Quality of Life in Patients With Generalized Myasthenia Gravis Achieving Sustained Versus Transient Minimal Symptom Expression in the Phase Three Vivacity-MG3 Trial
Elena Cortés Vicente1, Nolan Campbell2, Kavita Gandhi2, Marie Fitzgibbon2, Ibrahim Turkoz2
1Hospital Santa Creu i Sant Pau, 2Johnson & Johnson
Objective:
To evaluate minimal symptom expression (MSE) treatment response and quality of life (QoL) in patients achieving sustained vs transient MSE in Vivacity-MG3.
Background:
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.
Design/Methods:
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.
Results:
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).
Conclusions:
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.
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