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Drugs. 2019 Dec;79(18):1965-1976. doi: 10.1007/s40265-019-01229-3.
Dimethyl fumarate (Tecfidera) is approved for the treatment of relapsing forms of multiple sclerosis (MS). Based on evidence from the clinical trial and real-world settings, dimethyl fumarate is an effective treatment in this patient population, with benefits maintained over the longer term. In the pivotal, placebo-controlled phase III DEFINE and CONFIRM trials in adults with relapsing-remitting multiple sclerosis (RRMS), twice-daily dimethyl fumarate reduced clinical relapse and MRI measures of disease activity and improved some aspects of health-related quality of life (HR-QoL). Reduced disability progression was also observed with dimethyl fumarate in DEFINE. Results in predominantly East Asian patients (APEX trial) were reflective of those seen in DEFINE and CONFIRM. Dimethyl fumarate had an acceptable tolerability profile. The most common adverse events were flushing and gastrointestinal events, which were of mild or moderate severity and appear to be largely manageable. Thus twice-daily dimethyl fumarate remains an effective treatment option for use in patients with RRMS, with the convenience of oral administration.
富马酸二甲酯（特立氟胺）获批用于治疗复发型多发性硬化症（MS）。基于临床试验和真实世界环境中的证据，富马酸二甲酯在该患者人群中是一种有效的治疗药物，其疗效在长期内得以维持。在成人复发缓解型多发性硬化症（RRMS）的关键性、安慰剂对照 III 期DEFINE 和 CONFIRM 试验中，每日两次的富马酸二甲酯可降低临床复发和 MRI 疾病活动指标，并改善某些与健康相关的生活质量（HR-QoL）方面。DEFINE 中也观察到富马酸二甲酯可降低残疾进展。在以东亚患者为主的患者中（APEX 试验），结果与DEFINE 和 CONFIRM 中观察到的结果一致。富马酸二甲酯具有可接受的耐受性。最常见的不良事件是潮红和胃肠道事件，这些事件的严重程度为轻度或中度，且似乎基本可控。因此，每日两次的富马酸二甲酯仍然是 RRMS 患者的有效治疗选择，且具有口服给药的便利性。
