A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multiple Sclerosis Patients

Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 2604

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

Adult patients who had a first claim for either ofatumumab or ocrelizumab from August 20, 2020, with no claim for either drug during the preceding 12 months.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Pooled OMB Cohort; Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OMB from August 20, 2020.
Pooled OCR Cohort; Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OCR from August 20, 2020.
Treatment-naïve OMB Cohort; Adult MS patients who initiated OMB treatment and who did not use a DMT for MS treatment in the 12-month period before starting OMB.
Treatment-naïve OCR Cohort; Adult MS patients who initiated OCR treatment and who did not use a DMT for MS treatment in the 12-month period before starting OCR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Relapse Rate (ARR) in Treatment-Naïve Patients	ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period.	Up to approximately 3 years and 11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARR in All Patients	ARR was defined as the number of relapse episodes per PPY during the follow-up period.	Up to approximately 3 years and 11 months
Healthcare Visits PPY	Healthcare visits included IP stays, OP visits, and emergency department visits.	Up to approximately 3 years and 11 months
Inpatient Days PPY		Up to approximately 3 years and 11 months
Difference in Healthcare Costs in OMB Versus OCR	Healthcare costs included IP, OP, emergency department, and pharmacy costs.	Up to approximately 3 years and 11 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Link to study results

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ofatumumab; Multiple sclerosis; Comparative effectiveness; Ocrelizumab; Healthcare resource utilization; Real-world evidence; Annualized relapse rate; Anti-CD20 monoclonal antibody
• 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
• Other Study ID Numbers: COMB157GUS37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO