Examination of Disease Activity Measure Proves Need for Better Tools
Assessing disease activity is an important part of daily practice, clinical trials and other lupus – related research. There are several tools that have been developed, but none is perfect. Each has weaknesses due in part to the complexity of lupus. One of these instruments, the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), was evaluated to better understand its performance. Researchers found that the SLEDAI-2K was in “good agreement” when it came to measuring disease activity in people with lupus with clinically stable disease activity, but it did not do as good a job at identifying cases of significant improvement or worsening. This means that the tool was not sensitive enough to identify a “clinically meaningful” change. The concept of “clinically meaningful change” is important when evaluating potential new treatments, but also in disease management. Further research is needed, and these findings support the need for improved disease measures in lupus.
As a leader in supporting the improvement of lupus research and trial results, the Lupus Foundation of America developed REAL™ - Rapid Evaluation of Activity in Lupus - LFA-REAL. The tool is unique from other lupus measures because it incorporates both clinician and patient perspectives. LFA-REAL is currently being utilized in a phase III global clinical trial. The Lupus Foundation of America is also working with other researchers and the US Food and Drug Administration to identify tools that can be utilized in lupus trials and ultimately help bring new drugs to market for people with lupus.