Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Retrospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 - 65 years old;
- •Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
- •SELENA-SLEDAI score of at least 8 points (clinical symptoms of no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
- •Patients who have been using tofacitinib or belimumab for at least 12 weeks.
排除标准
- •Having active central nervous system diseases;
- •eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- •Pregnant women, or women planning to get pregnant in the near future while taking the medication, or lactating women;
- •Participants who are simultaneously participating in other clinical studies;
- •Patients who have received treatment with tixagrel or belimumab for less than 12 weeks.
研究组 & 干预措施
The Belimumab group
The participants in the study had previously used belimumab as a therapeutic drug.
The Telitacicept group
The participants in the study had previously used telitacicept as a therapeutic drug.
结局指标
主要结局
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response
时间窗: From baseline to the end of 1-year treatment period
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).
次要结局
- Proportion of Participants with Stable SLEDAI and PGA Scores(From baseline to the end of 1-year treatment period)
- The proportion of participants in the study who had their hormone dosage reduced(From baseline to the end of 1-year treatment period)
- The time of recurrence occurrence(From baseline to the end of 1-year treatment period)
研究者
Yipeng Liu
Clinical Professor
Qianfoshan Hospital