On 18th December 2019, GSK, a leading pharmaceutical company, announced positive results in their phase 3 study of intravenous (IV) Benlysta in Lupus Nephritis patients.
Lupus Nephritis is an inflammation of the kidney as a result of Systemic Lupus Erythematous (SLE) – an autoimmune disease that causes the immune system to target and attack its own body cells. Up to 60% of SLE patients develop Lupus Nephritis (LN), preventing the kidneys from functioning normally and eventually leading to renal failure.
‘The Efficacy and Safety of Belimumab in patients with Active Lupus Nephritis (BLISS-LN)’ study is the largest control phase 3 study in active LN. Involving 448 patients, the study focused on belimumab therapy and its effects on kidney functioning. The results showed that a statistically significant, greater number of patients achieved Primary Efficacy Renal Response (PERR) when treated with the drug and standard therapy as compared to placebo and standard therapy, over the course of two years.
The study included four major checkpoints: Complete Renal Response (CRR) after two years, Ordinal Renal Response (ORR) after two years, PERR after one year, and time to death or renal related event. The drug showed statistical significance as compared to placebo across all four.
According to the chief scientific officer and president R&D at GSK, Dr. Hal Barron,
“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 in the lives of these patients who currently have limited treatment options.”
Dr. Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes at Northwell Health and Lead Investigator of BLISS-LN also talked about his association with the massive trial, saying,
“My journey with Benlysta began nearly twenty years ago when we performed the very first clinical research trial in lupus patients. To see it culminate in a successful phase 3 lupus nephritis study is a key achievement as the inadequate response of our patients with kidney disease to conventional treatment has long been an area in need of major improvement.”
Benlysta (belimumab), however, is currently not recommended for consumption in severe active lupus nephritis. Given the successful phase 3 data, GSK plans to ‘progress regulatory submissions in the first half of 2020 to seek an update to the prescribing information’.
About Benlysta (belimumab)
Benlysta is a prescription medicine used to treat patients with Lupus. It is a monoclonal antibody that is a BLyS- specific inhibitor and binds to soluble BLyS. The drug doesn’t bind to B cells directly but through an intermediate. By bonding with BLys, it inhibits the survival of B cells, including autoreactive B cells – and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.