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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab Cohort | Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020). |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Baseline | |
| Number of Patients per Demographic Category | Demographics included:
| Baseline |
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Inclusion criteria:
Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 Categorized by Comorbidity | Baseline |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |