A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 3,506
- 试验地点
- 4
- 主要终点
- Malignancies
研究概览
简要总结
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.
详细描述
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date
- •A minimum data availability of 12 months prior to index date
- •Age ≥18 years at index date
- •SLE severity: patients with moderate to severe SLE at index date
- •SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date
排除标准
- •A diagnosis of any malignancy prior to index date
- •A diagnosis of HIV/AIDS or congenital immunodeficiency prior to index date
- •Organ or bone marrow transplant procedure prior to index date
- •A diagnosis of serious infection in the previous 6 months
结局指标
主要结局
Malignancies
时间窗: Indexdate to November 2031
Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source
Serious infection
时间窗: Indexdate to November 2027
Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death
Infections leading to hospitalisation
时间窗: Index date to November 2027
Infection diagnosis as a part of a hospitalization episode, use of IV antimicrobials, or death, or infection diagnosis in primary or secondary care settings up to 7 days before hospitalization
Infection-related death
时间窗: Indexdate to November 2027
Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month
次要结局
- Specific types of malignancies(Indexdate to November 2031)
- Serious infection components(Indexdate to November 2027)
- Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately)(Indexdate to November 2027)