Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,214
- 试验地点
- 1
- 主要终点
- Cutaneous toxicity of ICIs
研究概览
简要总结
Immune checkpoint inhibitors (ICIs) are associated with a wide variety of cutaneous immune-related adverse events (cirAEs). These cirAEs are reported to be the most common immune-related adverse events (irAEs) and the first to appear. This study examines the appearance of cirAEs within the World Health Organization (WHO) pharmacovigilance database, VigiBase.
详细描述
ICIs have revolutionized clinical oncologic care. The ICIs that are currently FDA approved fall into three main categories: those that block the cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4; ipilimumab), block the programmed cell death protein-1 (anti-PD-1; nivolumab, pembrolizumab, cemiplimab), and block the programmed cell death ligand-1 (anti-PD-L1; atezolizumab, avelumab, durvalumab) pathway. There is a considerable diversity of cirAEs that have been reported with these ICIs in both monotherapy and combination therapy.
VigiBase is the WHO pharmacovigilance database that monitors individual case safety reports associated with certain drugs. The largest database of its kind in the world, VigiBase is managed by the Uppsala Monitoring Center (UMC) in Sweden, and since its inception in 1967 has received over 19 million individual case safety reports (ICSRs) from over 130 contributing countries. In this study, the investigators examine the appearance of cutaneous immune related adverse events in the setting of immunotherapy within VigiBase.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with either Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), and Cemiplimab (L01XC33).
- •Developed an adverse reaction that was submitted to a pharmacovigilance center and was determined to be related to aforementioned immune checkpoint inhibitors.
- •Adverse reaction was determined to be within the System Organ Class (SOC) "Skin and subcutaneous disorder".
排除标准
- •Adverse event was determined not to be immune-related (for example, infectious etiology) or was a symptom (e.g., edema).
- •Adverse event developed before the administration of ICI.
研究组 & 干预措施
Cutaneous toxicity
Patients who reported a cutaneous immune related adverse event following ICI initiation with appropriate chronology that indicates drug toxicity.
干预措施: Immune checkpoint inhibitor (ICI) (Drug)
结局指标
主要结局
Cutaneous toxicity of ICIs
时间窗: From 01/01/2008 to 08/31/2020
Number of reported adverse events associated with ICIs within the Systems Organ Class (SOC) "Skin and subcutaneous disorders" with one of the 7 FDA-approved ICIs Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), or Cemiplimab (L01XC33), alone or in any combination with each other.
次要结局
- Reporting odds ratio for monotherapy vs combination therapy(From 01/01/2008 to 08/31/2020)
- Co-occuring irAEs(From 01/01/2008 to 08/31/2020)
- Time to onset(From 01/01/2008 to 08/31/2020)
- Reporting odds ratio for differing monotherapy(From 01/01/2008 to 08/31/2020)
- Disproportionality assessment of cirAEs with ICIs(From 01/01/2008 to 08/31/2020)
- Indication(From 01/01/2008 to 08/31/2020)