好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Quality of Life in Patients With Generalized Myasthenia Gravis Achieving Sustained Versus Transient Minimal Symptom Expression in the Phase Three Vivacity-MG3 Trial
Neuromuscular and Clinical Neurophysiology (EMG)
P9 - Poster Session 9 (5:00 PM-6:00 PM)
9-007

To evaluate minimal symptom expression (MSE) treatment response and quality of life (QoL) in patients achieving sustained vs transient MSE in Vivacity-MG3.
In the phase 3 Vivacity-MG3 study (NCT04951622), patients with generalized myasthenia gravis (gMG) receiving nipocalimab demonstrated improved and sustained efficacy vs those receiving placebo. Minimal symptom expression, defined as a Myasthenia Gravis-Activities of Daily Living score of ≤1, is a treatment goal in gMG; however, outcomes associated with achieving sustained MSE have not been fully explored.
Participants (primary efficacy dataset) were stratified into groups based on MSE status over 24 weeks in the double-blind phase: never achieved MSE (No MSE), achieved MSE sustained for ≥8 weeks (sustained MSE), or achieved MSE at least once but was not sustained for ≥8 weeks (transient MSE). Logistic regression models compared likelihood (odds ratio [OR]) of achieving sustained or transient MSE (reference=No MSE) for nipocalimab vs placebo. Myasthenia Gravis-QoL (Revised) Instrument (MG-QoL-15r) total score least-squares mean (LSM) change from baseline to week 24 (W24) were compared across MSE groups.

Of 153 patients, 35 achieved MSE by W24 (nipocalimab+SOC, n=24/77; placebo+SOC, n=11/76); 19 had sustained MSE (nipocalimab+SOC, n=15/77; placebo+SOC, n=4/76). Nipocalimab-treated patients were significantly more likely to achieve sustained MSE (OR [95% CI]: 4.35 [1.37, 13.81], p=0.013) vs placebo. At W24, sustained MSE patients demonstrated significantly greater improvements in MG-QoL-15r (change from baseline LSM [95% CI]: −12.7 [−16.3, −9.2]) vs those with transient MSE (−8.7 [−12.5, −5.0], p=0.016) and vs those with No MSE (−4.1 [−7.0, −1.3], p<0.001).

Nipocalimab-treated patients were 4-times more likely to achieve and sustain MSE for ≥8-weeks than placebo. Those achieving sustained MSE demonstrated greater improvements on MG-QoL-15r scores than those with transient MSE. This suggests sustained MSE is a more impactful treatment goal for gMG patients receiving advanced treatments.
Authors/Disclosures
Elena Cortes-Vicente (Hospital de la Santa Creu i Sant Pau)
PRESENTER 		Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharma. Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for argenx. Elena Cortes-Vicente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. The institution of Elena Cortes-Vicente has received research support from UCB Pharma. The institution of Elena Cortes-Vicente has received research support from Instituto de Salud Carlos III (España).
Nolan Campbell, PhD Dr. Campbell has received personal compensation for serving as an employee of Johnson and Johnson.
Kavita Gandhi, MS, BSPharm Ms. Gandhi has received personal compensation for serving as an employee of Johnson and Johnson . Ms. Gandhi has stock in Johnson and Johnson .
Marie Fitzgibbon, PhD Dr. Fitzgibbon has stock in Johnson & Johnson.
Ibrahim Turkoz (Janssen R&D) Ibrahim Turkoz has received personal compensation for serving as an employee of Johnson and Johnson. Ibrahim Turkoz has stock in Johnson and Johnson.