Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Number of Patients with a Minimum of 12 Months Follow-up by DMT Use
研究概览
简要总结
This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019.
The data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.
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 —（Adult, Older Adult）
- 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
结局指标
主要结局
Number of Patients with a Minimum of 12 Months Follow-up by DMT Use
时间窗: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use
时间窗: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
次要结局
- Mean Age(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 6 Months Follow-up by Age Group(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 12 Months Follow-up by Age Group(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up(6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment))
- Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up(12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment))
- Number of Patients with a Minimum of 6 months Follow-up by Gender(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 12 months Follow-up by Gender(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Percentage of Patients with MS Relapses(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT(Baseline, defined as the 12 months prior to the first observed MS therapy claim)
- Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type(Index date, defined as the date of the first claim for siponimod or MS-specific therapy)
- Mean Charlson Comorbidity Index (CCI) Score(Baseline, defined as the 12 months prior to the first observed MS therapy claim)