Rapid Serum IgG Reduction as a Potential Indicator of Short-Term Clinical Improvement in AChR-Ab-Positive Generalized Myasthenia Gravis: A Post Hoc Analysis of a Phase III Batoclimab Trial

INTRODUCTION: Generalized myasthenia gravis (gMG) is an autoimmune disorder often associated with anti-acetylcholine receptor antibodies (AChR-Abs). Identifying short-term predictors or indicators of clinical improvement is crucial for optimizing treatment strategies. METHODS: This post hoc analysis utilized data from a phase III, multicenter randomized controlled trial enrolling 65 patients with AChR-Ab-positive gMG across 27 centers in China. We evaluated serum immunoglobulin G (IgG) as a potential short-term indicator of clinical improvement in patients treated with batoclimab. Clinical severity was evaluated using the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales. Spearman correlation analyses, mixed-effects models, and multivariate analyses were performed to assess relations between biomarker changes and symptom improvement. RESULTS: Within-patient Spearman correlation showed significant associations between reductions in IgG or AChR-Ab levels and symptom improvement (ΔIgG vs. MG-ADL change: r = 0.372, p < 0.001; ΔIgG vs. QMG change: r = 0.492, p < 0.001). Mixed-effects modeling indicated that an 80% reduction in IgG corresponded to a 59% probability of MG-ADL improvement by ≥ 3 points and a 77% probability of QMG improvement by ≥ 3 points. High baseline body mass index (BMI) was identified as an independent risk factor for slower IgG decline. CONCLUSION: Batoclimab rapidly reduced IgG and pathogenic AChR-Ab levels, leading to improved clinical outcomes in patients with gMG. The reduction rate in total IgG may serve as a valuable short-term indicator of clinical response in patients with AChR-Ab-positive gMG following neonatal fragment crystallizable receptor antagonist therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05039190.

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Journal
Neurology and Therapy
Published
2026-10-13
DOI
https://doi.org/10.1007/s40120-026-01019-6
Primary Topic
Myasthenia Gravis and Thymoma
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article
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article

Rapid Serum IgG Reduction as a Potential Indicator of Short-Term Clinical Improvement in AChR-Ab-Positive Generalized Myasthenia Gravis: A Post Hoc Analysis of a Phase III Batoclimab Trial

Chen Zong, Song Tan, 李尊波, 奚剑英 et al.
Neurology and Therapy
Myasthenia Gravis and Thymoma
article

Rapid Serum IgG Reduction as a Potential Indicator of Short-Term Clinical Improvement in AChR-Ab-Positive Generalized Myasthenia Gravis: A Post Hoc Analysis of a Phase III Batoclimab Trial

Chen Zong, Song Tan, 李尊波, 奚剑英, Ting Chang, 涂江龙, Bitao Bu, Jianquan Shi, Zhangyu Zou, Yaoxian Yue, Hua Zhang, Zhijun Li, Huan Yang, Hongyu Zhou, Haibing Xiao, Wenyu Li, Ruisheng Duan, Yuzhou Guan, Haishan Jiang, Fei Xiao, Shuai Zhao, Haifeng Li, Yali Zhang, Chongbo Zhao, Wei Li, Qing Ke, Qiang Meng, Junhong Guo, Qun Xue, Hui Deng
article en

Abstract

INTRODUCTION: Generalized myasthenia gravis (gMG) is an autoimmune disorder often associated with anti-acetylcholine receptor antibodies (AChR-Abs). Identifying short-term predictors or indicators of clinical improvement is crucial for optimizing treatment strategies. METHODS: This post hoc analysis utilized data from a phase III, multicenter randomized controlled trial enrolling 65 patients with AChR-Ab-positive gMG across 27 centers in China. We evaluated serum immunoglobulin G (IgG) as a potential short-term indicator of clinical improvement in patients treated with batoclimab. Clinical severity was evaluated using the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales. Spearman correlation analyses, mixed-effects models, and multivariate analyses were performed to assess relations between biomarker changes and symptom improvement. RESULTS: Within-patient Spearman correlation showed significant associations between reductions in IgG or AChR-Ab levels and symptom improvement (ΔIgG vs. MG-ADL change: r = 0.372, p < 0.001; ΔIgG vs. QMG change: r = 0.492, p < 0.001). Mixed-effects modeling indicated that an 80% reduction in IgG corresponded to a 59% probability of MG-ADL improvement by ≥ 3 points and a 77% probability of QMG improvement by ≥ 3 points. High baseline body mass index (BMI) was identified as an independent risk factor for slower IgG decline. CONCLUSION: Batoclimab rapidly reduced IgG and pathogenic AChR-Ab levels, leading to improved clinical outcomes in patients with gMG. The reduction rate in total IgG may serve as a valuable short-term indicator of clinical response in patients with AChR-Ab-positive gMG following neonatal fragment crystallizable receptor antagonist therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05039190.

Neurology and Therapy
Central South University (CN), Nanchang University (CN), University of Electronic Science and Technology of China (CN), Army Medical University (CN), Shandong University (CN), Shanxi Medical University (CN), Capital Medical University (CN), Jilin University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Sichuan University (CN), Peking Union Medical College Hospital (CN), Sir Run Run Shaw Hospital (CN), West China Hospital of Sichuan University (CN), First People's Hospital of Yunnan Province (CN), Xuan Wu Hospital of the Capital Medical University (CN), Nanfang Hospital (CN), Xi'an Medical University (CN), Second Affiliated Hospital of Nanchang University (CN), Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (CN), Beijing Hospital (CN), Chifeng Municipal Hospital (CN), First Hospital of Jilin University (CN), First Hospital of Shanxi Medical University (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), University of Hong Kong - Shenzhen Hospital (CN), Shandong Provincial QianFoShan Hospital (CN), First Affiliated Hospital of Soochow University (CN), Tang Du Hospital (CN), Huashan Hospital (CN), Xiangya Hospital Central South University (CN), Tongji Hospital (CN), Qilu Hospital of Shandong University (CN), Shandong First Medical University (CN), Union Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Nanjing First Hospital (CN), Huazhong University of Science and Technology (CN), Southern Medical University (CN), Zhejiang University (CN), Nanjing Medical University (CN), University of Hong Kong (HK), Air Force Medical University (CN)
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Myasthenia Gravis and Thymoma
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