The addition of belimumab (Benlysta, GlaxoSmithKline) to standard maintenance therapy improves renal outcomes in patients with active lupus nephritis, according to the phase 3 BLISS-LN trial, the largest trial of the disease conducted to date.
Lupus nephritis "is a serious complication of systemic lupus erythematosus," said investigator Brad Rovin, MD, from Ohio State University in Columbus.
Even with aggressive treatment, renal response rates remain low, and 10% to 30% of patients progress to end-stage renal disease (ESRD), he explained during his presentation at the virtual European Renal Association–European Dialysis and Transplant Association 57th Congress.
More patients treated with belimumab — a novel monoclonal antibody that blocks B-cell activity — plus standard therapy "achieved and maintained a complete renal response and reached the primary efficacy response end point," compared with placebo plus standard therapy, he reported. "Importantly, improvement in renal outcomes was achieved on a background of sustained reduction in corticosteroid use."
For the 104-week randomized, double-blind, placebo-controlled trial, 448 patients with active lupus nephritis were randomized to intravenous belimumab 10 mg/kg a month or placebo, "but rather uniquely, investigators were allowed to choose the standard regimen," Rovin noted.
Standard therapy consisted of either high-dose corticosteroids plus cyclophosphamide induction followed by azathioprine maintenance plus low-dose corticosteroids, or high-dose corticosteroids plus mycophenolate mofetil (MMF) induction followed by MMF maintenance plus low-dose corticosteroids.
