Inter-department Multiple Sclerosis Research Centre, IRCCS Mondino Mondino, Pavia, Italy.
Multiple Sclerosis Study Centre, ASST Valle Olona, Gallarate, VA, Italy.
J Neurol. 2018 Aug;265(8):1850-1859. doi: 10.1007/s00415-018-8916-6. Epub 2018 Jun 14.
Dimethyl-fumarate (DMF) demonstrated efficacy and safety in relapsing-remitting multiple sclerosis (MS) in randomized clinical trials.
To track and evaluate post-market DMF profile in real-world setting.
Patients receiving DMF referred to Italian MS centres were enrolled and prospectively followed, collecting demographic clinical and radiological data.
Among the 735 included patients, 45.4% were naïve to disease-modifying therapies, 17.8% switched to DMF because of tolerance, 27.4% switched to DMF because of lack of efficacy, and 9.4% switched to DMF because of safety concerns. Median DMF exposure was 17 months (0-33). DMF reduced the annual relapse rate (ARR) by 63.2%. At 12 and 24 months, 85 and 76% of patients were relapse-free. NEDA-3 status after 12 months of DMF treatment was maintained by 47.5% of patients. 89 and 70% of patients at 12 and 24 months regularly continued DMF. Most frequent adverse events (AEs) were flushing (37.2%) and gastro-enteric AEs (31.1%).
Our post-market study corroborated that DMF is a safe and effective drug. Additionally, the study suggested that naïve patients strongly benefit from DMF and that DMF improved ARR also in patients who were horizontally switched from injectable therapies due to tolerability and efficacy issues.
富马酸二甲酯（DMF）在复发缓解型多发性硬化症（MS）的随机临床试验中显示出疗效和安全性。
在真实环境中跟踪和评估上市后 DMF 的情况。
将转诊至意大利 MS 中心的接受 DMF 治疗的患者纳入并前瞻性随访，收集人口统计学、临床和影像学数据。
在纳入的 735 例患者中，45.4%为疾病修正治疗初治患者，17.8%因耐受而改用 DMF，27.4%因疗效不佳而改用 DMF，9.4%因安全性问题而改用 DMF。DMF 的中位暴露时间为 17 个月（0-33 个月）。DMF 使年复发率（ARR）降低了 63.2%。在 12 个月和 24 个月时，85%和 76%的患者无复发。在 DMF 治疗 12 个月后，47.5%的患者达到了 NEDA-3 状态。在 12 个月和 24 个月时，89%和 70%的患者定期继续使用 DMF。最常见的不良反应（AE）是潮红（37.2%）和胃肠道 AE（31.1%）。
我们的上市后研究证实 DMF 是一种安全有效的药物。此外，该研究表明，初治患者从 DMF 中获益最大，并且 DMF 还改善了因耐受性和疗效问题而从注射治疗转换而来的患者的 ARR。
