020 to 19 April 2021. Use of BAM monotherapy changed to BAM/E combination on 27 March 2021. Primary outcome was overall rate of COVID-19 related-hospitalization, including comparison of hospitalization rates between MAB-formulation groups. Secondary outcomes were 30-day mortality and length of stay (LOS).
The population included 643 patients (BAM and BAM/E); median age was 58 years, 43% were male, median BMI was 33 kg/m , and 24% self-identified as Black. Patients in the BAM/E combination group were significantly younger with higher median BMI and a longer time from symptom onset to infusion. The incidence of 30-day COVID-19 related hospitalization was similar between patients receiving either BAM or BAM/E combination (7.8% and 7.2%, respectively).
This study represents the first such publication of real-world BAM/E hospitalization outcomes. Hospitalization rates utilizing BAM/E were comparable to BAM in our real-world study.
抗尖峰单克隆抗体(MAB)包括巴姆单抗(BAM)和巴姆单抗/埃特塞韦单抗(BAM/E),在临床试验中显示可降低非重症 2019 年冠状病毒病(COVID-19)的住院率。最近的数据提供了高危患者接受 BAM 治疗的真实世界住院率,但缺乏类似队列接受 BAM/E 治疗的数据。
本回顾性队列研究评估了 2020 年 12 月 1 日至 2021 年 4 月 19 日期间接受 MAB 的实验室确诊为轻度/中度 COVID-19 的年龄≥18 岁的门诊患者。自 2021 年 3 月 27 日起,BAM 单药治疗改为 BAM/E 联合治疗。主要结局是 COVID-19 相关住院的总体发生率,包括比较两种 MAB 制剂组的住院率。次要结局为 30 天死亡率和住院时间(LOS)。
该人群包括 643 例患者(BAM 和 BAM/E);中位年龄为 58 岁,43%为男性,中位 BMI 为 33kg/m ,24%自我认定为黑人。BAM/E 联合组的患者年龄明显较小,BMI 中位数较高,从症状出现到输注的时间较长。接受 BAM 或 BAM/E 联合治疗的患者 30 天 COVID-19 相关住院的发生率相似(分别为 7.8%和 7.2%)。
本研究是首次发表关于 BAM/E 真实世界住院结局的研究。在我们的真实世界研究中,BAM/E 的住院率与 BAM 相当。