Multiple Sclerosis
Conditions
Keywords
Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Time Between Prior DMT and Initiating OMB Treatment | Baseline | — |
| Number of Patients by Most Recent Prior DMT | Baseline | Most recent previous DMTs (in the last 6 months) included high efficacy and medium/low efficacy DMTs. |
| Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation | Baseline | — |
| Age | Baseline | — |
| Number of Patients per Demographic Category | Baseline | Demographics included: * Gender * Race * Ethnicity |
| Mean Duration of Disease | Baseline | — |
| Number of Patients by Most Recent Disease Course | Baseline | 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). |
| Number of Patients by Patient Determined Disease Steps (PDDS) Score | Baseline, Month 6, Month 12 | 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. |
| Number of Patients Categorized by Comorbidity | Baseline | — |
| Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs) | Baseline | — |
| Number of Patients by Number of New Brain T2 Lesions | Baseline, Month 6, Month 12 | — |
| Number of Patients who Switched From a DMT to OMB | Baseline | — |
| 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 | From Baseline up to Month 6 and Month 12 | 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. |
| Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment | From Baseline up to Month 6 and Month 12 | 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). |
| Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment | From Baseline up to Month 6 and Month 12 | 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. |
| Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment | From Baseline up to Month 6 and Month 12 | 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. |
| Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment | Month 6 and Month 12 | 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). |
| Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment | Month 6 and Month 12 | 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. |
| Number of Prior DMTs | Baseline | — |
| Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions | Baseline, Month 6, Month 12 | — |
Countries
United States
Outcome results
None listed