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Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis
by
Olsson, Tomas P
, Freedman, Mark S
, Wolinsky, Jerry S
, D’Castro, Laura
, O’Connor, Paul
, Miller, Aaron E
, Confavreux, Christian
, Wang, Lin
, Truffinet, Philippe
, Kappos, Ludwig
, Comi, Giancarlo
in
Adult
/ Anti-Inflammatory Agents - administration & dosage
/ Anti-Inflammatory Agents - adverse effects
/ Biological and medical sciences
/ Canada
/ Crotonates - administration & dosage
/ Crotonates - adverse effects
/ Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
/ Disability Evaluation
/ Disease Progression
/ Double-Blind Method
/ Europe
/ Humans
/ Kaplan-Meier Estimate
/ Magnetic Resonance Imaging
/ Medical sciences
/ Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
/ Multiple Sclerosis, Relapsing-Remitting - diagnosis
/ Multiple Sclerosis, Relapsing-Remitting - drug therapy
/ Neurology
/ Predictive Value of Tests
/ Proportional Hazards Models
/ Research Papers
/ Time Factors
/ Toluidines - administration & dosage
/ Toluidines - adverse effects
/ Treatment Outcome
/ United States
2012
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Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis
by
Olsson, Tomas P
, Freedman, Mark S
, Wolinsky, Jerry S
, D’Castro, Laura
, O’Connor, Paul
, Miller, Aaron E
, Confavreux, Christian
, Wang, Lin
, Truffinet, Philippe
, Kappos, Ludwig
, Comi, Giancarlo
in
Adult
/ Anti-Inflammatory Agents - administration & dosage
/ Anti-Inflammatory Agents - adverse effects
/ Biological and medical sciences
/ Canada
/ Crotonates - administration & dosage
/ Crotonates - adverse effects
/ Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
/ Disability Evaluation
/ Disease Progression
/ Double-Blind Method
/ Europe
/ Humans
/ Kaplan-Meier Estimate
/ Magnetic Resonance Imaging
/ Medical sciences
/ Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
/ Multiple Sclerosis, Relapsing-Remitting - diagnosis
/ Multiple Sclerosis, Relapsing-Remitting - drug therapy
/ Neurology
/ Predictive Value of Tests
/ Proportional Hazards Models
/ Research Papers
/ Time Factors
/ Toluidines - administration & dosage
/ Toluidines - adverse effects
/ Treatment Outcome
/ United States
2012
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Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis
by
Olsson, Tomas P
, Freedman, Mark S
, Wolinsky, Jerry S
, D’Castro, Laura
, O’Connor, Paul
, Miller, Aaron E
, Confavreux, Christian
, Wang, Lin
, Truffinet, Philippe
, Kappos, Ludwig
, Comi, Giancarlo
in
Adult
/ Anti-Inflammatory Agents - administration & dosage
/ Anti-Inflammatory Agents - adverse effects
/ Biological and medical sciences
/ Canada
/ Crotonates - administration & dosage
/ Crotonates - adverse effects
/ Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
/ Disability Evaluation
/ Disease Progression
/ Double-Blind Method
/ Europe
/ Humans
/ Kaplan-Meier Estimate
/ Magnetic Resonance Imaging
/ Medical sciences
/ Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
/ Multiple Sclerosis, Relapsing-Remitting - diagnosis
/ Multiple Sclerosis, Relapsing-Remitting - drug therapy
/ Neurology
/ Predictive Value of Tests
/ Proportional Hazards Models
/ Research Papers
/ Time Factors
/ Toluidines - administration & dosage
/ Toluidines - adverse effects
/ Treatment Outcome
/ United States
2012
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Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis
Journal Article
Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis
2012
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Overview
Background:
The Teriflunomide Multiple Sclerosis Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled phase III study, demonstrated that teriflunomide significantly reduced annualized relapse rate (ARR), disease progression and magnetic resonance imaging (MRI) activity, with a favorable safety profile in relapsing multiple sclerosis (RMS) patients.
Objective:
The purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.
Methods:
RMS patients (n=1088) were randomized to placebo or teriflunomide, 7 mg or 14 mg, once daily, for 108 weeks. Subgroup analyses were performed for ARR and disability progression by baseline demographics (gender, race, age), disease characteristics (Expanded Disability Status Scale (EDSS) strata, relapse history, multiple sclerosis (MS) subtype), MRI parameters (gadolinium-enhancing lesions, total lesion volume) and prior use of MS drugs. A generalized estimating equation method and Cox regression model were used to assess consistency of the treatment effect across subgroups, utilizing a treatment-by-subgroup interaction test for each factor separately.
Results:
Reductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.
Conclusion:
The positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.
Publisher
SAGE Publications,Sage Publications,Sage Publications Ltd
Subject
/ Anti-Inflammatory Agents - administration & dosage
/ Anti-Inflammatory Agents - adverse effects
/ Biological and medical sciences
/ Canada
/ Crotonates - administration & dosage
/ Crotonates - adverse effects
/ Europe
/ Humans
/ Multiple Sclerosis, Relapsing-Remitting - diagnosis
/ Multiple Sclerosis, Relapsing-Remitting - drug therapy
/ Toluidines - administration & dosage
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