Philadelphia, October 20, 2009—Drug company Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today reported details of the first of their two crucial Phase 3 trials of belimumab (Benlysta™) in people with systemic lupus erythematosus at the American College of Rheumatology’s (ACR) annual scientific meeting in Philadelphia.
“There is a lot of encouraging information in here for the 1.5 million Americans with lupus,” said Lupus Research Institute (LRI) President Margaret G. Dowd at the meeting.
HGS first reported on the clinical trial (BLISS-52) results this summer. If findings from the longer “BLISS-76” trial due in November are positive as well, the company can apply to the Food and Drug Administration (FDA) for drug approval in 2010—possibly the first drug approval for lupus in more than 50 years.
Specifics on effectiveness and safety
“The BLISS-52 Phase 3 results presented at ACR demonstrated that the efficacy of treatment with belimumab plus standard of care was superior to that of placebo [dummy drug] plus standard of care," explained David C. Stump, MD, executive vice president of research and development at HGS in a statement. “These data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points.”
The company shared these and other trial details on belimumab’s ability to significantly reduce lupus disease activity and the rate of lupus flares, as well as to lower the rate of flares and significantly delay the length of time to the first flare.
“Belimumab’s apparent capacity to lower the use of the dreaded corticosteroid, prednisone, is also notable,” said Dowd, who has heard from the thousands of LRI members that lessening the dosage of this often lifesaving but complication-ridden medicine is a priority. In the trial, a greater percentage of participants taking belimumab were able to reduce their prednisone use than those taking the placebo.
LRI Program Director Catherine Anastasia noted that the significant reductions in fatigue with belimumab would also come as particularly welcome news. “The fatigue of lupus can be draining and debilitating. A route out of the exhaustion would make a big difference in quality of life for so many.”
The company additionally reported that people taking belimumab generally tolerated the drug well.
Key trial design
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
Dowd and other LRI representatives are among the thousands of attendees—physicians, health professionals, and scientists—at the Philadelphia meeting designed to advance rheumatology through programs of education, research, advocacy and practice support.
The new details of the trial are available here.