Results from the regency trial assessing efficacy and safety of obinutuzumab in active lupus nephritis

Introduction: Obinutuzumab, a humanized type II anti-CD20 mono clonal antibody, is approved for B-cell malignancies. In the Phase II NOBILITY trial of patients with active lupus nephritis (LN;NCT02550652), study participants receiving obinutuzumab in addition to standard therapy were significantly more likely to achieve complete renal response than those receiving placebo in addition to standard therapy. The results of the Phase III REGENCY trial (NCT04221477), performed to verify NOBILITY, are presented here. Methods: REGENCY, a Phase III, double-blind placebo-controlled trial, randomized adults with biopsy-proven active proliferative LN 1:1 to placebo or one of two intravenous obinutuzumab dosing schedules (1000 mg: Day 1, Weeks 2, 24, 26, 50 and 52) in addition to standard therapy. The primary endpoint was complete renal response (CRR, defined as urine protein-to-creatinine ratio [UPCR] <0.5 g/g, estimated glomerular filtration rate [eGFR] $85% of baseline and no intercurrent events of rescue therapy, treatment failure, death or early study withdrawal) at Week 76 and assessed in the intention-to-treat population. Key secondary endpoints included CRR at Week 76 with successful prednisone taper to #7.5 mg/day between Weeks 64 and 76, and UPCR <0.8 g/g at Week 76 with no intercurrent events, change in eGFR from baseline to Week 76 and renal-related events or death through Week 76. Incidence and severity of adverse events through Week 76 were compiled

• Autores: Rovin, Brad; Furie, Richard; Garg, Jay
• Fecha de publicación: 2025
• Institución: Universidad Simón Bolívar
• Repositorio: Repositorio Digital USB
• Idioma: eng
• OAI Identifier: oai:bonga.unisimon.edu.co:20.500.12442/16245
• Acceso en línea: https://hdl.handle.net/20.500.12442/16245; https://www.kireports.org/article/S2468-0249(24)03382-5/fulltext
• Rights: openAccess
• License: Attribution-NonCommercial-NoDerivs 3.0 United States