Clinical trials in lupus nephritis.

Significant advances in the treatment of lupus nephritis have been made in the last 50 years, beginning with the use of high doses of corticosteroids. The addition of intravenous cyclophosphamide (IVC) to steroids, a regimen introduced by the National Institutes of Health, has become the standard of care therapy for severe active nephritis. However, not all patients respond to IVC, and among those who do, manifestations of toxicity (nausea, vomiting, alopecia, sterility, increased risk of infection, and increased risk of malignancy) are frequent. Despite successful induction and maintenance therapy with IVC, there is a relapse rate of more than 50% after 10 years. In recent years, new immunosuppressive agents have been studied as potential alternatives to IVC. The most promising of these appears to be mycofenolate mofetil, which is being evaluated in clinical trials. Biologic agents designed to interfere with the immunologic process leading to B- and T-lymphocyte activation are also being tested as alternative therapies in lupus nephritis.