Multiple Sclerosis: clinical aspectsMonday, June 22, 2009, 14:00 - 14:15Majority of patients with relapsing multiple sclerosis receiving oral fingolimod (FTY720, a sphingosine-1-phosphate receptor modulator) remain free from any inflammatory activity: results of a 4-yr, phase II extensionL. Kappos, E.W. Radue, P.W. O'Connor, X. Montalban, J. Antel, G. Karlsson, H. Pohlmann, A. de Vera, G. Comi on behalf of the FTY720D2201 Study Group
Objective: In the 6M (month) Phase II study in patients (n=281) with relapsing MS, oral fingolimod (1.25 and 5 mg) reduced Gd+ lesions by up to 80% and the annualized relapse rate (ARR) by >50% vs. placebo. We report the number of patients free of any new inflammatory activity (defined as % patients with no new T2 and no Gd+ T1 lesions) at M48.
Methods: Placebo-treated patients entering the extension were re-randomized to 1.25 or 5 mg while the fingolimod groups continued. From M15-24 on, all patients received open-label fingolimod 1.25 mg. Gd+T1 and new T2-hyperintense MRI lesions, relapses, Expanded Disability Status Score (EDSS), and adverse events (AEs) were recorded at pre-defined time points. 48M analyses used descriptive statistics.
Results: At M48, 155 patients were still participating in the extension study and the number (mean/median) of Gd+ T1 lesions (0.1/0.0) and new T2 lesions (0.5/0.0) were low. At M6, the % of patients free from new T2 and GD+ T1 lesions compared to M5, for the placebo and continuous fingolimod 1.25 and 5 mg groups, were 47.5%, 77%, and 80.7% respectively. At M48, the % of patients free of new inflammatory activity since M36, for the placebo/fingolimod 1.25 mg and continuous fingolimod 1.25 and 5/1.25 mg groups, were 88.2%, 78.8%, and 80%, respectively. At M48, patients continuously treated with fingolimod (1.25 or 5/1.25 mg) had a low ARR (0.18 or 0.20) respectively, and 63-70% of these patients remain relapse free; 51% of patients who switched to fingolimod from placebo at M7 were relapse-free. In all groups, most patients (65-75%), were free from 6M confirmed disability progression. Nasopharyngitis, headache, influenza, fatigue, and back pain were the most frequently reported AEs (>15% patients).
Conclusion: After 4 yrs, the majority of patients using oral fingolimod remained free from any MRI inflammatory activity, relapses and disability progression. The safety experience with one year longer exposure was similar to that previously reported
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