Trial reportBMC neurology2014
Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension.
Trial report in BMC neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00670449 (An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis), which is not on this map. Cited by 26 papers, 1 of them a synthesis 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.
An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Fingolimod for relapsing-remitting multiple sclerosis.The Cochrane database of systematic reviews · 2016Pooled it
- 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
- Use of MRI in neuromyelitis optica spectrum disorder and myelin oligodendrocyte glycoprotein antibody-associated disease - MAGNIMS consensus recommendations.Nature reviews. Neurology · 2026Review
- Challenging The Diagnosis of Multiple Sclerosis: Histopathological Insights Gained Through Brain Biopsies.Noro psikiyatri arsivi · 2026Article
- Article
- Do magnetic resonance imaging features differ between persons with multiple sclerosis of various races and ethnicities?Frontiers in neurology · 2023Review
- Case Report: Severe rebound after withdrawal of fingolimod in a patient with neuromyelitis optica spectrum disorder.Frontiers in immunology · 2023Article
- Depression and anxiety in patients with multiple sclerosis treated with interferon-beta or fingolimod: Role of indoleamine 2,3-dioxygenase and pro-inflammatory cytokines.Brain, behavior, & immunity - health · 2020Article
- The clinical profile of NMOSD in Australia and New Zealand.Journal of neurology · 2020Article
- Effects of fingolimod treatments on alanine transaminase and aspartate transaminase levels in patients with multiple sclerosis.International journal of physiology, pathophysiology and pharmacology · 2020Article
- Fingolimod-induced decrease in heart rate may predict subsequent decreasing degree of lymphocytes.Scientific reports · 2018Article
- Intracerebral lymphoproliferative disorder in an MS patient treated with fingolimod.Neurology(R) neuroimmunology & neuroinflammation · 2018Article
- Novel disease-modifying anti-rheumatic drug iguratimod suppresses chronic experimental autoimmune encephalomyelitis by down-regulating activation of macrophages/microglia through an NF-κB pathway.Scientific reports · 2018Article
- Neurological safety of fingolimod: An updated review.Clinical & experimental neuroimmunology · 2017Review
- Fingolimod Associated Bilateral Cystoid Macular Edema-Wait and See?International journal of molecular sciences · 2016Article
- Paediatric Multiple Sclerosis: Update on Diagnostic Criteria, Imaging, Histopathology and Treatment Choices.Current neurology and neuroscience reports · 2016Review
- Structural evidence of the species-dependent albumin binding of the modified cyclic phosphatidic acid with cytotoxic properties.Bioscience reports · 2016Article
- Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.Journal of neurology · 2016Article
- Status of diagnostic approaches to AQP4-IgG seronegative NMO and NMO/MS overlap syndromes.Journal of neurology · 2016Article
- Present and Future Therapies in Neuromyelitis Optica Spectrum Disorders.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA 6-month phase 2 study of fingolimod demonstrated efficacy and safety in Japanese patients with relapsing-remitting multiple sclerosis (MS). Here we report a 6-month observational extension that evaluated efficacy and safety in patients who received fingolimod continuously for 12 months or who switched from placebo to fingolimod.
methodsOf 147 patients who completed the 6-month core study, 143 entered the extension. Those originally randomized to placebo were re-randomized to fingolimod 1.25 mg or 0.5 mg. During the extension, all patients were switched to open-label fingolimod 0.5 mg.
resultsMagnetic resonance imaging (MRI) and relapse outcomes were maintained or improved in patients treated with fingolimod for 12 months versus those treated for 6 months. No new safety events were reported over 12 months of treatment. Infections occurred in similar proportions of continuously treated and switched patients, while cardiac and liver adverse events occurred in fewer continuously treated than switched patients. Four patients were aquaporin-4 (AQP4) antibody-positive, three of whom showed rapid disease exacerbations within 10 days of fingolimod initiation.
conclusionContinuous fingolimod treatment for up to 12 months was associated with maintained or improved efficacy and a manageable safety profile, consistent with that previously seen. Results in a small number of patients suggest lack of benefit in AQP4 antibody-positive patients. Meaningful statistical interpretation was limited by the small sample size in each treatment group, owing to the number of patients who completed the core study.
trial registrationClinicalTrials.gov NCT00670449.
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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.