Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis
Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis
This study is designed to evaluate the effectiveness and safety of tacrolimus combined with
 low-dose prednisone in the management of myasthenia gravis patients, compared to tacrolimus
 as initial immune monotherapy.
This is a single center, observational real-world study recruiting myasthenia gravis patients
 from Neurology Departments of Xuanwu Hospital, aiming to compare effectiveness and safety of
 2 different inmunotherapy for MG. The study plans to recruit 160 MG participants and divides
 into 2 treatment groups according to physician's judgment and preferences of patients, one is
 combined immunotherapy group in which tacrolimus added with low-dose prednisone
 (0.25mg/kg/d), and the other is tacrolimus monotherapy group. Both groups can be treated with
 pyridostigmine to relieve symptoms. Patients are followed up at 1, 3 and 6 month after
 treatment initiation to assess the efficacy of both regimen. The primary outcome is the
 change of MG-ADL scores. Also, liver and renal functions are tested to monitor any side
 effects. Patients' clinical records are uploaded to an online database.
Inclusion Criteria:

 -  Age ≥18

 -  Clinical Diagnosis of MG is confirmed based on typical clinical features of
 fluctuating muscle weakness, with at least 1 of the following supporting evidence:

 1. positive clinical response to acetylcholinesterase inhibitor

 2. positive AchR-Ab or MuSK-Ab testing

 3. decrement >10% in repetitive nerve stimulations study (RNS) or increased jitter
 on single-fibre electromyography (SFEMG)

 -  MGFA clinical classification: I - IV

 -  Baseline MG-ADL ≥ 3

 -  Disease course from onset to enrollment ≤ 12 months

 -  Cooperation to followup

 -  Written informed consent

 Exclusion Criteria:

 -  Initiation of immunosuppressant for MG prior to screening, including Prednisone,
 Methylprednisolone, Azathioprine, Methotrexate, Cyclosporine A, Mycophenolate Mofetil,
 Tacrolimus and Cyclophosphamide

 -  Treatment of immunosuppressant for other concomitant disease 6 months prior to
 recruitment

 -  Rapid immunosuppressive treatments like Intravenous immunoglobulin or plasma exchange
 1 month prior to recruitment

 -  Thymectomy within 3 months prior to Screening

 -  Concomitant chronic degenerative, psychiatric, or neurologic disorder that can cause
 weakness or fatigue

 -  Consciousness, dementia or schizophrenia

 -  Pregnancy or lactation, unwillingness to avoid pregnancy

 -  Uncontrolled hypertension or diabetes, Liver or kidney dysfunction, Cataract, Severe
 osteoporosis, Femoral head necrosis; Hyperkalemia, HIV, Acute or chronic infection

 -  Other conditions that would preclude participation