Optimization of Glucocorticoid Taper Strategies for SLE-ITP
Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic, Glucocorticoids
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring GCs taper strategy, Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 14-75 (including 14 and 75);
- It meets the 2012 Systemic lupus Erythematosus International Collaborative Group (SLICC) classification criteria or the 2019 ACR and European Society of Rheumatology (EULAR) classification criteria ;
- severe SLE-ITP patients with PLT≤30x10^9/L at onset and complete response (PLT ≥100x10^9/L) after induction therapy within 3 weeks;
- Prior to the commencement of any study-specific procedure, the patient or legal representative must provide signed and dated written informed consent.
Exclusion Criteria:
- Relapse in the presence of glucocorticoid and/or immunosuppressive maintenance therapy;
- Combined with antiphospholipid syndrome;
- Combined with other important organ damage such as lupus nephritis, neuropsychiatric lupus;
- Coexisting immune diseases require glucocorticoid and/or immunosuppressive therapy;
- There are serious comorbidities affecting treatment such as diabetes, severe hypertension, coronary heart disease;
- self-evaluation affected by poor understanding ability, vision decline and other reasons ;
- Poor adherence and failure to adhere to treatment as prescribed. -
Sites / Locations
- Fujian Medical University Union Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard GCs taper group
rapid GCs taper group
After a complete response (PLT ≥100x10^9/L) was confirmed, the dose of prednisone (or equivalent dose of glucocorticoids) would be reduced by 2 tablets every two weeks. When it reaches 6 tablets /d, the dose would be reduced by 1 tablet every 2 weeks, and when it reaches 15mg/d, the dose would be reduced by half tablet every 2 weeks.
After a complete response (PLT ≥100x10^9/L) was confirmed, the dose of prednisone (or equivalent dose of glucocorticoids) would be cut in half (25mg/d for weight less than 50kg, 30mg/d for weight 50-75kg , 40mg/d for weight more than 75kg ). After that, the dose would be reduced by 2 tablets every two weeks. When it reaches 6 tablets /d, the dose would be reduced by 1 tablet every 2 weeks, and when it reaches 15mg/d, the dose would be reduced by half tablet every 2 weeks.