Express . . . Treatment of lupus nephritis, GSK lupus treatment reached the end of phase 3.

▎ pharmaceutic Kant / report today, GSK announced that its intravenous infusion therapy of benlysta (belimumab) has achieved the primary and all secondary endpoints of the phase 3 trial bliss-ln for patients with lupus nephritis (LN).GlaxoSmithKline plans to submit regulatory applications for this indication in the first half of 2020.benlysta is the only biological product approved for the treatment of lupus erythematosus.ln is a renal inflammation caused by systemic lupus erythematosus (SLE), which is a manifestation of severe progression of SLE. Renal injury in patients withln results in proteinuria and / or hematuria, decreased renal function and increased serum creatinine levels.ln can cause permanent and irreversible tissue damage to the kidney, resulting in end-stage renal disease (ESRD). Therefore, LN is a serious life-threatening disease.benlysta is a humanized monoclonal antibody, which can specifically bind to B lymphocyte stimulating factor (BLyS) and inhibit the survival of B cells.from the perspective of mechanism, this drug can effectively inhibit the B cells which are self reactive and make it difficult for B cells to differentiate into plasma cells producing immunoglobulin.due to its effectiveness in the treatment of lupus erythematosus, it was approved by the US FDA as early as March 2011.a total of 448 patients participated in a randomized, double-blind, phase 3 clinical trial with placebo control.the primary endpoint of the trial was the proportion of patients who met the primary renal response (perR) criteria.the results showed that after two years of treatment, 43% of patients receiving benlysta combined with standard therapy achieved perR, which was significantly higher than that of patients receiving placebo and standard therapy (32%, P = 0.0311).in addition, patients in the benlysta treatment group also showed statistically significant advantages in key secondary endpoints, including complete renal response (CRR) and sequential renal response (ORR) after two years of treatment, and the proportion of patients with perR after one year of treatment."lupus nephritis is one of the most common and serious complications of SLE, affecting 60% of adult patients," said Dr. Hal Barron, chief scientific officer and head of research and development of GSK. "The bliss-ln study shows that benlysta can provide clinically significant improvements in patients with limited treatment options."References: [1] GSK announcements positive headline results in phase 3 study of benlysta in patients with lupus nephritis, retrieved December 18, 2019, from