Characteristics of Patients With Sickle Cell Disease Who Initiate Crizanlizumab Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Number of patients by Charlson Comorbidity Index (CCI) score category
研究概览
简要总结
This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases.
详细描述
Patients with a diagnosis of SCD between November 1, 2018 and April 30, 2021 were identified. Among these patients, those who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort. The indexing timeframe allowed for a 1-year lookback period and a minimum of 3 months (3m cohort) of follow-up. A subset of the 3m cohort with 6-months of available (6m cohort) follow-up was performed. The index date was the date of the first crizanlizumab administration.
Study period: 01 November 2018 - 30 April 2021 Index period: 01 November 2019 - 31 January 2021 Index date: Date of the first claim for administration of crizanlizumab in the index period
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
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 1 claim in IQVIA Patient Centric Medical Claims Database (Dx) with SCD diagnosis (ICD-10 D57.xx, except D57.3) within the study period;
- •At least 1 claim for administration of crizanlizumab within the index period. Index date was the date of first administration;
- •At least 1 claim with HCPCs for crizanlizumab (J0791) OR with at least one claim for an unspecified biologic (J3590) on the same day as a claim for SCD (ICD-10 D57.xx, except D57.3) OR with at least one claim with HCPCs C9053;
- •At least 16 years of age on the index date;
- •Linkage to the IQVIA Longitudinal Prescription Database (LRx) within the study period;
- •Stability and eligibility in Dx during the 12 months prior to the index date;
- •Stability and eligibility in LRx during the 12 months prior to the index date
排除标准
- 未提供
结局指标
主要结局
Number of patients by Charlson Comorbidity Index (CCI) score category
时间窗: Baseline
Severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.
Number of patients with history of additional SCD-related comorbidities associated with organ damage
时间窗: Baseline
Number of patients with history of additional SCD-related comorbidities associated with organ damage were reported.
Number of patients : History of hydroxyurea use
时间窗: Baseline
Pre-index treatment history for sickle cell disease was reported.
Number of patients by comorbidity
时间窗: Baseline
Number of patients by IQVIA's standard comorbidity list were reported.
Number of patients : SCD genotype
时间窗: Baseline
Number of patients with sickle cell disease genotype were reported.
Age
时间窗: Baseline
Age information was reported.
Number of patients: Gender
时间窗: Baseline
Gender information was reported.
Number of patients: Geographic region
时间窗: Baseline
The following categories were included: Northeast, Midwest, South, West
Number of patients : History of L-glutamine use
时间窗: Baseline
Pre-index treatment history for sickle cell disease was reported.
Number of patients : History of Voxelotor use
时间窗: Baseline
Pre-index treatment history for sickle cell disease was reported.
Number of patients: Insurance type
时间窗: Baseline
When multiple payer types were observed, the following hierarchy was used: Medicare, Commercial, Medicaid, Cash, Unspecifed. When commercially-managed Medicaid was observed, the Medicaid designation was assigned.
次要结局
- Number of hydroxyurea claims(Throughout the follow-up period, approximately 1.5 years)
- Number of voxelotor claims(Throughout the follow-up period, approximately 1.5 years)
- Proportion of patients with claims for L-glutamine while on crizanlizumab therapy(Throughout the follow-up period, approximately 1.5 years)
- Number of L-glutamine claims(Throughout the follow-up period, approximately 1.5 years)
- Proportion of patients with claims for hydroxyurea while on crizanlizumab therapy(Throughout the follow-up period, approximately 1.5 years)
- Proportion of patients with claims for voxelotor while on crizanlizumab therapy(Throughout the follow-up period, approximately 1.5 years)