Evidence map›Paper›PMID 29938336›Full record

Trial reportJournal of neurology2018

The effect of fingolimod on focal and diffuse grey matter damage in active MS patients.

Albulena Bajrami, Marco Pitteri, Marco Castellaro, Francesca Pizzini, Chiara Romualdi, Stefania Montemezzi, Salvatore Monaco, Massimiliano Calabrese

Abstract readClinical Trial, Phase IVObservational Study
PubMed Publisher
In one paragraph

Trial report in Journal of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. 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

8 authors.

Albulena BajramiNeurology B, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico "G.B. Rossi" Borgo Roma, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.
Marco PitteriNeurology B, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico "G.B. Rossi" Borgo Roma, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.
Marco CastellaroNeurology B, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico "G.B. Rossi" Borgo Roma, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.
Francesca PizziniNeuroradiology and Radiology Units, Department of Diagnostic and Pathology, University Hospital of Verona, Verona, Italy.
Chiara RomualdiDepartment of Biology, University of Padova, Padua, Italy.
Stefania MontemezziNeuroradiology and Radiology Units, Department of Diagnostic and Pathology, University Hospital of Verona, Verona, Italy.
Salvatore MonacoNeurology B, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico "G.B. Rossi" Borgo Roma, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.
Massimiliano CalabreseNeurology B, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Policlinico "G.B. Rossi" Borgo Roma, Piazzale L.A. Scuro, 10, 37134, Verona, Italy. massimiliano.calabrese@univr.it.ORCID http://orcid.org/0000-0002-6322-9545

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe mechanism of action of fingolimod within the central nervous system and its efficacy in reducing/preventing both focal and diffuse grey matter (GM) damage in active multiple sclerosis (MS) are not completely understood.

methodsIn this longitudinal, 2-year prospective, phase IV, single-blind study, 40 MS patients treated with fingolimod and 39 untreated age, gender, and disability-matched MS patients were enrolled. Each patient underwent a neurological examination every 6 months and a 3T MRI at the beginning of the treatment and after 24 months. The accumulation of new cortical lesions (CLs) and the progression of regional GM atrophy were compared between the two groups.

resultsAt the end of the study (T24), the percentage of patients with new CLs (13.5 vs. 89%, p < 0.001) and the percentage of GM volume change was lower in the treated group (p < 0.001). The regional analysis revealed that the treated group had also less volume loss in thalamus, caudatus, globus pallidus, cingulate cortex, and hippocampus (p < 0.001), as well as in, cerebellum, superior frontal gyrus, and insular-long gyrus (p < 0.05). Patients with no evidence of disease activity were 60% in the treated group and 10% in the untreated group (p < 0.001).

conclusionsThese results suggest a possible protective effect of fingolimod on focal and diffuse GM damage.

Indexed as

Disease ProgressionOutcome Assessment, Health CareAdolescentAdultAtrophyFemaleFingolimod HydrochlorideGray MatterHumansImmunosuppressive AgentsLongitudinal StudiesMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingSingle-Blind MethodYoung AdultFingolimod HydrochlorideImmunosuppressive AgentsAtrophyCortical lesionsFingolimodGrey matter damageMultiple sclerosis

Identifiers

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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.