Evidence map›Paper›PMID 37405689›Full record

Observational studyJournal of neurology2023

Effectiveness of teriflunomide on No Evidence of Disease Activity and cognition in relapsing remitting multiple sclerosis: results of the NEDA3PLUS study.

Maria Pia Amato, Roberto Bergamaschi, Diego Centonze, Massimiliano Mirabella, Girolama Alessandra Marfia, Rocco Totaro, Giacomo Lus, Vincenzo Brescia Morra, Umberto Aguglia, Cristoforo Comi and 21 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Observational
  3. Observational
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

31 authors at 19 institutions in 1 country.

Maria Pia AmatoDepartment of NEUROFARBA, Section of Neurosciences, University of Florence, Florence, Italy.
Roberto BergamaschiIRCCS Mondino Foundation, Pavia, Italy.
Diego CentonzeUnit of Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli, Italy.
Massimiliano MirabellaFondazione Policlinico Universitario 'Agostino Gemelli' IRCCS, Neurology Unit, Rome, Italy.
Girolama Alessandra MarfiaMultiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Rocco TotaroDemyelinating Disease Center, San Salvatore Hospital, L'Aquila, Italy.
Giacomo LusDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.
Vincenzo Brescia MorraDepartment of Neuroscience, Reproductive Science and Odontostomatology, University Federico II, Multiple Sclerosis Clinical Care and Research Centre, Naples, Italy.
Umberto AgugliaDepartment of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy.
Cristoforo ComiDepartment of Translational Medicine and Interdisciplinary Research Center of Autoimmune Diseases, University of Piemonte Orientale, Novara, Italy.
Paola CavallaDepartment of Neuroscience and Mental Health, City of Health and Science University Hospital of Turin, Multiple Sclerosis Center, Turin, Italy.
Mauro ZaffaroniASST della Valle Olona, Hospital of Gallarate, Neuroimmunology Unit, Gallarate, Italy.
Marco RovarisIRCCS Fondazione Don Carlo Gnocchi Onlus, Multiple Sclerosis Center, Milan, Italy.
Luigi Maria GrimaldiFoundation Institute "G. Giglio", MS Center, Cefalù-Palermo, Italy.
Stefania LeoniUnit of Clinical Neurology, AOU Sassari, Sassari, Italy.
Simona MalucchiUniversity Hospital San Luigi Gonzaga, SCDO Neurologia-CRESM, Orbassano, Turin, Italy.
Eleonora BaldiDepartment of Neuroscience and Rehabilitation, S. Anna Hospital, Multiple Sclerosis Center, Ferrara, Italy.
Marcello RomanoNeurology and Stroke Unit, Villa Sofia Cervello Hospital, Palermo, Italy.
Mario FalciniSanto Stefano Hospital, Neurology Unit, Prato, Italy.
Paola PeriniUniversity Hospital of Padua, Multiple Sclerosis Centre of the Veneto Region (CeSMuV), Padua, Italy.
Maurizio AssettaDepartment of Neurology, 'G. Mazzini' Hospital, Teramo, Italy.
Emilio PortaccioDepartment of NEUROFARBA, Section of Neurosciences, University of Florence, Florence, Italy.
Sergio SommacalMedical Department, Sanofi, Milan, Italy.
Nunzio OlivieriMedical Department, Sanofi, Milan, Italy.
Franco ParodiMedical Department, Sanofi, Milan, Italy.
Daniele Santo TodaroMedical Department, Sanofi, Milan, Italy.
Nicoletta GrassivaroMedical Department, Sanofi, Milan, Italy.
Alberto FarinaMedical Department, Sanofi, Milan, Italy.ORCID http://orcid.org/0000-0003-1896-1179
Margaret Mary MondinoMedical Department, Sanofi, Milan, Italy.
Massimo FilippiIRCCS San Raffaele Scientific Institute, Neurology Unit, Milan, Italy.
Maria TrojanoSchool of Medicine, University "Aldo Moro" of Bari, Bari, Italy. maria.troiano@uniba.it.
Sanofi (Italy) · ITDon Carlo Gnocchi Foundation · ITAzienda Ospedaliera Sant’Antonio Abate di Gallarate · ITAzienda Ospedaliero Universitaria di Sassari · ITFondazione Istituto G. Giglio di Cefalù · ITHospital of Prato · ITIstituto Neurologico Mediterraneo · ITMagna Graecia University · ITOspedale San Luigi Gonzaga · ITOspedale Sant'Anna · ITOspedale Vincenzo Cervello · ITSan Salvatore Hospital · ITUniversità Cattolica del Sacro Cuore · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity of Bari Aldo Moro · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Florence · ITUniversity of Rome Tor Vergata · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCognitive impairment (CI) is a prevalent and debilitating manifestation of multiple sclerosis (MS); however, it is not included in the widely used concept of No Evidence of Disease Activity (NEDA-3). We expanded the NEDA-3 concept to NEDA-3 + by encompassing CI assessed through the Symbol Digit Modality Test (SDMT) and evaluated the effect of teriflunomide on NEDA3 + in patients treated in a real-world setting. The value of NEDA-3 + in predicting disability progression was also assessed.

methodsThis 96-weeks observational study enrolled patients already on treatment with teriflunomide for ≥ 24 weeks. The predictiveness of NEDA-3 and NEDA-3 + at 48 weeks on the change in motor disability at 96 weeks was compared through a two-sided McNemar test.

resultsThe full analysis set (n = 128; 38% treatment naïve) featured relatively low level of disability (baseline EDSS = 1.97 ± 1.33). NEDA-3 and NEDA-3 + statuses were achieved by 82.8% and 64.8% of patients, respectively at 48 weeks vs. baseline, and by 57.0% and 49.2% of patients, respectively at 96 weeks vs. baseline. All patients except one were free of disability progression at Week 96, and NEDA-3 and NEDA-3 + were equally predictive. Most patients were free of relapse (87.5%), disability progression (94.5%) and new MRI activity (67.2%) comparing 96 weeks with baseline. SDMT scores were stable in patients with baseline score ˃35 and improved significantly in those with baseline score ≤ 35. Treatment persistence was high (81.0% at Week 96).

conclusionTeriflunomide confirmed its real-world efficacy and was found to have a potentially beneficial effect on cognition.

Indexed as

Motor DisordersMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingPersons with DisabilitiesCognitionCrotonatesHumansHydroxybutyratesNitrilesToluidinesCrotonatesHydroxybutyratesNitrilesteriflunomideToluidinesCognitionMultiple sclerosisNo Evidence of Disease ActivityObservationalTeriflunomide

Identifiers

PMID37405689
PMCPMC10511573
OpenAlexW4383186184

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.