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Lupus Research Alliance Response to Positive Trial Testing Obinutuzumab (Gazyva®) for Lupus Nephritis

NEW YORK, Nov. 10, 2019 /PRNewswire/ --A The Lupus Research Alliance (LRA) is pleased to acknowledge positive results presented at the American Society of Nephrology (ASN) and the 2019 ACR/ARP Annual Meeting demonstrating the effectiveness of obinutuzumab (GazyvaA®), a type I anti-CD20 monoclonal antibody, in the Phase 2 NOBILITY trial for proliferative lupus nephritis. Effectiveness increased over time from 52 weeks to 76 weeks. "Lupus nephritis is one of the most common and dangerous complications of lupus, and with no currently-approved treatments, it is truly exciting to see the promising clinical findings of the NOBILITY trial," commented Teodora Staeva, PhD, Chief Scientific Officer of the Lupus Research Alliance.A  ""We are also encouraged that the FDA granted Breakthrough Therapy Designation to obinutuzumab, and are hopeful that this will accelerate the drug development and approval process."Researchers have identified CD20 protein, found in B-cells, as potentially causing the inflammation that marks lupus and other autoimmune diseases. Previous type I anti-CD20 monoclonal antibodies have failed to show effectiveness in clinical trials. Obinutuzumab is the first type I anti-CD20 monoclonal antibody to show positive results and appears to work by depleting B-cells.The NOBILITY study compared standard-of-care (mycophenolate mofetilA and corticosteroids) plus the anti-CD20 obinutuzumab to standard-of-care plus placebo for the treatment of proliferative lupus nephritis. "One of the greatest unmet needs in the treatment of patients with SLE is for safer and more efficacious treatments for lupus nephritis," commented principal investigator Richard A. Furie, MD, chief of Rheumatology at Northwell Health and a member of LRA's affiliate Lupus Therapeutics' Lupus Clinical Investigators Network (LuCIN). "Obinutuzumab could potentially result in a change in the lupus nephritis treatment paradigm if all goes well in future studies."
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