Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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;
- •The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
- •Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug.
排除标准
- •Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction;
- •eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- •Pregnant women, or women who are about to become pregnant in the near future, or lactating women;
- •Participants who are simultaneously participating in other clinical studies;
- •Within 1 year before randomization, received B-cell targeted therapy (including belimumab);
- •During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.
研究组 & 干预措施
The Telitacicept group（the overall SLE population）
The participants in this group were diagnosed with SLE and were selected to use Telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.
The Belimumab group（the overall SLE population）
The participants in this group were diagnosed with SLE and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.
The Telitacicept group（the lupus nephritis subgroup）
The participants in this group were diagnosed with LN and were selected to receive telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.
The Belimumab group（the lupus nephritis subgroup）
The participants in this group were diagnosed with LN and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.
结局指标
主要结局
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population)
时间窗: From baseline to the end of 2-year treatment period
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).
The response rate for major kidney treatments(the lupus nephritis subgroup)
时间窗: From baseline to the end of 2-year treatment period
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.
次要结局
- Complete renal response rate(the lupus nephritis subgroup)(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)(From baseline to the end of 2-year treatment period)
- Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population)(From baseline to the end of 2-year treatment period)
- The time of recurrence occurrence(the overall SLE population)(From baseline to the end of 2-year treatment period.)
研究者
Yipeng Liu
Clinical Professor
Qianfoshan Hospital