First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness
July 20, 2009 — Lupus LA in conjunction with The Lupus Research Institute (LRI) and Dr. Daniel Wallace congratulates Human Genome Sciences (HGS) and GlaxoSmithKline on the promising results of this landmark clinical trial of Benlysta™ (belimumab) for people with systemic lupus.
“For the one million people with lupus in the United States, this is nothing short of revolutionary,” said Dr. Daniel J. Wallace, a clinical professor of medicine at the University of California, Los Angeles, who was a consultant to Human Genome Sciences on the structure of the trial.
“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” added Dr. Wallace. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”
50 lupus patients from Los Angeles were enrolled in the Benlysta-76 trial representing UCLA, USC, Cedars-Sinai and the Inland Empire.
“These results bring significant hope to the over 60,000 people with lupus and their families living in our community,” said Linda David, Executive Director of Lupus LA. “Our patients and their families have been anxiously awaiting this kind of substantial progress.”
“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.”
In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, Benlysta™ plus standard of care was 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.
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.
To learn more about lupus clinical trials, log on to www.LupusTrials.org.
About Lupus LA
Lupus LA, the West Coast division of the S.L.E. Lupus Foundation founded by renowned physician and author, Daniel J. Wallace, MD, serves the needs of people with lupus and their families in Los Angeles County and across southern California. Lupus LA raises awareness, conducts advocacy and community outreach, and supports novel lupus research on the national level. Committed to the hope and demonstrated promise of innovative science, Lupus LA partners with the Lupus Research Institute (LRI) to fund novel lupus research that will prevent, treat and cure the complex disease.
To learn more about Lupus LA, visit www.lupusla.org or contact Linda David, Executive Director at 310 657 5667.
About the Lupus Research Institute
Pioneering discovery to prevent, treat and cure lupus The Lupus Research Institute (LRI)—the world’s leading private supporter of innovative research in lupus—champions innovation, encourages scientific creativity and risks exploring uncharted territory to bring new scientific solutions to the complex and dangerous autoimmune disease of lupus. Founded by families and shaped by scientists, the Institute mandates sound science and rigorous peer review to uncover and support only the highest ranked novel research. Its bold and proven research strategy places the LRI at the forefront of lupus science as the Institute consistently achieves the breakthrough discoveries, novel insights and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide. To learn more about lupus and the Lupus Research Institute, visit www.lupusresearchinstitute.org.
About Dr. Daniel Wallace
Daniel J. Wallace, MD is a renowned physician and author. He is an attending physician in the division of rheumatology at Cedars-Sinai Medical Center and a clinical professor of medicine at UCLA’s David Geffen School of Medicine. In 2000 he founded Lupus LA to lead the way in funding research as well as in promoting awareness, education and hope for patients with lupus. His clinical practice is based at Cedars-Sinai, where he is involved in the care of 2,000 lupus patients, the largest practice of its kind in the United States.
Systemic lupus erythematosus (SLE) or lupus, one of the nation’s least recognized major diseases, is a chronic and potentially fatal autoimmune disorder that affects more than 1.5 million Americans, primarily women in their childbearing years. African American women are three times more likely to get lupus than white women. It is also more common among Hispanic/Latina, Asian and American Indian women. More Americans have lupus than cerebral palsy, multiple sclerosis, sickle-cell anemia, and cystic fibrosis combined, making it one of this country's most prevalent medical problems. In lupus, the body’s immune system forms antibodies that can attack virtually any healthy organ or tissue, from the kidneys to the brain, heart, lungs, skin, joints and blood. No new treatments for lupus have been approved in almost 50 years and many currently used treatments are as toxic as the disease itself. Lupus is a leading cause of premature cardiovascular disease, kidney disease and stroke among young women.