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Abstract
In multiple sclerosis (MS), the early detection of disease activity or progression is key to inform treatment changes and could be supported by digital tools. We present a novel CE-marked and FDA-cleared digital care management platform consisting of (1) a patient phone/web application and healthcare professional portal (icompanion) including validated symptom, disability, cognition, and fatigue patient-reported outcomes; and (2) clinical brain magnetic resonance imaging (MRI) quantifications (icobrain ms). We validate both tools using their ability to detect (sub)clinical disease activity (known-groups validity) and real-world data insights. Surveys showed that 95.6% of people with MS (PwMS) were interested in using an MS app, and 98.2% were interested in knowing about MRI changes. The icompanion measures of disability (p < 0.001) and symptoms (p = 0.005) and icobrain ms MRI parameters were sensitive to (sub)clinical differences between MS subtypes. icobrain ms also decreased intra- and inter-rater lesion count variability and increased sensitivity for detecting disease activity/progression from 24% to 76% compared to standard radiological reading. This evidence shows PwMS’ interest, the digital care platform’s potential to improve the detection of (sub)clinical disease activity and care management, and the feasibility of linking different digital tools into one overarching MS care pathway.
Highlights
Today, more than 2.8 million people are living with multiple sclerosis (MS), making it the most common progressive neurological condition in young people [1]
We found physical feeling to be significantly worse in people with secondary progressive MS (SPMS) compared to relapsing-remitting MS (RRMS), while patient-reported Expanded Disability Status Scale (prEDSS) scores for both RRMS and clinically isolated syndrome (CIS) showed to be significantly lower than both primary progressive MS (PPMS) and SPMS
Especially because many lesions can be present in an MS patient’s brain and subtle but significant brain atrophy is almost impossible to visually assess, it is known that visual magnetic resonance imaging (MRI) reading is prone to inter-rater variability and potential discrepancies [12]. This was confirmed by the results reported in this paper, which demonstrate a significant inter-rater lesion count difference, which can in part be explained by a subjective rater’s preference for merging certain nearby lesions into one connected lesion, or for indicating separate nearby lesion foci as distinct lesions
Summary
More than 2.8 million people are living with multiple sclerosis (MS), making it the most common progressive neurological condition in young people [1]. There are over 20 disease-modifying treatments (DMTs) available, aiming to slow down relapses and disease progression [2]. Thanks to these DMTs, the health of people with MS (PwMS), expressed in quality-adjusted life years (QALYs), has been estimated to have increased by 66% since the launch of the first drug in 1993 [3]. In order to make informed treatment decisions, it is crucial to measure disease activity and progression in a standardized manner. Disease activity and progression are typically evaluated by the clinical assessment of relapses and disability (measured by the Expanded Disability Status Scale (EDSS)), and longitudinal changes on the brain magnetic resonance imaging (MRI) scans (looking at new/enlarging lesions and/or brain atrophy) [6]
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