WASHINGTON, June 12, 2014 /PRNewswire-iReach/ -- A new Lupus Foundation of America analysis of data obtained from previous lupus clinical trials has identified factors that may help to improve future clinical trials, while results of another study show a new instrument under development by the Foundation can help clinicians assess changes in disease activity over time and in various organ systems. The data is being presented during the 2014 European League Against Rheumatism (EULAR) Congress, a major European medical conference focusing on the field of rheumatology that opens today in Paris, France.
The studies are part of two initiatives funded by Lupus Foundation of America's National Research program: Bringing Down the Barriers™. Both aim to improve the quality of life for people with lupus through the development of a full arsenal of safe and more tolerable therapies, and more effective tools to help physicians better manage this misunderstood and unpredictable autoimmune disease.
In the first study, the Foundation is presenting additional analysis from the Standard of Care in Clinical Investigational Trials™ (SOCCIT) program, part of an ongoing study to examine how background medications taken by people with lupus during clinical trials may mask the effectiveness of potential new treatments. This latest analysis examines flare rates among clinical trial participants who were on various standard-of care-medicines and the results were divided between two groups of patients – those who had lupus-related kidney disease (lupus nephritis) and those who did not have nephritis. The analysis compared the flare and response rates of both groups.
Individuals who had higher disease activity scores when they entered the studies were more likely to experience flares during the trial, possibly because they were sicker at the beginning of the study. The potential of these patients to experience more flares may confound study results and make it more difficult to prove a potential new treatment for lupus is effective.
The results of this SOCCIT program analysis will provide insight for future trial designs by identifying, from the start, those patient-specific factors that could predict a high response from those receiving 'standard of care'. The program is also helping to identify trends and provide new insights into real-life experiences of people with lupus who often receive these 'standard therapies' as part of their care.
In the second study, data from assessments of disease severity among a group of patients with lupus showed that the Lupus Foundation of America Rapid Evaluation of Activity in Lupus™ system (LFA-REAL) was a simple to use, intuitive measure of lupus disease activity that performs reliably. The study compared results of LFA-REAL to the British Isles Lupus Assessment Group index (BILAG) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), two instruments that are typically used in clinical trials to measure response to treatment. The results demonstrated that in this population of patients, the LFA-REAL system obtained assessments that were similar to those of the BILAG and SLEDAI.
The investigators concluded LFA-REAL is easy to administer and could help improve treatment justification that doctors must provide to insurance companies so their patients can receive reimbursement for lupus medications. The LFA-REAL offers a unique advantage in being the only tool with both clinician and patient components, and a tool for use in both clinical trials and clinical care. It also allows for the ability to distinguish involvement of different organ systems and a greater range measuring moderate/severe disease. Over time, the LFA-REAL system can also help document the progress of patients with lupus.
LFA-REAL is a two part system, with input from both the physician and the patient, based on a series of simple questions and observations, to determine a treatment's impact on the patient's health and daily life. The Lupus Foundation of America will seek additional input from physicians and make further refinements to the instrument before repeating the comparison using physicians who are not already familiar with the three instruments, to further evaluate the ease of use and effectiveness of the LFA-REAL system.
The full-news release is available of the Foundation's website at lupus.org/news.
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, we lead the fight to improve the quality of life for all people affected by lupus. Visit lupus.org for more information about lupus and the Foundation.
Media Contact: Duane Peters, Lupus Foundation of America, Inc., 202-349-1145, email@example.com
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SOURCE Lupus Foundation of America, Inc.