The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are: * In the overall SLE population: What are the SRI-4 response rates for both drugs? * In the lupus nephritis subgroup: What are the major renal response rates for both drugs? Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on: * The patient's objective clinical condition at enrollment * Physician's assessment * Joint decision-making between physicians and patients/family members As an observational study, no active intervention will be implemented.
Study Type
OBSERVATIONAL
Enrollment
180
Qianfoshan Hospital
Jinan, Shandong, China
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population)
1. A reduction of ≥ 4 points in the SELENA-SLEDAI score from baseline; 2. And no new BILAG A-level organ or ≤ 2 new BILAG B-level organs compared to baseline; 3. And no worsening in the physician's global assessment (PGA) (an increase of \< 0.30 points from baseline).
Time frame: From baseline to the end of 2-year treatment period
The response rate for major kidney treatments(the lupus nephritis subgroup)
1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure.
Time frame: From baseline to the end of 2-year treatment period
Complete renal response rate(the lupus nephritis subgroup)
1. 24-hour urine PCR \< 0.5 g/g (50 mg/mmol); 2. Stable or improved renal function (not exceeding 10% - 15% of the baseline).
Time frame: From baseline to the end of 2-year treatment period
Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population)
The percentage of study participants whose SLEDAI score decreased by at least 4 points and whose PGA did not worsen.
Time frame: From baseline to the end of 2-year treatment period
The proportion of participants in the study who had their hormone dosage reduced(the overall SLE population)
The ratio of study participants whose prednisone dose was reduced by ≥25% or ≤7.5 mg/day compared to the baseline at 44-48 weeks.
Time frame: From baseline to the end of 2-year treatment period
The time of recurrence occurrence(the overall SLE population)
The time of the first recurrence or the first severe recurrence.
Time frame: From baseline to the end of 2-year treatment period.
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