GlaxoSmithKline (GSK) has reported that a controlled Phase III BLISS-LN clinical trial of Benlysta (belimumab) showed improvements in systemic lupus erythematosus (SLE) patients.
The trial evaluated an intravenous 10mg/kg dose of the drug to treat active lupus nephritis (LN) associated with SLE in 448 adult patients.
Benlysta is a monoclonal antibody that attaches to and blocks BLyS, inhibiting the B-cell survival and differentiation into plasma cells that generate immunoglobulin.
BLISS-LN is a randomised, double-blind, placebo-controlled post-approval commitment trial of belimumab in combination with standard therapy.
The study met the primary endpoint with a statistically significant greater proportion of patients experiencing Primary Efficacy Renal Response (PERR) over two years with the belimumab combination compared to placebo plus standard of care.
Statistical significance was also achieved on secondary endpoints of complete renal response (CRR) and ordinal renal response (ORR) at two years, PERR following one year of treatment, and the time to death or renal-related event.
The safety profile was generally comparable across the study arms.
GSK chief scientific officer and R&D president Dr Hal Barron said: “Lupus nephritis is one of the most common and serious complications of SLE, occurring in up to 60% of adult patients.
“The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options.”
Based on the BLISS-LN data, the company intends to file regulatory submissions in the first half of next year to expand the indication of Benlysta.
Benlysta holds approval in the US and EU to treat certain patients with active, autoantibody-positive SLE.
The drug is yet to receive approval for the treatment of severe active lupus nephritis or severe active central nervous system lupus.