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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.'
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab and Self-injectable DMT Cohort | Adult patients with multiple sclerosis (MS) who newly initiated ofatumumab or other self-injectable DMTs. | ||
| Ofatumumab and Oral DMT Cohort | Adult patients with MS who newly initiated OMB or oral DMTs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Persistent on Ofatumumab and Self-injectable Disease-modifying Therapies (DMTs) | 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. | Month 6, month 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Persistent on Ofatumumab and Oral Disease-Modifying Therapies (DMTs) | Persistence was defined as no evidence of discontinuation of the therapy over the follow-up period. Oral DMTs included dimethyl fumarate, diroximel fumarate, monomethyl fumarate, fingolimod, siponimod, ozanimod, ponesimod, teriflunomide, and cladribine. | Month 6, month 12 |
Inclusion criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Number of Patients Adherent on Ofatumumab and Oral DMTs | Adherence was based on the proportion of days covered (PDC), calculated as the number of days with the drug on hand divided by the total number of days in the follow-up period. Oral DMTs included dimethyl fumarate, diroximel fumarate, monomethyl fumarate, fingolimod, siponimod, ozanimod, ponesimod, teriflunomide, and cladribine. | Month 6, month 12 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |