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Introduction <p>Nipocalimab, efgartigimod, and rozanolixizumab (the last two cyclically dosed) are approved neonatal Fc receptor (FcRn) blockers for treating generalized myasthenia gravis (gMG). No trials have directly compared these therapies; hence, indirect treatment comparisons (ITCs) were conducted to evaluate their relative efficacy.</p> Methods <p>Matching-adjusted indirect comparisons (MAICs) and Bucher ITCs were used to compare nipocalimab vs. efgartigimod and rozanolixizumab for changes from baseline (CFB) in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score observed in their phase&#xa0;3 registration trials. Bucher ITCs used the relative treatment effect vs. placebo. As there was considerable cross-trial heterogeneity, including uncertainty in using the placebo arm as a common comparator, active treatment arms were used in unanchored MAICs. MG-ADL CFB was compared between trials (1) at multiple timepoints to evaluate onset of action and disease control over time, and (2) using area under the curve (AUC) as a measure of cumulative effect normalized per week of follow-up.</p> Results <p>In both Bucher ITCs and MAICs, nipocalimab had a comparable MG-ADL CFB at week&#xa0;1 vs. the other FcRn blockers. In MAICs, MG-ADL CFB was significantly greater with nipocalimab vs. efgartigimod at week&#xa0;8 sustained up to 24&#xa0;weeks (<i>p</i> &lt; 0.05), and vs. rozanolixizumab at week&#xa0;10 sustained up to 14&#xa0;weeks (<i>p</i> &lt; 0.05); results numerically favored nipocalimab in corresponding Bucher ITCs. Using normalized AUC, MG-ADL CFB with nipocalimab was significantly greater in MAICs (<i>p</i> &lt; 0.05) and numerically greater in Bucher ITCs vs. the other FcRn blockers.</p> Conclusions <p>Sustained disease control is an important consideration in managing chronic diseases with fluctuating symptoms such as gMG. Study results showed that nipocalimab provided a comparable onset of action and consistent and sustained disease control that was numerically or statistically significantly greater (depending on ITC method) when compared with the symptom-based cyclic FcRn blockers efgartigimod and rozanolixizumab.</p>

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Indirect Comparison of Nipocalimab Versus Efgartigimod and Rozanolixizumab in the Treatment of Generalized Myasthenia Gravis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月12日

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  • Saiju Jacob,
  • Mahmoud Hashim,
  • Brian Hutton,
  • Kavita Gandhi,
  • Suzy Van Sanden,
  • Rafal Slowik,
  • Christopher Drudge,
  • Antoine C. El Khoury,
  • Mi Jun Keng,
  • Sumeet Singh,
  • Sindhu Ramchandren,
  • Nils Erik Gilhus

摘要

Introduction

Nipocalimab, efgartigimod, and rozanolixizumab (the last two cyclically dosed) are approved neonatal Fc receptor (FcRn) blockers for treating generalized myasthenia gravis (gMG). No trials have directly compared these therapies; hence, indirect treatment comparisons (ITCs) were conducted to evaluate their relative efficacy.

Methods

Matching-adjusted indirect comparisons (MAICs) and Bucher ITCs were used to compare nipocalimab vs. efgartigimod and rozanolixizumab for changes from baseline (CFB) in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score observed in their phase 3 registration trials. Bucher ITCs used the relative treatment effect vs. placebo. As there was considerable cross-trial heterogeneity, including uncertainty in using the placebo arm as a common comparator, active treatment arms were used in unanchored MAICs. MG-ADL CFB was compared between trials (1) at multiple timepoints to evaluate onset of action and disease control over time, and (2) using area under the curve (AUC) as a measure of cumulative effect normalized per week of follow-up.

Results

In both Bucher ITCs and MAICs, nipocalimab had a comparable MG-ADL CFB at week 1 vs. the other FcRn blockers. In MAICs, MG-ADL CFB was significantly greater with nipocalimab vs. efgartigimod at week 8 sustained up to 24 weeks (p < 0.05), and vs. rozanolixizumab at week 10 sustained up to 14 weeks (p < 0.05); results numerically favored nipocalimab in corresponding Bucher ITCs. Using normalized AUC, MG-ADL CFB with nipocalimab was significantly greater in MAICs (p < 0.05) and numerically greater in Bucher ITCs vs. the other FcRn blockers.

Conclusions

Sustained disease control is an important consideration in managing chronic diseases with fluctuating symptoms such as gMG. Study results showed that nipocalimab provided a comparable onset of action and consistent and sustained disease control that was numerically or statistically significantly greater (depending on ITC method) when compared with the symptom-based cyclic FcRn blockers efgartigimod and rozanolixizumab.