XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16,246
- 试验地点
- 1
- 主要终点
- Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation
研究概览
简要总结
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months
详细描述
This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders.
For this study, any persons from the Marketscan database with an asthma diagnosis and >= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab.
Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date
The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases.
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Commercial Population
Individuals with at least one omalizumab prescription in the Marketscan commercial claims during the identification period (07/07/2016 - 12/31/2018)
干预措施: Omalizumab (Drug)
Medicaid Population
Individuals with at least one omalizumab prescription in the Truven Medicaid claims during the identification period (07/07/2016 - 12/31/2018)
干预措施: Omalizumab (Drug)
结局指标
主要结局
Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Uncontrolled asthma was based on either impairment or risk criteria in a 12- month consecutive period. * Impairment was identified as ≥6 Short-acting Beta Agonist (SABA) prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. * Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. * The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria) or the first exacerbation outcome during a consecutive 12-months (risk criteria).
Proportion of patients with excessive SABA use (≥6 SABA prescriptions dispensed in 12 months) (impairment criteria)
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (impairment criteria) were reported. Impairment was identified as ≥6 SABA prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. - The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria).
Proportion of patients with exacerbations requiring IP visits (risk criteria)
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. - The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Proportion of patients with exacerbations requiring ED visits (risk criteria)
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. - The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Proportion of patients with exacerbations requiring Oral corticosteroids (OCS) prescriptions (risk criteria)
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. - The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Mean daily dose of Inhaled Corticosteroids (ICS) use
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean daily dose of Inhaled Corticosteroids (ICS) use was reported during the follow-up
Mean cumulative dose of OCS use
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean cumulative dose of Oral corticosteroids were reported during follow-up
Mean number of prescriptions of OCS use
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean number of prescriptions of OCS use were reported during follow-up
Mean days of supply of OCS use
时间窗: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean days of supply of OC were reported during follow-up
次要结局
- Proportion of uncontrolled asthma patients (total: risk and impairment criteria)(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Proportion of uncontrolled asthma patients (per impairment criteria)(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Proportion of uncontrolled asthma patients (per risk criteria)(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Mean difference in the total number of asthma-related prescriptions(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Mean difference in daily dose (of days supply) of ICS use(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Proportion of patients with a reduction in daily dose of ICS use(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Mean difference in daily dose of OCS use(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Mean difference in number of prescriptions of OCS use(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Mean difference in days of supply of OCS use(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))
- Proportion of patients with a reduction in total prescriptions of OCS use(through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019))