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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab Cohort | Adult patients with relapsing remitting multiple sclerosis (RRMS) who started treatment with ofatumumab, and were enrolled in the Kesimpta Go Program. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients who Discontinued Ofatumumab per Patient Characteristic | Patient characteristics included age group, gender, type of insurance, and experience (naive or experienced) of disease-modifying therapy (DMT) before starting ofatumumab. | Month 6, 12, 18, 24, 30, and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients per Demographic Category | Demographic categories included age, age group, gender, index year, and type of insurance. Index year was the year patients started their medication. | Baseline |
| Number of Patients per Clinical History Characteristic |
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Inclusion criteria:
Patients were included if they met all of the following criteria:
Exclusion criteria:
Patients were excluded if they met any of the criteria below:
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This was a retrospective, non-interventional 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41529661 | Derived | Selchen D, Grant R, Magnussen C, Murray J, Neish CS. A real-world study on persistence with ofatumumab in Canadian patients with multiple sclerosis. Mult Scler Relat Disord. 2026 Mar;107:106976. doi: 10.1016/j.msard.2026.106976. Epub 2026 Jan 6. |
| Label | URL |
|---|---|
| Results for COMB157GCA04 from the Novartis Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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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. |
| Baseline |
| Cox Proportional Hazard Ratio for the Association Between Discontinuation of Ofatumumab and Patient Characteristics | Patient characteristics included age group, gender, type of insurance, and type of last DMT used before starting ofatumumab. | Up to 3 years |
| Number of Patients by Reason for Discontinuation of Ofatumumab Treatment | 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. | Up to 3 years |
| Number of Patients by Reason for Leaving the Kesimpta Go Program | 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. | Up to 3 years |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |