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Remote monitoring of disease progression through smartphones and wearable devices has found increased utility during Covid-19 as patients have fewer clinical visits during the pandemic. Such monitoring is conducted through the industry-leading Floodlight Multiple Sclerosis (FL MS) app. The app consists of a series of active and passive assessments to capture daily changes in motor function, cognition/mood, and mobility. These digital biomarkers enable evaluating changes in patient pathophysiology that occur between clinical visits at a higher frequency (up to daily for active tests, and even higher frequency for passive measures), providing unprecedented granularity into the effect of MS over time. FL MS is actively deployed in a number of clinical trials, including CONSONANCE, an open-label Phase 3 study of ocrelizumab (Ocrevus) in patients with primary and secondary progressive MS.
In collaboration with OMNI-BD, PHC Floodlight and pREDi, we are conducting an analysis into FL MS data collected in CONSONANCE during the COVID-19 pandemic. MS disease severity and daily activity are typically correlated, as patients progress in their disease they also experience a decrease in daily activity. However, local government restrictions imposed in response to Covid-19 may effect an artificially-imposed decrease in daily activity, as patients may be more likely to remain in their homes. We are employing statistical and deep learning algorithms to detect individual-level changes in daily activity during the COVID-19 pandemic, and to evaluate the subsequent impact on MS patients’ disease trajectory.
Leveraging digital biomarkers to determine changes in patient behavior helps validate the underlying sensor-based technology and allows for further exploration of its utility. This work helps demonstrate that it is possible to detect changes in lifestyle behavior, such as decreased mobility during lockdowns, using the Floodlight MS app. Further evaluating changes in disease state as measured by digital health technologies and the impact of activity on disease progression in MS patients can help appropriately tailor treatment to individual patients, advancing the value of personalized health care.
Digital biomarkers are playing an increasing role in monitoring disease trajectories across indications, and digital health technologies are being deployed in clinical trials across the organization. Supplementing traditional biomarkers, these measures offer new measurements on an individual patient level. Biomarker scientists and clinical teams may leverage digital biomarkers to capture meaningful changes in patient behavior and disease progression. This marks a shift towards personalized healthcare solutions, novel endpoints, and virtual clinical trials.
Key DevSci Contacts:
Maxime Usdin
Sherman Jia
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