LFA’s platforms will analyze data from previous lupus clinical trials, establish outcome measures, and standardize lupus assessment tools
WASHINGTON--(BUSINESS WIRE)-- Fifty-two years since the last new drug approval for lupus, the Lupus Foundation of America (LFA) today announced three groundbreaking initiatives that aim to overcome the barriers that have plagued clinical research and the development of new, safe, effective, and more tolerable treatments for lupus, a potentially life-threatening and life-altering autoimmune disease.
Working with key scientific leaders from academia and industry, LFA’s platforms have been developed to help standardize and improve clinical trial design, allowing future studies to be completed more successfully. Improved clinical trials will ultimately lead to the development of an arsenal of new, safe, effective, and more tolerable treatments. From defining what is a lupus flare, to training clinical investigators on lupus assessment tools, to mining of scientific data from previous clinical trials, the LFA‘s goal is to bring lupus under control and improve the quality of life for people living with lupus.
“Last year, we saw several significant breakthroughs in lupus research, including the first-ever successful completion of two Phase III clinical studies for a potential new lupus treatment,” said Gary S. Gilkeson, M.D., Vice Chairman of the Department of Medicine for Research, Medical University of South Carolina and Chair, LFA Medical-Scientific Advisory Council. “The recent successes we have seen in lupus research and these initiatives will help provide a pathway forward for lupus drug development.”
The past two decades have witnessed several failed clinical trials for investigational therapies to treat lupus. Lupus is a heterogeneous disease that presents itself differently from patient to patient, which has resulted in numerous challenges when conducting clinical studies. The unique biology of this disease has made it difficult to assemble uniform patient groups to test new treatments, and the various background medications taken by patients have affected clinical trial results. The pharmaceutical and biotechnology industry has lacked a clearly defined pathway for measuring outcomes in lupus clinical trials as required by the U.S. Food and Drug Administration (FDA). The instruments used by investigators to assess disease activity are also extremely complex.
To further expand the medical research effort on lupus and ensure that the development of new lupus therapies continues and grows, the LFA has partnered with key stakeholders to:
Analyze Data from Past Clinical Trials
The LFA is working with partners from industry and the scientific community to collect and analyze data from previous lupus clinical trials. This initiative will provide needed insight on patient response and the challenges with lupus clinical trials.
“This data initiative is an important program and the first of its kind in lupus,” said Jane Salmon, M.D., Collette Kean Research Professor, Hospital for Special Surgery. “Analysis of data from past lupus clinical trials has the potential to provide data which will allow the lupus community and our partners in industry to improve the design of our clinical trials.”
Reach a Consensus Definition of a Lupus Flare
More than 120 international lupus experts from 11 countries have reached a consensus definition of a lupus flare, a period of increased disease activity. A standard definition is a significant achievement in establishing a potential outcome measure to demonstrate efficacy in clinical trials, where previously none existed. The study will be published in the internationally peer-reviewed medical journal Lupus.
Launch Standardized Investigator Training Program
Inconsistencies in training investigators on the use of the instruments to assess disease activity have impacted the outcomes of lupus clinical trials. In response, the LFA developed the LFA Professional Online Instrument Training Program™ (LFA POINT), a web-based training site for researchers and biotechnology companies, as well as investigators and staff participating in multi-center trials.
"UCB is pleased to work with the LFA in establishing programs like POINT, which helps to standardize training for lupus assessments for the clinician treating patients with lupus,” said Sabine Bongardt of UCB. “UCB believes that POINT will increase the reliability of data generated from lupus studies in the future and improve the efficiency of the pathway to bring safe and effective solutions to lupus patients."
The LFA’s National Research Program, Bringing Down the Barriers®, is dedicated to addressing research issues that have obstructed basic biomedical, clinical, epidemiological, behavioral, and translational lupus research for decades. The LFA’s National Research Program is unique because it directs LFA funding to areas of research where gaps exist in the understanding of lupus and promising areas of study in which other public and private organizations have not focused their efforts. Using a three-pronged strategy, the LFA and its national network are committed to advancing the science and medicine of lupus by: funding investigators through a peer-reviewed grant program; directly conducting special research initiatives; and advocating for increased investment by federal and state governments, as well as the nation's pharmaceutical and biotechnology industries. For more information about the LFA’s National Research Program, visit www.lupus.org/research.
About the Lupus Foundation of America
The Lupus Foundation of America (LFA) is the foremost national nonprofit organization dedicated to finding the causes of and cure for lupus, and providing support, services, and hope to all people affected by lupus. The LFA and its national network of chapters, support groups, and local representatives conduct programs of research, education, and advocacy.
Lupus is an unpredictable and potentially fatal autoimmune disease in which the immune system is out of balance, causing inflammation and tissue damage to any organ system in the body. The health effects of lupus include heart attacks, strokes, seizures, and organ failure. An estimated 1.5 million Americans and at least five million people worldwide have a form of lupus. For more information, visit www.lupus.org.
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