Positive one-year results from a recent study show that belimumab (BenlystaTM) achieved meaningful improvements and was safe in patients with systemic lupus erythematosus (SLE). Belimumab inhibits the B-lymphocyte stimulator and presumably reduces autoantibody levels in lupus. This is the first new treatment for lupus in decades; it has been more than 50 years since the US Food and Drug Administration (FDA) approved a new medication for lupus.

     In the study, belimumab significantly reduced disease activity, disease flares, and use of steroids; and it improved fatigue and quality of life, compared with placebo. Time to severe flares and moderate flares was delayed with belimumab, and belimumab was prednisone-sparing, with a higher percentage of patients who reduced their steroid drugs by at least 50 percent at week 52.

     Belimumab was generally well tolerated, with comparable rates of adverse events, serious adverse events, infections, and deaths for all three study groups (placebo, belimumab 1 mg/kg, and belimumab 10 mg/kg, all of whom received standard of care, including prednisone, 96 percent, and immunosuppressants, 42 percent). Serious infections occurred in 6.1 percent of the belimumab-treated patients and 5.9 percent of the placebo-treated patients. The most common adverse events included headache, arthralgia, upper respiratory tract infections, urinary tract infections, and influenza. These were comparable between groups.

     Zahi Touma, M.D., from the University of Toronto, in Ontario, called this trial a major achievement. He said, "Other trials of biologic agents for treatment of lupus have failed. Finally we have a study that shows a drug that works, with positive results in lupus patients. This is very important. Nothing has been approved by the FDA since cyclophosphamide."

     H. Thomas Watkins, President and Chief Executive Officer, of Human Genome Sciences, Inc., says, "We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the United States, Europe, and other regions. We will continue to work with GlaxoSmithKline to advance this drug to the market where it may benefit patients with significant need."

--Source: "First New Treatment for Lupus in Decades Shows Promise," Alice Goodman, Medscape Medical News, October 26, 2009; "Human Genome Sciences and GlaxoSmithKline Announce Positive Results in Second of Two Phase 3 Trials of BenlystaTM in Systemic Lupus Erythematosus," Human Genome Sciences, November 2, 2009