Department of Physiology and Pharmacology "V. Erspamer" University of Rome, Sapienza, Italy; Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy.
Department of Public Health and Infectious Diseases, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy.
Int Immunopharmacol. 2024 Dec 5;142(Pt A):113101. doi: 10.1016/j.intimp.2024.113101. Epub 2024 Sep 12.
Since the discovery of SARS-CoV-2, no treatment has been able to completely eradicate the virus. The study aimed to evaluate the virological and clinical impact of the vaccination in SARS-CoV-2 infected patients treated with monoclonal antibodies (mAbs).
This single-centre, observational, retrospective, real-life study was performed on SARS-CoV-2 symptomatic outpatients and inpatients treated with mAbs from March 2021 to November 2022 includes 726 patients. Each patient received available mAbs (bamlanivimab-etesevimab or casirivimab-indevimab or sotrovimab or tixagevimab-cilgavimab) according to the circulating virus strains. Age, comorbidities, vaccination status, death rates, duration of virological clearance, average length of stay, risk factors, and hospitalization or ICU admission were recorded.
Of 726 patients with complete data analyzed (median age 64), 516 outpatients and 210 inpatients were included. Vaccination status was known for all participants: 74.4 % and 51.7 % were vaccinated against SARS-CoV-2 among inpatients and outpatients, respectively. A shorter duration of virological clearance was observed in the vaccinated group, with a median of 16 days (IQR 15-17), compared to 19 days (IQR 18-21) in the unvaccinated group [HR 1.21; p < 0.032]. Multivariate analysis of virological clearance also showed statistical significance with tixagevimab cilgavimab 300 mg/300 mg (HR 2.73, p value < 0.001). No significant difference was found in worsening [OR 1,29; p = 0.57] and mortality [OR 0.65; p = 0.81] rates between vaccinated and unvaccinated patients treated with mAbs.
Key findings include a shorter duration of virological clearance in vaccinated outpatients but no significant differences in worsening or mortality rates between vaccinated and unvaccinated patients treated with mAbs. The study suggests a potential synergistic role of mAbs in accelerating virological clearance in vaccinated patients with mild to moderate COVID-19, with differing effects in hospitalized patients. Therefore, it is essential to implement health surveillance in high-risk patients with comorbidities in order to identify early any variants that might otherwise escape neutralizing antibodies.
自 SARS-CoV-2 被发现以来，尚无任何治疗方法能够完全清除该病毒。本研究旨在评估接种疫苗对接受单克隆抗体（mAbs）治疗的 SARS-CoV-2 感染患者的病毒学和临床影响。
本项单中心、观察性、回顾性、真实世界研究纳入了 2021 年 3 月至 2022 年 11 月期间接受 mAbs 治疗的 SARS-CoV-2 有症状门诊和住院患者，共纳入 726 例患者。每位患者根据循环病毒株接受了可用的 mAbs（巴姆单抗-etesevimab 或 casirivimab-indevimab 或 sotrovimab 或 tixagevimab-cilgavimab）。记录了年龄、合并症、疫苗接种状态、死亡率、病毒学清除时间、平均住院时间、危险因素、住院或 ICU 入院情况。
在纳入的 726 例有完整数据的患者中（中位年龄 64 岁），516 例为门诊患者，210 例为住院患者。所有患者的疫苗接种状态均已知：住院患者和门诊患者的 SARS-CoV-2 疫苗接种率分别为 74.4%和 51.7%。与未接种疫苗组（19 天 [IQR 18-21]）相比，接种疫苗组的病毒学清除时间更短，中位数为 16 天 [IQR 15-17] [HR 1.21；p<0.032]。病毒学清除的多变量分析也具有统计学意义，tixagevimab cilgavimab 300mg/300mg（HR 2.73，p 值<0.001）。接种 mAbs 治疗的接种组和未接种组的病情恶化[OR 1.29；p=0.57]和死亡率[OR 0.65；p=0.81]无显著差异。
主要发现包括接种门诊患者的病毒学清除时间缩短，但接种 mAbs 治疗的接种组和未接种组的病情恶化或死亡率无显著差异。研究表明，mAbs 可能在加速轻度至中度 COVID-19 接种患者的病毒学清除方面发挥协同作用，而对住院患者的影响则不同。因此，有必要对合并症高危患者进行健康监测，以便及早发现可能逃避中和抗体的任何变异。
