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Abstract Details

Real-world Digital Biomarkers Associated With Their Clinical Counterparts in the MS-DETECT Study
Multiple Sclerosis
P4 - Poster Session 4 (8:00 AM-9:00 AM)
18-004

This interim analysis describes baseline comparisons between MSCopilot® digital biomarkers, measured in-clinic or at-home, and individual MSCF-4 scores.
Standard clinical assessments lack the sensitivity to capture subtle disease progression in people living with multiple sclerosis (PwMS). MSCopilot®, a Software as a Medical Device, remotely assesses key functions such as cognition, dexterity, vision and walking. Previous French studies showed that the MSCopilot® scores correlate with Extended Disability Status Scale (EDSS) and the revised MS Functional Composite (MSFC-4). The international MS-DETECT study (NCT05816122) evaluates MSCopilot®’s ability to detect disability worsening in PwMS during 18-24 months.
Patients’ clinical data, including their MSFC-4 assessments, were collected during the inclusion visit. Patients performed MSCopilot® tests in-clinic and later at home. The association between the in-clinic and remote digital biomarkers scores was assessed using intraclass correlation coefficients and association with their MSFC-4 counterparts was assessed with Pearson correlation coefficients.
244 (68.4% female, mean age 49.15 ± 8.74, mean disease duration 17.57 ± 8.04 and mean EDSS: 3.8 ± 1.3) patients were included in this analysis. We collected 925 in-clinic and 829 remote MSCopilot® evaluations (243/218 cognition, 231/211 dexterity, 209/182 vision and 242/218 walking). Digital biomarkers measurements were consistent with good (0.64) to excellent (0.77) intraclass coefficients. Moderate to strong correlations were found between individual MSFC-4 items and digital tests: cognition (0.71/0.62), dexterity (0.45/0.47) and walking (0.54/0.66) tests. Composite MSFC-4 scores also correlated with MSCopilot® 's measured in-clinic (0.71, p<0.001) and at home (0.71, p<0.001).
MSCopilot® digital biomarkers met excellent quality standards with consistent measures correlating with clinical counterparts. These findings emphasize their potential use in detection of disease worsening leading to improved clinical monitoring of MS.
Authors/Disclosures
Patrick Vermersch (CHR de Lille)
PRESENTER 		Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Imcyse. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS-Celgene. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ad Scientiam. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for La revue des microbiotes. The institution of Patrick Vermersch has received research support from Roche. The institution of Patrick Vermersch has received research support from Sanofi.
Massimo Filippi, MD, FAAN (Ospedale San Raffaele, Neuroimaging Research Unit) Dr. Filippi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA. Dr. Filippi has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. The institution of Dr. Filippi has received research support from Biogen Idec, Merck-Serono, Novartis, Roche, the Italian Ministry of Health, the Italian Ministry of University and Research, and Fondazione Italiana Sclerosi Multipla.
Celia Oreja Guevara Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for viatris. Celia Oreja Guevara has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for biogen. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for bms. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for jannsen.
Jiwon Oh, MD, FAAN (St Michael's Hospital) Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD-Serono. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Oh has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen-Idec. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Oh has received research support from Biogen-Idec. The institution of Dr. Oh has received research support from Roche.
Tobias Sejbaek, MD, PhD (Esbjerg Hospital) Prof. Sejbaek has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, Merck, NeuroXpharm, Novartis, Roche, Sandoz and Sanofi. The institution of Prof. Sejbaek has received research support from Merck, Novartis, Roche and Sanofi.
Jennifer Graves, MD, PhD (UCSD) Dr. Graves has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Graves has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Graves has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MSJ. The institution of Dr. Graves has received research support from Octave. The institution of Dr. Graves has received research support from Sanofi. The institution of Dr. Graves has received research support from EMD Serono.
Lissandra Klaeylé (Ad Scientiam) Lissandra Klaeylé has received personal compensation for serving as an employee of Ad Scientiam.
Séverine Bieuvelet Séverine Bieuvelet has received personal compensation for serving as an employee of Ad Scientiam.
Loic Carment (Ad Scientiam) Loic Carment has received personal compensation for serving as an employee of Ad Scientiam.
Pierre DROUIN (AdScientiam) Pierre DROUIN has received personal compensation for serving as an employee of AdScientiam.
Saad Zinai Saad Zinai has received personal compensation for serving as an employee of AD Scientiam. Saad Zinai has stock in Ad Scientiam.
Pascal L. Rufi (Sanofi, Research and Development) Mr. Rufi has nothing to disclose.
Bruno Padrazzi, MD (Sanofi) Dr. Sanofi has received personal compensation for serving as an employee of Sanofi. Dr. Sanofi has received personal compensation for serving as an employee of Sanofi. Dr. Sanofi has stock in Sanofi. Dr. Sanofi has stock in Sanofi.
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden) Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from BMS. The institution of Dr. Ziemssen has received research support from Roche.