Nov. 06, 2017

Study Leads to a New Approach for Evaluating the Effectiveness of Experimental Therapies

A Lupus Foundation of America study has led to the development of a new model for assessing patient outcomes in clinical trials. The new model, based on findings from the Lupus Foundation of America’s Collective Data Analysis Initiative (LFA CDAI), yields a more comprehensive profile of a lupus patient’s response to therapy and takes into account the important fact that how well a patient responds to treatment varies over time.

This model is a significant improvement over the existing standard of using a single “landmark” visit to assess outcomes. The model can also be used to design future studies and to accelerate the identification of effective new therapies that would ultimately benefit people with lupus.

The data supporting the development of this new model is part of the LFA CDAI study, “Estimating Duration of Response in Systemic Lupus Erythematosus (SLE) Trials,” and was released at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Diego.

Measuring Efficacy at Single Landmark Visit is Insufficient

In a typical lupus trial, patient responses are analyzed only at their final visit (also known as a "landmark" visit), which doesn’t account for overall effectiveness of the treatment throughout the entire study. Additionally, the new method can handle drop-outs and missed patient visits which can further complicate evaluation of a patient's response to treatment.

"As a statistician, I'm interested in exploring novel analytical methods that might help to increase the signal-to-noise ratio in SLE trials,” said Dr. Mimi Kim, LFA CDAI Co-chair.

“Given the variability in lupus symptoms over time, investigating the effect of treatment on response duration may be a more robust approach for identifying effective new therapies and it is critical to explore this data in order to move lupus research forward."

Since its inception in 2009, LFA CDAI has published important findings on the impact of background medications taken by people with lupus during clinical trials. The latest LFA CDAI analysis builds upon this work with the goal of creating smarter trial design and moving us closer to new treatments for patients now.

During the ACR Meeting (November 3-8), the Lupus Foundation of America will conduct on-site Facebook Live interviews with lupus researchers and other health professionals about the findings from their research studies. More than 35 Lupus Foundation of America funded researchers will be presenting on findings from their lupus studies. To learn more about the Facebook Live interviews, visit our Facebook event.