Tracking Daily Impact of Generalized Myasthenia Gravis Using Smartphone-Based Digital Biomarkers: Lessons Learned from a 1-Year Study with ME&MGopen
Carolina Barnett-Tapia1, Sophie Lehnerer2, Loic Carment3, Clarissa Gorin3, Dellini Ravindra3, Noura Sellami3, Bhaskar Dutta4, Saad Zinaï3, James Howard5
1Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada, 2Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and HumboldtUniversität zu Berlin, Department of Neurology with Experimental Neurology, Charitéplatz 1, 10117 Berlin, Germany, 3Ad Scientiam, Paris, France, 4Alexion Pharmaceuticals Inc., 5The University of North Carolina, Dept of Neurology, CB 7025
Objective:
To describe longitudinal real-world adherence, digital biomarkers and satisfaction outcomes collected using the ME&MGopenTM app in patients with generalized myasthenia gravis (gMG).
Background:
Anti-acetylcholine receptor antibody-positive (AChR-Ab+) gMG is a rare neuromuscular condition characterized by fluctuating muscle weakness. Digital technologies offer a promising solution to track the daily impact of gMG. New strategies to optimize patient engagement, along with additional data to better characterize the clinical relevance of these novel digital tools, are needed.
Design/Methods:
ME&MGopen is a decentralized clinical study (USA, Canada) in adults with AChR-Ab+ gMG. Participants were followed for 1-year using ME&MGopenTM, a smartphone-based research tool that collects digital biomarkers through active tests (ptosis, dysarthria, respiratory capacity, upper and lower limb muscle function) and patient-reported outcomes via e-Questionnaires (Patient Health Questionnaire-8, Pain Likert scale, Insomnia Severity Index, revised Myasthenia Gravis Quality of Life Scale (MG-QOL-15r)).
Results:
Of 168 participants, 125 completed all scheduled activities and were analyzed. Baseline characteristics showed 70% females, mean age 59±16. There was a marked difference in disease onset with females being younger at first symptom appearance. Patients with a higher MGFA disease class and/or patients unable to work reported higher MG-QOL-15r and MG Activities of Daily Living (MG-ADL) scores, than patients with less severe disease. Disease severity, as measured by MG-ADL, was significantly associated with increased sleep disturbances, and chronic pain (p<0.001). Digital biomarkers are under analysis. Immediate engagement was high, with 93% completed digital tests at baseline, and adherence rate sustained above 65% after 1 year. ME&MGopen™ achieved an excellent usability score of 84/100 (System Usability Scale) after one month which remained stable throughout the study duration, indicating high user satisfaction.
Conclusions:
Preliminary results highlight the clinical value of ME&MGopenTM in tracking the daily impact of gMG symptoms. Findings indicate both long-term adherence and satisfaction with this tool, supporting its potential use in clinical care.
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