Evidence map›Paper›PMID 30637116›Full record

ArticleMultiple sclerosis journal - experimental, translational and clinical

The FLUENT study design: investigating immune cell subset and neurofilament changes in patients with relapsing multiple sclerosis treated with fingolimod.

Jeffrey A Cohen, Amit Bar-Or, Bruce A C Cree, Yang Mao-Draayer, May H Han, Barry Singer, Ann Jannu, Scott Kolodny, Xiangyi Meng, Ryan C Winger

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In one paragraph

Article in Multiple sclerosis journal - experimental, translational and clinical. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Review
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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

10 authors.

Jeffrey A CohenMellen Center, Cleveland Clinic, Cleveland, OH, USA.ORCID https://orcid.org/0000-0001-9245-9772
Amit Bar-OrCenter for Neuroinflammation and Experimental Therapeutics and Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
Bruce A C CreeUCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, CA, USA.
Yang Mao-DraayerDepartment of Neurology, University of Michigan, Ann Arbor, MI, USA.
May H HanDepartment of Neurology, Stanford University, Stanford, CA, USA.
Barry SingerThe MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.
Ann JannuNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Scott KolodnyNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Xiangyi MengNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Ryan C WingerNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

Funding

University of Michigan Clinical Autoimmunity Center of ExcellenceUM1AI144298 · NIAID · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI FOX, DAVID ALAN, KHANNA, DINESH · 2019 to 2023
$546k
University of Michigan Autoimmunity Center of Excellence, Clinical Research ProgrUM1AI110557 · NIAID · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI FOX, DAVID ALAN · 2014 to 2018
$543k
NIAID NIH HHS UM1 AI110557
6 · The paper itself

Abstract

backgroundFingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of patients with relapsing forms of multiple sclerosis (RMS). Fingolimod sequesters lymphocytes within lymphoid tissue thereby reducing the counts of circulating lymphocytes. However, fingolimod's effects on the innate and adaptive components of the immune system are incompletely understood.

objectiveThe FLUENT study will investigate temporal changes in circulating immune cell subsets in patients with RMS treated with fingolimod. Secondary objectives include examining the association between anti-John Cunningham virus (JCV) antibody status/index and phenotypic changes in innate and T and B cell subsets in patients on fingolimod therapy, and the association between serum neurofilament levels and clinical outcomes.

methodsFLUENT is a prospective, multicenter, two-cohort, nonrandomized, open-label Phase IV study. Cohort 1 will include fingolimod-naïve patients and Cohort 2 will include patients who have received fingolimod 0.5 mg/day continuously for ≥2 years. Changes in the cellular components of the innate and adaptive immune system will be characterized over 12 months.

resultsThe study is ongoing.

conclusionFLUENT may provide evidence for the use of immunologic profiling in predicting efficacy and risk of infection in patients with RMS treated with fingolimod.

Indexed as

biomarkerclinical outcomesFingolimodimmune systeminfectionrelapsing multiple sclerosis

Identifiers

PMID30637116
PMCPMC6318720

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