Evidence map›Paper›PMID 22307384›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2012

Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years.

Christian Confavreux, David K Li, Mark S Freedman, Philippe Truffinet, Hadj Benzerdjeb, Dazhe Wang, Amit Bar-Or, Anthony L Traboulsee, Lucy E Reiman, Paul W O'Connor and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIComparative 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 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 pooled it
13.9field-weighted citation impact, top 1% of its field
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

59 citing papers in PubMed, 1 synthesis or guideline pooled it, 141 citations in OpenAlex.

  1. Teriflunomide for multiple sclerosis.The Cochrane database of systematic reviews · 2016
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  10. A comparative study of teriflunomide and dimethyl fumarate within the Swedish MS Registry.Multiple sclerosis (Houndmills, Basingstoke, England) · 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

11 authors at 7 institutions in 2 countries.

Christian ConfavreuxHôpital Neurologique, Université Claude Bernard Lyon 1, France. christian.confavreux@chu-lyon.fr
David K Li
Mark S Freedman
Philippe Truffinet
Hadj Benzerdjeb
Dazhe Wang
Amit Bar-Or
Anthony L Traboulsee
Lucy E Reiman
Paul W O'Connor
Teriflunomide Multiple Sclerosis Trial Group
Sanofi (France) · FRMcGill University · CAResearch Canada · CAUniversité Claude Bernard Lyon 1 · FRUniversity of British Columbia · CAUniversity of Ottawa · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTeriflunomide, an oral disease-modifying therapy in development for patients with relapsing forms of multiple sclerosis (RMS), was well tolerated and effective in reducing magnetic resonance imaging (MRI) lesions in 179 RMS patients in a phase 2 36-week, placebo-controlled study.

methodsA total of 147 patients who completed the core study entered an open-label extension. Teriflunomide patients continued their assigned dose, and placebo patients were re-allocated to teriflunomide, 7 mg/day or 14 mg/day. An interim analysis was performed at a cut-off on January 8 2010.

resultsThe mean and median duration of study treatment, including both the core and extension phase, from baseline to the interim cut-off, was 5.6 years (standard deviation: 2.7 years) and 7.1 years (range: 0.05-8.5 years), respectively. Of 147 patients, 62 (42.2%) discontinued (19% due to treatment-emergent adverse events (TEAEs)). The most common TEAEs were mild infections, fatigue, sensory disturbances and diarrhoea. No serious opportunistic infections occurred, with no discontinuations due to infection. Asymptomatic alanine aminotransferase increases (≤3× upper limit of normal (ULN)) were common (7 mg, 64.2%; 14 mg, 62.1%); increases >3×ULN were similar across groups (7 mg, 12.3%; 14 mg, 12.1%). Mild decreases in neutrophil counts occurred; none led to discontinuation. The incidence of malignancies was comparable to that of the general population, and cases were not reminiscent of those observed in immunocompromised patients. Annualised relapse rates remained low, minimal disability progression was observed, with a dose-dependent benefit with teriflunomide 14 mg for several MRI parameters.

conclusionTeriflunomide had a favourable safety profile for up to 8.5 years.

Indexed as

Administration, OralAdultCrotonatesDisability EvaluationDisease ProgressionDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansHydroxybutyratesImmunologic FactorsMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingNitrilesCrotonatesHydroxybutyratesImmunologic FactorsNitrilesteriflunomideToluidines

Identifiers

PMID22307384
PMCPMC3573681
OpenAlexW2131078277

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.