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.
lupus
View drug information on CellCept.