Sibeprenlimab for the Treatment of IgAN: VISIONARY Phase 3 Interim and Prespecified Subgroup Analyses

Résumé fourni par la source

Background: In a prespecified interim analysis of VISIONARY, sibeprenlimab led to a 51.2% (P<0.0001) placebo (PBO)-adjusted reduction in uPCR-24h at 9 mos. We report on uPCR-24h, disease activity, and biomarkers through 12 mos of treatment and across prespecified subgroups. Methods: VISIONARY, a phase 3 double-blind, PBO-controlled trial (NCT05248646), randomized adults with IgAN on supportive therapy 1:1 to SC sibeprenlimab 400 mg or PBO Q4W. uPCR-24h reduction and remission, hematuria, serum immunoglobulins, APRIL, Gd-IgA1, and safety were assessed for up to 12 mos. uPCR-24h responses were assessed across subgroups (demographics, screening uPCR-24h, eGFR, SGLT2i use, and prior immunosuppression). Results: Greater reductions in uPCR-24h (54.3% PBO-adjusted) and spot uPCR were observed at 12 mos with sibeprenlimab vs PBO. Sibeprenlimab substantially reduced serum immunoglobulins, Gd-IgA1, APRIL, and rates of hematuria, and achieved higher rates of proteinuric remission (34.3%) vs PBO (12.7%). At 9 mos, uPCR-24h reduction was consistent across subgroups, including SGLT2i use. No deaths occurred; safety was comparable between groups. Conclusion: Sibeprenlimab reduced proteinuria and biomarkers and led to higher rates of hematuric/proteinuric remission up to 12 mos, with favorable safety; benefits were consistent across subgroups. VISIONARY is ongoing, evaluating sibeprenlimab’s safety and efficacy (eGFR) over 24 mos. Funding: Commercial Support - Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ, USA)

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