Evidence map›Paper›PMID 22558238›Full record

ArticlePloS one2012

Impact of natalizumab on cognitive performances and fatigue in relapsing multiple sclerosis: a prospective, open-label, two years observational study.

Pietro Iaffaldano, Rosa Gemma Viterbo, Damiano Paolicelli, Guglielmo Lucchese, Emilio Portaccio, Benedetta Goretti, Vita Direnzo, Mariangela D'Onghia, Stefano Zoccolella, Maria Pia Amato and 1 more

Abstract read
In one paragraph

Article in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 4 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

45 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. MS Fatigue Post High-Efficacy Treatment.European journal of neurology · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pharmacological treatment for memory disorder in multiple sclerosis.The Cochrane database of systematic reviews · 2013
    Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
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  14. Article
  15. Predictors of unemployment status in people with relapsing multiple sclerosis: a single center experience.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  16. Multiple sclerosis-related fatigue lacks a unified definition: A narrative review.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2022
    Review
  17. Article
  18. Natalizumab is associated with early improvement of working ability in relapsing-remitting multiple sclerosis patients: WANT observational study results.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Observational
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  20. 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

11 authors.

Pietro IaffaldanoDepartment of Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
Rosa Gemma Viterbo
Damiano Paolicelli
Guglielmo Lucchese
Emilio Portaccio
Benedetta Goretti
Vita Direnzo
Mariangela D'Onghia
Stefano Zoccolella
Maria Pia Amato
Maria Trojano

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesNatalizumab reduces the relapse rate and magnetic resonance imaging activity in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). So far the influence of natalizumab on cognitive functions and fatigue in MS remains uncertain. The aim of this prospective, open-label, observational study was to evaluate the possible effects of natalizumab on cognition and fatigue measures in RRMS patients treated for up to two years.

methodsCognitive performances were examined by the Rao's Brief Repeatable Battery (BRB), the Stroop test (ST) and the Cognitive Impairment Index (CII), every 12 months. Patients who failed in at least 3 tests of the BRB and the ST were classified as cognitively impaired (CI). Fatigue Severity Scale (FSS) was administered every 12 months to assess patient's self-reported fatigue. One hundred and 53 patients completed 1 and 2 year-natalizumab treatment, respectively.

resultsAfter 1 year of treatment the percentage of CI patients decreased from 29% (29/100) at baseline to 19% (19/100) (p = 0.031) and the mean baseline values of CII (13.52±6.85) and FSS (4.01±1.63) scores were significantly reduced (10.48±7.12, p<0.0001 and 3.61±1.56, p = 0.008). These significant effects were confirmed in the subgroup of patients treated up to two years.

conclusionsThese results demonstrate that a short-term NTZ treatment may significantly improve cognitive performances and fatigue in RRMS patients.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCognitionDrug Administration ScheduleFatigueFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingNatalizumabNeuropsychological TestsProspective StudiesRecurrenceSeverity of Illness IndexAntibodies, Monoclonal, HumanizedNatalizumab

Identifiers

PMID22558238
PMCPMC3338465

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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.