Evidence map›Paper›PMID 22723573›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2012

Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis.

Aaron E Miller, Paul O'Connor, Jerry S Wolinsky, Christian Confavreux, Ludwig Kappos, Tomas P Olsson, Philippe Truffinet, Lin Wang, Laura D'Castro, Giancarlo Comi and 2 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Teriflunomide for multiple sclerosis.The Cochrane database of systematic reviews · 2016
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  11. Beyond relapses: How BTK inhibitors are shaping the future of progressive MS treatment.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Aaron E MillerMount Sinai School of Medicine, USA. aaron.miller@mssm.edu
Paul O'Connor
Jerry S Wolinsky
Christian Confavreux
Ludwig Kappos
Tomas P Olsson
Philippe Truffinet
Lin Wang
Laura D'Castro
Giancarlo Comi
Mark S Freedman
Teriflunomide Multiple Sclerosis Trial Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

objectiveThe purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.

methodsRMS 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.

resultsReductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.

conclusionThe positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.

Indexed as

AdultAnti-Inflammatory AgentsCanadaCrotonatesDisability EvaluationDisease ProgressionDouble-Blind MethodEuropeHumansHydroxybutyratesKaplan-Meier EstimateMagnetic Resonance ImagingMultiple Sclerosis, Relapsing-RemittingNitrilesPredictive Value of TestsProportional Hazards ModelsAnti-Inflammatory AgentsCrotonatesHydroxybutyratesNitrilesteriflunomideToluidines

Identifiers

PMID22723573
PMCPMC3573676

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.