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Published on: December 9, 2015
Predicting relapse and infection to optimize patient outcomes in ANCA-associated vasculitis: data from the MAINRITSAN
Florence Delestre1, Pierre Charles2, Maxime Samson3
1Department of Internal Medicine, National Reference Center for Rare Systemic Autoimmune Diseases, Hopital Cochin AP-HP, Université Paris Centre, Paris, France.
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.
