The Lupus Research Alliance shared positive topline results from a Phase 2 clinical study of a potential new treatment for proliferative lupus nephritis, the most severe form of kidney damage caused by lupus. Genentech, a member of the Roche Group, reported that at one year their drug Gazyva® (obinutuzumab) helped more patients achieve a complete response to treatment when added to standard of care with either mycophenolate mofetil or mycophenolic acid plus corticosteroids than those receiving standard of care alone.
Lupus nephritis is a life-threatening complication of systemic erythematosus lupus (SLE), resulting from inflammation of the kidneys. In addition to achieving complete response, the study's primary measurement of the drug's effectiveness, results also met the secondary endpoints of improved overall response to treatment as well as reduced levels of antibodies in the blood. No new safety issues were seen.
Gazyva® (obinutuzumab) is approved by the U.S. Food and Drug Administration as a treatment for specific types of cancer. The monoclonal antibody blocks the CD20 protein found in immune B-cells and may prevent the inflammation that marks lupus and other autoimmune diseases.
"These are hopeful results for the lupus community, and we look forward to the complete study report," noted Lupus Research Alliance President and CEO, Kenneth M. Farber. "About half of people with lupus develop nephritis and new treatment options are urgently needed. Testing a drug that is already approved for another patient group can help speed up the process needed to demonstrate its safety and effectiveness in lupus."
For the full study please click here.