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Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension.
BMC Neurol. 2014 Jan 29; 14:21.BN

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.

Authors+Show Affiliations

Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. kira@neuro.med.kyushu-u.ac.jp.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Observational Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24475777

Citation

Kira, Jun-ichi, et al. "Fingolimod (FTY720) Therapy in Japanese Patients With Relapsing Multiple Sclerosis Over 12 Months: Results of a Phase 2 Observational Extension." BMC Neurology, vol. 14, 2014, p. 21.
Kira J, Itoyama Y, Kikuchi S, et al. Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension. BMC Neurol. 2014;14:21.
Kira, J., Itoyama, Y., Kikuchi, S., Hao, Q., Kurosawa, T., Nagato, K., Tsumiyama, I., von Rosenstiel, P., Zhang-Auberson, L., & Saida, T. (2014). Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension. BMC Neurology, 14, 21. https://doi.org/10.1186/1471-2377-14-21
Kira J, et al. Fingolimod (FTY720) Therapy in Japanese Patients With Relapsing Multiple Sclerosis Over 12 Months: Results of a Phase 2 Observational Extension. BMC Neurol. 2014 Jan 29;14:21. PubMed PMID: 24475777.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension. AU - Kira,Jun-ichi, AU - Itoyama,Yasuto, AU - Kikuchi,Seiji, AU - Hao,Qi, AU - Kurosawa,Takayoshi, AU - Nagato,Kazuo, AU - Tsumiyama,Isao, AU - von Rosenstiel,Philipp, AU - Zhang-Auberson,Lixin, AU - Saida,Takahiko, Y1 - 2014/01/29/ PY - 2013/04/18/received PY - 2014/01/24/accepted PY - 2014/1/31/entrez PY - 2014/1/31/pubmed PY - 2014/9/24/medline SP - 21 EP - 21 JF - BMC neurology JO - BMC Neurol VL - 14 N2 - 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. SN - 1471-2377 UR - https://www.unboundmedicine.com/medline/citation/24475777/Fingolimod__FTY720__therapy_in_Japanese_patients_with_relapsing_multiple_sclerosis_over_12_months:_results_of_a_phase_2_observational_extension_ L2 - https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-14-21 DB - PRIME DP - Unbound Medicine ER -