Multiple Sclerosis
Conditions
Keywords
Persistence, Adherence, Real world data
Brief summary
This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria: * Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS). * Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT). * Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period. * Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).
Exclusion criteria
Patients will be excluded if they meet any of the following criteria: * Have inactive SPMS or primary progressive multiple sclerosis (PPMS). * Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Persistent With OMB | 6 months, 12 months | Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up). |
| Proportion of Patients Adherent to OMB | 6 months, 12 months | Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatments Used | Baseline, up to approximately 4 years | — |
| Number of Patients by Sequence of Treatments Used | Baseline, up to approximately 4 years | — |
| Number of Patients by Line of Therapy (LOT) | Baseline, up to approximately 4 years | — |
| Number of Patients by Type of Treatment | Baseline, up to approximately 4 years | — |
| Duration of Treatment | Baseline, up to approximately 4 years | — |
| Percentage of Patients Who Switch Treatment | Up to approximately 4 years | Percentage of patients who switch from OMB treatment to another DMT. |
| Percentage of Patients Who Discontinue OMB Treatment | Up to approximately 4 years | — |
| Number of Patients by Treatments Received After OMB Treatment | Up to approximately 4 years | — |
| Baseline Demographics | Baseline | — |
| Number of Patients by Index Year | Baseline | Index year is the year of index date. Index date is the date of first claim for OMB or DMT. |
| Charlson Comorbidity Index (CCI) Score | Baseline | CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2). |
| Number of Patients per Top 10 Comorbidities Observed During the Baseline Period | Baseline | — |
| Frequency of at least One All-cause and MS-specific Hospitalization During the Baseline Period | Baseline | — |
| Number of Hospitalizations Per Person Year | Baseline | RMS-specific and all-cause hospitalizations. |
| Number of Relapses Per Person Year | Baseline | — |
Countries
Switzerland
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed