New Study Sheds Light on the Challenges of Developing Lupus Treatments

Lupus Foundation of America Funded Research First to Use Pooled Data from Previous Treatment Trials


WASHINGTON--Nov. 7, 2011--(BUSINESS WIRE)--LFA- Initial findings from a research study funded by the Lupus Foundation of America (LFA), the first-ever to use pooled data from five industry-sponsored treatment trials, will be presented during the annual scientific meeting of the American College of Rheumatology being held in Chicago, November 7-10, 2011. The study examines the effect of background medications taken by individuals enrolled in these clinical trials. This study is the first in a series of studies, and part of an overall initiative spearheaded by the LFA, that involves stakeholders from industry and key lupus opinion leaders to seek insights and trends from previous trials in an effort to improve the design of future lupus clinical trials. Due to the complexity of lupus, there is an urgent need for an arsenal of safe, effective, and tolerable treatments for lupus.

During a clinical trial, individual participants are on potent background medications, such as corticosteroids, chemotherapies, and antimalarials that may have toxic and disabling side effects, including bone loss and osteoporosis leading to joint replacements, loss of fertility, cardiovascular complications, and more. It is believed that these medications may have minimized or masked the impact of the investigational therapy in many recent lupus clinical trials.

Initial reports from the pooled data show that individuals enrolled in a standard of care treatment group during the clinical trials had a high response rate (38 percent to 52 percent over a 52-week period). High response rates for people receiving the standard of care treatments may explain the difficulty in demonstrating the efficacy of the investigational therapy over the standard of care medication.

“The LFA’s early findings are part of an ongoing effort to gather and analyze lupus clinical trial data,” said Kenneth C. Kalunian M.D., chair of the LFA data mining initiative and Associate Professor of Medicine, University of California at San Diego. “This study and future projects will include analyses on the effects of steroid dosing and patient demographics on response rates. These projects may provide needed insight on patient response and help create pathways forward for the development of new treatments.”

Potent background medications taken by individuals enrolled in clinical trials represent only one of a number of barriers that have slowed the development of new treatments for lupus. Others include: the unique biology and heterogeneity of the disease; the lack of a clearly defined pathway for measuring outcomes in lupus clinical trials; and the complexity of instruments used by investigators to assess disease activity.

About Lupus

Lupus is an acute and chronic autoimmune disease in which the immune system is out of balance, causing inflammation and tissue damage to virtually any organ in the body. Lupus can be unpredictable and potentially fatal. Its health effects include heart attacks, strokes, seizures, miscarriages, and organ failure.

About the LFA

The LFA is the foremost national nonprofit health 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, branches, and support groups conduct programs of research, education, and advocacy. For more information, visit www.lupus.org.

About the LFA National Research Program

The Lupus Foundation of America’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 national three-pronged strategy the LFA and its national network are committed to advancing the science 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 LFA’s National Research Program, visit www.lupus.org/research.

About the ACR Annual Scientific Meeting

The ACR Annual Scientific Meeting is the premier meeting in the field of rheumatology involving more than 10,000 rheumatology professionals.


Contacts
Lupus Foundation of America (LFA)
Maggie Maloney, maloney@lupus.org, 202-212-6766
Duane Peters, peters@lupus.org, 202-349-1145

 

Posted: November 2011

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