Evidence map›Paper›PMID 32284874›Full record

ArticleMultiple sclerosis journal - experimental, translational and clinical

The ACROSS study: Long-term efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis.

T Derfuss, J Sastre-Garriga, X Montalban, M Rodegher, J Wuerfel, L Gaetano, D Tomic, A Azmon, C Wolf, L Kappos

Registry-linked trialOpen access · goldAbstract read
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. It is linked to trial NCT00333138 (Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT00333138 phase2completednot on this map

Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

TypeinterventionalSponsorNovartisRan2003 to 2011Enrolled281ConditionsMultiple SclerosisArmsFTY720, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Approach to optic neuritis: An update.Indian journal of ophthalmology · 2021
    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

10 authors at 5 institutions in 4 countries.

T DerfussNeurologic Clinic and Policlinic, University Hospital and University of Basel, Switzerland.ORCID https://orcid.org/0000-0001-8431-8769
J Sastre-GarrigaMultiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology/Neuroimmunology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.ORCID https://orcid.org/0000-0002-1589-2254
X MontalbanMultiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology/Neuroimmunology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain; Division of Neurology, St Michael's Hospital, University of Toronto, Toronto, Canada.
M RodegherMS Centre, IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi, via Capecelatro, Milan.
J Wuerfel
L GaetanoMedical Image Analysis Center Basel and Department of Biomedical Engineering, University Hospital, Switzerland.ORCID https://orcid.org/0000-0002-5214-2858
D Tomic
A AzmonNovartis Pharma AG, Basel, Switzerland.
L KapposNeurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.ORCID https://orcid.org/0000-0003-4175-5509
Universitat Autònoma de Barcelona · ESUniversity of Basel · CHDon Carlo Gnocchi Foundation · ITNovartis (Switzerland) · CHUniversity Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn chronic diseases such as multiple sclerosis requiring lifelong treatment, studies on long-term outcomes are important.

objectiveTo assess disability and magnetic resonance imaging-related outcomes in relapsing multiple sclerosis patients from a Phase 2 study of fingolimod 10 or more years after randomization and to compare outcomes in patients who had a higher fingolimod exposure versus those with a lower fingolimod exposure.

methodsACROSS was a cross-sectional follow-up study of patients originally enrolled in a Phase 2 fingolimod proof-of-concept study (NCT00333138). Disability and magnetic resonance imaging-related outcomes were assessed in patients grouped according to fingolimod treatment duration, based on an arbitrary cut-off: ≥8 years (high exposure) and <8 years (low exposure).

resultsOverall, 175/281 (62%) patients participated in ACROSS; 104 (59%) of these were classified "high exposure." At 10 years, patients in the high-exposure group had smaller increases in Expanded Disability Status Scale (+0.55 vs. +1.21), and lower frequencies of disability progression (34.7% vs. 56.1%), wheelchair use (4.8% vs. 16.9%), or transition to secondary progressive multiple sclerosis (9.6% vs. 22.5%) than those in the low-exposure group. The high-exposure patients also had less progression in most magnetic resonance imaging-related outcomes.

conclusionAfter 10 years of fingolimod treatment, disability progression was lower in the high-exposure group than in the low-exposure group.

Indexed as

ambulatory assistancedisability progressionfingolimodlong-term treatmentoral therapyRelapsing–remitting multiple sclerosis

Identifiers

PMID32284874
PMCPMC7132565
OpenAlexW3015049303

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.