Evidence map›Paper›PMID 29075564›Full record

ArticleBrain and behavior2017

Gender differences in safety issues during Fingolimod therapy: Evidence from a real-life Relapsing Multiple Sclerosis cohort.

Alessia Manni, Vita Direnzo, Antonio Iaffaldano, Valentina Di Lecce, Carla Tortorella, Stefano Zoccolella, Pietro Iaffaldano, Maria Trojano, Damiano Paolicelli

Open access · goldAbstract read
In one paragraph

Article in Brain and behavior, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  3. Review
  4. Article
  5. Article
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  7. Review
  8. Review
  9. Observational
  10. COVID-19 Therapeutic Options Under Investigation.Frontiers in pharmacology · 2020
    Review
  11. Article
  12. X-tra X: An escape to autoimmunity.The Journal of clinical investigation · 2019
    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

9 authors at 1 institution in 1 country.

Alessia ManniDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Vita DirenzoDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Antonio IaffaldanoDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Valentina Di LecceDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Carla TortorellaDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Stefano ZoccolellaDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Pietro IaffaldanoDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Maria TrojanoDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.
Damiano PaolicelliDepartment of Basic Medical Sciences, Neuroscience and Sense Organs University of Bari" Aldo Moro" Bari Italy.ORCID 0000-0002-8645-1763
University of Bari Aldo Moro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveBenefits and risks of new therapies in Multiple Sclerosis (MS) must be balanced carefully and tailored to patients. We aimed to describe our experience with Fingolimod (FTY), correlating demographics, clinical and hematological features of the Relapsing MS (RMS) cohort with the occurring Adverse Events (AEs). MATERIAL AND

methodsPretreatment screening tests, cardiological observation, and safety follow-up data were analyzed in 225 RMS patients. Changes in continuous data were analyzed post hoc with Wilcoxon ranks test; categorical variables were examined using McNemar test. Two-way repeated-measures analysis of variance (ANOVA) was used to analyze differences between baseline characteristic of the cohorts and Liver Function Tests (LFT) alterations. Binary logistic regression models were used to identify which of the baseline factors influenced LFT alterations and the occurrence of infections.

resultsDuring 2 years of follow-up 24 patients (10%) interrupted FTY. Discontinuation most often was due to AEs (n = 14) or breakthrough disease (n = 5). The most frequently AEs were infections (10.6%). After the first year patients showing an infectious episode were mostly female (

conclusionsFor a patient-centered safety monitoring of FTY, we may apply gender-specific warnings, for the detection of transaminases abnormalities and infectious episodes.

Indexed as

Fingolimod HydrochlorideInfectionsMultiple Sclerosis, Relapsing-RemittingSecondary PreventionAdultCell MovementCohort StudiesDrug MonitoringFemaleHumansImmunosuppressive AgentsItalyLiver Function TestsLymphocyte CountMaleMiddle AgedFingolimod HydrochlorideImmunosuppressive Agentsfingolimodgender differencesinfectionsliver function testsmultiple sclerosis

Identifiers

PMID29075564
PMCPMC5651388
OpenAlexW2753504127

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.