Evidence map›Paper›PMID 33616742›Full record

ArticleJournal of neurology2021

Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study.

Sebastiano Bucello, Pietro Annovazzi, Paolo Ragonese, Marta Altieri, Valeria Barcella, Roberto Bergamaschi, Alessia Bianchi, Giovanna Borriello, Maria Chiara Buscarinu, Graziella Callari and 30 more

Abstract read
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In one paragraph

Article in Journal of neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Dimethyl Fumarate or Teriflunomide for Relapsing-Remitting Multiple Sclerosis: A Meta-analysis of Post-marketing Studies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Pooled it
  2. Article
  3. Article
  4. 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
  5. Article
  6. Observational
  7. Article
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  10. Article
  11. Article
  12. Article
  13. InjectableNeural regeneration research · 2022
    Article
  14. Article
  15. Article
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

40 authors at 20 institutions in 2 countries.

Sebastiano BucelloMultiple Sclerosis Centre, "E. Muscatello" Hospital - ASP8, Augusta, SR, Italy.
Pietro AnnovazziUOC Centro Sclerosi Multipla, Neurologia II ASST Valle Olona, PO di Gallarate (VA), Varese, Italy.
Paolo RagoneseDepartment of Biomedicine, Neurosciences and Advanced Diagnostics (BiND), University of Palermo, Palermo, Italy.
Marta AltieriMultiple Sclerosis Centre, Department of Human Neurosciences, Sapienza University, Rome, Italy.
Valeria BarcellaMultiple Sclerosis Centre, Department of Neurology, Papa Giovanni XXIII Hospital, Bergamo, Italy.
Roberto BergamaschiMultiple Sclerosis Research Centre, IRCCS Mondino Foundation, Pavia, Italy.
Alessia BianchiDepartment of Biomedicine, Neurosciences and Advanced Diagnostics (BiND), University of Palermo, Palermo, Italy.
Giovanna BorrielloMultiple Sclerosis Centre, S. Andrea Hospital, Sapienza University, Rome, Italy.
Maria Chiara BuscarinuCentre for Experimental Neurological Therapies, S. Andrea Hospital, Department of Mental Health and Sensory Organs, Sapienza University, Rome, Italy.
Graziella CallariInstitute Foundation "G. Giglio", Multiple Sclerosis Centre, Cefalù-Palermo, Italy.
Marco CapobiancoCentro di Riferimento Regionale Sclerosi Multipla (CReSM), SCDO Neurologia, AOU S. Luigi Gonzaga, Orbassano, TO, Italy.
Fioravante CaponeNeurology, Neurophysiology and Neurobiology Unit, Department of Medicine, Università Campus Bio-Medico, Rome, Italy.
Paola CavallaMultiple Sclerosis Centre, Department of Neurosciences, City of Health and Science University Hospital, Torino, Italy.
Rosella CavarrettaMultiple Sclerosis Centre, Scientific Institute S. Maria Nascente, Don Carlo Gnocchi Foundation, Milan, Italy.
Antonio CorteseMultiple Sclerosis Centre, Department of Human Neurosciences, Sapienza University, Rome, Italy.
Giovanna De LucaMultiple Sclerosis Centre, Clinical Neurology Unit, SS. Annunziata University Hospital, Chieti, Italy.
Massimiliano Di FilippoMultiple Sclerosis Centre, Department of Medicine and Surgery, University Hospital, Perugia, Italy.
Vincenzo DattolaUOC Neurologia, G.O.M. "Bianchi Melacrino Morelli", Reggio Calabria, Italy.
Roberta FantozziIRCCS Istituto Neurologico Mediterraneo (INM) Neuromed, Pozzilli, IS, Italy.
Elisabetta FerraroMultiple Sclerosis Centre, S. Filippo Neri Hospital, Rome, Italy.
Maria Maddalena FilippiFatebenefratelli Foundation for Health Research and Education AFaR Division, Rome, Italy.
Claudio GasperiniMultiple Sclerosis Centre, Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.
Luigi Maria Edoardo GrimaldiInstitute Foundation "G. Giglio", Multiple Sclerosis Centre, Cefalù-Palermo, Italy.
Doriana LandiMultiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
Marianna Lo ReCentro di Riferimento Regionale Sclerosi Multipla (CReSM), SCDO Neurologia, AOU S. Luigi Gonzaga, Orbassano, TO, Italy.
Giulia MallucciMultiple Sclerosis Research Centre, IRCCS Mondino Foundation, Pavia, Italy.
Paolo ManganottiClinica Neurologica, Azienda Ospedaliero-Universitaria di Cattinara, Trieste, Italy.
Girolama Alessandra MarfiaIRCCS Istituto Neurologico Mediterraneo (INM) Neuromed, Pozzilli, IS, Italy.
Massimiliano MirabellaCentro Sclerosi Multipla, Fondazione Policlinico Universitario "A. Gemelli" IRCCS Università Cattolica del Sacro Cuore, Rome, Italy.
Paola PeriniClinica Neurologica, Centro Sclerosi Multipla, Azienda Ospedaliera di Padova, Padova, Italy.
Marco PisaUnit of Neurology, Unit of Neurorehabilitation and Neurophysiology Service, IRCCS San Raffaele Institute, Milan, Italy.
Sabrina RealmutoMultiple Sclerosis Centre, Neurology Unit and Stroke Unit, AOOR "Villa Sofia-Cervello", Palermo, Italy.
Margherita RussoCentro Sclerosi Multipla, IRCCS Neurolesi "Bonino-Pulejo", Messina, Italy.
Valentina TomassiniMultiple Sclerosis Centre, Clinical Neurology Unit, SS. Annunziata University Hospital, Chieti, Italy.
Valentina Liliana Adriana Torri-ClericiCentro Sclerosi Multipla, UO Neuroimmunologia e Malattie Neuromuscolari, Fondazione IRCCS Ist. Neurologico C. Besta, Milan, Italy.
Mauro ZaffaroniUOC Centro Sclerosi Multipla, Neurologia II ASST Valle Olona, PO di Gallarate (VA), Varese, Italy.
Cristina ZulianiUOC di Neurologia, Ospedale di Mirano (VE), Mirano, Italy.
Sofia ZywickiClinica Neurologica, Centro Sclerosi Multipla, Azienda Ospedaliera di Padova, Padova, Italy.
Massimo FilippiUnit of Neurology, Unit of Neurorehabilitation and Neurophysiology Service, IRCCS San Raffaele Institute, Milan, Italy.
Luca ProsperiniMultiple Sclerosis Centre, Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy. luca.prosperini@gmail.com.ORCID http://orcid.org/0000-0003-3237-6267
Vita-Salute San Raffaele University · ITAssociazione Italiana Sclerosi Multipla · ITAzienda Ospedale - Università Padova · ITFondazione Istituto G. Giglio di Cefalù · ITOspedale San Filippo Neri · ITOspedale San Luigi Gonzaga · ITUniversity of Palermo · ITUniversity of Rome Tor Vergata · ITAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITAzienda Ospedaliera Sant'Andrea · ITCarlo Forlanini Hospital · ITCentro Neurolesi Bonino Pulejo · ITDon Carlo Gnocchi Foundation · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Neurologico Mediterraneo · ITNini Hospital · LBOspedale di Cattinara · ITOspedale di Mirano · ITOspedale Papa Giovanni XXIII · ITOspedale Vincenzo Cervello · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo identify baseline factors associated with disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) under teriflunomide treatment.

methodsThis was an independent, multi-centre, retrospective post-marketing study. We analysed data of 1,507 patients who started teriflunomide since October 2014 and were regularly followed in 28 Centres in Italy. We reported the proportions of patients who discontinued treatment (after excluding 32 lost to follow-up) and who experienced clinical disease activity, i.e., relapse(s) and/or confirmed disability worsening, as assessed by the Expanded Disability Status Scale (EDSS). Decision tree-based analysis was performed to identify baseline factors associated with clinical disease activity during teriflunomide treatment.

resultsAt database lock (September 2020), approximately 29% of patients (430 out of 1,475) discontinued teriflunomide because of disease activity (~ 46%), adverse events (~ 37%), poor tolerability (~ 15%), pregnancy planning (~ 2%). Approximately 28% of patients experienced disease activity over a median follow-up of 2.75 years: ~ 9% had relapses but not disability worsening; ~ 13% had isolated disability worsening; ~ 6% had both relapses and disability worsening. The most important baseline factor associated with disease activity (especially disability worsening) was an EDSS > 4.0 (p < 0.001). In patients with moderate disability level (EDSS 2.0-4.0), disease activity occurred more frequently in case of ≥ 1 pre-treatment relapses (p = 0.025). In patients with milder disability level (EDSS < 2.0), disease activity occurred more frequently after previous exposure to ≥ 2 disease-modifying treatments (p = 0.007).

conclusionsOur study suggests a place-in-therapy for teriflunomide in naïve patients with mild disability level or in those who switched their initial treatment for poor tolerability. Adverse events related with teriflunomide were consistent with literature data, without any new safety concern.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingCrotonatesHumansHydroxybutyratesItalyNitrilesRetrospective StudiesToluidinesCrotonatesHydroxybutyratesNitrilesteriflunomideToluidinesMultiple sclerosisOral drugsTeriflunomide

Identifiers

PMID33616742
OpenAlexW3130877213

What OpenQuestion holds

Textmetadata
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.