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Clinical evaluation of efficacy of leflunomide combined with low-dose prednisone for treatment of myasthenia gravis

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Abstract

This study evaluated the clinical efficacy of leflunomide combined with low-dose prednisone (0.25 mg/kg/day) for treatment of myasthenia gravis (MG). We enrolled 32 MG patients treated with leflunomide combined with low-dose prednisone. In the control group, 14 patients were treated with low-dose prednisone. Improvement in MG composite (MGC) score of ≥ 3 points from enrollment to 12-week follow-up indicated that the treatment was effective. In the leflunomide combined low-dose prednisone group, the median of MGC score at the time of enrollment was 8.5 points. After 12 weeks, the MGC score dropped to four points. There was statistically significant difference in MGC score before and after treatment (p < 0.001). In the low-dose prednisone group also followed up for 12 weeks, the median of MGC score of the patients decreased from 7 to 4 points, and the change was not statistically significant (p = 0.05). In the leflunomide combined low-dose prednisone group, the improvement of clinical symptoms occurred mainly in the first 4 weeks and the last 4 weeks. Relatively, the decline of the score was mostly seen during the first 8 weeks in the low-dose prednisone group. In leflunomide combined with low-dose prednisone group, the effective rate of generalized MG(gMG) was significantly higher than ocular MG(oMG) (χ2 test, p = 0.036). However, there is no significant difference in the effective rate between AChR-Ab-positive and -negative groups (Fisher’s Exact Test, p = 0.625). No serious side effects were observed in any of the subjects. Leflunomide combined with low-dose prednisone rapidly improved the clinical symptoms of patients with MG. It may be a promising treatment for gMG.

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All data in the study are real and available.

Abbreviations

MG:

Myasthenia gravis

MGFA:

Myasthenia Gravis Foundation of America

MGC score:

Myasthenia gravis composite score

QMG score:

Quantitative myasthenia gravis score

ADL score:

Activities of daily living score

oMG:

Ocular myasthenia gravis

gMG:

Generalized myasthenia gravis

AChR-Ab:

Anti-acetylcholine receptor antibody

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Acknowledgements

This study was supported by Chinese NSF (81371386, 81620108010), the Clinic Study of 5010 Plan, Sun Yat-sen University (2010003), and grants from the Southern China International Cooperation Base for Early Intervention and Functional Rehabilitation of Neurological Diseases (2015B050501003), Guangdong Provincial Engineering Center For Major Neurological Disease Treatment, Guangdong Provincial Translational Medicine Innovation Platform for Diagnosis and Treatment of Major Neurological Disease, Guangdong Provincial Clinical Research Center for Neurological Diseases.

Funding

This study was supported by Chinese NSF (81371386, 81620108010), the Clinic Study of 5010 Plan, Sun Yat-sen University (2010003), Guangdong basic and Applied Basic Research Fund (2020A1515110909), and grants from the Southern China International Cooperation Base for Early Intervention and Functional Rehabilitation of Neurological Diseases (2015B050501003), Guangdong Provincial Engineering Center For Major Neurological Disease Treatment, Guangdong Provincial Translational Medicine Innovation Platform for Diagnosis and Treatment of Major Neurological Disease, Guangdong Provincial Clinical Research Center for Neurological Diseases.

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Author notes

  1. Xin Huang and Li Qiu contributed equally to this work.

Authors and Affiliations

  1. Guangdong Provincial Key Laboratory of Diagnosis and Treatment of Major Neurological Diseases, National Key Clinical Department and Key Discipline of Neurology, Department of Neurology, The First Affiliated Hospital, Sun Yat-Sen University, No. 58 Zhongshan Road 2, Guangzhou, 510080, China

    Xin Huang & Weibin Liu

  2. School of Pharmaceutical Sciences, Sun Yat-Sen University, No. 135 West Xingang Road, Guangzhou, 510275, China

    Hao Ran

Authors
  1. Xin Huang
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  2. Li Qiu
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  3. Yaru Lu
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  4. Jiaxin Chen
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  5. Wenhao Yang
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  6. Changyi Ou
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  7. Hao Ran
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  8. Weibin Liu
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Contributions

XH, participated in the diagnosis and treatment of most cases, contributed in data entry, statistical analysis, manuscript writing and submission. LQ, contributed significantly to the database development, data processing and case follow-up. YL, collection of data, technical help. WY, collection of data, technical help. CO, case follow-up, collection of data. HR, corresponding author, design and conceptualization of the study, acquisition of funding. WL, corresponding author, diagnosed and treated most cases, established database, designed and supervised experiment conduction, data analysis.

Corresponding authors

Correspondence to Hao Ran or Weibin Liu.

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The authors declare that they have no conflict of interest.

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This study was approved by the appropriate ethics committees in the first affiliated hospital of Sun Yat-sen University. All participants gave informed consent prior to enrollment in the study. All human studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

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Huang, X., Qiu, L., Lu, Y. et al. Clinical evaluation of efficacy of leflunomide combined with low-dose prednisone for treatment of myasthenia gravis. Acta Neurol Belg 123, 153–160 (2023). https://doi.org/10.1007/s13760-021-01769-0

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  • DOI: https://doi.org/10.1007/s13760-021-01769-0

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