Immune-related Adverse Events From Immune Checkpoint Inhibitor Characterization Using VigiBase, the WHO Pharmacovigilance Database: An Exploration of Adverse Event Patterns and Signal Detection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141,630
- 试验地点
- 2
- 主要终点
- Factors associated with an increased rate of fatality among reports with an immune-related adverse event (irAE).
研究概览
简要总结
This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database.
This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction.
The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.
详细描述
Over the past ten years, immuno-oncology (IO) has gradually integrated the therapeutic arsenal of cancer treatment. CTLA-4, program-death 1 (PD1) and its ligand (PD-L1) and LAG3 were found to be major targets active in multiple tumor types. Immune checkpoint inhibitors (ICI) are antibodies blocking these targets and became a cornestone of cancer treatment.
This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database. VigiBase is managed by the Uppsala Monitoring Centre (UMC, Uppsala, Sweden) and contains about 30 million reports (as of Jan 2023) submitted by national pharmacovigilance centers since 1967.
The use of VigiBase® for pharmacovigilance analyses is not dependent on institutional review board approval. It is conditioned on institutional access provided and approved by the Uppsala Monitoring Centre. Since spontaneous reporting systems are based on anonymity and the process only requires patient non-opposition, no informed consent was requested to use VigiBase® in this study.
This study includes all reports associated with an ICI. The query is performed using the Medical Dictionary for Regulatory Activities (MedDRA), between January 1st 2008 (year of first report of ICI in VigiBase), and January 1st 2023. The analysis focused on reports suspected to be induced by an ICI (as opposed to concurrent use).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any report with an ICI "Suspect" or "Interacting" with the reported adverse drug reaction.
排除标准
- •ICI not FDA approved
- •No irAE identified in report
研究组 & 干预措施
immune-related adverse event reaction
Reports of identified immune-related adverse event reaction
干预措施: Immune checkpoint inhibitor (Drug)
结局指标
主要结局
Factors associated with an increased rate of fatality among reports with an immune-related adverse event (irAE).
时间窗: any report prior to january 2023
Reports with a fatal outcome will be compared to reports with no fatal outcome. Odds ratio will be calculated to compare covariates potentially associated with an increase risk of fatality, including irAE type, cancer type reported, patient's age, gender, comorbidities, type of ICI or ICI combination and other treatments.
次要结局
- Time to onset for each irAE type(any report prior to january 2023)
- Factors associated with an increased reporting of main irAE types(any report prior to january 2023)
- Rate of relapse with treatment rechallenge(any report prior to january 2023)
研究者
Joe Elie Salem
prof.
Groupe Hospitalier Pitie-Salpetriere