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. Lupus nephritis is treated with medications that suppress the immune system, so it stops attacking and damaging the kidneys. A preliminary analysis of the safety data did not reveal any new or unexpected safety signals in patients receiving Rituxan
We identified 13 studies that reported a total of 17 deaths in the 6 week post-partum period that were attributable to SLE and lupus nephritis. In all cases, death occurred in the setting of active disease, and was attributed either to infection in 41.2% (n=7), or disease activity in 29.4% (n=5). The remaining deaths were due to pulmonary embolus in 11.8% (n=2), pregnancy-associated cardiomyopathy in 5.9%(n=1), adrenal failure due to abrupt steroid withdrawal in 5.9% (n=1), and undefined in5.9% (n=1)
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.