Comparative Effect of Tocilizumab Versus Methotrexate on Major Adverse Cardiovascular Events in Giant Cell Arteritis: A Nationwide Target Trial Emulation Using the French SNDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,667
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
This nationwide observational study emulates a target trial to compare the effect of tocilizumab versus methotrexate initiation on major adverse cardiovascular events (MACE) in patients with incident giant cell arteritis using the French National Health Data System (SNDS).
详细描述
Study Design and Data Source This study is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. We emulated a hypothetical randomized trial comparing two treatment strategies: initiation of tocilizumab versus methotrexate within 6 months after hospital discharge for incident giant cell arteritis. Eligible patients aged ≥50 years hospitalized for incident GCA between 2012 and 2024 were included.
Statistical Analysis A clone-censor-weight approach was used to account for treatment initiation timing and avoid immortal time bias. Inverse probability of censoring weights were applied to adjust for informative censoring. Treatment effects were estimated using weighted Kaplan-Meier methods and Cox proportional hazards models.
Outcomes The primary outcome was the occurrence of major adverse cardiovascular events (MACE), defined as myocardial infarction, ischemic stroke, or all-cause death. Secondary outcomes included individual cardiovascular components, aortic events, and major vascular relapse.
Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years Incident hospitalization for giant cell arteritis Initiation of tocilizumab or methotrexate within 6 months Received systemic corticosteroids ≥20 mg/day within 30 days following hospital discharge
排除标准
- •Prior use of tocilizumab or methotrexate Age >90 years Length of stay >30 days Not discharged home Prior aortic disease or vascular imaging within 2 years Initiation of both treatments during grace period
研究组 & 干预措施
Tocilizumab group
Patients initiating tocilizumab within 6 months after discharge for incident GCA.
Methotrexate group
Patients initiating methotrexate within 6 months after discharge for incident GCA.
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 2 years
Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death
次要结局
- Lower limb revascularization(2 years)
- Coronary events(2 years)
- Ischemic stroke(2 years)
- All-cause mortality(2 years)
- Aortic events(2 years)
- Major vascular relapse(2 years)
- Anterior ischemic optic neuropathy (AION)(2 years)
- Peripheral artery disease events(2 years)
- Cancer incidence(2 years)