Tampa Neurology Associates, South Tampa Multiple Sclerosis Center, Tampa, FL 33609, USA.
J Med Econ. 2013 Jul;16(7):859-65. doi: 10.3111/13696998.2013.802239. Epub 2013 May 20.
The study to Evaluate Patient OutComes, Safety, and Tolerability of Fingolimod (EPOC; NCT01216072) aimed to test the hypothesis that therapy change to oral Gilenya (Novartis AG, Stein, Switzerland) (fingolimod) improves patient-reported outcomes compared with standard-of-care disease-modifying therapy (DMT) in patients with relapsing multiple sclerosis; safety and tolerability were also assessed. This communication describes the study rationale and design.
EPOC is a phase 4, open-label, multi-center study conducted in the US and Canada of patients with relapsing forms of multiple sclerosis who are candidates for therapy change. Therapy change eligibility was determined by the treating physician (US patients) or required an inadequate response to or poor tolerance for at least 1 MS therapy (Canadian patients). Patients were randomly assigned in a 3:1 ratio to 6 months of treatment with once-daily oral fingolimod 0.5 mg or standard-of-care DMTs. The primary study end-point was the change from baseline in treatment satisfaction as determined by the global satisfaction sub-scale of the Treatment Satisfaction Questionnaire for Medication. Secondary end-points included changes from baseline in perceived effectiveness and side-effects, and measures of activities of daily living, fatigue, depression, and quality-of-life. A 3-month open-label fingolimod extension was available for patients randomly assigned to the DMT group who successfully completed all study visits.
Enrollment has been completed with 1053 patients; the patient population is generally older and has a longer duration of disease compared with populations from phase 3 studies of fingolimod.
Inclusion criteria selected for patients with a sub-optimal experience with a previous DMT, limiting the collection of data on therapy change in patients who were satisfied with their previous DMT.
Results of the EPOC study are anticipated in early 2013 and will inform treatment selection by providing patient-centered data on therapy switch to fingolimod or standard-of-care DMTs.
ClinicalTrials.gov NCT01216072.
评估芬戈莫德（EPOC；NCT01216072）的患者结局、安全性和耐受性的研究旨在检验以下假设：与标准治疗疾病修正疗法（DMT）相比，改变为口服加利仑雅（诺华公司，瑞士施泰因）（芬戈莫德）可改善复发型多发性硬化症患者的报告结局；还评估了安全性和耐受性。本通讯介绍了研究的原理和设计。
EPOC 是在美国和加拿大进行的一项 4 期、开放标签、多中心研究，纳入适合改变治疗方案的复发型多发性硬化症患者。改变治疗方案的资格由主治医生（美国患者）确定，或至少有 1 种 MS 治疗药物疗效欠佳或耐受性差（加拿大患者）。患者按 3:1 的比例随机分配，接受为期 6 个月的每日一次口服芬戈莫德 0.5mg 或标准治疗 DMT。主要研究终点是治疗满意度的变化，通过用药治疗满意度问卷的总体满意度子量表确定。次要终点包括从基线开始感知有效性和副作用的变化，以及日常生活活动、疲劳、抑郁和生活质量的测量。成功完成所有研究访视的随机分配至 DMT 组的患者可接受为期 3 个月的开放性芬戈莫德扩展治疗。
已完成 1053 例患者的入组；与芬戈莫德 3 期研究人群相比，患者人群通常年龄更大，疾病持续时间更长。
纳入标准选择了之前 DMT 治疗效果不佳的患者，限制了对以前 DMT 治疗满意的患者的治疗改变数据的收集。
EPOC 研究的结果预计在 2013 年初公布，将提供以患者为中心的数据，以告知对芬戈莫德或标准治疗 DMT 的治疗选择。
ClinicalTrials.gov NCT01216072。
