Trial reportNeurology2015
Long-term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial.
Trial report in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
90 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Association of NEDA-4 With No Long-term Disability Progression in Multiple Sclerosis and Comparison With NEDA-3: A Systematic Review and Meta-analysis.Neurology(R) neuroimmunology & neuroinflammation · 2022Pooled it
- Pooled it
- Fingolimod for relapsing-remitting multiple sclerosis.The Cochrane database of systematic reviews · 2016Pooled it
- Trial
- Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2021Trial
- Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study.Journal of neurology · 2020Trial
- Long-term prognostic value of longitudinal measurements of blood neurofilament levels.Neurology(R) neuroimmunology & neuroinflammation · 2020Trial
- Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a randomized extension study.Multiple sclerosis (Houndmills, Basingstoke, England) · 2017Trial
- Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study.BMC neurology · 2017Trial
- Safety and tolerability of fingolimod in patients with relapsing-remitting multiple sclerosis: results of an open-label clinical trial in Italy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2017Trial
- Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study.Journal of neurology, neurosurgery, and psychiatry · 2016Trial
- Microglia-independent rAAV-induced inflammation causes persistent ocular immune dysregulation rescued by S1P receptor modulation.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- From Phenotypes to Spectrum: Rethinking RRMS, SPMS and PPMS in the Era of PIRA-A Framework Integrating PIRA, Smouldering-Associated Worsening, and Neurologic Reserve to Facilitate Earlier Recognition of Progression.Neurology international · 2026Review
- Clinical and radiological outcomes of directed treatment transitions from GilenyaMultiple sclerosis (Houndmills, Basingstoke, England) · 2026Article
- Drug- and Vaccine-Induced Cutaneous T-Cell Lymphoma: A Systematic Review of the Literature.Journal of skin cancer · 2025Review
- Deep learning-driven MRI for accurate brain volumetry in murine models of neurodegenerative diseases.Frontiers in neuroscience · 2025Article
- Fingolimod-Associated Central Serous Retinopathy Presenting Eight Years after Treatment Initiation: a Case Report.Maedica · 2024Article
- Clinical and radiological implications of subpotent generic fingolimod in multiple sclerosis: a case series.Therapeutic advances in neurological disorders · 2024Article
- Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials.Therapeutic advances in gastroenterology · 2024Article
- Association between clinic-level quality of care and patient-level outcomes in multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023Observational
30 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess long-term safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS).
methodsPatients completing FTY720 Research Evaluating Effects of Daily Oral Therapy in MS (FREEDOMS) were eligible for this dose-blinded, parallel-group extension study, continuing fingolimod 0.5 mg/day or 1.25 mg/day, or switching from placebo to either dose, randomized 1:1. Efficacy variables included annualized relapse rate (ARR), brain volume loss (BVL), and confirmed disability progression (CDP). Between-group analyses were conducted in the intent-to-treat (ITT) population from FREEDOMS baseline to end of study. Within-group analyses compared years 0-2 (FREEDOMS) and years 2-4 (extension) in the extension ITT population.
resultsOf 1,272 patients (FREEDOMS ITT population), 1,033 were eligible, and 920 enrolled in the extension study (continuous-fingolimod: 0.5 mg [n = 331], 1.25 mg [n = 289]; placebo-fingolimod: 0.5 mg [n = 155], 1.25 mg [n = 145]); 916 formed the extension ITT population (n = 330; n = 287; n = 154; n = 145) and 773 (84%) completed. In the continuous-fingolimod groups, ARR was lower (p < 0.0001), BVL was reduced (p < 0.05), and proportionately more patients were free from 3-month CDP (p < 0.05) than in a group comprising all placebo-fingolimod patients. Within each placebo-fingolimod group, ARR was lower (p < 0.001, both) and BVL was reduced after switching (p < 0.01, placebo-fingolimod 0.5 mg). Rates and types of adverse events were similar across groups; no new safety issues were reported.
conclusionEfficacy benefits of fingolimod during FREEDOMS were sustained during the extension; ARR and BVL were reduced after switching. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that long-term fingolimod treatment is well-tolerated and reduces relapse rates, disability progression, and MRI effects in patients with RRMS.
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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.