Author Topic: (Abst.) 2-year results from phase 2 extension study of oral amiselimod in RRMS  (Read 58 times)

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Online agate

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From Multiple Sclerosis Journal, September 15, 2017:

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

Ludwig Kappos, Douglas L Arnold, Amit Bar-Or, ...

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.

The abstract, along with more information on the authors, can be seen here.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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