The FDA has recently approved of GlaxoSmithKline’s (GSK) treatment for lupus nephritis (LN), BENLYSTA. This therapy is the first of its kind, meant to treat systemic lupus and adults with active LN. It addresses a previously unmet medical need, and its approval is a very exciting develop for those living with LN.
About Lupus Nephritis
Lupus nephritis is a common complication of lupus. In fact, 40% of lupus patients go on to develop LN. In this condition, antibodies attack the part of the kidneys that filter out waste, causing proteinuria, inflammation, hematuria, high blood pressure, and kidney failure in extreme cases. Females and those of African and Asian descent are at a higher risk of developing lupus.
Symptoms specific to lupus nephritis include pain and swelling in the joints, dark and foamy urine, edema, high blood pressure, muscle pain, fever, and rash. The cause is unknown, although medical professionals suspect that it is a combination of genetic and environmental factors. Various lab tests, including urine tests, blood tests, and a kidney biopsy, are used to diagnose this condition. Treatment aims to decrease inflammation, reduce high blood pressure, and suppress the immune system.
BENLYSTA is a human, monoclonal antibody that inhibits soluble BLyS by binding to it. When doing so, this treatment inhibits the survival of B cells. This reduces them into immunoglobulin-producing plasma cells instead, therefore improving the symptoms and quality of life of those with LN.
FDA Approval for BENLYSTA
Approval for this treatment came after it received the Breakthrough Therapy designation, which was based on data from the BLISS-LN study. This Phase 3 trial enrolled 448 adult participants in order to evaluate BENLYSTA’s effect on LN.
The primary endpoint of the study was met: a significant amount of people reached Primary Efficacy Renal Response (PERR). Researchers achieved this goal after two years of treatment with BENLYSTA in combination with standard therapy. Their secondary endpoints were also met in comparison to placebo, which included the time to a renal-related event or death and complete renal response.
It was these positive results that led the FDA to approve of BENLYSTA, which is very exciting for medical professionals and patients. This therapy allows more LN patients to reach remission, and it also stops other patients from seeing worsening kidney function or end-stage renal disease.
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