Scholarlink

Background <p>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.</p> Methods <p>Seropositive adults (anti-AChR/anti-MuSK/anti-LRP4) with gMG were randomized (1:1) to intravenous nipocalimab (30&#xa0;mg/kg loading, followed by 15&#xa0;mg/kg every 2&#xa0;weeks) or placebo, in addition to standard-of-care (SOC) for 24&#xa0;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.</p> Results <p>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.</p> Conclusions <p>Nipocalimab + SOC demonstrated early and sustained fatigue and HRQoL improvements over 24&#xa0;weeks. Consistency across patient-reported outcomes and correlation with clinical measures support the clinical meaningfulness of these HRQoL benefits in gMG.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Health-related quality of life outcomes with nipocalimab versus placebo in generalized myasthenia gravis: an analysis of the Vivacity-MG3 study

  • 期刊论文

  • 发表日期：

    2026年6月26日

查看全文
  • John Vissing,
  • Sheryl Pease,
  • Kayla Scippa,
  • Kavita Gandhi,
  • Sindhu Ramchandren,
  • Kavita Grover,
  • Dan Huang,
  • Genya Watanabe

摘要

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.