Evidence map›Paper›PMID 28828394›Full record

ArticleNeurology(R) neuroimmunology & neuroinflammation2017

Teriflunomide slows BVL in relapsing MS: A reanalysis of the TEMSO MRI data set using SIENA.

Ernst-Wilhelm Radue, Till Sprenger, Laura Gaetano, Nicole Mueller-Lenke, Steve Cavalier, Karthinathan Thangavelu, Michael A Panzara, Jessica E Donaldson, Fiona M Woodward, Jens Wuerfel and 2 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology(R) neuroimmunology & neuroinflammation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00134563 (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses), which is not on this map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 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.

NCT00134563 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

TypeinterventionalSponsorSanofiRan2004 to 2010Enrolled1,088ConditionsMultiple SclerosisArmsTeriflunomide, Placebo (for teriflunomide)
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  18. Smouldering multiple sclerosis: the 'real MS'.Therapeutic advances in neurological disorders · 2022
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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.

Ernst-Wilhelm RadueMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Till SprengerMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Laura GaetanoMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Nicole Mueller-LenkeMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Steve CavalierMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Karthinathan ThangaveluMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Michael A PanzaraMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Jessica E DonaldsonMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Fiona M WoodwardMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Jens WuerfelMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Jerry S WolinskyMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.
Ludwig KapposMedical Image Analysis Center (MIAC AG) (E.-W.R., L.G., N.M.-L., J.W.), Basel, Switzerland; DKD HELIOS Klinik (T.S.), Wiesbaden, Germany; Neurologic Clinic and Policlinic (T.S., L.G., L.K.), University Hospital Basel and University of Basel, Switzerland; Sanofi Genzyme (S.C., K.T.), Previously Sanofi Genzyme (M.A.P.), and WAVE Life Sciences (M.A.P.), Cambridge, MA; Fishawack Communications Ltd (J.E.D., F.M.W.), Abingdon, Oxfordshire, UK; and McGovern Medical School (J.S.W.), UTHealth, Houston, TX.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess, using structural image evaluation using normalization of atrophy (SIENA), the effect of teriflunomide, a once-daily oral immunomodulator, on brain volume loss (BVL) in patients with relapsing forms of MS enrolled in the phase 3 TEMSO study.

methodsTEMSO MR scans were analyzed (study personnel masked to treatment allocation) using SIENA to assess brain volume changes between baseline and years 1 and 2 in patients treated with placebo or teriflunomide. Treatment group comparisons were made via rank analysis of covariance.

resultsData from 969 patient MRI visits were included in this analysis: 808 patients had baseline and year 1 MRI; 709 patients had baseline and year 2 MRI. Median percentage BVL from baseline to year 1 and year 2 for placebo was 0.61% and 1.29%, respectively, and for teriflunomide 14 mg, 0.39% and 0.90%, respectively. BVL was lower for teriflunomide 14 mg vs placebo at year 1 (36.9% relative reduction,

conclusionsThe significant reduction of BVL vs placebo over 2 years achieved with teriflunomide is consistent with its effects on delaying disability worsening and suggests a neuroprotective potential. CLASSIFICATION OF EVIDENCE: Class II evidence shows that teriflunomide treatment significantly reduces BVL over 2 years vs placebo. CLINICALTRIALSGOV IDENTIFIER: NCT00134563.

Identifiers

PMID28828394
PMCPMC5550381

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