Phase 3 Trial Finds Benlysta Significantly Improves Kidney Response in People with Lupus Nephritis
In new results on the international phase 3 clinical trial (BLISS-LN) of the drug Benlysta (belimumab), researchers found that Benlysta reduced the risk of worsening kidney function during the study by almost 50%, compared with standard therapy alone.
The groundbreaking results from the phase 3 BLISS-LN clinical trial could lead to Benlysta becoming the first drug approved by the Food and Drug Administration (FDA) to treat lupus nephritis, the most common severe complication of SLE that could lead to end-stage kidney disease and death.
Inside Lupus Research will continue to share updates on this trial and next steps.
June 4, 2020
In the largest lupus nephritis (LN) study to date, data demonstrates that Benlysta (belimumab) significantly and safely improves kidney function compared to standard therapy alone. After a 2-year treatment period, significantly more people (43%) receiving intravenous Benlysta plus standard therapy achieved the target treatment goal of Primary Efficacy Renal Response (PERR), a multifactorial measure of improved kidney response. By comparison, 32% of people with LN on standard therapy plus placebo reached PERR. More people receiving Benlysta also reached key secondary efficacy endpoints compared to the placebo group.
These results, shared at this year’s European League Against Rheumatism virtual conference, inspire hope ahead of potential approval by the Food and Drug Administration this year. It’s estimated that up to 60% of people with lupus will develop LN, which can lead to kidney failure, and finding effective treatments for the disease is critically important. The Lupus Foundation of America first reported on the Phase 3 study late last year and will continue to share updates on the investigational drug as they develop. Learn about how lupus affects the renal (kidney) system.