Lupus Foundation Of America Statement On Results For Clinical Study Of CellCept(R) Released By Aspreva Pharmaceutical Company

Main Category: Lupus
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 28 Jun 2007 - 0:00 PST

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The Lupus Foundation of America, Inc. and more than 1.5 million Americans with lupus have been awaiting the preliminary findings of the Phase III clinical trials for CellCept(R), a potential treatment for lupus kidney disease being tested by Aspreva Pharmaceutical Company. Development of new treatments for lupus patients is critical because many of the drugs currently used to treat the disease are toxic and can cause serious medical complications or side effects, sometimes worse than the disease itself.

Preliminary data from the 24-week induction phase show that CellCept achieved results that are equivalent to those achieved with intravenous Cyclophosphamide (IVC), a chemotherapy which has been used to treat patients with lupus kidney disease (lupus nephritis) since the 1970s. However, while IVC has been referred to as the "standard of care" for treatment of lupus nephritis it has never been approved by the FDA as a treatment for lupus.

In order to meet the primary endpoint, the FDA required Aspreva Pharmaceutical Company to show that CellCept was superior in efficacy to IVC. The LFA contends that this bar was unreasonably set too high by the FDA. Equal efficacy and less severe side effects would be a compelling rationale for approving a drug for this underserved disease, which would be welcomed by people with lupus and their physicians. Furthermore, if more agents could be developed with less toxicity, there would be improved opportunities for combination therapies in the treatment of nephritis.

An additional concern is that if CellCept induces 52% remission and IVC induces the same percentage of remission, it may be that each is covering a different subset of the population. Thus having the alternative treatments available might be an important overall improvement in care for lupus nephritis patients. In line with this, the LFA is eager to see some subset analysis, for example, an analysis of how CellCept performs in patients of African descent, since IVC is known to be less effective for this population.

The preliminary data from Aspreva suggest that overall incidence of side effects were the same for CellCept and IVC. This is expected when all major and minor side effects are counted equally. However, there is a large body of published literature with convincing evidence that CellCept is better tolerated, and, more importantly to patients and their doctors, is associated with fewer serious or life-threatening infections, and hospitalizations. IVC is also linked to a high incidence of infertility, which is not the case with CellCept. We eagerly await further data from this new trial on these kinds of side effects, which patients and doctors are most concerned about.

The results released today are only preliminary findings. The LFA looks forward to further analysis of the data and will report this information as soon as it becomes available.

About the LFA: The Lupus Foundation of America is the nation's leading nonprofit voluntary health organization dedicated to finding the causes and cure for lupus. The LFA and its nationwide network of nearly 300 chapters, branches and support groups operate programs of research, education, support and advocacy.

Lupus Foundation of America, Inc.
http://www.lupus.org