GlaxoSmithKline (GSK) has recently completed and released the results of Phase 3 of its study of benlysta. This drug is made for the treatment of lupus nephritis. Their BLISS-LN study showed that this treatment has the potential to greatly improve the lives of those with lupus nephritis. Using the findings in this study, GSK will begin the process of of regulatory submissions in the first half of 2020.
About Lupus Nephritis
Lupus nephritis occurs from a complication of systemic lupus erythematosus, which is better known as lupus. It is inflammation in the kidneys, which occurs because the immune system produces autoantibodies that attack healthy tissue. These autoantibodies affect the part of the kidneys that filter out waste, which leads to the inflammation. Lupus, which brings the complication that causes this disease, is much more common in females, and it tends to occur during child-bearing years. It is also more likely to affect those of Asian and African descent.
Healthcare professionals are unsure of the exact cause of this disease. It is suspected that a combination of family history and environmental factors play a role. Some of these factors include toxic chemicals, pollutants, and infections.
Symptoms of this disease are high blood pressure, dark urine, and edema, which is swelling due to excess fluid. Edema usually occurs in the feet, legs, and ankles. These are the initial symptoms, but as lupus nephritis progresses, kidney problems will begin. Symptoms associated with these issues are swelling and pain in the joints, fevers, muscle pain, and red rashes that are often on the face.
Various lab tests are necessary to diagnose lupus nephritis. Kidney damage is looked for with a urine test. As kidney disease worsens, a blood test will be used. A diagnosis is confirmed through a kidney biopsy. A biopsy will also see how far the disease has progressed. After a doctor has confirmed a diagnosis, treatments aim to reduce blood pressure, suppress the immune system, and treat kidney inflammation. Medicines that may be prescribed include corticosteroids, ACE inhibitors, immunosuppressive drugs, diuretics, beta blockers, and calcium channel blockers. A healthy diet may also help those with lupus nephritis. If the disease progresses to a certain point, then dialysis and a kidney transplant may be necessary.
Benlysta is a BLyS-specific inhibitor. It is a human monoclonal antibody that is meant to bind to BLyS. By doing so, it inhibits the survival of B cells. In the United States it is indicated for the treatment of people who are five and older, have lupus, and do not receive standard therapy.
About the BLISS-LN Study
This study enrolled 448 participants and lasted for 104 weeks. This Phase 3 study was double-blind, randomized, and placebo-controlled. The purpose was to evaluate the safety and efficacy of 10 mg/kg of IV benlysta along with the standard therapy. The primary endpoint of this study was to prove that a statistically greater amount of participants achieved primary efficacy renal response (PERR). This endpoint was met, along with all of the major secondary endpoints. These endpoints included complete renal response (CRR), ordinal renal response (ORR), PERR after one year, and the time to death or renal-related event.
Many doctors see the treatment of lupus nephritis as an area that requires major improvement, so the results of this study are very positive for them. They hope that this drug and future developments will better the lives of those with this disease.
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