Phase III Study of Rituxan in Lupus Nephritis Did Not Meet Primary Endpoint

Genentech, Inc. (NYSE: DNA) and Biogen Idec (Nasdaq: BIIB) announced today 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. A preliminary analysis of the safety data did not reveal any new or unexpected safety signals in patients receiving Rituxan.

Lupus nephritis is an inflammation of the kidney and a complication of systemic lupus erythematosus (SLE or lupus), an autoimmune disease. Lupus nephritis can lead to a progressive loss of kidney function and may result in kidney failure in the most severe cases. Lupus nephritis occurs in approximately one-third of people with SLE.

"We are disappointed that Rituxan did not show a significant benefit in patients with lupus nephritis, a complex and serious disease. Using the insights from this study, we will continue to look for new approaches to the treatment of lupus," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer.

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