April 29, 2008 – The Lupus Research Institute and its National Coalition of state and local organizations, although disappointed by the flat top-line results announced today of a major clinical trial of Rituxan (rituximab) for systemic lupus, are encouraged that findings from this study will inform future trials and help advance drug development.
“Not every trial is going to be a success,” said Lupus Research Institute President Margaret G. Dowd. “But full data from this major study will be very important in designing and implementing future trials. We commend Genentech and Biogen Idec for their commitment and pioneering efforts to develop needed new treatments for people with lupus.”
The multi-center, double-blind, placebo-controlled study used sophisticated tools for measuring response. Rituxan failed to prove more effective than placebo in producing clinically meaningful benefits. More than 250 people with moderate-to-severe lupus were enrolled in the 52-week trial.
“While we were all hoping for a positive outcome, every trial is a learning process,” noted leading lupus physician Richard Furie, MD, chief of rheumatology at North Shore-LIJ Health System in New York.
“Important information gleaned from this ambitious trial and others will ultimately help people with lupus,” he added. “A failed trial does not mean the drug is ineffective. You chip away at the problem, and with help from patients, you learn what questions to ask and what measurements of success to look for.”
Decades have passed without an FDA drug approval for lupus, and current treatments are sparse and often toxic. “Now more than ever we need to dig deep and look into the human biology of lupus with new eyes to build a robust pipeline of new treatments,” Dowd said. “We need the research and we need to fill the trials. We must all do our part to succeed.”
To learn more about lupus clinical trials, log on to www.LupusTrials.org.
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. 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.
About the Lupus Research Institute
Pioneering Discovery to prevent, treat and cure lupus. The Lupus Research Institute (LRI), the country’s only nonprofit organization singularly devoted to novel 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.