Relapses and serious adverse events during rituximab maintenance therapy in ANCA-associated vasculitis: a multicentre retrospective study.

IF 4.7 2区医学 Q1 RHEUMATOLOGY

Rheumatology Pub Date : 2025-04-01 DOI:10.1093/rheumatology/keae409

Chrysoula G Gialouri, Aglaia Chalkia, Christos Koutsianas, Katerina Chavatza, Evangelia Argyriou, Alexandros Panagiotopoulos, Anastasios Karamanakos, Aikaterini Dimouli, Christina Tsalapaki, Konstantinos Thomas, Philippos Orfanos, Pagona Lagiou, George Katsikas, Kyriaki Boki, Dimitrios Boumpas, Dimitrios Petras, Dimitrios Vassilopoulos

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引用次数: 0

Abstract

Objectives: There are limited real-life data regarding the efficacy and safety of rituximab (RTX) as a remission maintenance agent in microscopic polyangiitis (MPA) and granulomatosis-with-polyangiitis (GPA). We aimed to estimate the incidence and risk factors for relapses, as well for serious adverse events (SAEs) in MPA/GPA patients during RTX maintenance.

Methods: A retrospective cohort of newly diagnosed/relapsing GPA/MPA patients who received RTX maintenance (≥1 RTX cycle, ≥6 months follow-up) following complete remission (BVAS version-3 = 0 plus prednisolone ≤7.5 mg/day) with induction regimens. SAEs included serious infections, COronaVIrus-Disease 2019 (COVID-19)-associated hospitalizations, deaths, cardiovascular events, malignancies and hypogammaglobulinemia. The incidence rates (IRs) and relapse-free survival were estimated through Kaplan-Meier plots. Cox regression was conducted to investigate factors associated with the time-to-relapse.

Results: A total of 101 patients were included: 48% females, 69% GPA, 53% newly diagnosed, median age 63 years. During follow-up (294.5 patient-years, median: 3 RTX cycles), 30 relapses (57% major) occurred among 24 patients (24%, IR 10.2/100 patient-years). Kidney involvement (adjusted hazard ratio/aHR: 0.20; 95% CI: 0.06-0.74, P = 0.016), prior induction with RTX plus CYC (vs RTX monotherapy: aHR = 0.02; 95% CI: 0.001-0.43, P = 0.012) and shorter time interval until complete remission (aHR = 1.07; 95% CI: 1.01-1.14, P = 0.023) were associated with decreased relapse risk. We recorded 17 serious infections (IR 5.8/100 patient-years), 11 COVID-19-associated hospitalizations (IR 3.7/100 patient-years), 4 malignancies (IR 1.4/100 patient-years), 6 cardiovascular events (IR 2/100 patient-years) and 10 deaths (IR 3.4/100 patient-years).

Conclusion: In this real-world study, relapses during RTX maintenance occurred in approximately 1 out of 4 patients. Kidney involvement, induction with RTX plus CYC, and earlier achievement of complete remission were associated with lower relapse risk. The serious infections rate was consistent with previous reports, whereas an increased rate of COVID-19-associated hospitalizations was observed.

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ANCA相关性血管炎患者利妥昔单抗维持治疗期间的复发和严重不良事件：一项多中心回顾性研究。

研究目的有关利妥昔单抗（RTX）作为微小病变性血管炎（ΜPA）和肉芽肿性血管炎（GPA）缓解维持治疗药物的有效性和安全性的真实数据非常有限。我们的目的是估计MPA/GPA患者在RTX维持治疗期间的复发率和风险因素以及严重不良事件（SAE）：方法：回顾性队列研究新诊断/复发的GPA/MPA患者，这些患者在使用诱导方案完全缓解（伯明翰-脉管炎活动评分-3版=0加泼尼松龙≤7.5毫克/天）后接受了RTX维持治疗（≥1个RTX周期，随访≥6个月）。SAE包括严重感染、COVID-19相关住院、死亡、心血管事件、恶性肿瘤和低丙种球蛋白血症。通过 Kaplan-Meier 图估算了发病率（IR）和无复发生存率。采用Cox回归法研究与复发时间相关的因素：共纳入101名患者，其中女性占48%，GPA占69%，新诊断患者占53%，中位年龄为63岁。在随访期间（294.5 患者年，中位数：3 RTX-周期），24 名患者（24%，IR 10.2/100患者年）中有 30 例复发（57%为重大复发）。肾脏受累（调整后危险比/aHR：0.20；95% CI：0.06-0.74，p= 0.016）、RTX加环磷酰胺诱导（与RTX单药相比：aHR=0.02；95% CI：0.001-0.43，p= 0.012）和较短的完全缓解时间间隔（aHR=1.07；95% CI：1.01-1.14，p= 0.023）与复发风险降低有关。我们记录了17例严重感染（IR 5.8/100例患者-年）、11例COVID-19相关住院（IR 3.7/100例患者-年）、4例恶性肿瘤（IR 1.4/100例患者-年）、6例心血管事件（IR 2/100例患者-年）和10例死亡（IR 3.4/100例患者-年）：在这项真实世界研究中，大约每4名患者中就有1名在RTX维持治疗期间复发。肾脏受累、RTX加环磷酰胺诱导以及较早实现完全缓解与较低的复发风险有关。严重感染率与之前的报告一致，而与COVID19相关的住院率则有所上升。

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

Rheumatology 医学-风湿病学

CiteScore

9.40

自引率

7.30%

发文量

1091

审稿时长

2 months

期刊介绍： Rheumatology strives to support research and discovery by publishing the highest quality original scientific papers with a focus on basic, clinical and translational research. The journal’s subject areas cover a wide range of paediatric and adult rheumatological conditions from an international perspective. It is an official journal of the British Society for Rheumatology, published by Oxford University Press. Rheumatology publishes original articles, reviews, editorials, guidelines, concise reports, meta-analyses, original case reports, clinical vignettes, letters and matters arising from published material. The journal takes pride in serving the global rheumatology community, with a focus on high societal impact in the form of podcasts, videos and extended social media presence, and utilizing metrics such as Altmetric. Keep up to date by following the journal on Twitter @RheumJnl.