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Abstract: SU-OR34

Belimumab (BEL) Improves Renal Outcomes in Active Lupus Nephritis (LN): A Phase 3 Randomized, Placebo (PBO)-Controlled Trial

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Rovin, Brad H., Division of Nephrology, The Ohio State University, Columbus, Ohio, United States
  • Houssiau, Frederic, Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain and Service de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium
  • Furie, Richard, Division of Rheumatology, Northwell Health, Great Neck, New York, United States
  • Malvar, Ana, Organizacion Medica de Investigacion, Buenos Aires, Argentina
  • Teng, Yoe Kie Onno, Expert Center for Lupus-, Vasculitis- and Complement-mediated Systemic diseases, Department of Internal Medicine – section Nephrology, Leiden University Medical Center, Leiden, Netherlands
  • Mok, Chi chiu, Tuen Mun Hospital Department of Medicine and Geriatrics, Hong Kong, Hong Kong
  • Contreras, Gabriel, Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, United States
  • Yu, Xueqing, Department of Nephrology, Guangdong Provincial People’s Hospital, Guangzhou, China
  • Dolff, Sebastian, Department of Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
  • Ji, Beulah, GlaxoSmithKline, Uxbridge, United Kingdom
  • Roth, David A., GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Kleoudis, Christi, Parexel, Durham, North Carolina, United States
  • Makowiak, Susan, GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Madan, Anuradha, GlaxoSmithKline, Collegeville, Pennsylvania, United States
  • Gilbride, Jennifer, GlaxoSmithKline, Stevenage, United Kingdom
  • Green, Yulia, GlaxoSmithKline, Uxbridge, United Kingdom
Background

BEL is approved for patients (pts) with systemic lupus erythematosus (SLE). We evaluated intravenous (IV) BEL in active LN.

Methods

This 104-week trial (GSK Study BEL114054; NCT01639339) randomized adults with active LN (class III, IV, and/or V) 1:1 to monthly BEL 10 mg/kg IV or PBO, plus standard therapy (ST) with high-dose corticosteroids + either cyclophosphamide (CyC) or mycophenolate mofetil (MMF) for induction at the investigator’s discretion. CyC was followed by azathioprine (AZA), and MMF by MMF maintenance. The primary endpoint was Primary Efficacy Renal Response (PERR = urine protein:creatinine ratio [uPCR] ≤0.7; estimated glomerular filtration rate [eGFR] no more than 20% below pre-flare value or ≥60 ml/min/1.73m2; no rescue therapy) at Week 104. Other endpoints were Complete Renal Response (CRR = uPCR <0.5; eGFR no more than 10% below pre-flare value or ≥90 ml/min/1.73m2; no rescue therapy) at Week 104; time to renal event (end-stage kidney disease, doubling of serum creatinine, increased proteinuria and/or impaired renal function, renal disease-related treatment failure) or death. Endpoints were analyzed by ST regimen.

Results

224 pts were randomized to each arm. At Week 104, there were significantly more PERR and CRR responders on BEL vs PBO: (43.0% vs 32.3%, OR [95% CI] 1.6 [1.0, 2.3]; p=0.03) and (30.0% vs 19.7%, OR [95% CI] 1.7 [1.1, 2.7]; p=0.02), respectively. Risk of renal event or death was lower in BEL pts relative to PBO (HR [95% CI] 0.5 [0.3, 0.8]; p<0.01). Week 104 PERR response rates in pts on CyC/AZA were 33.9% with BEL and 27.1% with PBO, and 46.3% with BEL vs 34.1% with PBO in those on MMF. BEL reduced risk of renal event or death on background of CYC/AZA (HR [95% CI] 0.5 [0.2, 1.0]) and MMF (HR [95% CI] 0.5 [0.3, 0.8]) relative to PBO. Adverse events (AEs; ≥1) occurred in 95.5% of BEL and 94.2% of PBO pts, and 25.9% of BEL and 29.9% of PBO pts had ≥1 serious AE.

Conclusion

The addition of BEL to commonly used ST for the treatment of LN significantly improved renal responses with no unexpected safety signals.

Funding

  • Commercial Support – GSK