Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice

This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 175

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, noninterventional cohort study

Description

Inclusion criteria:

• Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
• Aged 18 years or older at index date, and
• Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
• Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.

Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ofatumumab Cohort; Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Patients Categorized by Number of Relapses	Baseline, Month 6, Month 12
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment	From Baseline up to Month 6 and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		Baseline
Number of Patients Categorized by Comorbidity		Baseline
Number of Patients per Demographic Category	Demographics included: Gender; Race; Ethnicity	Baseline
Mean Duration of Disease		Baseline
Number of Patients by Most Recent Disease Course	Most recent disease course (in the last 6 months) included relapsing-remitting MS (RRMS)/clinically isolated syndrome (CIS), secondary progressive MS (SPMS), and primary progressive MS (PPMS).	Baseline
Number of Patients by Patient Determined Disease Steps (PDDS) Score	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.	Baseline, Month 6, Month 12
Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)		Baseline
Number of Prior DMTs		Baseline
Number of Patients who Switched From a DMT to OMB		Baseline
Duration of Time Between Prior DMT and Initiating OMB Treatment		Baseline
Number of Patients by Most Recent Prior DMT	Most recent previous DMTs (in the last 6 months) included high efficacy and medium/low efficacy DMTs.	Baseline
Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation		Baseline
Number of Patients by Number of New Brain T2 Lesions		Baseline, Month 6, Month 12
Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions		Baseline, Month 6, Month 12
Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment		From Baseline up to Month 6 and Month 12
Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment		From Baseline up to Month 6 and Month 12
Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.	From Baseline up to Month 6 and Month 12
Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment	Neuro-performance measures included four assessments, cognitive assessment through the processing speed test (PST), upper extremity motor function through the manual dexterity test (MDT), lower extremity function through the walking speed test (WST), and vision assessment through the contrast sensitivity test (CST). PST and CST were scored based on the number of correct responses (with a higher score representing better performance), while MDT and WST were measured based on time to completion (with a lower score representing better performance).	From Baseline up to Month 6 and Month 12
Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment	When available, disability progression measures were calculated for patients. No evidence of disease activity (NEDA-2) status was defined and measured as the absence of clinical relapses and new/enlarging T2 and GdE lesions. NEDA-3 status was defined as components of NEDA-2 and absence of PDDS score worsening. NEDA-2 and NEDA-3 were only evaluated in patients who had all relevant parameters available for review.	From Baseline up to Month 6 and Month 12
Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.	From Baseline up to Month 6 and Month 12
Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment	Neuro-performance measures included four assessments, cognitive assessment through the processing speed test (PST), upper extremity motor function through the manual dexterity test (MDT), lower extremity function through the walking speed test (WST), and vision assessment through the contrast sensitivity test (CST). PST and CST were scored based on the number of correct responses (with a higher score representing better performance), while MDT and WST were measured based on time to completion (with a lower score representing better performance).	Month 6 and Month 12
Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.	Month 6 and Month 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Relapsing-remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Clinically Isolated Syndrome; Primary Progressive Multiple Sclerosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: COMB157GUS15