Evidence map›Paper›PMID 34003862›Full record

ArticlePloS one2021

Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry.

Viktoria Papp, Mathias Due Buron, Volkert Siersma, Peter Vestergaard Rasmussen, Zsolt Illes, Matthias Kant, Claudia Hilt, Zsolt Mezei, Homayoun Roshanisefat, Tobias Sejbæk and 6 more

Abstract read
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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

11 citing papers in PubMed.

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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

16 authors.

Viktoria PappOdense University Hospital, Odense, Denmark.ORCID 0000-0001-9968-549X
Mathias Due BuronThe Danish Multiple Sclerosis Registry, University Hospital Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Volkert SiersmaThe Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Peter Vestergaard RasmussenAarhus University Hospital, Aarhus, Denmark.
Zsolt IllesOdense University Hospital, Odense, Denmark.
Matthias KantHospital of Southern Jutland, Sønderborg, Denmark.
Claudia HiltAalborg University Hospital, Aalborg, Denmark.
Zsolt MezeiAalborg University Hospital, Aalborg, Denmark.
Homayoun RoshanisefatSlagelse/Odense University Hospital, Odense, Denmark.ORCID 0000-0002-3019-8826
Tobias SejbækDepartment of Neurology, Hospital of South West Jutland, Esbjerg, Denmark.ORCID 0000-0002-7682-2188
Arkadiusz WeglewskiCopenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark.
Janneke van WingerdenSanofi, Amsterdam, The Netherlands.
Svend Sparre GeertsenSanofi, Copenhagen, Denmark.ORCID 0000-0003-4497-3616
Stephan BramowDanish Multiple Sclerosis Center, University Hospital Copenhagen, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-9482-1771
Finn SellebjergDanish Multiple Sclerosis Center, University Hospital Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Melinda MagyariThe Danish Multiple Sclerosis Registry, University Hospital Copenhagen, Rigshospitalet, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTeriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Sclerosis Registry (DMSR) who started teriflunomide treatment between 2013-2019.

methodsThis was a complete nationwide population-based cohort study with prospectively enrolled unselected cases. Demographic and disease-specific patient parameters related to treatment history, efficacy outcomes, and discontinuation and switching rates among other clinical variables were assessed at baseline and during follow-up visits.

resultsA total of 3239 patients (65.4% female) started treatment with teriflunomide during the study period, 56% of whom were treatment-naïve. Compared to previously treated patients, treatment-naïve patients were older on average at disease onset, had a shorter disease duration, a lower Expanded Disability Status Scale score at teriflunomide treatment start and more frequently experienced a relapse in the 12 months prior to teriflunomide initiation. In the 3001 patients initiating teriflunomide treatment at least 12 months before the cut-off date, 72.7% were still on treatment one year after treatment start. Discontinuations in the first year were due mainly to adverse events (15.6%). Over the full follow-up period, 47.5% of patients discontinued teriflunomide treatment. Sixty-three percent of the patients treated with teriflunomide for 5 years were relapse-free, while significantly more treatment-naïve versus previously treated patients experienced a relapse during the follow-up (p<0.0001). Furthermore, 85% of the patients with available data were free of disability worsening at the end of follow-up.

conclusionsSolid efficacy and treatment persistence data consistent with other real-world studies were obtained over the treatment period. Treatment outcomes in this real-world scenario of the population-based cohort support previous findings that teriflunomide is an effective and generally well-tolerated DMT for relapsing MS patients with mild to moderate disease activity.

Indexed as

AdultCohort StudiesCrotonatesDenmarkFemaleHumansHydroxybutyratesImmunosuppressive AgentsMaleMiddle AgedMultiple SclerosisNitrilesRegistriesToluidinesTreatment OutcomeCrotonatesHydroxybutyratesImmunosuppressive AgentsNitrilesteriflunomideToluidines

Identifiers

PMID34003862
PMCPMC8130956

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Registered trials

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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.