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

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 analyzed. 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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Lara D. Veeken
Published
2026-09-27
DOI
https://doi.org/10.1093/rheumatology/keag542
Primary Topic
Vasculitis and related conditions
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article
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article

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

I de Lacroix-Szmania, Xavier Delbrel, D. Sène, Romain Paule et al.
Lara D. Veeken
Vasculitis and related conditions
article

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

I de Lacroix-Szmania, Xavier Delbrel, D. Sène, Romain Paule, NADINE MÉAUX-RUAULT, Christine Vinter, F. Grassin, Serge Perrot, Thomas Le Gallou, Marie Frimat, Florence Delestre, Anne-Bérangère Beucher, Pierre Charles, Bertrand Dunogué, D. Bagnères, G. Gondran, Bernard Gilson, Sophie Rivière, N. M. Silva, Ursula Warzocha, Alain Ramassamy, Marc Fabre, Stéphanie Mestrallet, B. Brihaye, Catherine Hanrotel‐Saliou, N. Schleinitz, Sébastien Canet, Stanislas Faguer, H. Kassem, Christian Delafosse, Richard Damade, Olivier Lidove, X. Kyndt, Guillaume Leveiller, L Wemeau, Helder Gil, Isabelle Guichard, Sébastien Delbès, Pascal Godmer, Edouard Bégon, Claire Rigothier, Roderich Meckenstock, N. Tieulié, Constance Guillaud, Simona Pavel, L. Lahaxe, Nolwenn Rabot, Audrey Sultan, Vincent Poindron, Stephane Vinzio, Alexandre Karras, N. Antoine, Anthony Bonnin, Nathalie Lerolle, Robin Dhôte, Claire Blanchard‐Delaunay, Raphaele Seror, Jean-Benoit Arlet, Jean-Francois Viallard, Raphael Porcher, the French Vasculitis Study Group (FVSG), Mathias Buchler, Thomas Quéméneur, Marie Lino-Daniel, Grégory Pugnet, Alexis Régent, Christian Agard, Olivier Fain, Abdeldjallil Koreichi, Jean-Michel Galempoix, Cécile-Audrey Durel, François Maurier, Claire de Moreuil, Loïc Guillevin, Xavier Puéchal, Thomas Papo, François Lifermann, Luc Mouthon, Eric Hachulla, Aurélie Schiffman, Hélène Francois, Julien Allard, Ali Boumallassa, Maxime Samson, Mathilde de Menthon, Laurent Perard, Mathieu Puyade, Frédéric Bocquentin, Benjamin Terrier
article en

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 analyzed. 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.

Lara D. Veeken
Inserm (FR), Université Paris Cité (FR), Université de Lille (FR), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Nantes (FR), Centre Hospitalier Universitaire de Toulouse (FR), Centre Hospitalier Universitaire de Besançon (FR), Sorbonne Paris Cité (FR), Institute Mutualiste Montsouris (FR), Hôpital Cochin (FR), Assistance Publique – Hôpitaux de Paris (FR), Hôpital Européen Georges-Pompidou (FR), Centre hospitalier Bretagne Atlantique (FR), Centre Hospitalier Universitaire de Caen Normandie (FR), CHU Dijon Bourgogne (FR), Metabolism and Renal Physiology (FR), Centre Hospitalier Régional Universitaire de Brest (FR), Hôtel-Dieu de Paris (FR), Centre Hospitalier de Dax –Côte d’Argent (FR), Centre Hospitalier Universitaire de Rennes (FR), Centre Hospitalier de Valenciennes (FR), Institute for Translational Research in Inflammation (FR), Centre de Recherche Épidémiologie et Statistique (FR)
Good health and well-being
Openalex Percentile: Top 12%
Vasculitis and related conditions
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