Abstract: TH-PO1218
Kidney Function Preservation with Belimumab in Patients with Lupus Nephritis Receiving Mycophenolate Mofetil (MMF) Standard Therapy in the BLISS-LN Trial: Improved Proteinuria, Clinical Outcomes, and Biomarkers for Belimumab vs. Placebo
Session Information
- Late-Breaking Research Posters
November 06, 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
- Rovin, Brad, Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- Anders, Hans J., Hospital of LMU Munich, Munich, Germany
- Bertsias, George, University of Crete School of Medicine, Heraklion, Greece
- Delgado, Ana, GSK, London, United Kingdom
- Abramino Levy, Roger, GSK, Collegeville, Pennsylvania, United States
- Curtis, Paula S., GSK, London, United Kingdom
- O'Shea, Ciara, GSK, Dublin, Ireland
- Tomlinson, Ryan, GSK, Collegeville, Pennsylvania, United States
- Furie, Richard, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States
Background
Belimumab (BEL) is a B-cell modulating anti-BLyS mAb approved for SLE (2011) and LN (2020). BLISS-LN’s unique design (104-week registrational Phase 3 study; NCT01639339) investigating kidney outcomes with BEL allowed ISN/RPS class III or IV ± V or pure class V, and CYC or MMF standard therapy (ST). To mitigate challenges of comparing LN trial outcomes due to design differences and better align the BLISS-LN population with other B-cell therapy LN trials (REGENCY), we recently reported a 14.9% Wk 104 CRR treatment difference in favor of BEL vs placebo (PBO) in a BLISS-LN subgroup restricted to class III or IV ± V (excluding pure class V) receiving only MMF ST. We now present further MMF subgroup outcomes.
Methods
This BLISS-LN MMF subgroup post hoc analysis reports for BEL vs PBO at Wk 104: uPCR <0.5 responders, changes from baseline (BL) in biomarkers (uPCR; eGFR; positive at BL: anti-dsDNA, anti-C1q; low BL C3/C4); and over Wk 104: time to kidney-related event. Data are descriptive.
Results
MMF subgroup cohorts (BEL=135; PBO=136) had similar BL uPCR (Table). Greater improvements in uPCR <0.5 responders and biomarkers, and lower risk of kidney-related events or death were noted with BEL vs PBO in MMF subgroup (Table). uPCR <0.5 responders in MMF subgroup showed greater benefits with BEL vs PBO vs BLISS-LN overall population, while other endpoints showed consistent results (Table). eGFR data will be presented.
Conclusion
Clinical trial differences make comparing outcomes challenging. Our findings build on BEL’s extensive evidence and underline kidney function preservation in an MMF subgroup similar to other Phase 3 LN trial populations. This and the ongoing OBSErve-LN study (NCT06527872) provide further kidney function maintenance data to support LN treatment decisions.
Funding
- Commercial Support – This post hoc analysis of BLISS-LN (NCT01639339, GSK Study 114054) was funded by GSK. Medical writing support was provided by Casmira Brazaitis, PhD, CMPP, and Catriona Marshall, PhD, of Fishawack Indicia Ltd, UK, part of Avalere Health, and was funded by GSK.