Trial reportJournal of neurology2026
Health-related quality of life outcomes with nipocalimab versus placebo in generalized myasthenia gravis: an analysis of the Vivacity-MG3 study.
Trial report in Journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04951622 (Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
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Authors and funding
8 authors.
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Abstract
backgroundGeneralized 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.
methodsSeropositive 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.
resultsNipocalimab + 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.
conclusionsNipocalimab + 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.
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