Evidence map›Paper›PMID 35452476›Full record

Observational studyPloS one2022

The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary.

Tamás Biernacki, Dániel Sandi, Judit Füvesi, Zsanett Fricska-Nagy, Tamás Zsigmond Kincses, Péter Ács, Csilla Rózsa, Enikő Dobos, Botond Cseh, László Horváth and 7 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 29% 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

6 citing papers in PubMed, 13 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

17 authors at 8 institutions in 1 country.

Tamás BiernackiDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.ORCID 0000-0003-3097-6779
Dániel SandiDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.
Judit FüvesiDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.
Zsanett Fricska-NagyDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.
Tamás Zsigmond KincsesDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.
Péter ÁcsDepartment of Neurology, Faculty of General Medicine, University of Pécs, Pécs, Hungary.
Csilla RózsaJahn Ferenc South-Pest Hospital and Clinic, Budapest, Hungary.
Enikő DobosSzent Imre Hospital, Budapest, Hungary.
Botond CsehBorsod-Abaúj-Zemplén County Hospital, Miskolc, Hungary.
László HorváthBorsod-Abaúj-Zemplén County Hospital, Miskolc, Hungary.
Zsuzsanna NagySzent Rafael Zala County Hospital, Zalaegerszeg, Hungary.
Attila CsányiPetz Aladár County Teaching Hospital, Győr, Hungary.
Krisztina KovácsPéterfy Sándor str. Hospital and Clinic, Budapest, Hungary.
Tünde CsépányDepartment of Neurology, Faculty of General Medicine, University of Debrecen, Deberecen, Hungary.
László VécseiDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.
Krisztina BencsikDepartment of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.ORCID 0000-0002-1400-1288
on the behalf of the study investigators
University of Szeged · HUBorsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház · HUJahn Ferenc Dél-Pesti Kórház és Rendelőintézet · HUPéterfy Sándor Utcai Kórház-Rendelőintézet és Baleseti Központ · HUPetz Aladár Megyei Oktató Kórház · HUSzent Imre Egyetemi Oktatókórház · HUUniversity of Debrecen · HUUniversity of Pecs · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFingolimod was approved and reimbursed by the healthcare provider in Hungary for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS) in 2012. The present study aimed to assess the effectiveness, safety profile, and persistence to fingolimod in a real-life setting in Hungary in RRMS patients who were either therapy naïve before enrollment or have changed to fingolimod from another disease-modifying therapy (DMT) for any reason.

methodsThis cross-sectional, observational study with prospective data collection was performed nationwide at 21 sites across Hungary. To avoid selection bias, sites were asked to document eligible patients in consecutive chronological order. Demographic, clinical, safety and efficacy data were analysed for up to 5 years from 570 consenting adult patients with RRMS who had received treatment with fingolimod for at least one year.

results69.6% of patients remained free from relapses for the whole study duration; in the first year, 85.1% of patients did not experience a relapse, which rose to 94.6% seen in the 5th year. Compared to baseline at study end, 28.2% had higher, and 9.1% had lower, meanwhile, 62.7% of the patients had stable EDSS scores. Overall, the annualized relapse rate decreased from 0.804 observed at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (77.0%, 82.1%, 85.2%, 89.7%, and 89.0% relative reduction, respectively) after 1, 2, 3, 4, and 5 years of treatment. The greatest reduction rate was seen in the group of therapy naïve patients. Treatment persistence on fingolimod after 60 months was 73.4%.

conclusionIn this nationwide Hungarian cohort, most patients under fingolimod treatment were free from relapses and disability progression. In addition, fingolimod has proven to be a well-tolerated DMT that has sustained its manageable safety profile, high efficacy, and positive benefit/risk ratio for up to 5 years in a real-life setting.

Indexed as

Fingolimod HydrochlorideMultiple Sclerosis, Relapsing-RemittingAdultCross-Sectional StudiesHumansHungaryImmunosuppressive AgentsRecurrenceFingolimod HydrochlorideImmunosuppressive Agents

Identifiers

PMID35452476
PMCPMC9032373
OpenAlexW4224243155

What OpenQuestion holds

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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.