Long-Term Comparative Effectiveness of Rituximab vs. Calcineurin Inhibitors for the Treatment of Membranous Nephropathy

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Background: Clinical trials in membranous nephropathy (MN) may establish treatment efficacy for short-term outcomes but are limited by small sample sizes and short study duration. This study applied modern statistical methods to CureGN data to compare effectiveness of rituximab (RTX) and calcineurin inhibitors (CNIs) for long-term MN outcomes. Methods: MN participants initiating RTX or CNI 6+ months after any previous immunosuppressant (IST) exposure were eligible. Propensity scores (PS) based on demographics, labs, pathology, and comorbidities at treatment start were generated and PS-matching with exact matching on history of RTX and CNI was applied. Individuals were censored if they started a different IST during follow-up and inverse probability weights were used. Outcomes included time from treatment start to proteinuria remission, relapse following remission, and kidney disease progression. Hazard ratios (HR) were estimated from Cox models with variance adjustment to account for matching and multiple treatments within individuals. Differences in restricted mean survival time (RMST) were also estimated. Results: 331 treatment initiations across 254 unique participants were eligible, with median follow-up 53 months (IQR=26, 79). Participants on CNIs had significantly higher risks of disease progression (HR=2.83; 95% CI: 1.20, 6.68) than RTX. Proteinuria remission risks were similar in both groups (HR=0.97; 95% CI: 0.61, 1.52), though CNIs had higher risks of relapse (HR=2.14, 95% CI: 1.04, 4.40). Conclusion: RTX was more effective for preserving eGFR than CNIs. Proteinuria remission and relapse results align with a prior clinical trial but extend trial results past 24 months. High-quality evidence on long-term treatment effectiveness in rare diseases can be generated from observational studies.

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