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  1. R. Furie1,
  2. B. H. Rovin2,
  3. F. Houssiau3,
  4. Z. Amoura4,5,
  5. M. Santiago6,
  6. G. Contreras7,
  7. A. Malvar8,
  8. C. C. Mok9,
  9. A. Saxena10,
  10. X. Yu11,
  11. Y. K. O. Teng12,
  12. C. Barnett13,
  13. S. Burriss14,
  14. Y. Green13,
  15. B. Ji13,
  16. C. Kleoudis15,
  17. D. Roth14
  1. 1Northwell Health, Great Neck, United States of America
  2. 2The Ohio State University, Columbus, United States of America
  3. 3Cliniques Universitaires Saint-Luc, Brussels, Belgium
  4. 4Sorbonne Université, Paris, France
  5. 5Hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France
  6. 6Escola de Medicina e Saúde Pública, Salvador Bahia, Brazil
  7. 7University of Miami Miller School of Medicine, Miami, United States of America
  8. 8Organizacion Medica de Investigacion, Buenos Aires, Argentina
  9. 9Tuen Mun Hospital, Hong Kong SAR, China
  10. 10NYU School of Medicine, New York City, United States of America
  11. 11The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
  12. 12Leiden University Medical Center, Leiden, Netherlands
  13. 13GlaxoSmithKline, Uxbridge, United Kingdom
  14. 14GlaxoSmithKline, Collegeville, United States of America
  15. 15Parexel, Durham, United States of America


Background: Lupus nephritis (LN), a serious manifestation of systemic lupus erythematosus (SLE), affects nearly 70% of patients (pts) in high-risk groups. To preserve renal function, LN requires fast and effective treatment. Despite medical advances, progression rates at 15 years to end-stage renal disease (ESRD) remain >40% for pts with diffuse proliferative LN. Belimumab (BEL), approved in pts aged ≥5 years with active SLE, improved renal parameters in pts with baseline renal involvement in a post hoc analysis of Phase 3 trials data.

Objectives: To assess efficacy and safety of intravenous (IV) BEL vs placebo (PBO), plus standard therapy (ST), in pts with active LN.

Methods: BLISS-LN is a Phase 3, randomised, double-blind, PBO-controlled, 104-week study (GSK Study BEL114054, NCT01639339). Adults with SLE and biopsy-proven LN (class III, IV, and/or V) were randomised (1:1) to monthly BEL 10 mg/kg IV or PBO, plus ST. Primary endpoint: Primary Efficacy Renal Response (PERR); defined as urine protein creatinine ratio [uPCR] ≤0.7; estimated glomerular filtration rate [eGFR] within 20% of the pre-flare value or ≥60 ml/min/1.73m2; no rescue therapy) at Week (Wk) 104. Key secondary endpoints: Complete Renal Response (CRR; defined as uPCR <0.5; eGFR within 10% of the pre-flare value or ≥90 ml/min/1.73m2; no rescue therapy) at Wk 104; PERR at Wk 52; time to renal-related event (defined as ESRD/doubling of serum creatinine/renal worsening/renal disease-related treatment failure) or death. Other endpoints: time to PERR/CRR sustained through Wk 104; SLEDAI-S2K score <4 points at Wk 104; safety.

Results: Overall, 448 pts were randomised (efficacy: 223/group; safety: 224/group). Significantly more BEL (43%) than PBO (32.3%) pts achieved PERR at Wk 104 (OR 1.55, 95% CI 1.04, 2.32; p=0.0311). More BEL than PBO pts achieved key secondary and other efficacy endpoints (Table).

Overall, 214 (95.5%) BEL and 211 (94.2%) PBO pts had ≥1 adverse event (AE); 58 (25.9%) BEL and 67 (29.9%) PBO pts had ≥1 serious AE; 29 (12.9%) pts in each group had ≥1 AE resulting in study treatment discontinuation; 4 (1.8%) BEL and 3 (1.3%) PBO pts developed on-treatment fatal AEs.

Conclusion: In the largest LN study to date, data from BLISS-LN demonstrate that BEL plus ST significantly improves LN renal responses compared with ST alone with a favourable safety profile.

Study funding: GSK.


Disclosure of Interests: Richard Furie Grant/research support from: GSK, Consultant of: GSK, Brad H Rovin Grant/research support from: GSK, Consultant of: GSK, Frederic Houssiau Grant/research support from: UCB, Consultant of: GSK, Zahir Amoura Grant/research support from: GSK, Roche, Consultant of: GSK, Astra Zeneca, Amgen, Mittermayer Santiago: None declared, Gabriel Contreras Grant/research support from: Genentech, Merck, Consultant of: Genentech, Merck, Ana Malvar Consultant of: GSK and Roche, chi chiu mok: None declared, Amit Saxena Consultant of: GSK, AZ, BMS, Xueqing Yu: None declared, Y.K. Onno Teng Grant/research support from: GSK, Consultant of: GSK, Aurinia Pharmaceuticals, Novartis, Carly Barnett Shareholder of: GSK, Employee of: GSK, Susan Burriss Shareholder of: GSK, Employee of: GSK, Yulia Green Shareholder of: GSK, Employee of: GSK, Beulah Ji Shareholder of: GSK, Employee of: GSK, Christi Kleoudis Shareholder of: GSK, Consultant of: GSK, Employee of: Parexel, David Roth Shareholder of: GSK, Employee of: GSK

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