Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension.
Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension.
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DOI：
10.1186/1471-2377-14-21
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发表时间：
2014-01-29
期刊：
影响因子：
2.6
通讯作者：
Saida T
中科院分区：
文献类型：
--
作者：
Kira J;Itoyama Y;Kikuchi S;Hao Q;Kurosawa T;Nagato K;Tsumiyama I;von Rosenstiel P;Zhang-Auberson L;Saida T
一项为期6个月的芬戈莫德II期研究证明了在日本复发缓解型多发性硬化症（MS）患者中的疗效和安全性。在这里，我们报告了一项为期6个月的观察性扩展研究，评估了连续接受芬戈莫德12个月或从安慰剂转换为芬戈莫德的患者的疗效和安全性。在完成6个月核心研究的147例患者中，143例进入扩展期。最初随机分配至安慰剂组的患者重新随机分配至芬戈莫德1.25 mg或0.5 mg组。在扩展期间，所有患者均转换为开放标签的芬戈莫德0.5 mg。与治疗6个月的患者相比，接受芬戈莫德治疗12个月的患者的磁共振成像（MRI）和复发结局得以维持或改善。在12个月的治疗期间未报告新的安全性事件。感染发生在连续治疗和转换患者中的比例相似，而心脏和肝脏不良事件发生在连续治疗患者中的比例低于转换患者。4例患者为水通道蛋白-4（AQP 4）抗体阳性，其中3例患者在芬戈莫德治疗开始后10天内出现疾病快速加重。连续芬戈莫德治疗长达12个月与维持或改善疗效和可管理的安全性特征相关，与先前观察到的一致。少数患者的结果表明AQP 4抗体阳性患者缺乏益处。由于完成核心研究的患者数量，每个治疗组的样本量较小，限制了有意义的统计学解释。ClinicalTrials.gov NCT00670449
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. 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. 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. 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. ClinicalTrials.gov NCT00670449
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影响因子：
5.8
作者：
Min, Ju-Hong;Kim, Byoung Joon;Lee, Kwang Ho
通讯作者：
Lee, Kwang Ho
影响因子：
9.9
作者：
Wingerchuk, D. M.;Lennon, V. A.;Weinshenker, B. G.
通讯作者：
Weinshenker, B. G.
影响因子：
5.8
作者：
Saida, T.;Kikuchi, S.;Kira, J.
通讯作者：
Kira, J.
DOI：
10.1177/1352458509357065
发表时间：
2010-02-01
期刊：
MULTIPLE SCLEROSIS
影响因子：
--
作者：
Comi, G.;O'Connor, P.;Kappos, L.
通讯作者：
Kappos, L.
影响因子：
158.5
作者：
Cohen, Jeffrey A.;Barkhof, Frederik;Kappos, Ludwig
通讯作者：
Kappos, Ludwig