Efficacy and safety of FcRn inhibitors in patients with Myasthenia gravis: An updated systematic review and meta‑analysis.

BACKGROUND

Myasthenia gravis (MG) is a chronic, complex autoimmune disorder characterized by the production of autoantibodies that destroy neuromuscular junctions. Blocking the neonatal Fc receptors (FcRn) enhances IgG catabolism, offering a novel therapeutic approach.

METHODS

PubMed, Embase, and the Cochrane Library were searched up to February 2025, for RCTs evaluating FcRn inhibitors in MG. A random effects model to calculate pooled risk ratios (RR) and mean differences with 95 % confidence intervals (CI).

RESULTS

873 patients from 8 randomized control trials (RCTs) were analyzed. Compared to placebo, FcRn inhibitors significantly reduced Myasthenia Gravis Activities of Daily Living (MG-ADL) scores (MD of -1.45 [95 % CI, -1.91 to -0.99]; P < 0.00001), Quantitative Myasthenia Gravis( QMG) scores (MD = -2.33 [95 % CI, -3.57 to -1.09]; P = 0.0002), and Myasthenia Gravis Composite (MGC) scores (MD = -2.96 [95 % CI, -4.29 to -1.63]; P < 0.0001). The FcRn inhibitors improved MG-ADL responder rates (RR = 1.60 [95 % CI, 1.27-2.02]; P < 0.0001), and Myasthenia Gravis Quality of Life (MGQoL15r) scores (MD = -2.18 [95 % CI, -3.35 to -1.00]; P = 0.0003). Serious adverse events were lower with the FcRn inhibitors (32/519) than the placebo (39/397). Subgroup analysis revealed that Rozanolixizumab and Nipocalimab improved MG-ADL scores, but had inferior responder rates. Additionally, Rozanolixizumab significantly improved MGC scores but had more adverse events.

CONCLUSION

FcRn inhibitors demonstrated good efficacy and safety in MG, with efgartigimod and nipocalimab showing strong efficacy without added risk. Further research is required to evaluate long-term outcomes and optimize treatment.