Abstract: SA-PO0786
Evaluation of Long-Term Disease Modification with Belimumab (BEL) in Routine Care of Patients (Pts) with Lupus Nephritis (LN): The OBSErve-LN Study
Session Information
- Glomerular Research: Design, Registries, Surveys, and Epidemiology
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Hiromura, Keiju, Gunma University Graduate School of Medicine, Department of Nephrology and Rheumatology, Maebashi, Japan
- Weinmann-Menke, Julia, University Hospital Department of Nephrology, Rheumatology and Center of Immunotherapy, Mainz, Germany
- Morales, Enrique, Hospital Universitario 12 de Octubre, Department of Nephrology, Madrid, Spain
- Rovin, Brad, The Ohio State University Wexner Medical Center, Division of Nephrology, Columbus, Ohio, United States
- Petri, Michelle, Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, Maryland, United States
- Chen, Wei, The First Affiliated Hospital of Sun Yat-sen University, Department of Nephrology, Guangzhou, China
- Tanaka, Yoshiya, University of Occupational and Environmental Health, The First Department of Internal Medicine, Fukuoka, Japan
- Ubhi, Harveen, Syneos Health, Real World & Late Phase Science Group, San Francisco, California, United States
- Vossen, Carla, Syneos Health, Project Management Real World Evidence, Montreal, Quebec, Canada
- Mokhtarian, Natasha, Syneos Health, Project Management Real World Evidence, Montreal, Quebec, Canada
- Hammer, Anne, GSK, Immunology Biostatistics, Collegeville, Pennsylvania, United States
- Sadhu, Sanchayita, GSK, Statistics, Mahadevapura, Bangalore, India
- Wall Morris, Lise, GSK, Study Delivery, Stevenage, United Kingdom
- Delgado, Ana, GSK, Global Medical Affairs, Brentford, United Kingdom
- Moldaver, Daniel, GSK, Global Real-World Evidence & Health Outcomes Research, Toronto, Ontario, Canada
Background
In LN, the treatment goal of disease modification is indicated by preserved kidney function and end-stage kidney disease prevention >5 years after treatment. BEL was approved for active LN following the 2-year BLISS-LN trial (NCT01639339), which demonstrated significant kidney outcome improvements. OBSErve-LN will assess real-world BEL outcomes in active LN, providing the first long-term evaluation of kidney function preservation with BEL.
Methods
OBSErve-LN (NCT06527872) is an ongoing Phase 4, non-interventional, global, observational study collecting routine care data retrospectively from enrolment to 12 months pre-index (BEL initiation) and prospectively up to 60 months post-index (Fig) from pts ≥18 years with active LN [Class III–V] initiating BEL 6–24 months before enrolment in China, Japan, Europe, US. Primary endpoint: maintenance of kidney function at Month 24 (≤30% decline in estimated glomerular filtration rate [eGFR] without kidney replacement therapy). Key secondary endpoints: modified partial renal response (≤20% eGFR decline and urine protein/creatinine ratio [uPCR] ≤0.7) and modified complete renal response (≤10% eGFR decline and uPCR ≤0.5) at Months 24 and 60. Other endpoints: changes in glucocorticoid dose and eGFR slope up to Month 60. Pts will complete FACIT-Fatigue and LupusQoL measures at enrolment and specified time points (Fig). Endpoints are evaluated descriptively; target sample size is 300. OBSErve-LN began in October 2024, with last pt last visit anticipated in March 2029.
Results
OBSErve-LN is progressing as planned, with recruitment and data collection underway. Planned annual interim analyses will track cohort characteristics.
Conclusion
OBSErve-LN demonstrates the feasibility of identifying diverse LN populations across countries. The study will inform on clinical and quality of life real-world outcomes with BEL to support its confirmation as a disease-modifying LN treatment.
Funding
- Commercial Support – GSK