Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06644638
• Lead Sponsor: Novartis

Brief Summary

This was a retrospective cohort study utilizing the IQVIA PharMetrics® Plus claims database from 01 August 2019 through 31 May 2022.

The database is comprised of fully adjudicated (i.e., paid by the health plan) medical and pharmacy claims and is representative of the commercially insured United States population. Adults treated with ofatumumab (OMB), oral disease-modifying therapies (DMTs) (dimethyl fumarate, diroximel fumarate, monomethyl fumarate, fingolimod, siponimod, ozanimod, ponesimod, teriflunomide, cladribine) or platform self-injectable DMTs (glatiramer acetate, interferon beta-1a, peginterferon beta-1a, interferon beta-1b) between 01 August 2020, through 30 November 2021, were identified. The date of the first incident DMT (OMB, oral DMT, or injectable DMT) during the identification window served as the index date. The baseline period was the 12 months before the index date, and the follow-up period was at least 6 months after the index date. Patients treated with OMB were selected first to maximize sample size, and these patients were allowed to have an oral or injectable DMT in the baseline period. Patients without OMB use during the identification period were categorized into the oral DMT or platform self-injectable DMT cohort based on the first-observed incident DMT during the identification period. For the purpose of this study, platform self-injectable DMTs were referred to as 'self-injectable DMTs.'

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3632

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients Persistent on Ofatumumab and Self-injectable Disease-modifying Therapies (DMTs)	Month 6, month 12	Persistence was defined as no evidence of discontinuation of the therapy over the follow-up period. Self-injectable DMTs included daclizumab, glatiramer acetate, interferon beta-1a, peginterferon beta-1a, and interferon beta-1b.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States