Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior to Copaxone (glatiramer acetate) injections at lowering relapses and disease activity over one year in patients with relapsing–remitting multiple sclerosis (RRMS), according to results of a Phase 3b trial.
The research, “Efficacy and Safety of Fingolimod 0.5 mg and 0.25 mg Versus Glatiramer Acetate 20 mg in Patients with Relapsing-Remitting Multiple Sclerosis − ASSESS Study Group,” was presented at the recent 2019 American Academy of Neurology (AAN) Annual Meeting by Bruce Cree, MD, PhD, clinical research director at the University of California San Francisco (UCSF) MS Center.
Previous results of a Phase 3 clinical trial (NCT00340834) showed that Gilenya (marketed by Novartis) at 0.5 mg — the dose recommended for adults and children weighing above 40 kilograms (about 88 pounds) — had superior efficacy to Avonex (interferon beta-1a, by Biogen).
Such head-to-head comparisons of disease-modifying therapies can help to inform treatment decisions made by doctors in the clinic.
A team from the U.S., Canada, and Novartis conducted the multi-center, Phase 3b ASSESS study (NCT01633112) to determine whether the 0.25 mg and the 0.5 mg doses of Gilenya were more effective than 20 mg of Copaxone (by Teva) in easing disease activity over 12 months in RRMS patients.
In total, 1,064 participants (mean age, 39.6 ) were randomized to either once-daily oral Gilenya at 0.5 mg (352 patients) and 0.25 mg (370 patients), or to subcutaneous (under-the-skin) Copaxone injections (342 patients).
The trial’s primary endpoint, or goal, was a reduction in annualized relapse rates — the number of confirmed relapses per year — while secondary endpoints were magnetic resonance imaging (MRI) measures of disease activity at 12 months. Safety and tolerability were also assessed.
A total of 859 patients (80.7%) completed the study. Over its 12 months, the relapse rate was 0.153 with Gilenya 0.5 mg, and 0.258 with Copaxone, a 40.7% difference. The 0.25 mg dose of Gilenya had a 14.6% rate difference to Copaxone, but this was not statistically significant.
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