Evidence map›Paper›PMID 32132224›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2020

Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIG

Douglas L Arnold, Brenda Banwell, Amit Bar-Or, Angelo Ghezzi, Benjamin M Greenberg, Emmanuelle Waubant, Gavin Giovannoni, Jerry S Wolinsky, Jutta Gärtner, Kevin Rostásy and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.5field-weighted citation impact, top 7% 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

18 citing papers in PubMed, 44 citations in OpenAlex.

  1. Early and active treatment with fingolimod for pediatric onset multiple sclerosis: the experience of an Italian pediatric center over the past 3 years.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Article
  2. Pediatric multiple sclerosis: Improving outcome through high-efficacy therapies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
  3. Article
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Observational
  9. Observational
  10. Review
  11. Article
  12. How patients with multiple sclerosis acquire disability.Brain : a journal of neurology · 2022
    Article
  13. Fingolimod as a first- or second-line treatment in a mini-series of young Hellenic patients with adolescent-onset multiple sclerosis: focus on immunological data.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  14. Review
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  16. Review
  17. Review
  18. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 14 institutions in 6 countries.

Douglas L ArnoldMontreal Neurological Institute, McGill University, Montreal, Quebec, Canada douglas.arnold@mcgill.ca.ORCID 0000-0003-4266-0106
Brenda BanwellThe Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Amit Bar-OrPerelman School of Medicine, University of Pennsylvania, Philadephia, Pennsylvania, USA, Montreal, Quebec, Canada.
Angelo GhezziCentro Studi Sclerosi Multipla, Ospedale di Gallarate, Gallarate, Italy.
Benjamin M GreenbergDepartment of Neurology and Neurotherapeutics, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0002-2091-8201
Emmanuelle WaubantDepartment of Neurology, University of California, San Francisco, California, USA.
Gavin GiovannoniBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK.
Jerry S WolinskyMcGovern Medical School, Department of Neurology, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA, Houston, Texas, USA.
Jutta GärtnerDepartment of Paediatrics and Adolescent Medicine, German Centre for Multiple Sclerosis in Childhood and Adolescence, University Medical Centre, Göttingen, Germany.
Kevin RostásyDivision of Paediatric Neurology, Children's Hospital Datteln, University Witten/Herdecke, Datteln, Germany.
Lauren KruppDepartment of Neurology; Pediatric MS Center, NYU Langone Health, New York, NY USA, USA, New York, USA.
Marc TardieuHôpitaux universitaires Paris Sud, Paediatric Neurology Department, Assistance Publique-Hôpitaux de Paris, Paris France, Paris, France.
Wolfgang BrückDepartment of Neuropathology, University Medical Centre, Göttingen, Germany.
Tracy E StitesNeuroscience TA, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Gregory L PearceGCE Solutions, Bloomington, Illinois, USA.
Dieter A HäringNeuroscience TA, Novartis Pharma AG, Basel, Switzerland.
Martin MerschhemkeNeuroscience TA, Novartis Pharma AG, Basel, Switzerland.
Tanuja ChitnisPartners Pediatric Multiple Sclerosis Center, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.
PARADIGMS Study Investigators
Montreal Neurological Institute and Hospital · CANovartis (Switzerland) · CHAssistance Publique – Hôpitaux de Paris · FRChildren's Hospital of Philadelphia · USGCE Lab School · USMassachusetts General Hospital · USNovartis (United States) · USNYU Langone Health · USQueen Mary University of London · GBThe University of Texas Health Science Center at Houston · USThe University of Texas Southwestern Medical Center · USUniversity of California, San Francisco · USUniversity of Göttingen · DEWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePARADIG

methodsPatients with multiple sclerosis (MS) (aged 10-<18 years) were randomised to once-daily oral fingolimod (n=107) or once-weekly intramuscular IFN β-1a (n=108) in this flexible duration study. MRI was performed at baseline and every 6 months for up to 2 years or end of the study (EOS) in case of early treatment discontinuation/completion. Key MRI endpoints included the annualised rate of formation of new/newly enlarging T2 lesions, gadolinium-enhancing (Gd+) T1 lesions, new T1 hypointense lesions and combined unique active (CUA) lesions (6 months onward), changes in T2 and Gd+ T1 lesion volumes and annualised rate of brain atrophy (ARBA).

resultsOf the randomised patients, 107 each were treated with fingolimod and IFN β-1a for up to 2 years. Fingolimod reduced the annualised rate of formation of new/newly enlarging T2 lesions (52.6%, p<0.001), number of Gd+ T1 lesions per scan (66.0%, p<0.001), annualised rate of new T1 hypointense lesions (62.8%, p<0.001) and CUA lesions per scan (60.7%, p<0.001) versus IFN β-1a at EOS. The percent increases from baseline in T2 (18.4% vs 32.4%, p<0.001) and Gd+ T1 (-72.3% vs 4.9%, p=0.001) lesion volumes and ARBA (-0.48% vs -0.80%, p=0.014) were lower with fingolimod versus IFN β-1a, the latter partially due to accelerated atrophy in the IFN β-1a group.

conclusionFingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.

Indexed as

AdolescentBrainChildDisease ProgressionFemaleFingolimod HydrochlorideHumansInterferon beta-1aMagnetic Resonance ImagingMaleMultiple SclerosisNeuroimagingSphingosine 1 Phosphate Receptor ModulatorsFingolimod HydrochlorideInterferon beta-1aSphingosine 1 Phosphate Receptor Modulators

Identifiers

PMID32132224
PMCPMC7231437
OpenAlexW3010457503

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.