AMETYST – Results of an Observational Phase IV Clinical Study Evaluating the Effect of Intramuscular Interferon Beta-1a Therapy in Patients with Clinically Isolated Syndrome or Clinically Definite Multiple Sclerosis

Czech version

Authors: P. Štourač ¹; D. Horáková ²;  e. Klímová ³; P. Turčáni ⁴
Authors‘ workplace: Neurologická klinika LF MU a FN Brno ¹; Neurologická klinika a Centrum klinických neurověd 1. LF UK a VFN v Praze ²; FZ PU a FNsP J. A. Reimana v Prešově ³; Neurologická klinika 1. LF UK a UN Bratislava ⁴
Published in: Cesk Slov Neurol N 2017; 80(6): 660-665
Category: Original Paper
doi: https://doi.org/10.14735/amcsnn2017660

Poděkování kolektivu lékařů českých a slovenských MS center a firmě Biogen za provedení klinické studie AMETYST.

Overview

Introduction:
AMETYST, a prospective, non-interventional phase IV clinical study, evaluating subjective and objective parameters of 3-year intramuscular interferon beta-1a therapy in patients with clinically isolated syndrome or clinically definite multiple sclerosis.

Aim:
The primary objective of the study was to evaluate the impact of the study treatment on quality of life assessed by the patient using the visual analogue scale (VAS) and 36-item Short Form Health Survey. Secondary objectives included quality of life assessed using the VAS by the physician, assessment of cognitive functions by the physician using the PASAT test, the occurrence of relapses in the course of the study and the development of clinically definite multiple sclerosis in patients with clinically isolated syndrome, and the evaluation of weekly intramuscular injection administration by patient.

Material and methods:
The study was conducted in centres specialized in the treatment of multiple sclerosis – 14 sites in the Czech Republic and 10 sites in Slovakia. A total of 559 patients were enrolled in the study. Clinical parameters were assessed every six months, the other parameters every 12 months. An analysis of data was performed using descriptive statistic methods. To eliminate the impact of prematurely withdrawn patients on the study results, the data of patients who completed all study visits were analysed separately.

Results:
An improvement of the quality of life was detected during the study treatment; however, this improvement was only mild or unconvincing. The quality of life assessed by patient corresponded very well to the quality of life assessed by the physician.

Conclusion:
It was confirmed that the treatment has an important effect on relapse rate reduction and stabilization of patients’ clinical status, including their cognitive functions.

Key words:
multiple sclerosis – clinically isolated syndrome – quality of life – cognition – clinical course

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

Chinese summary - 摘要

AMETYST - 观察性IV期临床研究结果评估肌肉干扰素β-1a治疗对临床孤立综合征或临床确诊多发性硬化症患者的影响

介绍：

AMETYST，一项前瞻性、非介入性IV期临床研究被用来评估临床孤立综合征或临床确诊多发性硬化症患者3年肌注干扰素β-1a治疗的主观和客观指标。

目标：

该研究的主要目的是使用由病人自评的视觉模拟量表（VAS）和36项简版健康调查来评估研究治疗对生活质量的影响。次要目的包括：由医生使用VAS评估患者的生活质量，由医生使用PASAT测试评估其认知功能，研究过程中的发病率，独立症状多发性硬化症的发展、以及患者对每周肌内注射的评价。

材料和方法：

这项研究是在专门治疗多发性硬化症的中心进行的，在捷克共有14个中心，斯洛伐克有10个中心。共有559名患者参加了这项研究。临床数据每6个月评估一次，其他参数每12个月评估一次。数据分析使用描述性统计方法进行。为了消除提前退出患者对研究结果的影响，仅对完成了所有访问的患者的数据进行了分析。

结果：

研究发现患者治疗期间的生活质量有一定改善。然而，这种改善只是轻微的或不能令人信服。患者自评的生活质量与医生评估的生活质量非常吻合。

结论：

确认治疗对降低复发率和稳定患者临床状况（包括认知功能）有重要作用。

关键词：

多发性硬化 - 临床孤立综合征 - 生活质量 - 认知 - 临床过程

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