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.
Study Type
OBSERVATIONAL
Enrollment
5,448
Novartis
East Hanover, New Jersey, United States
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.
Time frame: Month 6, 12, 18, 24, 30, and 36
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.
Time frame: Baseline
Number of Patients per Clinical History Characteristic
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 years
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