Evidence map›Paper›PMID 30143944›Full record

Observational studyCNS drugs2018

Improvement in Cognitive Function as Measured by NeuroTrax in Patients with Relapsing Multiple Sclerosis Treated with Natalizumab: A 2-Year Retrospective Analysis.

Mark Gudesblatt, Karl Wissemann, Myassar Zarif, Barbara Bumstead, Lori Fafard, Jeffrey Wilken, Karen Blitz, Marijean Buhse, Sourav Santra, Christophe Hotermans and 1 more

Erratum issuedAbstract readObservational Study
In one paragraph

Observational study in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  6. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Mark GudesblattSouth Shore Neurologic Associates, Patchogue, NY, USA.
Karl WissemannSouth Shore Neurologic Associates, Patchogue, NY, USA.
Myassar ZarifSouth Shore Neurologic Associates, Patchogue, NY, USA.
Barbara BumsteadSouth Shore Neurologic Associates, Patchogue, NY, USA.
Lori FafardSouth Shore Neurologic Associates, Patchogue, NY, USA.
Jeffrey WilkenWashington Neuropsychology Research Group LLC, Fairfax, VA, USA.
Karen BlitzSouth Shore Neurologic Associates, Patchogue, NY, USA.
Marijean BuhseSouth Shore Neurologic Associates, Patchogue, NY, USA.
Sourav SantraBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Christophe HotermansBiogen, 225 Binney Street, Cambridge, MA, 02142, USA.
Lily LeeBiogen, 225 Binney Street, Cambridge, MA, 02142, USA. lily.lee@biogen.com.ORCID http://orcid.org/0000-0002-7166-0677

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCognitive impairment affects many patients with multiple sclerosis (MS). NeuroTrax, a computerized cognitive screen that can be administered during routine clinical care, provides a consistent, validated, objective cognitive profile measure with a global cognitive score (GCS) and seven individual domain scores. Natalizumab is an efficacious therapy for relapsing MS, demonstrating reductions in disability worsening and MS disease activity measured by magnetic resonance imaging.

objectiveThe aim of this study was to assess cognitive function as measured by NeuroTrax in MS patients treated with natalizumab for ≥ 2 years.

methodsThis retrospective observational study included adult MS patients in the United States who received 300 mg intravenous natalizumab every 4 weeks for ≥ 2 years. NeuroTrax data were evaluated at baseline and yearly thereafter. Changes in GCS and the seven individual cognitive domain scores from baseline to after 24 infusions of natalizumab were analyzed.

resultsIn the study population at baseline (N = 52), 22 patients (42.3%) had disease duration of 0-5 years; 12 patients (23.1%) were treatment naive. GCS score improved significantly from baseline [mean 95.5, standard deviation (SD) 12.9] to year 2 (mean 98.9, SD 13.2; change from baseline 3.4; p = 0.003). After 2 years on natalizumab, 17 patients (32.7%) demonstrated clinically significant improvement (increase from baseline > 1 SD) in GCS. Results were similar regardless of whether patients had previously received MS therapy.

conclusionsPatients treated with natalizumab demonstrated significant improvement in cognitive function, measured by NeuroTrax GCS, over 2 years of treatment.

Indexed as

Neuropsychological TestsAdultCognition DisordersDisability EvaluationFemaleHumansImmunologic FactorsMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingNatalizumabRetrospective StudiesTime FactorsTreatment OutcomeUnited StatesImmunologic FactorsNatalizumab

Identifiers

PMID30143944
PMCPMC6280854

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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.