Efficacy and Safety of FcRn Inhibitors in Adults with Generalized Myasthenia Gravis: A Systematic Review and Meta-analysis
NagaVenkata Priya Sri Harshitha Somarouthu1, Farheen Kooliyattayil2, Caleb Karani3, Berra Nuran Baloglu4, Mehwish Shoaib5, Vindhya Chavali6, Maurya Patel7
1Apollo Institute of Medical Sciences and Research, 2Pondicherry Institute of Medical Sciences, 3University of Nairobi, 4Yuksek Ihtisas University, 5Moti Lal Nehru Medical College, 6Sri Devraj Urs Academy of Higher Education and Research, 7Smt. NHL Municipal Medical College
Objective:
To evaluate the efficacy and safety of FcRn inhibitors compared with placebo or standard therapy in adults with generalized myasthenia gravis.
Background:
Generalized myasthenia gravis is an antibody-mediated autoimmune disorder
characterized by fluctuating skeletal muscle weakness. Current therapies may be limited by inadequate response or adverse effects. FcRn inhibitors are novel agents that reduce
pathogenic IgG by blocking neonatal Fc receptor–mediated recycling.
Design/Methods:
A systematic search of Embase, Cochrane, MEDLINE, and ClinicalTrials.gov was conducted for studies published up to April 2026. Randomized controlled trials and observational studies involving adults with generalized myasthenia gravis treated with FcRn inhibitors versus placebo or standard therapy were included. Outcomes included changes in MG-ADL and QMG scores, as well as safety endpoints. Risk of bias was assessed using RoB 2 and ROBINS-I. Random-effects meta-analysis was performed using R (version 4.5.3).
Results:
Of 712 identified studies, five were included (4 RCTs, 1 observational; N=581). Pooled analysis showed no statistically significant difference in MG-ADL scores (MD −0.94, 95% CI −2.45 to 0.57; p=0.22; I²=91%) or QMG scores (MD −1.74, 95% CI −7.27 to 3.79; p=0.31; I²=90%). However, both outcomes demonstrated a consistent trend favoring FcRn inhibitors, with substantial heterogeneity. Safety outcomes suggested that FcRn inhibitors were well tolerated, with no significant safety concerns.
Conclusions:
FcRn inhibitors were well tolerated and showed a trend toward clinical improvement,
although results were not statistically significant and were limited by high heterogeneity
and small sample size. Larger randomized controlled trials are needed to confirm their
efficacy in generalized myasthenia gravis.
Generative AI Usage
No, did not use generative AI in the drafting or editing in this abstract.
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