Earlier this year, Evidation shared results of its exploratory research work in multiple sclerosis digital biomarkers in partnership with Novartis. The objective of the research was to explore endpoints computed from wearables that could differentiate patients with multiple sclerosis (MS) from matched non-MS patients in everyday life.
To support the retrospective analysis, Evidation was fortunate to have access to the one of the largest real world data sets that brought together medical claims and objective, everyday behavior data from consumer wearables, including daily activity and minute-level sleep data.
The findings of this exploratory work in a retrospective setting have implications to future MS studies focused on new ways to measure disease burden and progression, including prospective validation of digital biomarkers and the usage of novel endpoints within clinical trials focused on MS.
This initial study found significant differences in mobility and sleep endpoints between MS and non-MS patients, providing hypotheses on MS-specific features that could be used to understand disease progression and treatment effectiveness. These features would need to be prospectively validated in a future study. Additionally, this study provides insights into the role that actigraphy could play in creating a novel endpoint for MS clinical trials, replacing certain components of the Expanded Disability Status Scale (EDSS). Finding an objective, passively-collected substitute for EDSS (or parts of EDSS) could result in reduced score variability, shorter requisite observation periods, and the need for fewer trial participants—all of which would improve clinical trial efficiency.
Utilizing the same data set, Evidation completed additional studies in MS—including relapse detection—as part of an overall research project in the therapeutic area. We hope to share this work in upcoming publications.