NCT07450170已完成不适用
Treatment Patterns of Omalizumab in Chronic Urticaria Patients in China: A Retrospective Real-World Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,485
- 试验地点
- 1
- 主要终点
- Average Dose of Omalizumab Per Patient-Year
研究概览
简要总结
The aim of this study was to characterize the real-world treatment patterns of omalizumab among adult patients with chronic urticaria in China using data from a regional electronic healthcare (rEHR) database. This included assessing the frequency and proportion of prescriptions across different dosages of omalizumab in real-world clinical practice.
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
- •Patients with at least one diagnosis of chronic urticaria during the study period. A chronic urticaria diagnosis is defined as including "chronic urticaria" but without any rule-out terms in the diagnosis name.
- •Patients treated with omalizumab during the identification period. The date of first omalizumab prescription is defined as the index date.
- •Patients aged 18 years or older at index.
- •Patients with at least one medical record ≥12 months prior to index date.
- •Additional inclusion criterion for patients included in healthcare resource utilization (HCRU) outcomes:
- •Patients with at least one medical record ≥12 months post index date.
排除标准
- •Patients with a diagnosis of allergic asthma during the study period.
- •Patients without any dosing information (raw or derived) for omalizumab.
研究组 & 干预措施
Chronic Urticaria Cohort
Chronic urticaria patients with at least one prescription of omalizumab after March 2023 in the selected database.
Chronic Spontaneous Urticaria (CSU) Cohort
A subgroup of the Chronic Urticaria Cohort. Adult patients diagnosed with CSU with at least one prescription of omalizumab after March 2023 in the selected database.
Chronic Inducible Urticaria (CIndU) Cohort
A subgroup of the Chronic Urticaria Cohort. Adult patients diagnosed with CIndU with at least one prescription of omalizumab after March 2023 in the selected database.
结局指标
主要结局
Average Dose of Omalizumab Per Patient-Year
时间窗: Up to approximately 2 years and 10 months
Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage
时间窗: Up to approximately 2 years and 10 months
Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and \>450 mg.
次要结局
- Duration of Omalizumab Re-treatment(Up to approximately 2 years and 10 months)
- Number of Medicine Switches Prior to Omalizumab Initiation(Baseline)
- Cost for Urticaria-related Medications Prior to Omalizumab Initiation(12 months)
- Cost for Urticaria-related Medications After Omalizumab Initiation(12 months)
- Average Dose of Omalizumab Per Patient-Year by Calendar Year(1 year)
- Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year(1 year)
- Time to Omalizumab Treatment Discontinuation(Up to approximately 2 years and 10 months)
- Number and Percentage of Patients Re-treated With Omalizumab After Omalizumab Discontinuation(Up to approximately 2 years and 10 months)
- Number and Percentage of Patients Re-treated With Other Urticaria-related Treatment After Omalizumab Discontinuation by Type of Medication(Up to approximately 2 years and 10 months)
- Time From Omalizumab Discontinuation to Re-treatment(Up to approximately 2 years and 10 months)
- Number and Percentage of Patients by Concomitant Treatment With Omalizumab(Up to approximately 2 years and 10 months)
- Number of Patients by Demographic Category(Baseline)
- Number of Patients by Clinical Characteristic(Baseline)
- Number of Patients by Type of Treatment Used Before Omalizumab(Baseline)
- Number of AH Drugs Used Prior to Omalizumab Initiation(Baseline)
- Time From AH Initiation to Omalizumab Initiation(Baseline)
- Time From Other Urticaria-related Medication Initiation to Omalizumab Initiation(Baseline)
- Number of All-cause Healthcare Visits Prior to Omalizumab Initiation(12 months)
- Number of Urticaria-related Healthcare Visits Prior to Omalizumab Initiation(12 months)
- Number of Angioedema-related Inpatient Admissions Prior to Omalizumab Initiation(12 months)
- Number of All-cause Healthcare Visits After Omalizumab Initiation(12 months)
- Number of Urticaria-related Healthcare Visits After Omalizumab Initiation(12 months)
- Number of Angioedema-related Inpatient Admissions After Omalizumab Initiation(12 months)
- Duration of Inpatient Admissions Prior to Omalizumab Initiation(12 months)
- Duration of Inpatient Admissions After Omalizumab Initiation(12 months)
- Cost for All-cause Healthcare Visits Prior to Omalizumab Initiation(12 months)
- Cost for Urticaria-related Healthcare Visits Prior to Omalizumab Initiation(12 months)
- Cost for All-cause Healthcare Visits After Omalizumab Initiation(12 months)
- Cost for Urticaria-related Healthcare Visits After Omalizumab Initiation(12 months)
研究者
研究点 (1)
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