June 2010

Lupus Research Institute Hails Results of CellCept® Trial in People with Lupus Kidney Disease

Persistence pays off as phase III study points to possible new treatment for this often deadly lupus complication

The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations are very encouraged by trial results released by Vifor Pharma, Galencia Group, and Roche demonstrating that the drug CellCept® (mycophenolate mofetil) helps in maintaining remission of lupus nephritis (lupus kidney disease).

After being treated for up to three years, participants in the trial taking CellCept® were able to stave off “treatment failure” for a significantly longer time than those on the “standard of care” drug, azathioprine (Imuran®). Treatment failure was defined as relapse of lupus nephritis, serious renal damage, or death.

“This is a significant finding in lupus research” said LRI President Margaret G. Dowd. “As the organization uniquely dedicated to funding bold approaches to novel research in lupus, the Lupus Research Institute commends the companies for their commitment and perseverance in pursuing this promising therapy, and also thanks the hundreds of people with lupus who enrolled and took part in this important trial.”

Approximately 1 in 3 people with lupus develop kidney disease, and even after successful treatment the complication can still relapse.

Results Spell Hope: A Potential New Option for Staving Off Lupus Kidney Disease

In the trial, known as the Aspreva Lupus Maintenance Study (ALMS), 227 patients with lupus kidney disease who had been successfully induced into remission with either Cytoxan® (cyclophosphamide) or CellCept® received either CellCept® or azathioprine to maintain that remission. Patients were treated for up to three years.

The topline primary endpoint results for the trial indicate that CellCept® was highly statistically significantly superior to azathioprine in delaying the time to treatment failure.

Vifor Pharma plans to present more extensive trial results at the 9th International Congress on Systemic Lupus Erythematosus in Vancouver, Canada, in late June. Because of the positive results, the companies are currently exploring the possibility of seeking FDA approval for CellCept® for use in the treatment of lupus nephritis.

No new treatment has been approved for lupus in over 50 years.



About the LRI
The nation’s only nonprofit singularly dedicated to novel research in lupus, we champion innovation and scientific risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease.

Lupus Research Institute
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