Comparing Tools for Measuring Stages in Progressive MS

Researchers compared 58 outcomes in progressive MS trials in order to validate and select one that best measured how the condition was proceding.

The research was conducted by Peter Kosa, a research fellow with the Neuroimmunological Diseases Unit at the National Institute of Health in Bethesda, MD, and colleagues, and the results were published in journal Frontiers in Neurology in August 2016.

The authors assert that “therapeutic progress in relapsing remitting multiple sclerosis (RRMS) has been facilitated by the recognition that contrast-enhancing lesions (CELs) on brain magnetic resonance imaging (MRI) can serve as a predictive marker of multiple sclerosis (MS) relapses.”

However, progressive MS patients don’t have many CELs, have not experienced the same benefits of therapeutic progress.

Further, “these patients relentlessly accumulate neurological disability, albeit at a pace that requires observation of hundreds of patients for a minimum of 2-3 years to reliably detect moderate (30-50%) therapeutic effects using the expanded disability status scale (EDSS),” say the researchers. The authors of the present study are pursuing more sensitive outcomes in order “to facilitate broader therapeutic advances for progressive MS,” they say.

In pursuit of that goal, the researchers integrated comparisons of multiple systems and measures, to develop a combinatorial weight-adjusted disability score they call CombiWISE. CombiWISE included 58 measured variables, and the researchers say, “Because clinical progression as measured by EDSS has been an accepted outcome for regulatory approval of MS treatments, we evaluated correlations between validated outcomes in EDSS, in cross-sectional and longitudinal paradigms.”

As part of testing the performance of CombiWISE, the researchers compared 500 permutations of data sets, and say, “we observed that CombiWISE outperformed all other clinical scales.”

New therapies for progressive MS are needed, but, the researchers say, “the present bottleneck resides in the inability to screen them in small, but adequately powered, Phase II trials that can correctly predict efficacy on FDA-accepted clinical endpoint utilized for Phase III trials.”

They conclude by saying that CombiWISE is “the most sensitive clinical outcome for progressive MS,” adding, “It has consistently higher sensitivity for detecting longitudinal changes in progressive MS in comparison to MRI measures of brain atrophy, currently broadly utilized in Phase II progressive MS trials.”

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