[Pubmed] Indirect Comparison of Nipocalimab Versus Efgartigimod and Rozanolixizumab in the Treatment of Generalized Myas
Posté : 12 mars 2026 11:00
Adv Ther. 2026 Mar 12. doi: 10.1007/s12325-026-03543-1. Online ahead of print.
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.
PMID:41817915 | DOI:10.1007/s12325-026-03543-1
Source: https://pubmed.ncbi.nlm.nih.gov/4181791 ... t6+133c1fe