Department of Neurology, Università Vita-Salute San Raffaele, Milan, Italy.
Mult Scler. 2010 Feb;16(2):197-207. doi: 10.1177/1352458509357065. Epub 2009 Dec 22.
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 5.0 mg switched to 1.25 mg. 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 (3-5 mmHg) 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 months with 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.
在一项为期 6 个月、安慰剂对照的临床试验中，与安慰剂相比，每日口服 fingolimod（FTY720）1.25 或 5.0mg 可显著降低复发型多发性硬化症（MS）患者的 MRI 炎症活动度和年复发率。本研究旨在监测该研究正在进行的扩展研究的 36 个月的中期疗效和安全性结果。在扩展期（第 7-36 个月）中，安慰剂治疗的患者重新随机分配至 fingolimod 的任一剂量；fingolimod 治疗的患者继续接受相同剂量的治疗。在第 15-24 个月时，所有接受 fingolimod 5.0mg 治疗的患者转换为 1.25mg。在进入扩展研究的 250 例患者中，173 例（69%）患者持续至第 36 个月。在第 36 个月时，大多数患者无钆增强病灶（88-89%）或新的 T2 病灶（70-78%）。接受持续 fingolimod 治疗的患者年复发率持续较低，为 0.20-0.21，68-73%的患者在第 36 个月时无复发。在 36 个月期间，最常见的不良反应为鼻咽炎（34%）、头痛（30%）、疲劳（19%）和流感（18%）。肺功能在 fingolimod 治疗的前 6 个月内稳定，血压稳定，初始时升高（3-5mmHg）；严重不良反应包括感染和皮肤癌。在 36 个月时，fingolimod 可维持 6 个月时的低 MRI 和临床疾病活动度，大多数患者对其具有良好的耐受性。口服 fingolimod 的疗效和安全性正在一项大型 III 期 MS 研究项目中进一步评估。
