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The efficacy and safety of FcRn inhibitors in patients with myasthenia gravis: a systematic review and meta-analysis

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Abstract

Background

Myasthenia gravis (MG) is an autoimmune disease that causes local or generalized muscle weakness. Complement inhibitors and targeting of the neonatal Fc receptor (FcRn) to block IgG cycling are two novel and successful mechanisms.

Methods

PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were systematically searched to identify relevant studies published before May 18, 2023. Review Manager 5.3 software was used to assess the data.

Results

We pooled 532 participants from six randomized controlled trials (RCTs). Compared to the placebo, the FcRn inhibitors were more efficacy in Myasthenia Gravis Activities of Daily Living (MG-ADL) (MD = − 1.69 [− 2.35, − 1.03], P < 0.00001), MG-ADL responder (RR = 2.01 [1.62, 2.48], P < 0.00001), Quantitative Myasthenia Gravis (QMG) (MD = − 2.45 [− 4.35, − 0.55], P = 0.01), Myasthenia Gravis Composite (MGC) (MD = − 2.97 [− 4.27, − 1.67], P < 0.00001), 15-item revised version of the Myasthenia Gravis Quality of Life (MGQoL15r) (MD = − 2.52 [− 3.54, − 1.50], P < 0.00001), without increasing the risk of safety. The subgroup analysis showed that efgartigimod was more effective than placebo in MG-ADL responders. Rozanolixizumab was more effective than the placebo except in QMG, and batoclimab was more effective than the placebo except in MG-ADL responder. Nipocalizumab did not show satisfactory efficacy in all outcomes. With the exception of rozanolixizumab, all drugs showed non-inferior safety profiles to placebo.

Conclusion

FcRn inhibitors have good efficacy and safety in patients with MG. Among them, efgartigimod and nipocalimab were effective without causing an increased safety risk. Rozanolixizumab, despite its superior efficacy, caused an increased incidence of adverse events. Current evidence does not suggest that nipocalimab is effective in patients with MG.

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Availability of data and material

All data generated or analyzed during this study are included in this published article and its supplementary information files.

Code availability

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Funding

The preparation of this article was supported by the Suzhou Health Talents Training Project (GSWS2019002) to Zhong Wang. Zhouqing Chen was supported by the Natural Science Foundation of Jiangsu Province (BK20200203) and the Suzhou Health Talents Training Project (GSWS2020022).

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Author notes

  1. Jiaxuan Li and Xin Wu have contributed equally to this work.

Authors and Affiliations

  1. Department of Neurosurgery and Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu Province, China

    Jiaxuan Li, Xin Wu, Tianchen Chu, Shixin Wang, Ruisi Qu, Zhouqing Chen & Zhong Wang

  2. Department of Neurology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, Jiangsu Province, China

    Xin Tan

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  1. Jiaxuan Li
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Contributions

ZW and ZQC were the principal investigators. JXL and XW designed the study and developed the analysis plan. JXL, XW and TCC analyzed the data and performed the meta-analysis. JXL and XW contributed to the writing of the article. XT, SXW, and RSQ revised the manuscript and polished the language. All authors read and approved the final submitted paper.

Corresponding authors

Correspondence to Zhouqing Chen or Zhong Wang.

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Li, J., Wu, X., Chu, T. et al. The efficacy and safety of FcRn inhibitors in patients with myasthenia gravis: a systematic review and meta-analysis. J Neurol 271, 2298–2308 (2024). https://doi.org/10.1007/s00415-024-12247-x

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