Clinical trial NCT06459232: Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies
Official title: Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-06-14
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief 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.


Eligibility criteria: Inclusion criteria

* With 1 or more claims of siponimod or MS-related FDA-approved DMT during the index calendar year. The date of first claim was the index date.
* With 1 or more MS diagnosis for 12 months prior to the index date \[inclusive\].
* Were continuously enrolled in pharmacy and medical benefits for 12 months prior to the index date \[inclusive\].
* Include patients who were 18 years or older on the index date.
* Include patients continuously enrolled in pharmacy and medical benefits from the index date \[inclusive\] to 6 months/12 months post-index date.

Exclusion criteria

• Patients with 1 or more claims of index drug within 12 months prior to index date.

Primary outcomes:
measure: Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
measure: Number of Patients with a Minimum of 12 Months Follow-up by DMT Use
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)
Secondary outcomes:
measure: Mean Age
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 6 Months Follow-up by Age Group
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 12 Months Follow-up by Age Group
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 6 months Follow-up by Gender
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 12 months Follow-up by Gender
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type
timeFrame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy
measure: Percentage of Patients with MS Relapses
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Mean Charlson Comorbidity Index (CCI) Score
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT
timeFrame: Baseline, defined as the 12 months prior to the first observed MS therapy claim
measure: Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up
timeFrame: 6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
measure: Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up
timeFrame: 12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: