Abstract: SA-OR084
Beyond Clinical Response in the REGENCY Trial: The Impact of Obinutuzumab on Histologic Remission in Patients with Active Lupus Nephritis
Session Information
- High-Impact Clinical Trials - 2
November 08, 2025 | Location: Hall A, Convention Center
Abstract Time: 11:00 AM - 11:15 AM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Rovin, Brad, The Ohio State University College of Medicine, Columbus, Ohio, United States
- Alberton, Valeria Gabriela, Fernández Hospital, Buenos Aires, Argentina
- Gonçalves Martins, Elsa, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Garg, Jay P., Genentech, Inc., San Francisco, California, United States
- Santiago, Mittermayer Barreto, Bahiana School of Medicine and Public Health and UFBA, Federal University of Bahia, and Clínica SER da Bahia, Salvador, Brazil
- Aroca Martinez, Gustavo, Universidad Simón Bolívar, Barranquilla, Colombia y Clínica de la Costa, Barranquilla, Colombia
- Irazoque, Fedra C, Centro de Investigación y Tratamiento Reumatológico S.C., Mexico City, Mexico
- Baczkowska, Teresa M, Medical University of Warsaw, Warsaw, Poland
- Alfaro, Jose, Instituto Peruano del Hueso y la Articulación, Lima, Peru
- Ravelo, Jorge Luis, Clinica San Juan Bautista, Unidad de Investigacion en Reumatologia e Inmunologia, Lima, Peru
- Furie, Richard, Division of Rheumatology, Northwell Health, Great Neck, New York, United States
- Pinto, Luis Fernando, Hospital Pablo Tobon Uribe, Medellín, Antioquia, Colombia
- Albiero, Eduardo Horacio, Sanatorio Allende, Córdoba, Córdoba Province, Argentina
- Larsen, Christopher Patrick, Arkana Laboratories, Little Rock, Arkansas, United States
- Pulley, Jennifer A, Roche Products Ltd, Welwyn Garden City, United Kingdom
- Schindler, Thomas, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Omachi, Theodore A., Genentech, Inc., San Francisco, California, United States
- Pendergraft, William Franklin, Genentech, Inc., San Francisco, California, United States
- Malvar, Ana, Organización Médica de Investigación, Buenos Aires, Argentina
Background
The REGENCY trial (NCT04221477) randomized adults with active lupus nephritis (LN) to placebo or obinutuzumab plus standard therapy (PBO+ST; OBI+ST). At Week 76 (W76), significantly more OBI+ST patients (pts) vs PBO+ST pts achieved complete renal response (CRR) (46.4% vs 33.1% [adjusted difference 13.4%, 95% CI, 2.0% to 24.8%; P=0.0232]). Evaluating histologic changes of paired baseline and W76 biopsies, we postulated that OBI+ST would yield greater rates of histologic remission at W76 than PBO+ST.
Methods
Sixty-four (32 OBI+ST, 32 PBO+ST) blinded baseline and W76 biopsies were interpreted by Arkana Laboratories using 2018 ISN/RPS LN classification and NIH activity index (AI) and chronicity index. Proportions of pts achieving histologic or near-histologic remission (AI=0 or AI≤1) were determined.
Results
Baseline characteristics were balanced and consistent with the overall REGENCY cohort (Table 1). Significantly more pts achieved AI≤1 or AI=0 with OBI+ST vs PBO+ST at W76 (Figure 1). For pts who did not achieve CRR, 52.6% (10/19) in the OBI+ST group had AI=0 at W76 vs 8.3% (2/24) in the PBO+ST group.
Conclusion
In the largest longitudinal kidney biopsy cohort ever reported for a registrational LN clinical trial, significantly more pts treated with OBI+ST achieved complete and/or near-complete histologic remission vs PBO+ST. The higher proportion of pts achieving histologic remission vs CRR suggests that the impact of OBI in LN is greater than that implied by CRR rate. Achieving histologic remission reduces future LN flare risk and should preserve functional kidney mass.
Funding
- Commercial Support – F. Hoffmann-La Roche Ltd