Ruxolitinib for the Treatment of Polycythemia Vera in Patients Who Are Resistant to or Intolerant of Hydroxyurea: a Retrospective Non-interventional Study Using the US Optum Electronic Health Record Data Source.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,576
- 试验地点
- 1
- 主要终点
- Number of Thromboembolic events between the RUX and BAT group
研究概览
简要总结
This was an analytical and descriptive, non-interventional, retrospective cohort study of PV patients aged ≥ 18 years in the US using a secondary data source, Optum EHR database.
详细描述
The Optum EHR database was current up to 30-Jun-2020.
Identification period: From 01-Apr-2007 to 30-Jun-2019
Study period: From 01-Jan-2007 to 30-Jun-2020
Index date:
First evidence of resistance to or intolerance of HU treatment in patients with PV according to modified European Leukemia Net (ELN) criteria and defined as:
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included patients:
- •With at least one International Classification of Diseases, 9th Revision, Clinical Modification/International Classification of Diseases,10th Revision, Clinical Modification code for PV in the identification period (01-Apr-2007 until 30-Jun-2019) that had non-missing sex and year of birth data and who were treated as part of the Integrated Delivery Network
- •That were ≥ 18 years old at PV diagnosis
- •With ≥ 2 prescriptions of HU
- •That were classified as resistant to or intolerant of HU after a minimum of 3 months HU treatment (index date), defined as:
- •HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) or Platelet count > 400 x 109/L and presence of palpable splenomegaly (palpable spleen up to 3 months after platelet count).
- •To identify patients in the RUX group:
- •With ≥ 2 prescriptions of RUX in the post-index period.
排除标准
- •Excluded patients:
- •With a MF or AML diagnosis prior to a PV diagnosis.
结局指标
主要结局
Number of Thromboembolic events between the RUX and BAT group
时间窗: throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020)
Thromboembolic events in overall Polycythemia Vera cohort and in the BAT and RUX groups were reported. A TE was defined using International Classification of Diseases 9th Revision (ICD-9- CM) and International Classification of Diseases 10th Revision (ICD-10-CM) codes previously curated as restrictive (RESPONSE RCT) and extensive (GEMFIN) definitions of TE's within the Diagnosis table in Optum EHR database.
Number of Thromboembolic events between the high and low risk subgroups of BAT group
时间窗: throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020)
Within the BAT group, high risk (≥ 1 TE on average per year ) and low risk (\< 1 TE on average per year) subgroups were identified based on the frequency of TEs and characterized according to patient sociodemographics, comorbidities, symptoms, clinical, and medication variables.
次要结局
- Time to first thromboembolic event(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Time to first phlebotomy procedure(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Incidence rate of thromboembolic event(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Treatment patterns: Proportion of patients using different PV-related treatments(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Healthcare resource utilization (HCRU): Number of emergency room visits(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Incidence rate of phlebotomy procedures(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Time to first neoplasm transformation(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Incidence rate of neoplasm transformations(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Healthcare resource utilization (HCRU): Number of outpatient visits(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))
- Healthcare resource utilization (HCRU): Number of inpatient hospitalizations(throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020))