Teriflunomide Tecfidera LMCE

Study Overview
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Brief Summary
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This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)

Official Title
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Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study

Conditions
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Tecfidera, Teriflunomide

Intervention / Treatment
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* Drug: Dimethyl Fumarate
* Drug: Teriflunomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with MS according to McDonald criteria Age 18-65 years Relapsing disease course Expanded Disability Status Scale (EDSS) score of ≤ 5.5 MRI obtained at baseline (medication start date), 12 months, and 24 months Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label Clinical information available over the 24 month follow-up None of the exclusion criteria Exclusion Criteria: Diagnosis of non-relapsing MS Use of experimental drug or investigational procedure during the study period Pregnancy during study period Severe hepatic impairment Relapse within 30 days prior to any of the 3 MRIs Corticosteroid use within 30 days prior to the MRIs Teriflunomide patients who have used leflunomide Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aubagio<br>Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio). | Drug: Teriflunomide<br>* Individuals with MS treated with teriflunomide (Aubagio)<br>* Other names: Aubagio;|
| Tecfidera<br>Individuals diagnosed with multiple sclerosis (MS) who have been treated with dimethyl fumarate (Tecfidera) and matched with the teriflunomide (Aubagio) patients on age, sex, disease duration, and disability level | Drug: Dimethyl Fumarate<br>* Individuals with MS treated with dimethyl fumarate (Tecfidera)<br>* Other names: Tecfidera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in CGM between teriflunomide and dimethyl fumarate | Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate | 24 months | 
| LM CE lesions at 24 months | Frequency of leptomeningeal (LM) lesions as measured by presence (number) of LM contrast enhancing (CE) lesions foci on three-dimensional fluid-attenuated-inversion recovery (3D_FLAIR) MRI performed 10 minutes post-contrast injection between those on teriflunomide and dimethyl fumarate | 24 months | 
| CGM atrophy and LM inflammation | Association between the development of CGM atrophy and LM inflammation | 24 months |