Villanego Florentino, Mazuecos Auxiliadora, Cubillo Beatriz, Merino M José, Poveda Inmaculada, Saura Isabel M, Segurado Óscar, Cruzado Leónidas, Eady Myriam, Zárraga Sofía, Aladrén M José, Cabello Sheila, López Verónica, González Esther, Lorenzo Inmaculada, Espí-Reig Jordi, Fernández Constantino, Osma July, Ruiz-Fuentes M Carmen, Toapanta Néstor, Franco Antonio, Burballa Carla C, Muñoz Miguel A, Crespo Marta, Pascual Julio
Department of Nephrology, Hospital Universitario Puerta del Mar, Cádiz, Spain.
Department of Nephrology, Hospital Clínico San Carlos, Madrid, Spain.
Clin Kidney J. 2022 Jul 28;15(10):1847-1855. doi: 10.1093/ckj/sfac177. eCollection 2022 Oct.
Sotrovimab is a neutralizing monoclonal antibody (mAb) that seems to remain active against recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. The evidence on its use in kidney transplant (KT) recipients, however, is limited.
We performed a multicenter, retrospective cohort study of 82 KT patients with SARS-CoV-2 infection {coronavirus disease 2019 [COVID-19]} treated with sotrovimab.
Median age was 63 years. Diabetes was present in 43.9% of patients, and obesity in 32.9% of patients; 48.8% of patients had an estimated glomerular filtration rate under 30 mL/minute/1.73 m. Additional anti-COVID-19 therapies were administered to 56 patients, especially intravenous steroids (65.9%). Sotrovimab was administered early (<5 days from the onset of the symptoms) in 46 patients (56%). Early-treated patients showed less likely progression to severe COVID-19 than those treated later, represented as a lower need for ventilator support (2.2% vs 36.1%; < .001) or intensive care admission (2.2% vs 25%; = .002) and COVID-19-related mortality (2.2% vs 16.7%; = .020). In the multivariable analysis, controlling for baseline risk factors to severe COVID-19 in KT recipients, early use of sotrovimab remained as a protective factor for a composite outcome, including need for ventilator support, intensive care, and COVID-19-related mortality. No anaphylactic reactions, acute rejection episodes, impaired kidney function events, or non-kidney side effects related to sotrovimab were observed.
Sotrovimab had an excellent safety profile, even in high-comorbidity patients and advanced chronic kidney disease stages. Earlier administration could prevent progression to severe disease, while clinical outcomes were poor in patients treated later. Larger controlled studies enrolling KT recipients are warranted to elucidate the true efficacy of monoclonal antibody therapies.
索托维单抗是一种中和性单克隆抗体（mAb），似乎对近期的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变体仍具有活性。然而，其在肾移植（KT）受者中使用的证据有限。
我们对82例接受索托维单抗治疗的SARS-CoV-2感染（2019冠状病毒病[COVID-19]）的KT患者进行了一项多中心回顾性队列研究。
中位年龄为63岁。43.9%的患者患有糖尿病，32.9%的患者患有肥胖症；48.8%的患者估计肾小球滤过率低于30毫升/分钟/1.73平方米。56例患者接受了额外的抗COVID-19治疗，尤其是静脉注射类固醇（65.9%）。46例患者（56%）在症状出现后5天内早期使用了索托维单抗。与晚期治疗的患者相比，早期治疗的患者进展为重症COVID-19的可能性较小，表现为对呼吸机支持的需求较低（2.2%对36.1%；<0.001）或重症监护病房收治率较低（2.2%对25%；=0.002）以及COVID-19相关死亡率较低（2.2%对16.7%；=0.020）。在多变量分析中，在控制KT受者发生重症COVID-19的基线风险因素后，早期使用索托维单抗仍然是包括对呼吸机支持、重症监护和COVID-19相关死亡率在内的综合结局的保护因素。未观察到与索托维单抗相关的过敏反应、急性排斥反应、肾功能损害事件或非肾脏副作用。
即使在高合并症患者和晚期慢性肾脏病阶段，索托维单抗也具有良好的安全性。早期给药可预防进展为重症疾病，而晚期治疗的患者临床结局较差。有必要开展纳入KT受者的更大规模对照研究，以阐明单克隆抗体疗法的真正疗效。
