Studies Provide Insight on New Ways to Improve Care and Management of Lupus
(WASHINGTON, DC) JUNE 11, 2013 -- A new Lupus Foundation of America analysis of data obtained from previous lupus clinical trials has identified factors that may help to improve future 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 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. A Lupus Foundation of America survey found that an estimated 1.5 million Americans are living with lupus, a chronic and potentially fatal disease in which the immune system is out of balance, causing damage to any organ system in the body, including the heart, lungs, brain, kidneys and skin.
Standard of Care in Clinical Investigational Trials Program Provides Insight for Future Lupus Trial Designs
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. The Foundation established the SOCCIT program as part of the Lupus Foundation of America Collective Data Analysis Initiative (LFA-CDAI), a first-of-its-kind research study created to improve clinical trials so new treatments for lupus can be more easily developed.
Previous analysis of data from the SOCCIT program revealed that the background drug mycophenolate mofetil (MMF) was associated with an improvement in health status, which may have masked the efficacy of the investigational medicine under study. This latest analysis, being presented during EULAR 2014, examines flare rates among clinical trial participants who were on MMF, azathioprine (AZA), methotrexate (MTX) and high dose cyclophosphamide (IVCY). The analysis used data from 933 patients who participated in six different clinical studies. 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’.
“Using combined data gathered from multiple trials allows us to learn something quite different than what we get from each individual trial,” said Dr. Joan Merrill, Head of the Clinical Pharmacology Research Program at the Oklahoma Medical Research Foundation, and Medical Director for the Lupus Foundation of America. “We are gaining insight into what happens when these standard-of-care therapies are used to treat patients and this is valuable for designing more effective trials and also increases our understanding of their relative effects in clinical practice.”
"Developing new therapies for lupus is incredibly complex, and researchers face a number of obstacles that can hinder their ability to demonstrate whether a potential new treatment is effective,” said Sandra C. Raymond, President & CEO of the Lupus Foundation of America. “The goal of the LFA-CDAI is to improve the design of future lupus clinical trials and is an important part of the Foundation’s urgent mission to improve the quality of life for people with lupus by supporting development of safe and more tolerable treatments.”
The next step in the SOCCIT program is to analyze how different definitions of response affect the relative ranking of background medications with respect to response rates.
Lupus Foundation of America Rapid Evaluation of Activity in Lupus™ System Allows for Greater Range in Measuring Disease
In the second study, data from assessments of disease severity among 91 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 advantages of LFA-REAL over other existing disease activity measurement tools are its ability to distinguish involvements of different organ systems and to allow for a greater range measuring moderate/severe disease.
The study was conducted at two different clinics and compared results of LFA-REAL to the British Isles Lupus Assessment Group index (BILAG) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Patients were assessed using all three instruments and the results were compared to see how well the measurements related to each other. 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 system also can help document the progress of patients with lupus.
The Lupus Foundation of America will seek additional input from physicians and make further refinements to the instrument. The next steps for validating this portion of the LFA-REAL system will be to repeat 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.
For additional information about the Lupus Foundation of America’s national research program, visit the Foundation’s website at lupus.org/research.
About the LFA SOCCIT Program
The SOCCIT program is part of the LFA-CDAI, which combines data from pharmaceutical and biotechnology–sponsored lupus studies from across the world. By analyzing data from the standard-of-care (placebo) arm of these studies, this initiative will help the entire lupus research community conduct stronger clinical trials that produce more meaningful data, which in turn will help to accelerate development of new therapies. The program also is 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.
About the LFA-REAL System
LFA-REAL is a two part system, based on a series of simple questions and observations, to determine a treatment’s impact on the patient’s health and daily life. Currently, there are no adequate measures or tools designed to quickly and easily help a doctor and patient work together to evaluate lupus disease activity and make informed treatment decisions. The Foundation is spearheading development of the LFA-REAL system, a first-of-its-kind set of tools to monitor lupus disease activity, addressing both the needs and concerns of clinicians, clinical trials and people with 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, hits out of nowhere, 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 its scope and devastation.