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2-year data positive in extension study, but no control group
An extension of the phase II BOLD study found sustained reductions in gadolinium-enhancing T1 and new or enlarging T2 lesions over 2 years with siponimod in patients with relapsing-remitting multiple sclerosis (RRMS), researchers reported.
The data also showed sustained reductions in combined unique active lesions (CUALs) when counting Gd-enhancing T1 lesions and new or enlarging T2 lesions together — but only for two of the five doses used in the study, Ludwig Kappos, MD, of University Hospital in Basel, Switzerland, and colleagues reported online in JAMA Neurology.
The investigational treatment was well tolerated and there were no new safety signals, the researchers added.
Siponimod is an oral, once-daily selective sphingosine 1-phosphate receptor modulator, which is thought to be more selective than its cousin agent, fingolimod (Gilenya), which is approved to treat RRMS.
Siponimod targets only the 1 and 5 receptor subtypes, compared with the 1, 3, 4, and 5 subtypes engaged by fingolimod.
To assess the more selective drug, Kappos and colleagues conducted the randomized, double-blind, placebo-controlled phase II BOLD study in 252 RRMS patients from 73 MS centers around the world, with participants randomized to receive placebo or one of five different doses of the drug.
Siponimod was found to reduce CUALs by up to 80% compared with placebo at 6 months, with a dose-response relationship.
The team then conducted a 2-year extension study, in which 184 of the original participants enrolled, with 159 completing the full 2 years. Patients in the original placebo groups were randomized to receive the active drug at one of the five dosage levels.
The reduction in MRI activity seen in the initial 6 months of the trial was sustained for several doses of the drug. The proportion of patients free from CUALs was higher in the 2-mg and 1.25-mg doses than in the 10-mg, 0.5-mg, and 0.25-mg doses (57.7% and 58.1% versus 43.8%, 31%, and 47.9%)
There were, however, sustained improvements on each measure alone, with declines in gadolinium-enhancing T1 lesions lasting 2 years for patients on the four highest dosage levels (10 mg, 2 mg, 1.25 mg, and 0.5 mg) and numerically fewer new or enlarging T2 lesions for those on the three highest doses (10 mg, 2 mg, 1.25 mg).
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