GlaxoSmithKline PLC's lupus drug Benlysta helped treat certain kidney inflammation patients in a late-stage study.
The phase 3 study, dubbed Bliss-LN, evaluated the efficacy and safety of Benlysta, or belimumab, in 448 patients with active lupus nephritis against placebo.
Lupus is a chronic autoimmune disease that causes damage to the skin, joints and organs. Lupus nephritis is the inflammation of the kidneys caused by systematic lupus erythematosus, or SLE, that can lead to end-stage kidney disease.
The U.K.-based company said the study met its primary goal as a statistically greater number of patients saw an improvement in their disease over two years when treated with the combination of Benlysta and standard therapy, compared to placebo and standard therapy.
About 43% of patients responded to the Benlysta-standard therapy combination, compared to 32% responding in the placebo group.
In addition, the study met its major secondary goals including a higher number of patients regaining kidney function, or partially regaining kidney function after two years. Safety results of the therapy were consistent with its known profile.
GlaxoSmithKline's Benlysta is the only approved treatment for lupus but is not recommended for use in severe active lupus nephritis anywhere in the world because it has not been previously evaluated in these patients. The company plans to file for regulatory approval for the treatment of lupus nephritis in the first half of 2020.
AstraZeneca PLC is also planning to seek regulatory approval of its lupus drug anifrolumab in the second half of 2020. Anifrolumab showed a statistically significant reduction in disease in 47.8% of lupus patients in the phase 3 Tulip-2 study. However, the drug missed its main goal in treating SLE in the Tulip-1 study.
Earlier in December, Aurinia Pharmaceuticals Inc. also reported positive results from a phase 3 study of its drug voclosporin in treating Lupus nephritis patients, while Equillium Inc.'s lupus drug itolizumab was granted the U.S. Food and Drug Administration's fast-track designation.
Lupus affects about 5 million people worldwide, mainly women in their 30s and 40s, and is highly prevalent in South and East Asia. Half to 70% of patients are diagnosed with the lupus nephritis form.