Abstract Details

Title Validation of ME&MGTM Digital Biomarkers in Monitoring Generalized Myasthenia Gravis Symptoms: The DOMYA Study

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P9 - Poster Session 9 (5:00 PM-6:00 PM)

Poster/Presentation
Number 9-017

Objective The ongoing DOMYA (NCT05564936) study’s objective is to validate ME&MG™ clinical performance by comparing individual’s Quantitative MG (QMG) scores to home-measured digital biomarkers’ scores in people with gMG and healthy controls (HCs).

Background Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease characterized by fluctuating muscle weakness, making it essential to monitor symptoms between infrequent clinical visits. ME&MGTM is a software as medical device (SaMD) allowing remote self-assessment of gMG symptoms using five digital biomarkers (dBMKs) measuring ptosis, dysarthria, respiratory function, upper and lower limb muscle weakness. In the ME&MGopen decentralized study, proof-of-concept was established with dBMKs’ scores correlating with MG-ADL (daily activities) and MG-QoL-15r (quality of life) sub-scores.

Design/Methods DOMYA aims to recruit 94 adult patients with anti-acetylcholine receptor antibody-positive gMG and 50 HCs in France and the USA. Patients are monitored for one year with in-clinic visits at days 0, 90 and 365, along with monthly home-performed ME&MGTM active tests in the mornings and evenings. HCs will perform active tests in-clinic on day 0 and at home on day 1. Correlation coefficients between dBMKs and ptosis, speech, lung function, limb stretch sub-items of QMG, will be calculated to determine the clinical significance of dBMKs and, safety related to the SaMD will be reported.

Results As of October 2025, a total of 93 out of 94 gMG patients (France: 46; USA: 47) and 47 out of 50 HCs (France: 20; USA: 27) have been recruited; with 16 patients having already completed the study. Study completion is anticipated by November 2026.

Conclusions ME&MGTM dBMKs reliability and quality have been established in the ME&MGopen study. Validation of their clinical performance and safety in DOMYA will further support dBMKs’ adoption for objective tracking of gMG symptoms in routine practice to support HCPs in their decision-making processes.

Authors/Disclosures
Bhaskar Dutta, PhD (Alexion) PRESENTER	Dr. Dutta has received personal compensation for serving as an employee of AstraZeneca. An immediate family member of Dr. Dutta has received personal compensation for serving as an employee of Sanofi.
Edouard Berling	Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Edouard Berling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LFB.
David Orlikowski, MD (Hospital R Poincare)	Dr. Orlikowski has nothing to disclose.
Guillaume Nicolas (AP-HP)	Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson & Johnson. Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Guillaume Nicolas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson & Johnson.
Helene Prigent (Hopital Raymond Poincaré - APHP)	Helene Prigent has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Amicus therapeutics SAS. Helene Prigent has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lowenstein Medical. Helene Prigent has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer. Helene Prigent has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SOS Oxygen. Helene Prigent has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ASV Santé- Oxylis.
Clarissa Gorin, Other (Ad Scientiam)	Dr. Gorin has received personal compensation for serving as an employee of Ad Scientiam.
Aurore Balique-Laplanche	Mrs. Balique-Laplanche has received personal compensation for serving as an employee of Ad Scientiam.
Noura Sellami	Miss Sellami has nothing to disclose.
Saad Zinai	Saad Zinai has received personal compensation for serving as an employee of AD Scientiam. Saad Zinai has stock in Ad Scientiam.
Benjamin Yungher, PhD (Alexion)	Dr. Yungher has received personal compensation for serving as an employee of Alexion AstraZeneca Rare Disease.
Loic Carment (Ad Scientiam)	Loic Carment has received personal compensation for serving as an employee of Ad Scientiam.
Pascal Lafort	Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ALEXION. The institution of Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ARGENX. Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as a Consultant for JOHNSON and JOHNSON. Pascal Lafort has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Revue Neurologique.

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