Evidence map›Paper›PMID 28911260›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2018

Two-year results from a phase 2 extension study of oral amiselimod in relapsing multiple sclerosis.

Ludwig Kappos, Douglas L Arnold, Amit Bar-Or, A John Camm, Tobias Derfuss, Till Sprenger, Martin Davies, Alexandra Piotrowska, Pingping Ni, Tomohiko Harada

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Single-dose of LC51-0255, a selective S1PClinical and translational science · 2022
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  8. Sphingosine-1-phosphate receptor modulators versus interferon beta for the treatment of relapsing-remitting multiple sclerosis: findings from randomized controlled trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
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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

10 authors.

Ludwig KapposNeurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.
Douglas L ArnoldMontreal Neurological Institute and Hospital, Montreal, QC, Canada.
Amit Bar-OrUniversity of Pennsylvania, Philadelphia, PA, USA.
A John CammSt George's, University of London, London, UK.
Tobias DerfussNeurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.
Till SprengerDKD HELIOS Klinik Wiesbaden, Wiesbaden, Germany.
Martin DaviesMitsubishi Tanabe Pharma Europe Ltd, London, UK.
Alexandra PiotrowskaMitsubishi Tanabe Pharma Europe Ltd, London, UK.
Pingping NiMitsubishi Tanabe Pharma Europe Ltd, London, UK.
Tomohiko HaradaMitsubishi Tanabe Pharma Europe Ltd, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmiselimod, an oral selective sphingosine-1-phosphate 1 receptor modulator, suppressed disease activity dose-dependently without clinically relevant bradyarrhythmia in a 24-week phase 2, placebo-controlled study in relapsing-remitting multiple sclerosis.

objectiveTo assess safety and efficacy of amiselimod over 96 weeks.

methodsAfter completing the core study, patients on amiselimod continued at the same dose, whereas those on placebo were randomised 1:1:1 to amiselimod 0.1, 0.2 or 0.4 mg for another 72 weeks. Most patients receiving 0.1 mg were re-randomised to 0.2 or 0.4 mg upon availability of the core study results.

resultsOf 415 patients randomised in the core study, 367 (88.4%) entered and 322 (77.6%) completed the extension. One or more adverse events were reported in 303 (82.6%) of 367 patients: 'headache', 'lymphocyte count decreased', 'nasopharyngitis' and 'MS relapse' were most common (14.7%-16.9%). No serious opportunistic infection, macular oedema or malignancy was reported and no bradyarrhythmia of clinical concern was observed by Holter or 12-lead electrocardiogram. The dose-dependent effect of amiselimod on clinical and magnetic resonance imaging-related outcomes from the core study was sustained in those continuing on amiselimod and similarly observed after switching to active drug.

conclusionFor up to 2 years of treatment, amiselimod was well tolerated and dose-dependently effective in controlling disease activity.

Indexed as

AdultDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingPropanolaminesReceptors, LysosphingolipidTimeTreatment OutcomeamiselimodPropanolaminesReceptors, LysosphingolipidAmiselimod (MT-1303)clinical trialslong-term treatmentmultiple sclerosissphingosine-1-phosphate receptor modulator

Identifiers

PMID28911260
PMCPMC6196590

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Registered trials

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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.