Abolfazli Roya, Sahraian Mohammad Ali, Tayebi Atefeh, Kafi Hamidreza, Samadzadeh Sara
Department of Neurology, Amiralam Hospital, Tehran University of Medical Sciences, Tehran 11457-65111, Iran.
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran 19978-66837, Iran.
J Clin Med. 2023 Jul 27;12(15):4937. doi: 10.3390/jcm12154937.
This study evaluates the real-world safety and discontinuation rate of Zadiva (generic product of dimethyl fumarate (DMF)) in Iranian patients with relapsing-remitting multiple sclerosis (RRMS), supplementing existing clinical evidence from randomized controlled trials.
This retrospective observational study evaluated the real-world safety and discontinuation rate of DMF in RRMS patients from Amir A'lam referral hospital's neurology clinic. Data on safety, discontinuation rate, and clinical disease activity were collected retrospectively. The study aimed to assess the discontinuation rate, safety, and reasons for discontinuation, as well as the number of patients experiencing a relapse, MRI activity, and EDSS scores.
In total, 142 RRMS patients receiving DMF were included in the study, with 15 discontinuing treatment due to adverse events, lack of efficacy, or pregnancy. Notably, a significant reduction in relapse rates was observed, with 90.8% of patients remaining relapse-free throughout the study period. After 1 year of treatment with Zadiva, only 17.6% of patients experienced MRI activity, whereas the EDSS score remained stable.
This study provides important real-world data on the safety and tolerability of Zadiva in RRMS patients. The results indicate that Zadiva is generally well tolerated and safe, with a low discontinuation rate due to adverse events or lack of efficacy. These findings suggest that Zadiva is an effective and safe treatment option for RRMS patients in real-world practice.
本研究评估了Zadiva（富马酸二甲酯（DMF）的仿制药）在伊朗复发缓解型多发性硬化症（RRMS）患者中的真实世界安全性和停药率，补充了随机对照试验的现有临床证据。
这项回顾性观察研究评估了阿米尔·阿拉姆转诊医院神经科诊所RRMS患者中DMF的真实世界安全性和停药率。回顾性收集了有关安全性、停药率和临床疾病活动的数据。该研究旨在评估停药率、安全性和停药原因，以及复发患者数量、MRI活动和扩展残疾状态量表（EDSS）评分。
本研究共纳入142例接受DMF治疗的RRMS患者，其中15例因不良事件、缺乏疗效或妊娠而停药。值得注意的是，观察到复发率显著降低，90.8%的患者在整个研究期间无复发。使用Zadiva治疗1年后，只有17.6%的患者出现MRI活动，而EDSS评分保持稳定。
本研究提供了关于Zadiva在RRMS患者中安全性和耐受性的重要真实世界数据。结果表明，Zadiva总体耐受性良好且安全，因不良事件或缺乏疗效导致的停药率较低。这些发现表明，在实际临床实践中，Zadiva是RRMS患者一种有效且安全的治疗选择。
