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


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‘ workplace: Neurologická klinika 2. LF UK a FN Motol, Praha 1;  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;  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
Published in: Cesk Slov Neurol N 2019; 82(4): 442-447
Category: Original Paper
doi: 10.14735/amcsnn2019442

Overview

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.

Keywords:

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


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Paediatric neurology Neurosurgery Neurology

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