Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) announced that BENLYSTA (belimumab, formerly LymphoStat-B?) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE).
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.
Source: Lupus Research Institute, USA