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 Type
OBSERVATIONAL
Enrollment
175
Novartis
East Hanover, New Jersey, United States
Number of Patients Categorized by Number of Relapses
Time frame: Baseline, Month 6, Month 12
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Time frame: From Baseline up to Month 6 and Month 12
Age
Time frame: Baseline
Number of Patients per Demographic Category
Demographics included: * Gender * Race * Ethnicity
Time frame: Baseline
Mean Duration of Disease
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Month 6, Month 12
Number of Patients Categorized by Comorbidity
Time frame: Baseline
Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)
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Time frame: Baseline
Number of Prior DMTs
Time frame: Baseline
Number of Patients who Switched From a DMT to OMB
Time frame: Baseline
Duration of Time Between Prior DMT and Initiating OMB Treatment
Time frame: 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.
Time frame: Baseline
Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation
Time frame: Baseline
Number of Patients by Number of New Brain T2 Lesions
Time frame: Baseline, Month 6, Month 12
Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Month 6 and Month 12