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Open Access Research article

Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension

Jun-ichi Kira1*, Yasuto Itoyama2, Seiji Kikuchi3, Qi Hao4, Takayoshi Kurosawa5, Kazuo Nagato6, Isao Tsumiyama5, Philipp von Rosenstiel7, Lixin Zhang-Auberson7 and Takahiko Saida489

Author Affiliations

1 Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

2 National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan

3 Hokkaido Medical Center, National Hospital Organization, Sapporo, Japan

4 Institute of Neurotherapeutics, Kyoto, Japan

5 Novartis Pharma KK, Tokyo, Japan

6 Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan

7 Novartis Pharma AG, Basel, Switzerland

8 Department of Neurology, Kyoto Min-Iren-Central Hospital, Kyoto, Japan

9 Kyoto University Hospital, Kyoto, Japan

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BMC Neurology 2014, 14:21  doi:10.1186/1471-2377-14-21

Published: 29 January 2014

Abstract

Background

A 6-month phase 2 study of fingolimod demonstrated efficacy and safety in Japanese patients with relapsing-remitting multiple sclerosis (MS). Here we report a 6-month observational extension that evaluated efficacy and safety in patients who received fingolimod continuously for 12 months or who switched from placebo to fingolimod.

Methods

Of 147 patients who completed the 6-month core study, 143 entered the extension. Those originally randomized to placebo were re-randomized to fingolimod 1.25 mg or 0.5 mg. During the extension, all patients were switched to open-label fingolimod 0.5 mg.

Results

Magnetic resonance imaging (MRI) and relapse outcomes were maintained or improved in patients treated with fingolimod for 12 months versus those treated for 6 months. No new safety events were reported over 12 months of treatment. Infections occurred in similar proportions of continuously treated and switched patients, while cardiac and liver adverse events occurred in fewer continuously treated than switched patients. Four patients were aquaporin-4 (AQP4) antibody-positive, three of whom showed rapid disease exacerbations within 10 days of fingolimod initiation.

Conclusion

Continuous fingolimod treatment for up to 12 months was associated with maintained or improved efficacy and a manageable safety profile, consistent with that previously seen. Results in a small number of patients suggest lack of benefit in AQP4 antibody-positive patients. Meaningful statistical interpretation was limited by the small sample size in each treatment group, owing to the number of patients who completed the core study.

Trial registration

ClinicalTrials.gov NCT00670449

Keywords:
Aquaporin 4; Fingolimod; Longitudinally extensive spinal cord lesions; Multiple sclerosis; Phase 2 study