Abolfazli Roya, Pournourmohammadi Shirin, Shamshiri Ahmadreza, Samadzadeh Sara
Neurology Department, Tehran University of Medical Sciences, Amiralam Hospital, Tehran, Iran.
Medical Affairs Department, Zahravi Pharmaceutical Company, Tehran, Iran.
Curr Ther Res Clin Exp. 2018 May 28;88:47-51. doi: 10.1016/j.curtheres.2018.05.001. eCollection 2018.
The aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month period. A noninterventional cohort study was conducted on 185 patients. The patients had a confirmed and documented diagnosis of relapsing-remitting multiple sclerosis as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by glatiramer acetate 40 mg/mL was just started.
Adverse drug reactions, relapse rate, magnetic resonance imaging parameters, and Expanded Disability Status Scale score were evaluated over 1 year.
Of 185 enrolled patients from 21 different cities, 170 completed the study. The mean (SD) Expanded Disability Status Scale score was 1.97 (0.75) at the time of screening. The mean age was 33 years with an average of 4-year multiple sclerosis history, and 83% were women. Hepatic disorder and depression were the most frequent medical history. The most common adverse drug reactions were local pain (45.4%) and erythema (38.9%). The immediate postinjection reactions included dyspnea (10.3%), anxiety (9.7%), palpitation (8.1%), urticaria (5.4%), flushing (3.24%), chest pain (2.16%), and throat constriction (0.54%). The percentage of relapse-free patients at Month 12 was 87%, and the annual relapse rate was 0.134. An increase in the Expanded Disability Status Scale score was observed in 20% of patients, and new T2 and gadolinium-enhancing lesions were found in 34.7% and 9.4%, respectively. The rate of treatment failure was 1.6% and 4.3% according to the Modified Rio and Rio scores, respectively.
The 40 mg brand-generic glatiramer acetate product was well tolerated in this selected group of Iranian patients with relapsing-remitting multiple sclerosis, and patient adherence was favorable over 1 year. (. 2018; 79:XXX-XXX).
本研究旨在评估一种品牌通用型醋酸格拉替雷产品在复发缓解型多发性硬化症患者中12个月期间的安全性、耐受性和疗效。对185例患者进行了一项非干预性队列研究。这些患者根据修订的麦克唐纳标准（2010年）确诊并记录为复发缓解型多发性硬化症，能够行走，库尔特克扩展残疾状态量表评分为0至5.5，且刚开始接受40mg/mL醋酸格拉替雷治疗。
在1年时间内评估药物不良反应、复发率、磁共振成像参数和扩展残疾状态量表评分。
来自21个不同城市的185例入组患者中，170例完成了研究。筛查时扩展残疾状态量表的平均（标准差）评分为1.97（0.75）。平均年龄为33岁，平均有4年多发性硬化症病史，83%为女性。肝脏疾病和抑郁症是最常见的病史。最常见的药物不良反应是局部疼痛（占45.4%）和红斑（占38.9%）。注射后即刻反应包括呼吸困难（占10.3%）、焦虑（占9.7%）、心悸（占8.1%）、荨麻疹（占5.4%）、潮红（占3.24%）、胸痛（占2.16%）和咽喉紧缩感（占0.54%）。第12个月时无复发患者的比例为87%，年复发率为0.134。20%的患者扩展残疾状态量表评分升高，分别有34.7%和9.4%的患者发现新的T2病灶和钆增强病灶。根据改良里约和里约评分，治疗失败率分别为1.6%和4.3%。
在这群选定的伊朗复发缓解型多发性硬化症患者中，40mg品牌通用型醋酸格拉替雷产品耐受性良好，患者在1年期间的依从性良好。（. 2018；79：XXX - XXX）
