The objective of this observational study is to compare the efficacy and safety of tixocutibine and belizumab in the treatment of systemic lupus erythematosus in patients aged 18-65 years with systemic lupus erythematosus. The main question it aims to answer is: In the overall population of systemic lupus erythematosus: What is the response rate (SRI-4) of the two drugs in treating systemic lupus erythematosus? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
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
1. The SELENA-SLEDAI score decreased by ≥ 4 points compared to the baseline; 2. And there were no new BILAG-assessed grade A organs or ≤ 2 new BILAG-assessed grade B organs compared to the baseline; 3. And the overall physician assessment (PGA) did not deteriorate (an increase of \< 0.30 points compared to the baseline).
Time frame: From baseline to the end of 1-year treatment period
Proportion of Participants with Stable SLEDAI and PGA Scores
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 1-year treatment period
The proportion of participants in the study who had their hormone dosage reduced
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 1-year treatment period
The time of recurrence occurrence
The time of the first recurrence or the first severe recurrence.
Time frame: From baseline to the end of 1-year treatment period
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