Clinic of Infectious Diseases, Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", Bari, Italy.
Department of Biomedical Sciences and Human Oncology, Section of Internal Medicine 'G. Baccelli' University Hospital Policlinico, Bari, Italy.
Pathog Glob Health. 2022 Jul;116(5):297-304. doi: 10.1080/20477724.2021.2024030. Epub 2022 Feb 9.
The early administration of anti-SARS-CoV-2 monoclonal antibodies (mAb) could decrease the risk of severe disease and the need of inpatients care. Herein, our clinical experience with Bamlanivimab/Etesevimab for the treatment of early SARS-CoV-2 infection through an outpatient service was described. Patients with confirmed COVID-19 were selected by General Practitioners (GPs) if eligible to mAb administration, according to manufacturer and AIFA (Agenzia-Italiana-del-Farmaco) criteria. If suitability was confirmed by the Multidisciplinary Team, the patient was evaluated within the next 48-72 hours. Then, all patients underwent a medical evaluation, followed by mAb infusion or hospitalization if the medical condition had worsened. Overall, from March 29th to June 4th, 2021, 106 patients with confirmed COVID-19 were identified by GPs; 26 were considered not eligible and then excluded, while 9 refused treatment. Among the 71 remaining, 6 were not treated because of worsening of symptoms soon after selection. Finally, 65 received mAb therapy. All treated patients survived. However, 2/65 developed adverse events (allergic reaction and atrial fibrillation, respectively) and 6/65 needed hospitalization. By performing univariate logistic regression analysis, diabetes was the only risk factor for hospitalization after mAb administration [aOR = 9.34, 95%CI = 1.31-66.49, = .026]. Importantly, subjects who worsened awaiting mAb were more frequently obese (OR = 16.66, 95%CI = 1.80-153.9, = .013) and received home corticosteroid therapy for COVID-19 (OR = 14.11, 95%CI = 1.53-129.6, = .019). Establishing a network among GPs and COVID units could be an effective strategy to provide mAb treatment to patients with early SARS-CoV-2 infection to reduce hospitalizations and pressure on healthcare systems.
早期使用抗 SARS-CoV-2 单克隆抗体(mAb)可降低重症疾病风险和住院治疗需求。在此,我们描述了通过门诊服务使用 Bamlanivimab/Etesevimab 治疗早期 SARS-CoV-2 感染的临床经验。符合 mAb 给药条件的患者由全科医生(GPs)选择,如果符合制造商和 AIFA(意大利药品管理局)标准。如果多学科团队确认符合条件,患者将在接下来的 48-72 小时内进行评估。然后,所有患者接受医学评估,如果病情恶化则进行 mAb 输注或住院治疗。总体而言,从 2021 年 3 月 29 日至 6 月 4 日,GPs 共发现 106 例确诊 COVID-19 患者;26 例因不符合条件而被排除在外,9 例拒绝治疗。在剩余的 71 例患者中,有 6 例在选择后不久因症状恶化而未接受治疗。最终,65 例接受了 mAb 治疗。所有接受治疗的患者均存活。然而,2/65 例患者出现不良反应(分别为过敏反应和心房颤动),6/65 例患者需要住院治疗。通过单变量逻辑回归分析,糖尿病是 mAb 给药后住院的唯一危险因素[aOR=9.34,95%CI=1.31-66.49,=0.026]。重要的是,等待 mAb 治疗时病情恶化的患者更常伴有肥胖(OR=16.66,95%CI=1.80-153.9,=0.013)和接受 COVID-19 家庭皮质类固醇治疗(OR=14.11,95%CI=1.53-129.6,=0.019)。在全科医生和 COVID 病房之间建立网络可能是为早期 SARS-CoV-2 感染患者提供 mAb 治疗以减少住院治疗和减轻医疗系统压力的有效策略。