Evidence map›Paper›PMID 32240213›Full record

ArticlePloS one2020

Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study.

Francisco Barrero, Javier Mallada-Frechin, María Luisa Martínez-Ginés, María Eugenia Marzo, Virginia Meca-Lallana, Guillermo Izquierdo, José Ramón Ara, Celia Oreja-Guevara, José Meca-Lallana, Lucía Forero and 3 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2020. 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
1.6field-weighted citation impact, top 17% 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. Observational
  2. Article
  3. Observational
  4. Review
  5. Article
  6. Review
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

13 authors at 11 institutions in 1 country.

Francisco BarreroNeurology Department, Hospital Uniersitario San Cecilio de Granada, Granada, Spain.ORCID 0000-0001-8490-2789
Javier Mallada-FrechinNeurology Department, Hospital General Universitario de Elda, Alicante, Spain.
María Luisa Martínez-GinésNeurology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
María Eugenia MarzoNeurology Department, Hospital San Pedro, Logroño, Spain.
Virginia Meca-LallanaDemyelinating Disorders Unit, Hospital Universitario de La Princesa, Madrid, Spain.
Guillermo IzquierdoNeurology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain.
José Ramón AraNeurology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Celia Oreja-GuevaraNeurology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain.
José Meca-LallanaHospital Virgen de la Arrixaca (IMIB-Arrixaca), Murcia, Spain.
Lucía ForeroNeurology Department, Hospital Universitario Puerta del Mar, Cádiz, Spain.ORCID 0000-0003-0256-6748
Irene Sánchez-VeraNovartis Farmacéutica S.A., Barcelona, Spain.
María José MorenoNovartis Farmacéutica S.A., Barcelona, Spain.ORCID 0000-0003-3956-8392
in representation of the MS NEXT study investigators
Novartis (Spain) · ESHospital Clínico San Carlos · ESHospital General de Elda · ESHospital General Universitario Gregorio Marañón · ESHospital San Pedro · ESHospital Universitario de La Princesa · ESHospital Universitario Miguel Servet · ESHospital Universitario Puerta del Mar · ESHospital Universitario Virgen de la Arrixaca · ESHospital Universitario Virgen Macarena · ESInstituto de Investigación Biosanitaria de Granada · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice.

methodsThis observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months.

resultsThe mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had >20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naïve patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P<0.001. The ARR of patients who switched from natalizumab to fingolimod was stable over the study. Most of the patients (88.7%) were free from confirmed disability and MRI activity (67.3%) after 24 months. The persistence after 12 months on fingolimod was 93.9%.

conclusionsThe subgroups of patients analysed showed differential baseline demographic and clinical characteristics. The analysis of patients who received fingolimod in routine clinical practice confirmed adequate efficacy and safety, even for long-term treatment. The present data also confirmed the positive benefit/risk balance with fingolimod in real-world clinical practice setting.

Indexed as

AdultAgedFemaleFingolimod HydrochlorideHumansImmunosuppressive AgentsMagnetic Resonance ImagingMaleMiddle AgedMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingNatalizumabPersons with DisabilitiesRecurrenceRetrospective StudiesSpainFingolimod HydrochlorideImmunosuppressive AgentsNatalizumab

Identifiers

PMID32240213
PMCPMC7117743
OpenAlexW3014410239

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.