The Real-World Safety and Effectiveness of Rituximab in Preventing Antibody-Mediated Rejection in ABO-Incompatible Liver Transplantation: All-Case Postmarketing Surveillance in Japan

IF 0.8 4区医学 Q4 IMMUNOLOGY

Transplantation proceedings Pub Date : 2026-07-01 Epub Date: 2026-06-11 DOI:10.1016/j.transproceed.2026.05.014

Mana Kobayashi, Junko Sakamoto, Takashi Ando

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引用次数: 0

Abstract

Background

In ABO-incompatible (ABOi) liver transplantation, antibody-mediated rejection (AMR) is a challenging post-transplant complication. In Japan, rituximab was approved in 2016 to prevent AMR in ABOi kidney and liver transplantation and in 2023 to prevent and treat AMR in kidney, liver, heart, lung, pancreas, and intestine transplantation.

Methods

We conducted an all-case postmarketing surveillance to assess the safety and effectiveness of rituximab in ABOi liver transplant recipients, with a registration period between February 29, 2016 and May 9, 2021. The safety endpoint was the occurrence of adverse drug reactions (ADRs). The effectiveness endpoints were the AMR-free rates at weeks 4 and 24 post-transplant. Graft survival rates, rejection-free rates (excluding AMR), and survival rates at weeks 24 and 48 were also assessed.

Results

In the safety analysis set, 50.3% (91/181) were male, 8.8% (16/181) were aged ≥ 65 years, 12.8% (23/180) were considered at high risk for cytomegalovirus (CMV) infection, and 95.0% (171/180) received a single infusion preoperatively. ADRs and serious ADRs occurred in 65.7% (119/181) and 27.6% (50/181), respectively. ADRs associated with infection occurred in 57.5% (104/181), with CMV infection being the most frequent event. Twenty-four adverse events leading to death occurred in 16 patients, 7 of whom died from 11 ADRs. In the effectiveness analysis set of 183 patients, the AMR-free rate was 93.4% at weeks 4 and 24. At week 48, the graft survival rate was 94.8%, and the survival rate was 90.6%.

Conclusion

Rituximab had an acceptable safety profile in real-world settings in ABOi liver transplantation.

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利妥昔单抗预防abo血型不相容肝移植抗体介导排斥反应的安全性和有效性：日本所有病例上市后监测

背景：在abo血型不相容（ABOi）肝移植中，抗体介导的排斥反应（AMR）是一个具有挑战性的移植后并发症。在日本，利妥昔单抗于2016年被批准用于预防ABOi肾和肝移植中的AMR，并于2023年被批准用于预防和治疗肾、肝、心、肺、胰腺和肠移植中的AMR。方法：我们进行了一项全病例上市后监测，以评估利妥昔单抗在ABOi肝移植受者中的安全性和有效性，注册期为2016年2月29日至2021年5月9日。安全性终点是药物不良反应（adr）的发生。疗效终点为移植后第4周和第24周的无amr率。移植存活率、无排斥反应率（不包括AMR）以及第24周和第48周的存活率也进行了评估。结果：安全性分析集中，50.3%（91/181）的患者为男性，8.8%（16/181）的患者年龄≥65岁，12.8%（23/180）的患者为巨细胞病毒（CMV）感染高危人群，95.0%（171/180）的患者术前接受过单次输液。adr发生率为65.7%(119/181)，严重adr发生率为27.6%（50/181）。与感染相关的不良反应发生率为57.5%(104/181)，其中巨细胞病毒感染是最常见的事件。16例患者发生24例导致死亡的不良事件，其中7例死于11例adr。在183例患者的疗效分析集中，在第4周和第24周，amr无率为93.4%。第48周，移植物成活率为94.8%，存活率为90.6%。结论：利妥昔单抗在ABOi肝移植中具有可接受的安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Transplantation proceedings 医学-免疫学

CiteScore

1.70

自引率

0.00%

发文量

502

审稿时长

60 days

期刊介绍： Transplantation Proceedings publishes several different categories of manuscripts, all of which undergo extensive peer review by recognized authorities in the field prior to their acceptance for publication. The first type of manuscripts consists of sets of papers providing an in-depth expression of the current state of the art in various rapidly developing components of world transplantation biology and medicine. These manuscripts emanate from congresses of the affiliated transplantation societies, from Symposia sponsored by the Societies, as well as special Conferences and Workshops covering related topics. Transplantation Proceedings also publishes several special sections including publication of Clinical Transplantation Proceedings, being rapid original contributions of preclinical and clinical experiences. These manuscripts undergo review by members of the Editorial Board. Original basic or clinical science articles, clinical trials and case studies can be submitted to the journal?s open access companion title Transplantation Reports.