Belimumab Improves Renal Responses in Patients With Active Lupus Nephritis

June 9, 2020

By Eric Ramos

CHICAGO -- June 8, 2020 -- Adding belimumab to standard therapy significantly improves renal responses in patients with active lupus nephritis, compared with standard therapy alone, according to a study presented at the 2020 Virtual Meeting of the European League Against Rheumatism (EULAR).

Findings from the phase 3 BLISS-LN study showed that 43% of patients randomised to receive monthly intravenous belimumab 10 mg/kg plus standard therapy achieved the primary endpoint of Primary Efficacy Renal Response (PERR) at week 104 compared with 32.3% of patients randomised to placebo plus standard therapy (P = .0157)

PEER was defined as urine protein creatinine ratio (uPCR) ≤0.7, an estimated glomerular filtration rate (eGFR) within 20% of the pre-flare value or ≥60 ml/min/1.73m2, and no rescue therapy at week 104.

Complete renal response -- defined as uPCR 2, and no rescue therapy -- was achieved by 30% of patients in the belimumab arm compared with 19.7% of patients in the placebo arm at week 104 (P = .0167).

The findings are important because lupus nephritis affects nearly 70% of high-risk patients with systemic lupus erythematosus.

“To preserve renal function, lupus nephritis requires fast and effective treatment,” said Richard Furie, MD, Northwell Health, Great Neck, New York. “Despite medical advances, progression rates at 15 years to end-stage renal disease remain at more than 40% for patients with diffuse proliferative lupus nephritis.”

Overall, 95.5% of patients in the belimumab arm had ≥1 adverse event (AE), as did 94.2% of placebo-treated patients. Serious AEs occurred in 25.9% and 29.9%, respectively, and treatment discontinuation due to adverse events occurred in 12.9% of patients in each group. On-treatment fatal AEs occurred in 1.8% and 1.3% of patients, respectively.

In the study, standard therapy included treatment with high-dose steroids plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy or high-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy.

[Presentation title: BLISS-LN: a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial of Intravenous Belimumab in Patients With Active Lupus Nephritis. Abstract OP0164]