Contributions
Abstract: EP1492
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: RIS subjects present MRI features highly typical for multiple sclerosis (MS) without clinical symptomatology suggestive of CNS demyelination. These subjects are frequently exposed to treatment despite the lack of scientific evidence supporting DMT use. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from central nervous system (CNS) demyelination and reduce new radiological activity. Early treatment may also result in more profound effects on reducing disability progression long-term.
Objective: The objective of this upcoming investigation is to prospectively study the efficacy of teriflunomide 14mg/day (Aubagio®) in extending the time to a seminal acute or progressive demyelinating event in a cohort of European and Turkish radiologically isolated syndrome (RIS) subjects.
Methods: This multi-center, randomized (1:1; placebo: Aubagio®), double-blinded 2-year trial will target 200 RIS subjects who fulfill 2009 RIS Criteria. The primary outcome measure will be the time to the first acute or progressive neurological event resulting from CNS demyelination. We will evaluate the time from randomization to the first demyelinating event (acute or initial symptom resulting in a progressive clinical course) utilizing Kaplan-Meier survival analyses. Log-rank tests will be used to compare survival data between groups at univariate analysis. Secondary outcome measures will include the change in the number of new or enlarging T2 lesions, contrast enhancing lesions, T2-lesion volumes, and brain atrophy at 2-years. Environmental exposure, cognitive function, and patient reported outcome data will be captured in addition to biological samples for future mechanistic studies.
Results: Enrollment will begin in November 2016.
Conclusions: This study aims to explore an important initiative of investigating the impact of early treatment intervention in subjects who fulfill radiological criteria of MS.
Disclosure:
Study Supported by: Nice Universitary Hospital (France) and Radiologically Isolated Syndrome Consortium
CLF received honoraria as consultant from Almirall, Merck, Novartis, Biogen, MEDDAY, Roche, Teva.
AS received Honoraria or consultation fees and/or travel and registration coverage for attending several national or international congresses or symposia, from Merck Serono, Biogen/Gen Pharma of Turkey, Novartis, Genzyme, Teva and Roche. Educational presentations at programmes & symposia prepared by Excemed internationally and at national meetings and symposia sponsored by Merck-Serono;. Novartis, Teva and Biogen/Gen Pharma of Turkey.
OK none
CA received personal compensation for scientific advisory boardsfor Genzyme and Biogen.
MPS has received personal compensation for consulting services andfor speaking activities from Genzyme, Merck, Teva, Synthon, Vertex,
Novartis and Biogen
DP received consulting honoraria from Biogen, Sanofi-Genzyme, Novartis, EMD-Serono, Vertex, and Roche.
DO received lecture fees from Acorda Therapeutics, Genzyme, and TEVANeuroscience, consulting and advisory board fees from EMD Serono,Genentech, Genzyme,Novartis and TEVA Neuroscience, and research support from Biogen.
Abstract: EP1492
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: RIS subjects present MRI features highly typical for multiple sclerosis (MS) without clinical symptomatology suggestive of CNS demyelination. These subjects are frequently exposed to treatment despite the lack of scientific evidence supporting DMT use. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from central nervous system (CNS) demyelination and reduce new radiological activity. Early treatment may also result in more profound effects on reducing disability progression long-term.
Objective: The objective of this upcoming investigation is to prospectively study the efficacy of teriflunomide 14mg/day (Aubagio®) in extending the time to a seminal acute or progressive demyelinating event in a cohort of European and Turkish radiologically isolated syndrome (RIS) subjects.
Methods: This multi-center, randomized (1:1; placebo: Aubagio®), double-blinded 2-year trial will target 200 RIS subjects who fulfill 2009 RIS Criteria. The primary outcome measure will be the time to the first acute or progressive neurological event resulting from CNS demyelination. We will evaluate the time from randomization to the first demyelinating event (acute or initial symptom resulting in a progressive clinical course) utilizing Kaplan-Meier survival analyses. Log-rank tests will be used to compare survival data between groups at univariate analysis. Secondary outcome measures will include the change in the number of new or enlarging T2 lesions, contrast enhancing lesions, T2-lesion volumes, and brain atrophy at 2-years. Environmental exposure, cognitive function, and patient reported outcome data will be captured in addition to biological samples for future mechanistic studies.
Results: Enrollment will begin in November 2016.
Conclusions: This study aims to explore an important initiative of investigating the impact of early treatment intervention in subjects who fulfill radiological criteria of MS.
Disclosure:
Study Supported by: Nice Universitary Hospital (France) and Radiologically Isolated Syndrome Consortium
CLF received honoraria as consultant from Almirall, Merck, Novartis, Biogen, MEDDAY, Roche, Teva.
AS received Honoraria or consultation fees and/or travel and registration coverage for attending several national or international congresses or symposia, from Merck Serono, Biogen/Gen Pharma of Turkey, Novartis, Genzyme, Teva and Roche. Educational presentations at programmes & symposia prepared by Excemed internationally and at national meetings and symposia sponsored by Merck-Serono;. Novartis, Teva and Biogen/Gen Pharma of Turkey.
OK none
CA received personal compensation for scientific advisory boardsfor Genzyme and Biogen.
MPS has received personal compensation for consulting services andfor speaking activities from Genzyme, Merck, Teva, Synthon, Vertex,
Novartis and Biogen
DP received consulting honoraria from Biogen, Sanofi-Genzyme, Novartis, EMD-Serono, Vertex, and Roche.
DO received lecture fees from Acorda Therapeutics, Genzyme, and TEVANeuroscience, consulting and advisory board fees from EMD Serono,Genentech, Genzyme,Novartis and TEVA Neuroscience, and research support from Biogen.