#4499 MATCHING-ADJUSTED INDIRECT COMPARISON OF SPARSENTAN VS DELAYED-RELEASE FORMULATION BUDESONIDE FOR PROTEINURIA REDUCTION IN ADULTS WITH IGA NEPHROPATHY

Abstract Background and Aims Immunoglobulin A (IgA) nephropathy is a rare kidney disorder characterized by deposition of IgA in the glomeruli associated with reduction renal function increased risk failure [1,2]. In absence head-to-head trials, this study used matching-adjusted indirect comparison (MAIC)[3] randomized control trial data to compare 9-month efficacy outcomes between potential treatment options for nephropathy, sparsentan recently FDA EMA approved delayed-release formulation budesonide [4,5]. Method An unanchored MAIC was conducted using individual patient level from PROTECT aggregate NefIgArd budesonide. Patients arm were weighted match key baseline characteristics patients NefIgArd. After matching, percentage urine protein-creatinine ratio (UPCR) at Month 9 relative compared two-tailed z-test performed estimate p-value. Results Assessment cross-trial heterogeneities suggested that trials sufficiently similar terms population, inclusion exclusion criteria, outcome definitions; however, due differences arms (renin-angiotensin system blocker [RASB] optimization), an (comparing directly) selected. all matched well-balanced corresponding two trials. The comparative results showed treated achieved greater mean UPCR months budesonide-treated (p-value withheld pending approval regulatory requirements). Conclusion significantly larger UPCR, recognized surrogate long-term outcomes, month