Evidence map›Paper›PMID 25755648›Full record

ArticleFrontiers in neurology2015

Improvement in Fatigue during Natalizumab Treatment is Linked to Improvement in Depression and Day-Time Sleepiness.

Iris-Katharina Penner, Eva Catharina Sivertsdotter, Elisabeth G Celius, Siegrid Fuchs, Karen Schreiber, Sara Berkö, Anders Svenningsson, TYNERGY trial investigators

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00884481 (A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.7field-weighted citation impact, top 11% 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.

NCT00884481 completednot on this map

A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months

TypeobservationalSponsorBiogenRan2009 to 2011Enrolled195ConditionsRelapsing-Remitting Multiple Sclerosis, FatigueArmsNatalizumab
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 44 citations in OpenAlex.

  1. Review
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  3. Real-world evidence and patient preference for subcutaneousTherapeutic advances in neurological disorders · 2024
    Article
  4. Review
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  6. Review
  7. Article
  8. Review
  9. Insomnia in neurological diseases.Neurological research and practice · 2021
    Article
  10. Review
  11. Review
  12. Immunotherapy in Narcolepsy.Current treatment options in neurology · 2020
    Review
  13. Pathophysiological and cognitive mechanisms of fatigue in multiple sclerosis.Journal of neurology, neurosurgery, and psychiatry · 2019
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. 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 at 1 institution in 1 country.

Iris-Katharina PennerDepartment of Cognitive Psychology and Methodology, University of Basel , Basel , Switzerland.
Eva Catharina SivertsdotterBiogenIdec Sweden AB , Upplands Väsby , Sweden (formerly employed).
Elisabeth G CeliusDepartment of Neurology, Oslo University Hospital , Ullevål , Norway.
Siegrid FuchsDepartment of Neurology, Medical University of Graz , Graz , Austria.
Karen SchreiberDepartment of Neurology, Copenhagen University Hospital Rigshospitalet , Copenhagen , Denmark.
Sara BerköBiogenIdec Sweden AB , Upplands Väsby , Sweden.
Anders SvenningssonDepartment of Pharmacology and Clinical Neuroscience, University Hospital of Northern Sweden, Umeå University , Umeå , Sweden.
TYNERGY trial investigators
Medical University of Graz · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue is a frequent symptom in multiple sclerosis (MS) and often interrelated with depression and sleep disorders making symptomatic treatment decisions difficult. In the single-arm, observational phase IV TYNERGY study, relapsing-remitting MS patients showed a clinically meaningful decrease in fatigue over 1 year of treatment with natalizumab.

objectiveTo evaluate whether fatigue improvement might be directly linked to improved depression and day-time sleepiness.

methodsPatients were assessed regarding fatigue, depression, and day-time sleepiness. The relation between changes of the two latter symptoms and changes in fatigue was analyzed.

resultsAfter 1 year of natalizumab treatment, the majority of patients (>92%) remained stable or improved in total, motor, and cognitive fatigue. Proportion of patients without depression increased by 17% while proportions of mildly depressed patients or patients with potential major depression decreased by 5 and 12%, respectively. Proportion of patients classified as not being sleepy increased by 13% while proportions of sleepy and very sleepy patients decreased by 11 and 2%, respectively. Most importantly, improved depression and sleepiness were significantly related to improved fatigue.

conclusionOur findings highlight the importance of patient-reported outcomes in identifying potential benefits of drug treatment beyond its well-established effects on disease activity and disability progression.

Indexed as

depressionfatiguemultiple sclerosissleepinesstreatment response

Identifiers

PMID25755648
PMCPMC4337367
OpenAlexW1483021778

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.