Nov 24 2005
A new study has shown that the drug CellCept is just as good at fighting kidney complications from the debilitating disease lupus with far fewer side effects than standard treatment using the cancer drug Cytoxan.
The study found that CellCept, produced by drug giant Roche, produced an almost 23 percent complete remission rate in the 71 CellCept recipients compared to only 6 percent of the 69 volunteers treated with intravenous Cytoxan, available in generic form as cyclophosphamide.
Sandra Raymond, president of the Lupus Foundation of America says the findings are encouraging news for the millions around the world who are suffering from the devastating effects of lupus.
The disease which affects about 1.5 million Americans, causes the immune system to attack the body, resulting in inflammation and widespread tissue damage.
Apparently between one-third and one-half of lupus sufferers have serious kidney disease, and since the 1970s Cytoxan has been the established treatment.
Ellen Ginzler of the State University of New York Downstate Medical Center says she and her team believe that CellCept, normally used to prevent organ rejection in transplant patients, should be first-line therapy in lupus patients with the exception of those who have rapidly progressive severe renal failure.
She says it is probably more effective at inducing remission, is safer in terms of producing a lower risk of infection, and it's better tolerated by patients.
Ginzler says that CellCept, which is also known as mycophenolate mofetil, did cause some mild nausea or diarrhea but no patient dropped out of the study because the side effects were intolerable,whereas patients refused to take Cytoxan all the time because it caused terrible nausea and vomiting and resulted in hospitalization for dehydration.
It is also understood that two patients in the Cytoxan group died, while there were no deaths among recipients of CellCept.
Joseph McCune of the University of Michigan Medical Center comments that CellCept needs more testing before it could be given to patients with rapidly progressing kidney disease, but the drug may be a good first-treatment for newly diagnosed lupus patients with mild or moderate kidney disease.
However CellCept, which is given by mouth, is 10 times more expensive than generic Cytoxan.
Ginzler estimates though, that when the cost of giving Cytoxan intravenously, and the expense of medications to ward off side effects are factored in, the CellCept treatment is about 20 percent cheaper.
The study and comments on it are published in The New England Journal of Medicine.