Predicting relapse and infection to optimize patient outcomes in ANCA-associated vasculitis: data from the MAINRITSAN trials cohort.

IF 4.7 2区医学 Q1 RHEUMATOLOGY

Rheumatology Pub Date : 2026-10-01 DOI:10.1093/rheumatology/keag542

Florence Delestre, Pierre Charles, Maxime Samson, Antoine Néel, Stanislas Faguer, Alexandre Karras, François Lifermann, Pascal Godmer, Catherine Hanrotel-Saliou, Nicolas Martin-Silva, Grégory Pugnet, François Maurier, Thomas Le Gallou, Thomas Quéméneur, Nadine Meaux-Ruault, Jean-François Viallard, Eric Hachulla, Xavier Puéchal, Loïc Guillevin, Raphaël Porcher, Benjamin Terrier

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引用次数: 0

Abstract

Objectives: Long-term follow-up of the MAINRITSAN trials confirmed the efficacy of rituximab (RTX) in preventing relapses in ANCA-associated vasculitis (AAV). Extending RTX maintenance beyond 18 months may benefit high-risk patients. The aim of this study was to validate relapse and infection prediction models to guide individualized RTX extension decisions.

Methods: Data from 217 patients in the MAINRITSAN1 and MAINRITSAN2 trials treated with RTX for 18 months with follow-up through December 2020 were analysed. We externally validated relapse and infection prediction models from McClure et al. Primary endpoints were relapse-free survival and serious infection-free survival.

Results: Relapse occurred in 76 patients, with a 72-month relapse-free survival rate of 55% (95% CI 48-64). Serious infections occurred in 33 patients, with a cumulative 72-month incidence of 20%. The relapse model (factors: male sex, age >60 years, ANCA positivity, relapsing disease, ENT involvement, prednisone dose) predicted major relapse (coefficient 1.34, P = 0.04) and identified high-risk patients with shorter major relapse-free survival (HR 1.91, 95% CI 0.97-3.76, P = 0.059). The relapse score was associated with major relapse risk predominantly within the PR3-ANCA subgroup (coefficient 2.76, P = 0.01). The infection model (factors: male sex, structural lung disease, diabetes, occurrence of infections during maintenance therapy and gammaglobulin level) identified high-risk patients with shorter serious infection-free survival (HR 2.93, 95% CI 1.28-6.72, P = 0.011).

Conclusion: The relapse prediction model demonstrated reproducible performance in this external validation cohort and may contribute to clinically relevant risk stratification, especially in PR3-ANCA patients. The infection model showed stronger predictive performance and may support individualized discussions regarding RTX extension.

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预测复发和感染以优化anca相关血管炎患者预后：MAINRITSAN试验队列数据

目的：MAINRITSAN试验的长期随访证实了利妥昔单抗（RTX）在预防anca相关性血管炎（AAV）复发方面的有效性。延长RTX维持时间超过18个月可能有利于高危患者。本研究的目的是验证复发和感染预测模型，以指导个体化RTX延长决策。方法：分析217例MAINRITSAN1和MAINRITSAN2试验患者的数据，这些患者接受RTX治疗18个月，随访至2020年12月。我们从外部验证了来自McClure等人的复发和感染预测模型。主要终点为无复发生存期和无严重感染生存期。结果：76例患者复发，72个月无复发生存率为55% （95% CI 48-64）。33例患者发生严重感染，72个月累计发病率为20%。复发模型（影响因素：男性、年龄0 ~ 60岁、ANCA阳性、疾病复发、耳鼻喉部受累、泼尼松剂量）预测主要复发（系数1.34,p = 0.04），确定高危患者主要无复发生存期较短（HR 1.91, 95% CI 0.97 ~ 3.76, p = 0.059）。在PR3-ANCA亚组中，复发评分与主要复发风险相关（系数2.76,p = 0.01）。感染模型（因素：男性、结构性肺部疾病、糖尿病、维持治疗期间感染的发生和丙种球蛋白水平）确定了高危患者较短的严重无感染生存期（HR 2.93, 95% CI 1.28-6.72, p = 0.011）。结论：复发预测模型在该外部验证队列中表现出可重复性，可能有助于临床相关的风险分层，特别是在PR3-ANCA患者中。感染模型显示出较强的预测性能，可能支持有关RTX扩展的个性化讨论。

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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.