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Two-year results from a phase 2 extension study of oral amiselimod in relapsing multiple sclerosis
- Source :
- Multiple Sclerosis (Houndmills, Basingstoke, England)
- Publication Year :
- 2017
-
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.
- Subjects :
- Oncology
Adult
Male
medicine.medical_specialty
Long term treatment
030204 cardiovascular system & hematology
multiple sclerosis
Sphingosine 1-phosphate Receptor Modulator
Time
Disease activity
Propanolamines
03 medical and health sciences
0302 clinical medicine
Multiple Sclerosis, Relapsing-Remitting
Double-Blind Method
Internal medicine
medicine
Humans
long-term treatment
Receptor modulator
sphingosine-1-phosphate receptor modulator
clinical trials
Dose-Response Relationship, Drug
business.industry
Extension study
Multiple sclerosis
Middle Aged
medicine.disease
Clinical trial
Receptors, Lysosphingolipid
Treatment Outcome
Neurology
Immunology
Female
Neurology (clinical)
business
Original Research Papers
Amiselimod (MT-1303)
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 14770970
- Volume :
- 24
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- Multiple sclerosis (Houndmills, Basingstoke, England)
- Accession number :
- edsair.doi.dedup.....dac4bf077f45a867492f5b52a5767d95