Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results
Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results
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DOI：
10.1177/1352458509357065
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发表时间：
2010-02-01
期刊：
影响因子：
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通讯作者：
Kappos, L.
中科院分区：
文献类型：
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作者：
Comi, G.;O'Connor, P.;Kappos, L.
在一项为期6个月的安慰剂对照试验中，口服Fingolimod(FTY720)1.25或5.0毫克，每天一次，与安慰剂相比，显著降低了复发性多发性硬化症(MS)患者的MRI炎症活动和年复发率。其目的是监测正在进行的这项研究的36个月中期疗效和安全性结果。在延长期(7-36个月)中，安慰剂治疗的患者被重新随机分配到任一剂量的Fingolimod；Fingolimod治疗的患者继续服用相同的剂量。在15-24个月期间，所有服用Fingolimod 5.0 mg的患者都改为1.25 mg。在进入扩展研究的250名患者中，173名(69%)持续到36个月。大多数患者在36个月时没有Gd强化的病变(88-89%)或新的T2病变(70-78%)。持续接受Fingolimod治疗的患者的年复发率持续较低，为0.20-0.21，在36个月时仍有68%-73%的患者没有复发。在36个月内，鼻咽炎(34%)、头痛(30%)、乏力(19%)和流感(18%)是最常见的不良事件。在Fingolimod治疗的前6个月中，肺功能保持稳定，血压在最初上升(3-5 mmHg)后保持稳定；严重的不良事件包括感染和皮肤癌。6个月时，Fingolimod的MRI和临床疾病活动度维持在36个月，大多数患者对此耐受性良好。口腔指状物的有效性和安全性正在一项大型的III期MS研究计划中进一步评估。
In a 6-month, placebo-controlled trial, oral fingolimod (FTY720) 1.25 or 5.0 mg, once daily, significantly reduced MRI inflammatory activity and annualized relapse rate compared with placebo in patients with relapsing multiple sclerosis (MS). The objectives were to monitor the 36-month, interim efficacy and safety results of the ongoing extension of this study. In the extension (months 7-36), placebo-treated patients were re-randomized to either dose of fingolimod; fingolimod-treated patients continued at the same dose. During months 15-24, all patients receiving fingolimod 5.0mg switched to 1.25mg. Of the 250 patients who entered the extension study, 173 (69%) continued to month 36. Most patients were free from gadolinium-enhanced lesions (88-89%) or new T2 lesions (70-78%) at month 36. Patients receiving continuous fingolimod treatment had sustained low annualized relapse rates of 0.20-0.21, and 68-73% remained relapse-free at month 36. Over 36 months, nasopharyngitis (34%), headache (30%), fatigue (19%) and influenza (18%) were the most commonly reported adverse events. Pulmonary function remained stable and blood pressure was stable after an initial increase (3-5mmHg) during the first 6 months of fingolimod treatment; serious adverse events included infections and skin cancer. The low MRI and clinical disease activity at 6 months were maintained at 36 monthswith fingolimod, which was generally well tolerated by most patients. The efficacy and safety of oral fingolimod are being further evaluated in a large phase III MS study programme.