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

Kappos, L; Arnold, DL; Bar-Or, A; Camm, AJ; Derfuss, T; Sprenger, T; Davies, M; Piotrowska, A; Ni, P; Harada, T (2018) Two-year results from a phase 2 extension study of oral amiselimod in relapsing multiple sclerosis. Mult Scler, 24 (12). pp. 1605-1616. ISSN 1477-0970 https://doi.org/10.1177/1352458517728343
SGUL Authors: Camm, Alan John

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Abstract

BACKGROUND: Amiselimod, 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. OBJECTIVE: To assess safety and efficacy of amiselimod over 96 weeks. METHODS: After 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. RESULTS: Of 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. CONCLUSION: For up to 2 years of treatment, amiselimod was well tolerated and dose-dependently effective in controlling disease activity.

Item Type: Article
Additional Information: © The Author(s), 2017. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
Keywords: Amiselimod (MT-1303), clinical trials, long-term treatment, multiple sclerosis, sphingosine-1-phosphate receptor modulator, Amiselimod (MT-1303), clinical trials, long-term treatment, multiple sclerosis, sphingosine-1-phosphate receptor modulator, Neurology & Neurosurgery, 1103 Clinical Sciences, 1109 Neurosciences
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) > Cardiac (INCCCA)
Journal or Publication Title: Mult Scler
ISSN: 1477-0970
Language: eng
Dates:
DateEvent
1 October 2018Published
15 September 2017Published Online
2 August 2017Accepted
Publisher License: Creative Commons: Attribution-Noncommercial 4.0
Projects:
Project IDFunderFunder ID
UNSPECIFIEDMitsubishi Tanabe Pharma CorporationUNSPECIFIED
PubMed ID: 28911260
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/109274
Publisher's version: https://doi.org/10.1177/1352458517728343

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