Belimumab added to standard therapy is safe and effective over the longer term in patients with lupus nephritis (LN), researchers confirmed at the 58th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress. .
In a 6-month, open-label extension of the 2-year BLISS-LN trial, 132 patients taking belimumab and 122 patients formerly assigned to placebo received intravenous belimumab (10 mg/kg) every 28 days for an additional 24 weeks in addition to standard therapy. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF).
The proportion of patients achieving primary efficacy renal response (PERR) increased from 59.8% and 70.5% at baseline to 66.9% and 71.6% at week 28 among patients previously assigned to placebo and belimumab, respectively, Brad Rovin, MD, of Ohio State University in Columbus, and colleagues reported. Complete renal response (CRR) increased from 36.1% and 47.7% at baseline to 48.3% and 62.3% at week 28, respectively. PERR was defined as a urine protein to creatinine ratio (UPCR) of 0.7 or less, an estimated glomerular filtration rate (eGFR) not exceeding 20% below baseline value or 60 mL/min/1.73 m2 or higher, and no rescue therapy. CRR was a UPCR less than 0.5, an eGFR not more than 10% below baseline value or 90 mL/min/1.73 m2 or higher, and no rescue therapy.
The proportion of patients with a systemic lupus erythematosus disease activity index (SLEDAI) score of less than 4 increased slightly among patients previously taking belimumab and increased among patients previously taking placebo. Worsening of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) occurred in 7 patients overall. There was no appreciable change in patients receiving prednisone equivalent doses of 5 mg or less or 7.5 mg or less.
With respect to safety, 2.0% of all patients initially withdrew from the extension study due to adverse events (AE). Two-thirds of patients experienced 1 or more AE over 28 weeks, 19.2% had at least 1 treatment-emergent AE, and 5.9% had at least 1 serious AE, including 1 death in the placebo group.
Belimumab was well tolerated as an add-on to standard therapy, with no new safety signals, Dr Rovin’s team concluded.
Disclosure: This research was supported by Glaxo Smith Kline. Please see the original reference for a full list of disclosures.
Rovin B, Furie R, Houssiau FA, et al. Safety and efficacy of intravenous belimumab in patients with lupus nephritis: a 6-month open-label extension. Presented at the 58th ERA-EDTA Congress 2021, June 5-8, 2021. Abstract FC034.