Effect of subcutaneously administered interferon β-1a on disease activity in patients with clinically isolated syndrome – ATRACT observational study

Česká verzia

Authors: E. Meluzínová ¹; A. Tvaroh ^2,3; M. Bludovská ^4,5; J. Piťha ²; M. Vališ ⁶; J. Mareš ⁷; Y. Benešová ⁸; A. Martinková ⁹; M. Dufek ¹⁰; P. Hradílek ¹¹; R. Ampapa ¹²; M. Grunermelová ¹³; T. Božovský ¹⁴; J. Adámková ¹⁵; D. Zimová ¹⁶
Authors place of work: Neurologická klinika 2. LF UK a FN Motol, Praha ¹; Neurologické oddělení, Nemocnice Teplice, o. z., Krajská zdravotní, a. s. ²; Merck spol. s r. o., Praha ³; Ústav farmakologie a toxikologie, LF UK v Plzni ⁴; Ústav hygieny a preventivní medicíny, LF UK v Plzni ⁵; Neurologická klinika LF UK a FN Hradec Králové ⁶; Neurologická klinika LF UP a FN Olomouc ⁷; Neurologická klinika LF MU a FN Brno ⁸; Neurologická klinika FZS UP a Pardubické krajské nemocnice, a. s. ⁹; I. neurologická klinika LF MU a FN u sv. Anny v Brně ¹⁰; Neurologická klinika LF OU a FN, Ostrava ¹¹; Neurologické oddělení, Nemocnice Jihlava, a. s. ¹²; Neurologická klinika 3. LF UK a Thomayerovy nemocnice, Praha ¹³; Neurologická klinika LF UK a FN, Plzeň ¹⁴; Neurologické oddělení, Nemocnice České Budějovice, a. s. ¹⁵; Neurologická klinika 3. LF UK a FN Královské Vinohrady, Praha ¹⁶
Published in the journal: Cesk Slov Neurol N 2019; 82(4): 442-447
Category: Original Paper
doi: https://doi.org/10.14735/amcsnn2019442

Summary

Background: Several clinical studies have shown that early treatment of clinically isolated syndrome (CIS), can improve the course and prognosis of the disease.

Patients and methods: ATRACT was an observational, non-interventional, prospective, non-comparative, non-randomized, single-arm, open-label, multicentre phase IV study, which primary aim was to investigate a relationship between clinical features of CIS and therapeutic response to 44 μg of subcutaneous interferon (IFN) β-1a administered three times a week. A total number of 250 subjects aged 18 - 65 years, diagnosed with CIS and treated with IFN β-1a, were enrolled in the study. Patients were followed up for 24 months from baseline and during visits scheduled 6, 12, 18 and 24 months after the baseline visit. Data on the disability level (evaluated by Expanded Disability Status Scale [EDSS]), and number and time of relapses were collected.

Results: The proportion of clinically stable subjects was 75.11% within the first year after the treatment initiation, and 59.11% at the end of the follow-up period. Throughout the 2 years, majority of subjects (85.45%) did not experience 3-month confirmed EDSS progression, and the proportion of relapse-free subjects was 62.67%. There was no significant difference in clinical activity between subgroups with mono- and polysymptomatic CIS.

Conclusion: IFN β-1a treatment led to a stabilization of clinical activity in most subjects with CIS within 2 years. The clinical stabilization had not been affected by the clinical nature of CIS and the initial MRI finding.

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.

皮下注射干扰素β-1a对临床孤立综合征患者疾病活动的影响– ATRACT观察性研究

背景：多项临床研究表明，临床隔离综合征（CIS）的早期治疗可以改善疾病的病程和预后。

患者和方法：ATRACT是一项观察性，非干预性，前瞻性，非比较性，非随机性，单组，开放标签，多中心IV期研究，其主要目的是研究CIS与临床特征之间的关系。每周3次对44μg皮下干扰素（IFN）β-1a的治疗反应。该研究共纳入250名年龄在18-65岁之间的，被诊断为CIS并接受IFNβ-1a治疗的受试者。从基线开始对患者进行24个月的随访，并在基线随访后的6、12、18和24个月进行随访。收集有关残疾水平的数据（通过扩展的残疾状态量表[EDSS]进行评估）以及复发的次数和时间。

结果：临床稳定受试者的比例在治疗开始后的第一年为75.11％，在随访期结束时为59.11％。在整个2年中，大多数受试者（85.45％）没有经历3个月的EDSS确诊进展，无复发受试者的比例为62.67％。具有单症状和多症状CIS的亚组之间的临床活动无显著差异。

结论：IFNβ-1a治疗可导致大多数CIS患者在2年内临床活动稳定。 CIS的临床性质和最初的MRI发现并未影响临床稳定性。

关键词：多发性硬化症–临床孤立综合征–干扰素β-1a–治疗反应–疾病活动

Keywords:

Multiple sclerosis – clinically isolated syndrome – interferon β-1a – treatment response – disease activity

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