Lupus Foundation of America Announces Collective Data Analysis Initiative Results at 2016 EULAR Congress
First-of-its-kind study may help expedite the delivery of new and safer therapies for lupus
WASHINGTON, DC - June 9, 2016 – Today, the Lupus Foundation of America announces results of a new study that could expedite the delivery of new and safer therapies to people with lupus. The data is being presented during the 2016 European League Against Rheumatism (EULAR) Congress, a major European medical conference focusing on the field of rheumatology in London, England.
The study is part of the Lupus Foundation of America Collective Data Analysis Initiative (LFA CDAI), which is a collaboration among multiple companies to improve lupus clinical trials. Developed in 2009, LFA CDAI analyzes data from pharmaceutical and biotechnology–sponsored lupus studies from around the world to identify trends and gain new insights.
Since its inception, LFA CDAI has published important findings on the impact of background medications taken by people with lupus during clinical trials. The latest LFA CDAI analysis builds upon this work.
Lupus trials have generally reported response rates based on landmark instead of sustained response. The new results show that the rate of response to background medications in the placebo group of two previously conducted 52-week lupus clinical trials was reduced from 37% to 14% when response was assessed over time (sustained response) at each visit throughout the trial instead of only at specific landmark visits.
“We have found that the use of many different kinds of background medications in lupus trials results in high response rates in the placebo group. This makes it challenging to evaluate new treatments that might be safer or more effective.” said Dr. Mimi Kim, LFA CDAI Co-chair and the lead author who conducted the analysis through funding from the Lupus Foundation of America. “Our analysis includes some insights that can help people who design clinical trials come up with ways to improve study designs, in order to be able to see whether an investigational treatment has advantages over current options.”
Using LFA CDAI’s ever growing database, the researchers plan to conduct additional studies to explore whether using response duration as an endpoint (goal) in clinical trials improves discrimination between an investigational drug and placebo.
“This is an excellent example of our commitment to conducting smarter research to make faster progress in bringing the disease under control and eventually finding cures,” said Sandra C. Raymond, Lupus Foundation of America President and CEO. “These findings will help researchers secure more meaningful data through clinical trials in order to accelerate the development of new therapies.”
The Lupus Foundation of America supports research to improve the quality of life for all people affected by lupus. For more information on Foundation research priorities, visit lupus.org/research. The latest lupus research can also be accessed in Lupus Science & Medicine, the first-ever international, Open Access medical journal dedicated to advancing knowledge in the diagnosis, treatment and management of lupus and related diseases. Lupus Science & Medicine is owned by the Lupus Foundation of America and published by BMJ, a respected global provider of evidence-based medical knowledge.
Media Contact: Tracy Cooley, APR, 202-349-1162, cooley@lupus.org
About Lupus
Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body. It is difficult to diagnose, hard to live with and a challenge to treat. Lupus is a cruel mystery because it is hidden from view and undefined, has a range of symptoms, strikes without warning, and has no known cause and no known cure. Its health effects can range from a skin rash to a heart attack. Lupus is debilitating and destructive and can be fatal, yet research on lupus remains underfunded relative to diseases of similar scope and devastation.
About the Lupus Foundation of America
The Lupus Foundation of America is the only national force devoted to solving the mystery of lupus, one of the world’s cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact. Through a comprehensive program of research, education, and advocacy, the Foundation leads the fight to improve the quality of life for all people affected by lupus. Learn more about lupus, Lupus Science & Medicine Journal and the Lupus Foundation of America at lupus.org. For the latest news and updates, follow us on Twitter and Facebook.