A Canadian Study of Persistence on Ofatumumab Using Patient Support Program Data (CAPES)

A Canadian Retrospective Analysis of Persistence on Ofatumumab Using Patient Support Program Data

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Study Type: Observational
• Enrollment (Actual): 5448

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ofatumumab Cohort; Adult patients with relapsing remitting multiple sclerosis (RRMS) who started treatment with ofatumumab, and were enrolled in the Kesimpta Go Program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for COMB157GCA04 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Actual): August 27, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ofatumumab; Persistence; Patient Support Program
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: COMB157GCA04