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논문분류	춘계학술대회 초록집
제목	Longer Follow-up of Povetacicept Shows Potential for Treatment of IgA Nephropathy (RUBY-3 Study)
저자	Ju-Young Moon
출판정보	2025; 2025(1):
키워드	IgAN, povetacicept, best-in-class, RUBY-3, BAFF/APRIL
초록	The pathogenesis of IgAN is due to genetic and environmental factors that prime B-cells to express Gd-IgA1, an auto-antigen, triggering autoantibody production, forming immune complexes that deposit in glomerular mesangium, leading to inflammation and injury. BAFF and APRIL are involved in survival and maturation of transitional and naïve B-cells, T-cell-independent B-cell responses to certain antigens, B-cell regulation, and Ig class-switch recombination. Povetacicept, a dual inhibitor of BAFF and APRIL, represents significant therapeutic advancement by targeting the root cause of IgAN. Updated interim data for participants dosed with povetacicept in the RUBY-3 study are provided. RUBY-3 is an ongoing Phase 1/2, open-label study in adults with IgAN, receiving povetacicept 80 mg (n=21 dosed; n=8 at 48 weeks) or 240 mg (n=33 dosed; n=12 at 48 weeks) subcutaneously Q4W. Primary objective: evaluation of the safety of povetacicept. Secondary objectives: efficacy, PK, and biomarker changes with povetacicept treatment. Data at 48 weeks indicate mean 24-hour UPCR decreased 66% from baseline (from 1.3g/g to 0.5g/g) in the 80 mg cohort, and 53% (from 1.2g/g to 0.6g/g) in the 240mg cohort. In both cohorts, eGFR was stable through 48 Weeks. By Week 48, clinical remission was achieved by 63% of the 80 mg cohort and 33% of the 240 mg cohort. Gd-IgA1 declined 64% in the 80 mg cohort and 60% in the 240 mg cohort by Week 24, with sustained declines through Week 44. Povetacicept doses were generally safe and well tolerated at both dose levels. Povetacicept was generally safe and well tolerated in adults with IgAN and resulted in substantial and sustained reductions in UPCR and Gd-IgA1, with stable eGFR, through 48 weeks. These updated data reinforce the potential of povetacicept as therapy for IgAN; a Phase 3 randomized, controlled study of povetacicept in IgAN is well underway.
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