Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Also called lupus, SLE is an autoimmune disease. With lupus, the body's immune system targets its own body tissues. Lupus nephritis happens when lupus involves the kidneys. A preliminary analysis of the safety data did not reveal any new or unexpected safety signals in patients receiving Rituxan. Lupus nephritis is treated with medications that suppress the immune system, so it stops attacking and damaging the kidneys.
Among the 203 initially selected patients, 150 presented with SLE and 53 had FHN at onset. Among these latter patients, 11 (20.7%) developed other SLE symptoms on average after 5.0 years (range 0.6–14.3 years). These 11 patients were included in the study and were labelled, for the purpose of the analyses, as d-SLE. Thus, a total of 161 patients were studied.
Standard treatment includes a corticosteroid, usually prednisone, to reduce inflammation in the kidneys. An immunosuppressive medication, such as cyclophosphamide or mycophenolate mofetil, is typically used with prednisone. These medications—when taken as prescribed by a health care provider—further decrease the activity of the immune system and block the body’s immune cells from attacking the kidneys directly or making antibodies that attack the kidneys.
Genentech, Inc. (NYSE: DNA) and Biogen Idec (Nasdaq: BIIB) announced that a Phase III study of Rituxan® (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks. The primary endpoint evaluated improvements in kidney response as measured by standard laboratory tests used to assess kidney health.