NEW YORK, NY. June 11, 2019. The Lupus Research Alliance is pleased to share 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.”
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latin Americans, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About the Lupus Research Alliance
The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.