Doctors are reporting the first advance in three decades in treating kidney complications from lupus, a life-threatening disease that primarily affects young women.
A small study showed that an immune-suppression drug worked better than the standard chemotherapy medication, which can cause infertility and other problems.
Nearly a quarter of patients who took the newer drug, CellCept, saw their kidney problems go into complete remission after six months, compared with just 6 percent of those who received the older treatment, cyclophosphamide. The CellCept patients also had fewer side effects.
“This holds great promise for a better quality of life for people with lupus,” said Sandra Raymond, president of the Lupus Foundation of America.
The study was led by Dr. Ellen Ginzler of the SUNY Downstate Medical Center in New York and published in Thursday’s New England Journal of Medicine. Partial results were presented in 2003 at a scientific conference in Orlando, Fla.
Lupus is a crippling and sometimes fatal disease that mostly strikes women of childbearing age. About 1.5 million Americans have the disorder, in which the body’s immune system attack its own organs and tissue. No one knows why it happens. One third of all lupus patients suffer from inflammation of the kidney that can lead to kidney failure.
For the past 30 years, chemotherapy has been the standard treatment for the kidney complications. But the side effects can include hair loss, nausea and infertility — problems that can lead patients to skip their chemo.
CellCept, made by Hoffmann-La Roche Inc., is approved by the Food and Drug Administration to prevent organ rejection in transplant patients. But some doctors prescribe it to lupus patients who cannot tolerate chemotherapy.
In the study, 140 people received either daily oral doses of CellCept or monthly intravenous doses of cyclophosphamide.
After six months, 23 percent of those who took CellCept had complete remission. An additional 30 percent in the CellCept group had partial remission, versus 25 percent of those in the chemotherapy group.
Patients who took CellCept also had fewer infections and hospitalizations but experienced more diarrhea.
The study was supported by grants from the FDA and Roche Laboratories.
In an accompanying editorial, Dr. W. Joseph McCune of the University of Michigan Medical Center wrote that CellCept will not become the standard of care until a larger, more definitive study is done. But he said it is reasonable for doctors to prescribe the drug to patients worried about preserving fertility.
A larger international study sponsored by a Canadian pharmaceutical company is under way, comparing the long-term effects of CellCept and chemotherapy in lupus patients.