This study is designed to explore the efficacy and safety of Telitacicept combined with low-dose steroids for the treatment of refractory MG, and to investigate related biomarkers such as immunoglobulins, BlyS/APRIL, and AChR-Ab titers, in order to clarify whether Telitacicept can rapidly and effectively help achieve MG treatment goals and assist in steroid reduction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients with MG who fulfill the inclusion criteria will receive Telitacicept 240mg weekly as an adjunct to their medication. Upon reaching MMS, significant symptom improvement, or a QMG score reduction of at least 6 points, Telitacicept is reduced to biweekly doses. Pyridostigmine and NSISTs are tapered based on patient response. Following this, Prednisone is tapered, starting with rapid reduction early and slowing later. If a patient on 60mg Prednisone daily achieves treatment goals within 6-8 weeks of Telitacicept initiation, the tapering sequence is 60mg every other day for 4 weeks, then 30mg daily for 2-4 weeks, and so on, until reaching 5mg daily or 10mg every other day. At this point, Telitacicept may be reduced to 160mg biweekly.
The change in patients' ADL scores
The variation in ADL scores at 52 weeks compared to baseline in patients. Total MG -ADL scores range from 0 (normal) to 24 (severe).
Time frame: from baseline to week 52
The change in patients' QMG scores
The variation in QMG scores at 52 weeks compared to baseline in patients. Total QMG scores range from 0 (none) to 39 (severe).
Time frame: from baseline to week 52
MGFA-PIS
Change in MGFA-PIS grading from baseline to week 52
Time frame: from baseline to week 52
the average daily corticosteroid usage
Change in the average daily corticosteroid usage from baseline to week 24 during follow-up；Change in the average daily corticosteroid usage from baseline to week 52 during follow-up
Time frame: from baseline to week 24；from baseline to week 52
the usage of traditional non-steroidal immunosuppressants
Change in the usage of traditional non-steroidal immunosuppressants from baseline to week 24 during follow-up; Change in the usage of traditional non-steroidal immunosuppressants from baseline to week 52 during follow-up. Medication usage logs or medical record reviews to document the changes in the use of traditional non-steroidal immunosuppressants (such as Azathioprine, Mycophenolate Mofetil, Tacrolimus, Methotrexate, Cyclosporine, etc.) from baseline to week 52. The change in the use of traditional non-steroidal immunosuppressants will be assessed by comparing the medication usage at baseline and at weeks 24 and 52. This includes details on the type of medication, dosage, frequency, and any adjustments or discontinuations.
Time frame: from baseline at weeks 24 and 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of relapses
Number of relapses in both groups by the end of treatment (clinical relapse is defined as an increase in QMG score of ≥3 points);
Time frame: week 52
AUDTC
Area under the corticosteroid dose-time curve (AUDTC) at week 52
Time frame: week 52
Proportion of patients with a corticosteroid dose ≤10mg/d
Proportion of patients with a corticosteroid dose ≤10mg/d at weeks 24 and 52 during follow-up;
Time frame: at weeks 24 and 52
Proportion of patients achieving MMS with a corticosteroid dose ≤ 5mg/d
Proportion of patients achieving MMS with a corticosteroid dose ≤5mg/d at week 24;
Time frame: week 24
MG QoL15r scores
Change in MG QoL15r scores from baseline at weeks 24 and 52 during follow-up
Time frame: from baseline at weeks 24 and 52
safety（Incidence, severity, and outcome of adverse events）
Incidence, severity, and outcome of adverse events
Time frame: 52 weeks
relevant biomarkers
relevant biomarkers, such as immunoglobulins,lymphocyte subpopulation changes, BlyS/APRIL, and AChR-Ab titers.
Time frame: from baseline at week 52