Multiple Sclerosis
Conditions
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.'
Interventions
None listed
Sponsors
Novartis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with 1 claim or more for ofatumumab, a newly initiated oral DMT (dimethyl fumarate, fingolimod, teriflunomide, cladribine, siponimod, ozanimod, diroximel fumarate, monomethyl fumarate, ponesimod) or a newly initiated self-injectable DMT (daclizumab, glatiramer acetate, interferon beta-1a, peginterferon beta-1a, interferon beta-1b) occurring during the index window. * Patients with 12 months or more of pre-index continuous enrollment \[CE\] with medical and pharmacy benefits. * Patients with 6 months or more of post-index CE with medical and pharmacy benefits. * Patients with 2 or more non-ancillary outpatient medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\] code: G35) in any position or 1 or more inpatient claims with a diagnosis of MS in the first position during pre-index period. * No data quality issues (defined as missing age or sex). * Having two DMTs on the same day was very rare in MS patients per clinician's inputs, but if it happened, those patients were excluded from analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Persistent on Ofatumumab and Oral Disease-Modifying Therapies (DMTs) | Month 6, month 12 | 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. |
| Number of Patients Adherent on Ofatumumab and Oral DMTs | Month 6, month 12 | 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. |
Countries
United States
Outcome results
None listed