July 20, 2009 — The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline on the highly promising results of this landmark clinical trial of Benlysta™ (belimumab) for people with systemic lupus.
“We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years,” said LRI President, Margaret G. Dowd. “We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness.”
“This is a major advance for patients, families, and physicians—the entire lupus community!” said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. “There is no doubt that a drug approval will foster further drug development and additional discoveries.”
In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta™ plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.
“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.”
Results of a second Phase 3 trial of Benlysta™, known as BLISS-76, are expected later this year. That trial has enrolled 826 participants at 133 clinical sites in 19 countries, primarily in North America and Europe.
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.
First of its kind
“Benlysta™ is the first ‘targeted biological agent’ developed specifically for systemic lupus that has the potential to obtain FDA approval…with the positive results of this 52-week trial and pending the results of the 76-week trial,” said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago.
“HGS took a very ambitious development approach—huge international concurrent trials which represent a large investment in systemic lupus therapy," Utset added.
“The lupus community commends HGS and GlaxoSmithKline for their commitment and perseverance in finally bringing this potential new lupus treatment to trial,” said Dowd. “And we thank the hundreds of people with lupus who enrolled and took part in this important trial. Participation like theirs is critical to finding answers to this illness.”
The LRI builds the research pipeline and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.
To learn more about lupus clinical trials, log on to www.LupusTrials.org.