A Prospective Cohort Study of Myasthenia Gravis in China

Study Overview
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Brief Summary
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The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are: Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG. To identify potential biomarkers that can predict disease progression and prognosis. This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.

Official Title
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Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Drug: Steroid Drug
* Other: Withdraw all immunosuppresants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024. 2: Diagnosed as myasthenia gravis. 3: Follow-up time at PUMCH>6 months. 4: The patient understood and signed the informed consent form. Exclusion Criteria: 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess 2: Records related to comorbidities and medications were not available at baseline and during follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| maintenance steroid therapy group<br>Maintaining low-dose oral steroids | Drug: Steroid Drug<br>* Maintaining low-dose oral steroids<br>|
| immunosuppresants withdrawal group<br>Withdraw all immunosuppresants | Other: Withdraw all immunosuppresants<br>* Withdraw all immunosuppresants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of myasthenia gravis | One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status. | Within two years after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of relapse | The time between recruitment and relapse of MG. | Within two years after recruitment | 
| Change of MG assessment scales at relapse | Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite). | Within two years after recruitment | 
| Adverse events of steroids | Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events. | Within two years after recruitment |