Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Anti-CD20 monoclonal antibody, Ofatumumab, Ocrelizumab, Real-world evidence, Comparative effectiveness, Annualized relapse rate, Healthcare resource utilization
Brief summary
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pooled OMB and OCR Cohorts: * ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date). * No claims for OMB or OCR within the 12 months prior to the index date. * ≥2 outpatient (OP) 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, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with a diagnosis of MS in the first position in the 12 months prior to or on index date. * ≥18 years of age on index date. * Continuous healthcare plan enrollment for ≥12 months prior to index date (baseline period) and ≥6 months after index date (follow-up period). * Persistent use of OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) for ≥6 months after index date. Treatment-naïve OMB and OCR Cohorts: * Included in Pooled OMB Cohort or Pooled OCR Cohort. * No claims for a disease modifying therapy (DMT) used for the treatment of MS within the 12-month baseline period.
Exclusion criteria
• None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate (ARR) in Treatment-Naïve Patients | Up to approximately 3 years and 11 months | ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARR in All Patients | Up to approximately 3 years and 11 months | ARR was defined as the number of relapse episodes per PPY during the follow-up period. |
| Healthcare Visits PPY | Up to approximately 3 years and 11 months | Healthcare visits included IP stays, OP visits, and emergency department visits. |
| Inpatient Days PPY | Up to approximately 3 years and 11 months | — |
| Difference in Healthcare Costs in OMB Versus OCR | Up to approximately 3 years and 11 months | Healthcare costs included IP, OP, emergency department, and pharmacy costs. |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed