Evidence map›Paper›PMID 32221861›Full record

Observational studyCNS drugs2020

Changes in Anti-JCV Antibody Status in a Large Population of Multiple Sclerosis Patients Treated with Natalizumab.

Eleonora Sgarlata, Clara Grazia Chisari, Emanuele D'Amico, Enrico Millefiorini, Francesco Patti

Open access · greenAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in CNS drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
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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

5 authors at 3 institutions in 1 country.

Eleonora SgarlataDepartment of Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy.
Clara Grazia ChisariDepartment "GF Ingrassia", Section of Neurosciences, University of Catania, Via S. Sofia 78, 95129, Catania, Italy.
Emanuele D'AmicoDepartment "GF Ingrassia", Section of Neurosciences, University of Catania, Via S. Sofia 78, 95129, Catania, Italy.
Enrico MillefioriniDepartment of Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy.
Francesco PattiDepartment "GF Ingrassia", Section of Neurosciences, University of Catania, Via S. Sofia 78, 95129, Catania, Italy. patti@unict.it.ORCID 0000-0002-6923-0846
University of Catania · ITOspedali Riuniti Umberto I · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNatalizumab (NTZ) can be associated with an opportunistic infection, progressive multifocal leukoencephalopathy (PML), caused by John Cunningham virus (JCV). High titer of anti-JCV antibody (JCV index) in patients treated with NTZ for over 2 years limit it use, leading to treatment discontinuation.

objectiveAim of the study was to investigate the JCV index changes pre, during and post NTZ treatment and describe the trend after a long period of NTZ discontinuation.

methodsPatients with relapsing-remitting multiple sclerosis (RR-MS) treated with NTZ between 2010 and 2018 were enrolled in this retrospective-prospective observational study. Inclusion criteria were: (1) diagnosis of RR-MS according to the McDonald criteria 2010, (2) at least six NTZ administrations, (3) at least two determinations of JCV Index during the follow-up period, (4) NTZ discontinuation period for more than 6 months. JCV index was determined by STRATIFY II. There were three different timepoints: NTZ initiation (T0), NTZ discontinuation (T1) and time after NTZ suspension (T2). Seroconversion was defined as changing status of serum JCV antibody. Main outcomes were the JCV index changes and the rate of seroconversion.

resultsAt baseline we enrolled 285 patients (208 JCV negative, 67 JCV positive, and 10 not available). There was a statistically significant increase of JCV index during NTZ treatment period (T0 vs T1, p =0.0009) and during NTZ discontinuation period (T1 vs T2, p =0.04). Patients seroconverted to a positive status more frequently during NTZ treatment than after discontinuation (p =0.008). Moreover, patients who shifted to fingolimod (FTY) as exit strategy after NTZ discontinuation, showed a statistically significant increase of JCV index.

conclusionOur data confirmed that a high percentage of patients shift to or remain in a positive JCV status during NTZ treatment and after discontinuation. NTZ suspension seems not to be able to interfere on JCV status modification over an extended period. The choice of alternative treatment as exit strategy after NTZ discontinuation should be carefully considered because it could negatively influence the PML risk stratification of patients.

Indexed as

AdultFemaleHumansImmunologic FactorsJC VirusLeukoencephalopathy, Progressive MultifocalMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingNatalizumabOpportunistic InfectionsProspective StudiesRetrospective StudiesTime FactorsImmunologic FactorsNatalizumab

Identifiers

PMID32221861
OpenAlexW3012982694

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.