Effectiveness and Safety of Switching to Ravulizumab From Eculizumab in Kidney Transplant Recipients With Atypical Hemolytic Uremic Syndrome: A Global aHUS Registry Analysis

IF 1.9 4区 医学 Q2 SURGERY
Anja Gaeckler, Imad Al-Dakkak, Nuria Saval, Hans Herman Dieperink, Margriet Eygenraam, Larry A. Greenbaum, Nicole Isbel, Johan Vande Walle
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引用次数: 0

Abstract

Introduction

Atypical hemolytic uremic syndrome (aHUS) is a disease of complement dysregulation that may lead to kidney failure. Ravulizumab and eculizumab are complement C5 inhibitors approved for the treatment of aHUS. This study assessed the real-world effectiveness and safety of switching to ravulizumab from eculizumab in kidney transplant recipients with aHUS.

Methods

The Global aHUS Registry is a multicenter study enrolling patients with aHUS since 2012. Effectiveness and safety outcomes were assessed in kidney transplant recipients with aHUS who switched to ravulizumab from eculizumab up to September 2, 2024.

Results

Overall, 38 patients received a kidney transplant before ravulizumab initiation; 27 patients with ≥3 months of ravulizumab treatment were included in the patient characteristics and effectiveness analyses. Median (range) time on eculizumab and ravulizumab treatment was 66.1 (3.7, 158.3) and 24.1 (4.2, 49.3) months, respectively (n = 27); time from last kidney transplantation to ravulizumab initiation was 65.9 (3.7, 184.0) months. Following ravulizumab initiation, laboratory parameters remained stable, and no kidney transplant rejections/graft failures were reported. In the safety analysis (n = 38), 23 adverse events were reported in 19 patients (50.0%) at or after ravulizumab initiation, and none were considered treatment-related. No new events of thrombotic microangiopathy or kidney impairment and no meningococcal infections or deaths were reported.

Conclusion

This analysis from the Global aHUS Registry provides real-world evidence to demonstrate that the transition to ravulizumab from eculizumab in kidney transplant recipients with aHUS is successful, with stable graft function with no treatment-related safety concerns.

Trial Registration

ClinicalTrials.gov identifier: NCT01522183

Abstract Image

非典型溶血性尿毒症综合征肾移植受者从Eculizumab切换到Ravulizumab的有效性和安全性:一项全球aHUS注册分析
非典型溶血性尿毒症综合征(aHUS)是一种补体失调的疾病,可导致肾衰竭。Ravulizumab和eculizumab是批准用于治疗aHUS的补体C5抑制剂。本研究评估了aHUS肾移植受者从eculizumab切换到ravulizumab的实际有效性和安全性。方法全球aHUS注册是一项多中心研究,自2012年以来纳入了aHUS患者。在2024年9月2日之前,对患有aHUS的肾移植受者从eculizumab转为ravulizumab的有效性和安全性结果进行了评估。总体而言,38例患者在开始ravulizumab治疗前接受了肾移植;27例患者接受了≥3个月的ravulizumab治疗,纳入患者特征和疗效分析。eculizumab和ravulizumab治疗的中位(范围)时间分别为66.1(3.7,158.3)和24.1(4.2,49.3)个月(n = 27);从最后一次肾移植到ravulizumab启动的时间为65.9(3.7,184.0)个月。在ravulizumab启动后,实验室参数保持稳定,没有肾移植排斥反应/移植失败的报告。在安全性分析(n = 38)中,19例患者(50.0%)在ravulizumab开始或开始后报告了23例不良事件,并且没有被认为与治疗相关。没有新的血栓性微血管病变或肾脏损害事件,也没有脑膜炎球菌感染或死亡的报道。这项来自全球aHUS登记处的分析提供了真实的证据,证明aHUS肾移植受者从eculizumab过渡到ravulizumab是成功的,移植物功能稳定,没有治疗相关的安全问题。试验注册ClinicalTrials.gov标识符:NCT01522183
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来源期刊
Clinical Transplantation
Clinical Transplantation 医学-外科
CiteScore
3.70
自引率
4.80%
发文量
286
审稿时长
2 months
期刊介绍: Clinical Transplantation: The Journal of Clinical and Translational Research aims to serve as a channel of rapid communication for all those involved in the care of patients who require, or have had, organ or tissue transplants, including: kidney, intestine, liver, pancreas, islets, heart, heart valves, lung, bone marrow, cornea, skin, bone, and cartilage, viable or stored. Published monthly, Clinical Transplantation’s scope is focused on the complete spectrum of present transplant therapies, as well as also those that are experimental or may become possible in future. Topics include: Immunology and immunosuppression; Patient preparation; Social, ethical, and psychological issues; Complications, short- and long-term results; Artificial organs; Donation and preservation of organ and tissue; Translational studies; Advances in tissue typing; Updates on transplant pathology;. Clinical and translational studies are particularly welcome, as well as focused reviews. Full-length papers and short communications are invited. Clinical reviews are encouraged, as well as seminal papers in basic science which might lead to immediate clinical application. Prominence is regularly given to the results of cooperative surveys conducted by the organ and tissue transplant registries. Clinical Transplantation: The Journal of Clinical and Translational Research is essential reading for clinicians and researchers in the diverse field of transplantation: surgeons; clinical immunologists; cryobiologists; hematologists; gastroenterologists; hepatologists; pulmonologists; nephrologists; cardiologists; and endocrinologists. It will also be of interest to sociologists, psychologists, research workers, and to all health professionals whose combined efforts will improve the prognosis of transplant recipients.
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