Evidence map›Paper›PMID 29063244›Full record

Trial reportJournal of neurology2017

Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing-remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study).

Giancarlo Comi, Francesco Patti, Maria Assunta Rocca, Flavia Caterina Mattioli, Maria Pia Amato, Paolo Gallo, Diego Centonze, Carlo Pozzilli, Francesco Saccà, Florian Then Bergh and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 10 pooled it
–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

27 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  11. Trial
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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

14 authors.

Giancarlo ComiDepartment of Neurology, Institute of Experimental Neurology, San Raffaele Hospital, Milan, Italy. comi.giancarlo@hsr.it.
Francesco Patti"GF Ingrassia", Section of Neurosciences, Department of Medical, Surgery Science and Advanced Technology, MS Center, University Hospital, Catania, Italy.
Maria Assunta RoccaDepartment of Neurology, Institute of Experimental Neurology, San Raffaele Hospital, Milan, Italy.
Flavia Caterina MattioliNeuropsychology Unit, Spedali Civili of Brescia, Brescia, Italy.
Maria Pia AmatoDepartment NEUROFARBA, University of Florence, Florence, Italy.
Paolo GalloDepartment of Neurosciences, Multiple Sclerosis Centre, Veneto Region (CeSMuV), University Hospital of Padova, Padua, Italy.
Diego CentonzeMultiple Sclerosis Research Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
Carlo PozzilliDepartment of Neurology and Psychiatry, Multiple Sclerosis Centre, S. Andrea Hospital, Sapienza University, Rome, Italy.
Francesco SaccàDepartment of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Florian Then BerghDepartment of Neurology, University of Leipzig, Leipzig, Germany.
Marta BartezaghiNovartis Farma, Origgio, Varese, Italy.
Renato TurriniNovartis Farma, Origgio, Varese, Italy.
Massimo FilippiDepartment of Neurology, Institute of Experimental Neurology, San Raffaele Hospital, Milan, Italy.
Golden Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cognitive impairment (CI) affects 40-65% of multiple sclerosis (MS) patients. This study attempted evaluating the effects of fingolimod and interferon beta-1b (IFN β-1b) on CI progression, magnetic resonance imaging (MRI) and clinical outcomes in relapsing-remitting MS (RRMS) patients over 18 months. The GOLDEN study was a pilot study including RRMS patients with CI randomised (2:1) to fingolimod (0.5 mg daily)/IFN β-1b (250 µg every other day). CI was assessed via Rao's Brief Repeatable Battery and Delis-Kaplan Executive Function System test. MRI parameters, Expanded Disability Status Scale scores and relapses were measured. Overall, 157 patients were randomised, of whom 30 discontinued the study (fingolimod, 8.49%; IFN β-1b, 41.18%; p ≤ 0.0001). Patients randomised to fingolimod had more severe clinical and MRI disease characteristics at baseline compared with IFN β-1b. At Month (M) 18, both treatment groups showed improvements in all cognitive parameters. At M18, relapse rate, total number and volume of T2/T1 gadolinium-enhancing lesions were higher with IFN β-1b, as well as the percentage brain volume change during the study. Safety and tolerability of both treatments were similar to previous studies. Both treatments showed improvements in cognitive parameters. Fingolimod demonstrated significantly better effects on MRI parameters and relapse rate. Imbalance in baseline characteristics and the drop-out pattern may have favoured IFN β-1b. A longer duration trial may be needed to observe the complete expression of differential effects on CI scales reflecting the between-groups differences on MRI. Although limited in size, the GOLDEN study confirms the favourable benefit-risk profile of fingolimod reported in previous studies.

Indexed as

Cognition DisordersMagnetic Resonance ImagingMultiple Sclerosis, Relapsing-RemittingAdolescentAdultDepressionDisability EvaluationElectrocardiographyExecutive FunctionFemaleFingolimod HydrochlorideHumansImmunologic FactorsInterferon beta-1bLongitudinal StudiesMaleFingolimod HydrochlorideImmunologic FactorsInterferon beta-1bBrain atrophyBrief repeatable battery testCognitive impairmentDelis–Kaplan executive function testFingolimodInterferon beta-1b

Identifiers

PMID29063244
PMCPMC5688215

What OpenQuestion holds

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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.