Indirect comparison of nipocalimab versus efgartigimod and rozanolixizumab in the treatment of generalized myasthenia gravis
Jacob, Saiju Hashim, Mahmoud Hutton, Brian Gandhi, Kavita Van Sanden, Suzy Slowik, Rafal Drudge, Christopher Khoury, Antoine C El Keng, Mi Jun Singh, Sumeet
Jacob, Saiju
Hashim, Mahmoud
Hutton, Brian
Gandhi, Kavita
Van Sanden, Suzy
Slowik, Rafal
Drudge, Christopher
Khoury, Antoine C El
Keng, Mi Jun
Singh, Sumeet
Abstract
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.
MIDER Authors
Date
2026-03-12
Type
Article
Subject
Collections
Citation
Jacob S, Hashim M, Hutton B, Gandhi K, Van Sanden S, Slowik R, Drudge C, Khoury ACE, Keng MJ, Singh S, Ramchandren S, Gilhus NE. Indirect Comparison of Nipocalimab Versus Efgartigimod and Rozanolixizumab in the Treatment of Generalized Myasthenia Gravis. Adv Ther. 2026 Mar 12. doi: 10.1007/s12325-026-03543-1. Epub ahead of print.
Journal / Source Title
Advances in Therapy
DOI
10.1007/s12325-026-03543-1
PMID
41817915
Publisher
Springer Healthcare Communications
Publisher’s URL
https://link.springer.com/journal/12325