Journal of neurology · 2026
Health-related quality of life outcomes with nipocalimab versus placebo in generalized myasthenia gravis: an analysis of the Vivacity-MG3 study.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Vissing John, Pease Sheryl, Scippa Kayla, Gandhi Kavita, Ramchandren Sindhu, Grover Kavita, Huang Dan, Watanabe Genya
Аннотация
BACKGROUND: Generalized myasthenia gravis (gMG) is an autoimmune disorder that is marked by fluctuating muscle weakness and poor health-related quality of life (HRQoL). This pre-specified analysis of the phase 3 Vivacity-MG3 study (NCT04951622) assessed the effect of nipocalimab (fully human anti-FcRn monoclonal antibody) on HRQoL in patients with gMG.
METHODS: Seropositive adults (anti-AChR/anti-MuSK/anti-LRP4) with gMG were randomized (1:1) to intravenous nipocalimab (30 mg/kg loading, followed by 15 mg/kg every 2 weeks) or placebo, in addition to standard-of-care (SOC) for 24 weeks. The Myasthenia Gravis-Quality-of-Life 15-item revised scale (MG-QoL15r), Neuro-QoL Fatigue, EQ-5D-5L, Patient Global Impression (PGI) of Severity-Fatigue (PGI-S), and PGI-Change Fatigue (PGI-C) were used to measure patient-reported HRQoL.
RESULTS: Nipocalimab + SOC improved MG-QoL15r scores versus placebo + SOC (Least square (LS) mean change -5.87 vs -4.42; difference -1.45). By week 2, the fatigue had improved (-10 points) and continued to improve during the double-blind phase; LS mean change in Neuro-QoL Fatigue was -13.17 vs -10.02 (difference: -3.15) over weeks 22-24. Nipocalimab showed greater improvements at week 24 than placebo in EQ-5D-5L index values (0.13 vs 0.07), VAS scores (14.55 vs 7.27) and PGI-C perceived fatigue status (56.5% vs 41.0% reporting "moderate" and "much better"). The correlation analyses confirmed association between fatigue improvement and gains in physical function, MG-ADL, QMG, and overall health status.
CONCLUSIONS: Nipocalimab + SOC demonstrated early and sustained fatigue and HRQoL improvements over 24 weeks. Consistency across patient-reported outcomes and correlation with clinical measures support the clinical meaningfulness of these HRQoL benefits in gMG.
METHODS: Seropositive adults (anti-AChR/anti-MuSK/anti-LRP4) with gMG were randomized (1:1) to intravenous nipocalimab (30 mg/kg loading, followed by 15 mg/kg every 2 weeks) or placebo, in addition to standard-of-care (SOC) for 24 weeks. The Myasthenia Gravis-Quality-of-Life 15-item revised scale (MG-QoL15r), Neuro-QoL Fatigue, EQ-5D-5L, Patient Global Impression (PGI) of Severity-Fatigue (PGI-S), and PGI-Change Fatigue (PGI-C) were used to measure patient-reported HRQoL.
RESULTS: Nipocalimab + SOC improved MG-QoL15r scores versus placebo + SOC (Least square (LS) mean change -5.87 vs -4.42; difference -1.45). By week 2, the fatigue had improved (-10 points) and continued to improve during the double-blind phase; LS mean change in Neuro-QoL Fatigue was -13.17 vs -10.02 (difference: -3.15) over weeks 22-24. Nipocalimab showed greater improvements at week 24 than placebo in EQ-5D-5L index values (0.13 vs 0.07), VAS scores (14.55 vs 7.27) and PGI-C perceived fatigue status (56.5% vs 41.0% reporting "moderate" and "much better"). The correlation analyses confirmed association between fatigue improvement and gains in physical function, MG-ADL, QMG, and overall health status.
CONCLUSIONS: Nipocalimab + SOC demonstrated early and sustained fatigue and HRQoL improvements over 24 weeks. Consistency across patient-reported outcomes and correlation with clinical measures support the clinical meaningfulness of these HRQoL benefits in gMG.