Yamamura Takashi, Ashtamker Natalia, Ladkani David, Fukazawa Toshiyuki, Houzen Hideki, Tanaka Masami, Miura Toshiro, Knappertz Volker
Department of Immunology National Center of Neurology and Psychiatry National Institute of Neuroscience, and Multiple Sclerosis Center Tokyo Japan.
Research and Development Teva Pharmaceutical Industries Netanya Israel.
Clin Exp Neuroimmunol. 2017 May;8(2):129-137. doi: 10.1111/cen3.12383. Epub 2017 Mar 23.
Multiple sclerosis (MS) prevalence, clinical patterns, and treatment responses vary between races and geographical latitudes. Glatiramer acetate (GA; Copaxone) has provided a safe, effective treatment option for relapsing-remitting MS patients in the USA, European nations, and other countries for decades. The objective of the present study was to assess the safety and efficacy of GA in reducing magnetic resonance imaging disease activity in Japanese patients with active relapsing-remitting MS.
This phase 2, multicenter, open-label, single-arm, 52-week study measured the effect of GA 20 mg once-daily on magnetic resonance imaging disease activity. GA efficacy was evaluated through week 36, and safety through week 52. The primary end-point was change in the mean number of T-weighted gadolinium-enhancing (GdE) lesions from pretreatment (weeks -8, -4 and baseline) to weeks 28, 32 and 36. Secondary end-points included a change in mean number of new T-weighted lesions, GdE lesion and T lesion volumes, annualized relapse rate, and Expanded Disability Status Scale scores.
GA therapy reduced the number of new GdE lesions by 65.66% (95% CI 33.19-82.35%). The number of new T lesions and GdE lesion volume were also reduced from pretreatment. The annualized relapse rate was reduced by 42% compared with the 1 year before treatment. Changes in T lesion volume and Expanded Disability Status Scale scores were favorable, but less pronounced. Most common adverse events were injection-site reactions.
The present study confirmed the well-established safety, tolerability and efficacy profile of GA in Japanese MS patients.
多发性硬化症（MS）的患病率、临床模式及治疗反应在不同种族和地理纬度间存在差异。数十年来，醋酸格拉替雷（GA；考帕松）已为美国、欧洲国家及其他国家的复发缓解型MS患者提供了一种安全有效的治疗选择。本研究的目的是评估GA在降低日本复发缓解型MS活动期患者磁共振成像疾病活动度方面的安全性和有效性。
这项2期、多中心、开放标签、单臂、为期52周的研究测量了每日一次20 mg GA对磁共振成像疾病活动度的影响。在第36周评估GA的疗效，在第52周评估安全性。主要终点是从预处理期（第-8、-4周和基线期）到第28、32和36周T加权钆增强（GdE）病灶平均数量的变化。次要终点包括新T加权病灶平均数量的变化、GdE病灶和T病灶体积、年化复发率以及扩展残疾状态量表评分。
GA治疗使新GdE病灶数量减少了65.66%（95%CI 33.19 - 82.35%）。与预处理期相比，新T病灶数量和GdE病灶体积也有所减少。年化复发率较治疗前1年降低了42%。T病灶体积和扩展残疾状态量表评分的变化是有利的，但不太明显。最常见的不良事件是注射部位反应。
本研究证实了GA在日本MS患者中已确立的安全性、耐受性和疗效。
