Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies
NCT Number: NCT06459232
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Sponsor: Novartis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 143
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-11-19
Completion Date: 2021-12-17
Locations: Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States

Summary:
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.

Primary Outcome Measures: Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use, Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)|Number of Patients with a Minimum of 12 Months Follow-up by DMT Use, Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
Secondary Outcome Measures: 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, Age group categories included:

* 18-34 years
* 35-44 years
* 45-54 years
* 55-64 years
* 65+ years, 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, Age group categories included:

* 18-34 years
* 35-44 years
* 45-54 years
* 55-64 years
* 65+ years, 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 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 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 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 Insurance Plan Type, 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 Insurance Plan Type, 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 Health Plan Type, 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 MS Relapses, Baseline, defined as the 12 months prior to the first observed MS therapy claim|Mean Charlson Comorbidity Index (CCI) Score, CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2)., 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 Disability Level, Disability levels included: No symptoms, Mild, Moderate, and Severe., 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 Disability Level, Disability levels included: No symptoms, Mild, Moderate, and Severe., 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|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|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 Type of Prior DMT, Baseline, defined as the 12 months prior to the first observed MS therapy claim|Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up, Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period., 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, Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period., 12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)