Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Patient Support Program, Ofatumumab, Persistence
Brief summary
This was an observational, non-interventional, real world study involving secondary use of de-identified aggregate data from patients prescribed ofatumumab, collected by the Kesimpta Go Program in Canada. This study utilized a cohort design. The study period included all available data captured by the Kesimpta Go Program from program inception (April 2, 2021) to the time of data transfer (May 1, 2024). Patients were indexed into the study on the date they started their medication, from April 2, 2021 to May 1, 2024. The baseline period represented the period prior to ofatumumab treatment initiation. Baseline variables were collected from the enrollment form, which include demographic and clinical history, such as whether the patient had prior treatment with disease-modifying therapy (DMT). Patients were followed until the first of the following censoring events: ofatumumab discontinuation; end of the study period; or leaving the Kesimpta Go Program.
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
Patients were included if they met all of the following criteria: * Patients enrolled in the Kesimpta Go Program * Patients with documented informed consent from enrollment in the Kesimpta Go Program * Patients who started treatment with ofatumumab
Exclusion criteria
Patients were excluded if they met any of the criteria below: * Patients with no demographic information * Patients who could not be linked across the data sources required for analysis (Kesimpta Go Program Enrollment Form, Pharmacy Claims Forms, Kesimpta Go Program Database) * Patients with 3+ treatment interruptions (patient was on hold - i.e., not currently receiving the treatment in the patient support program)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic | Month 6, 12, 18, 24, 30, and 36 | Patient characteristics included age group, gender, type of insurance, and experience (naive or experienced) of disease-modifying therapy (DMT) before starting ofatumumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients per Demographic Category | Baseline | Demographic categories included age, age group, gender, index year, and type of insurance. Index year was the year patients started their medication. |
| Number of Patients per Clinical History Characteristic | Baseline | Clinical history characteristics included experience of disease-modifying therapy (DMT) before starting ofatumumab (naive or experienced) and the type of last DMT used before starting ofatumumab. |
| Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics | Up to 3 years | Patient characteristics included age group, gender, type of insurance, and type of last DMT used before starting ofatumumab. |
| Number of Patients by Reason for Discontinuation of Ofatumumab Treatment | Up to 3 years | Reasons for discontinuation included lack of efficacy, non-adherence, side effects, switched medications, trying to conceive/pregnancy, patient request, physician request, treatment interruption gap \>90 days. |
| Number of Patients by Reason for Leaving the Kesimpta Go Program | Up to 3 years | Reasons for leaving the Kesimpta Go program included could not contact participant, deceased, doesn't meet eligibility, patient moved, refused coverage, reimbursement issues, no reason given. |
Countries
United States
Outcome results
None listed