Jul. 19, 2010

Successful Phase III Trial of CellCept® for Lupus Nephritis

Aspreva Lupus Management Study maintenance results.
Wofsy D, Appel GB, Dooley MA, Ginzler EM, Isenberg D, Jayne D, Solomons N, Lisk L, The ALMS Study Group (2010).  
International Lupus Congress Abstracts CS12.6.

What is the topic?
Lupus nephritis, or inflammation of the kidney, is a somewhat common and potentially serious manifestation of lupus. There has not been a new FDA-approved treatment for lupus nephritis in over 50 years. 

Current treatment for lupus nephritis commonly involves a combination of steroids and a strong immune-suppressing agent such as CellCept®, cyclophosphamide (Cytoxan®), or azathioprine (Imuran).  

What did the researchers hope to learn?
The researchers wanted to compare the effectiveness of mycophenolate mofetil (CellCept) with that of azathioprine to prevent kidney flares after the initial treatment for nephritis was successful. This is called “maintenance therapy” because the goal is to keep the kidneys healthy after an initial response to treatment.  

Who was studied?
227 lupus patients who had recently completed an initial treatment for active kidney disease (class III - V lupus nephritis) were studied. They were mostly women, 32 years of age, who had lupus nephritis for an average of 3.4 years. All patients had successfully responded to initial treatment with either CellCept or cyclophosphamide.    

How was the study conducted?
116 patients were randomly chosen to receive CellCept (2 grams per day) and 111 were randomly chosen to receive azathioprine (2 mg per kilogram of body weight per day). Patients received steroids at a maximum of 10 milligrams per day. 

The patients were followed for up to three years and the two groups were compared for the time that it took to see a failure in treatment; this was defined as a patient developing major kidney damage, another active flare of nephritis, or death. 

What did the researchers find?
101 patients withdrew from the study while it was going on and 126 completed it. Of the 227 who started the study, more CellCept-treated patients completed the full three years of therapy than those on azathioprine (62.9% for CellCept vs. 48.6% for azathioprine).  

CellCept was associated with longer time without treatment failure. Both drugs were well-tolerated, but there were more serious complications in patients taking azathioprine than in those taking CellCept. No new safety concerns were reported for either CellCept or azathioprine that were not already known. 

What were the limitations of the study?
This was an international study that was carefully set up to meet regulatory requirements for clinical trials. Because of this size and scope of the study and the regulatory requirements that were met, the information about this study can be considered more reliable than most preliminary results from smaller studies. 

What do the results mean for you?
A number of studies have suggested that CellCept may have a role in the treatment of lupus nephritis. This result is strong corroborating evidence of those previous results.

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