Evidence map›Paper›PMID 34377047›Full record

ArticleJournal of central nervous system disease2021

Efficacy and Safety of Teriflunomide in Multiple Sclerosis across Age Groups: Analysis from Pooled Pivotal and Real-world Studies.

Jiwon Oh, Sandra Vukusic, Klaus Tiel-Wilck, Jihad Said Inshasi, David Rog, Darren P Baker, Yelena Pyatkevich, Elizabeth M Poole, Patrick Vermersch

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Article in Journal of central nervous system disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

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4 · The record

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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

9 authors.

Jiwon OhSt. Michael's Hospital, University of Toronto, Toronto, ON, Canada.ORCID https://orcid.org/0000-0001-5519-6088
Sandra VukusicService de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-inflammation et Fondation Eugène Devic EDMUS Pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France.
Klaus Tiel-WilckNeurologisches Facharztzentrum Berlin, Berlin, Germany.
Jihad Said InshasiDubai Medical College, Dubai, United Arab Emirates.
David RogManchester Centre for Clinical Neurosciences, Salford, UK.
Darren P BakerSanofi, Cambridge, MA, USA.
Yelena PyatkevichSanofi, Cambridge, MA, USA.
Elizabeth M PooleSanofi, Cambridge, MA, USA.
Patrick VermerschUniversite de Lille, Inserm U1172, CHU Lille, FHU Precise, Lille, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence suggests that efficacy and safety of disease-modifying treatments for multiple sclerosis may differ with age. We evaluate efficacy and safety of teriflunomide across age subgroups of patients from pooled clinical trials and real-world studies.

methodsPost hoc analyses of patients who received teriflunomide 14 mg in the pooled phase II and III TEMSO, TOWER, TENERE, and TOPIC core and extension studies (n

resultsIn the pooled core studies, teriflunomide reduced annualized relapse rate (ARR) versus placebo across all ages. Unadjusted ARRs remained low across age groups in pooled extensions (0.18-0.30), Teri-PRO (0.10-0.35), and TAURUS-MS I (0.14-0.35). Baseline Expanded Disability Status Scale scores were higher with age, but stable through core and extension studies (mean increases over 7 years: ⩽25 years, +0.59; >25 to ⩽35 years, +0.46; >35 to ⩽45 years, +0.35; >45 years, +0.81). Across age groups, adverse event (AE) incidences were 78.4% to 90.7% in pooled core and extension studies and Teri-PRO, and 29.2% to 37.7% in TAURUS-MS I; serious AE incidences were ⩽21.3% in all studies. In pooled phase III and Teri-PRO studies, lymphocyte count decreases over 1 year after initiating teriflunomide, and proportions of patients developing lymphopenia, were small across age groups.

conclusionsTeriflunomide efficacy was demonstrated regardless of age. Safety was generally consistent across age groups.

Indexed as

central nervous systemdemyelinating diseasesMultiple sclerosis

Identifiers

PMID34377047
PMCPMC8330455

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