Treatment of systemic lupus erythematosus was based on limited data until the end of the 20th century, according to Dr. David Wofsy of the University of California at San Francisco. Fortunately, the pace of research has increased. Dr. Daniel J. Wallace of Cedars-Sinai Medical Center in West Hollywood, California, echoed this report and added that guidelines finalized by the United States Food and Drug Administration in June 2010 have revolutionized the process of drug development for lupus. Wallace described himself as an experienced lupologist who was able to improve his own research efforts as a result of the new guidelines.
Lupus research got low priority for decades, according to Wallace, for three reasons. First, it is considered a “woman's disease”, striking mostly women of childbearing age. Second, there was inadequate advocacy for lupus treatment. Third, a clinical trial for lupus nephritis sponsored by the National Institutes of Health that ran for 20 years in the 1970's and 1980's showed that lupus research can take much more time than other autoimmune research. A mean time of five years was required in this early trial to show which treatment was superior. For rheumatoid arthritis and spondylitis, equivalent results require only three to six months. Thus, the pharmaceutical industry favored these conditions over lupus. The new FDA guidelines help researchers to optimize trial design and get results faster.
The approval of Benlysta for lupus on March 9, 2011, is one of the most notable results of the accelerated research pace. This is the first new drug approved for lupus in over 50 years, and represents a welcome advance. However, much more research is needed. In clinical trials, only about one third of the lupus patients saw benefits from Benlysta.
Other important research results reported by Wofsy include:
1. Mini-pulse therapy with cyclophosphamide is as effective as conventional dosing, and may be the treatment of choice for some patients. Mini-pulse therapy consists of six biweekly infusions of cyclophosphamide, followed by maintenance therapy with azathioprine.
2. Mycophenolate mofetil is an attractive option for maintenance therapy.