The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis

Abstract Background Myasthenia gravis (MG) is a chronic autoimmune disorder affecting the neuromuscular junction, where autoreactive immunoglobulin G (IgG) plays a key role in disease pathogenesis. The novel biologic Efgartigimod is a neonatal Fc receptor (FcRn) antagonist, promotes the lysosomal de...

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Main Authors: Jia-Jun Cheng, Fu-Qiang Wang, Zhang-Yi Dai, Xin-Wei Wang, Yun Wang
Format: Article
Language:English
Published: BMC 2025-08-01
Series:European Journal of Medical Research
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Online Access:https://doi.org/10.1186/s40001-025-03057-6
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author Jia-Jun Cheng
Fu-Qiang Wang
Zhang-Yi Dai
Xin-Wei Wang
Yun Wang
author_facet Jia-Jun Cheng
Fu-Qiang Wang
Zhang-Yi Dai
Xin-Wei Wang
Yun Wang
author_sort Jia-Jun Cheng
collection DOAJ
description Abstract Background Myasthenia gravis (MG) is a chronic autoimmune disorder affecting the neuromuscular junction, where autoreactive immunoglobulin G (IgG) plays a key role in disease pathogenesis. The novel biologic Efgartigimod is a neonatal Fc receptor (FcRn) antagonist, promotes the lysosomal degradation of IgG, and may offer a targeted approach for managing MG. Despite the growing interest in efgartigimod, there remains a lack of comprehensive evaluation of its efficacy and safety in different MG subtypes. Methods Comprehensive retrieval and screening were conducted on Pubmed, Embase, Web of Science, and Cochrane library to search studies on efgartigimod treatment. The data on response rates and adverse events were extracted, and the pooled effect size (ES) with the 95% confidence interval (CI) was calculated by fixed or random effect models. Sensitivity analysis and subgroup analysis were employed to test the heterogeneity. Funnel plots and trim-and-fill methods were used to test for publication bias. Results Data from 10 studies involving 305 patients were analyzed. The overall treatment response rate was 78% (95% CI: 67%–87%, I 2 = 73.4%). Subgroup analysis revealed pooled response rates of 79.2% (95% CI: 68.5%–88.4%, I 2 = 25.08%) in acetylcholine receptor antibody-positive MG (AChR+MG) patients and 76.2% (95% CI: 56.8%–91.5%, I 2 = 85.95%) in group that did not differentiate auto-antibody types. The pooled incidence of adverse events was 38% (95% CI: 17%–51%, I 2 = 92.59%), with infections (7%, 95% CI: 2%–14%, I 2 = 62.5%), headache (7%, 95% CI: 1%–18%, I 2 = 82.69%) and other (16%, 95% CI: 7%–28%, I 2 = 71.81%). Among them, grade 3–4 adverse events are 1% (95% CI: 0%–2%, I 2 = 0%). Conclusion Our study demonstrates that efgartigimod is highly effective and well-tolerated in patients with refractory MG. These findings suggest that efgartigimod is a promising drug for the treatment of MG.
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spelling doaj-art-c15927c775bf4c5eacdc43b65ea1a6722025-08-24T11:15:00ZengBMCEuropean Journal of Medical Research2047-783X2025-08-0130111210.1186/s40001-025-03057-6The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysisJia-Jun Cheng0Fu-Qiang Wang1Zhang-Yi Dai2Xin-Wei Wang3Yun Wang4Department of Thoracic Surgery, West China Hospital, Sichuan UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversitySchulich School of Medicine and Dentistry, Western UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversityAbstract Background Myasthenia gravis (MG) is a chronic autoimmune disorder affecting the neuromuscular junction, where autoreactive immunoglobulin G (IgG) plays a key role in disease pathogenesis. The novel biologic Efgartigimod is a neonatal Fc receptor (FcRn) antagonist, promotes the lysosomal degradation of IgG, and may offer a targeted approach for managing MG. Despite the growing interest in efgartigimod, there remains a lack of comprehensive evaluation of its efficacy and safety in different MG subtypes. Methods Comprehensive retrieval and screening were conducted on Pubmed, Embase, Web of Science, and Cochrane library to search studies on efgartigimod treatment. The data on response rates and adverse events were extracted, and the pooled effect size (ES) with the 95% confidence interval (CI) was calculated by fixed or random effect models. Sensitivity analysis and subgroup analysis were employed to test the heterogeneity. Funnel plots and trim-and-fill methods were used to test for publication bias. Results Data from 10 studies involving 305 patients were analyzed. The overall treatment response rate was 78% (95% CI: 67%–87%, I 2 = 73.4%). Subgroup analysis revealed pooled response rates of 79.2% (95% CI: 68.5%–88.4%, I 2 = 25.08%) in acetylcholine receptor antibody-positive MG (AChR+MG) patients and 76.2% (95% CI: 56.8%–91.5%, I 2 = 85.95%) in group that did not differentiate auto-antibody types. The pooled incidence of adverse events was 38% (95% CI: 17%–51%, I 2 = 92.59%), with infections (7%, 95% CI: 2%–14%, I 2 = 62.5%), headache (7%, 95% CI: 1%–18%, I 2 = 82.69%) and other (16%, 95% CI: 7%–28%, I 2 = 71.81%). Among them, grade 3–4 adverse events are 1% (95% CI: 0%–2%, I 2 = 0%). Conclusion Our study demonstrates that efgartigimod is highly effective and well-tolerated in patients with refractory MG. These findings suggest that efgartigimod is a promising drug for the treatment of MG.https://doi.org/10.1186/s40001-025-03057-6EfgartigimodFcRnMyasthenia gravisMeta-analysisIgG
spellingShingle Jia-Jun Cheng
Fu-Qiang Wang
Zhang-Yi Dai
Xin-Wei Wang
Yun Wang
The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis
European Journal of Medical Research
Efgartigimod
FcRn
Myasthenia gravis
Meta-analysis
IgG
title The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis
title_full The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis
title_fullStr The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis
title_full_unstemmed The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis
title_short The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis
title_sort efficacy and safety of efgartigimod for refractory myasthenia gravis a systematic review and meta analysis
topic Efgartigimod
FcRn
Myasthenia gravis
Meta-analysis
IgG
url https://doi.org/10.1186/s40001-025-03057-6
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