期刊
MULTIPLE SCLEROSIS JOURNAL
卷 24, 期 12, 页码 1605-1616出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458517728343
关键词
Amiselimod (MT-1303); sphingosine-1-phosphate receptor modulator; multiple sclerosis; long-term treatment; clinical trials
资金
- Mitsubishi Tanabe Pharma Corporation
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 96weeks. 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 0.4mg for another 72weeks. Most patients receiving 0.1mg were re-randomised to 0.2 or 0.4mg 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 2years of treatment, amiselimod was well tolerated and dose-dependently effective in controlling disease activity.
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