Breakthrough Treatment Offers Hope for Lupus Patients

For the first time in 40 years, a new medicine to treat lupus has proved effective in a large clinical trial.

The drug Benlysta, developed by Human Genome Sciences (HGS) in Rockville, Md., is promising, particularly for African American women, who are three times more likely than white woman to develop the disease, experts say. Additionally, black women tend to get the disease at a younger age and have more severe symptoms than their white counterparts.

Lupus is a chronic and sometimes fatal autoimmune disorder that affects more than 1.5 million Americans, mostly women of childbearing age, rendering some disabled. According to the Lupus Foundation of America, patients can develop fatigue, cardiovascular disease, kidney disorder, kidney failure, arthritis and rashes.

"The findings are remarkable," says Dr. Nathaniel Neal, a clinical practicing rheumatologist at the Valerius Medical Group in Long Beach, Calif. "It's the first drug to significantly impact the course of the disease. This is a breakthrough treatment."

Dr. Neal, who has been working to treat lupus patients for 26 years, says the most exciting part about Benlysta is that it allows doctors to minimize the dose of steroids, which lead to massive weight gain, high blood pressure, diabetes and other side effects in patients. "We now have one agent that really has been shown to be effective with minimum side effects."

Benlysta, given by monthly infusions, is generally well tolerated, according to a 52-week study of 865 Asian, Eastern European and South American patients. The medicine works by inhibiting the B-lymphocyte stimulator, which produces B blood cells that help the body fight infection. In lupus, elevated levels of B-lymphocyte stimulator are believed to produce antibodies that attack and destroy the body's own healthy tissue.

Findings from the trial showed that 57.3 percent of patients on a higher dose of Benlysta and 51.7 percent of those on a lower dose had a meaningful improvement in their symptoms, compared with 43.6 of those taking a placebo.

Benlysta has yet to be approved. HGS, which is working to develop and market the drug with GlaxoSmithKline, will apply for approval later this year.

Tomiko Frasier Hines, a board member and spokeswoman for the National Lupus Foundation of America in Los Angeles, is optimistic about the potential bright spot for lupus patients. In the past, clinical trials conducted by other drug companies have all but failed in their efforts to develop a new medicine to treat the disease.

"It's very hopeful," says Hines, whose sister died in March after a 12-year battle with lupus. "There hasn't been a new medication approved in years. I'm sure that everyone is quite pleased with the news."

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