Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies

Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis (MS) Cohort; Adult MS patients with at least 1 claim of siponimod or an MS-related FDA-approved DMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CBAF312AUS16