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- Title
Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study.
- Authors
Takahiko Saida; Yasuto Itoyama; Seiji Kikuchi; Qi Hao; Takayoshi Kurosawa; Kengo Ueda; Lixin Zhang Auberson; Isao Tsumiyama; Kazuo Nagato; Jun-ichi Kira; Saida, Takahiko; Itoyama, Yasuto; Kikuchi, Seiji; Hao, Qi; Kurosawa, Takayoshi; Ueda, Kengo; Auberson, Lixin Zhang; Tsumiyama, Isao; Nagato, Kazuo; Kira, Jun-Ichi
- Abstract
<bold>Background: </bold>The low level of disease activity and manageable safety profile seen with fingolimod versus placebo in a 6-month, phase 2, randomized controlled trial in Japanese patients with relapsing multiple sclerosis (MS; ClinicalTrials.gov Identifier NCT00537082) were maintained in the initial 6-month observational study extension. Here, we report long-term safety and efficacy results of the 3-year follow-up to the phase 2 study extension.<bold>Methods: </bold>The 6-month core study was completed by 147 patients, of whom 143 entered the extension and took at least one dose of fingolimod. Those originally randomized to placebo were re-randomized to fingolimod 1.25 mg (n = 23) or 0.5 mg (n = 27). During the extension, the patients taking fingolimod 1.25 mg (n = 46) were switched to open-label fingolimod 0.5 mg, and those originally randomized to fingolimod 0.5 mg (n = 47) continued with open-label fingolimod 0.5 mg.<bold>Results: </bold>Continuous fingolimod treatment was associated with a sustained low level of MRI and relapse activity for the duration of the extension phase; 75-100% (range across all assessment time points up to end of study) of patients remained free of Gd-enhanced T1 lesions, 88-100% remained free of new/newly enlarged T2 lesions, and 45-62% remained relapse-free. In patients who switched to the active treatment, a 79.5% decrease in annualized relapse rate (ARR; from 1.131 before switch to 0.232 6-months after switch) was observed in the first 6 months of the extension phase and thereafter remained low until the end of study (0.16-0.31 across all assessment time points after switch up to end of study). The mean number of Gd-enhanced T1 and new/newly enlarged T2 lesions decreased up to month 9 and thereafter remained low until the end of study (0.0-0.1 and 0.0-0.3, respectively, across all assessment time points after switch up to end of study). Fingolimod was generally well-tolerated and the safety profile was consistent with the core and 6-month extension. Serious adverse events were reported in 13.3% of patients during the extension study, with the range in the continuous fingolimod and placebo-fingolimod switch groups (3.7-21.7%) being similar to that reported in the core study for the placebo and fingolimod groups (5.3-20.4%).<bold>Conclusion: </bold>Continuous fingolimod treatment over 36 months was associated with maintained efficacy and a manageable safety profile with no new safety signals. These results indicate that fingolimod provides long-term treatment benefit for Japanese patients with relapsing MS.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT00670449 (April 28, 2008).
- Subjects
JAPAN; FINGOLIMOD; MULTIPLE sclerosis; RANDOMIZED controlled trials; MAGNETIC resonance imaging; PLACEBOS; JAPANESE people; DISEASES; COMPARATIVE studies; IMMUNOSUPPRESSIVE agents; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; HEALTH outcome assessment; RESEARCH; EVALUATION research; PHARMACODYNAMICS
- Publication
BMC Neurology, 2017, Vol 17, p1
- ISSN
1471-2377
- Publication type
journal article
- DOI
10.1186/s12883-017-0794-5