Department of Pharmacology, All India Institute of Medical Sciences, Bibinagar, Hyderabad, India.
Department of Pharmacology, TRR Institute of Medical Sciences, Patancheru, India.
Monoclon Antib Immunodiagn Immunother. 2023 Apr;42(2):77-94. doi: 10.1089/mab.2022.0036.
Monoclonal antibodies (mAbs) had received emergency use authorization for mild-to-moderate coronavirus disease 2019 (COVID-19) or for prophylaxis against COVID-19, including casirivimab plus imdevimab (C+I), bamlanivimab plus etesevimab (B+E), tixagevimab plus cilgavimab (T+CG), and sotrovimab (S) and bebtelovimab (BEB). This systematic review was done to assess the efficacy and safety of the same. PubMed, Embase, Scopus, medRxiv, bioRxiv, and FDA fact sheets were searched for the studies published between January 2021 and May 2022, and appropriate search terms related to the mentioned mAbs were used for data collection. Review included original research including randomized clinical trials and observational studies published or preprints. Studies included in the review had compared with placebo or standard of care or no treatment or mAbs with each other and also of various doses. Data extraction was done and reviewed the same for both efficacy and safety. Total of 20 studies were included in this review. The rate of hospitalization within 30 days showed ∼2% in comparison to ∼7% with placebo. Significant reduction in viral load was more observed with combination mAbs. Combination therapy showed faster virological cure against the Gamma variant. With C + I as postexposure prophylaxis (PEP), 29.0% of asymptomatic participants developed symptomatic COVID-19. Pre-exposure prophylaxis with T+CG reduced the incidence of infection by 77%. Infusion-related reaction was the most common adverse event (AE). The neutralizing mAbs reduced hospitalization in mild-to-moderate patients with infusion-related reactions as common AE. The response was better in the seronegative patients. Most of these studies were conducted in unvaccinated individuals and against Alpha, Gamma, and Delta variants.
单克隆抗体（mAbs）已获得用于轻度至中度 2019 年冠状病毒病（COVID-19）或用于预防 COVID-19 的紧急使用授权，包括 casirivimab 加 imdevimab（C+I）、bamlanivimab 加 etesevimab（B+E）、tixagevimab 加 cilgavimab（T+CG）和 sotrovimab（S）以及 bebtelovimab（BEB）。本系统评价旨在评估这些 mAbs 的疗效和安全性。在 2021 年 1 月至 2022 年 5 月期间发表的研究中，检索了 PubMed、Embase、Scopus、medRxiv、bioRxiv 和 FDA 情况说明书，并使用了与上述 mAbs 相关的适当搜索词进行数据收集。综述包括随机临床试验和观察性研究，这些研究已发表或为预印本。综述中包括的研究将接受 mAbs 治疗与安慰剂或标准治疗或不治疗进行了比较，也包括了各种剂量的比较。进行了数据提取，并对疗效和安全性进行了审查。本综述共纳入 20 项研究。与安慰剂相比，30 天内住院率约为 2%，而安慰剂组约为 7%。联合 mAbs 可更显著降低病毒载量。联合治疗对 Gamma 变异株显示更快的病毒学清除。作为暴露后预防（PEP），C+I 使 29.0%的无症状参与者发生有症状 COVID-19。T+CG 的预先暴露预防可将感染发生率降低 77%。输注相关反应是最常见的不良事件（AE）。中和 mAbs 可降低伴有输注相关反应的轻度至中度患者的住院率，常见 AE。在血清阴性患者中反应更好。这些研究大多在未接种疫苗的个体中进行，针对 Alpha、Gamma 和 Delta 变异株。
