Glatiramer Acetate (Copaxone®) in the Treatment of Relapsing/Remitting Cerebrospinal Multiple Sclerosis – Clinical Efficacy and Safety Profile

Czech version

Authors: P. Štourač ^1,2; P. Praksová ¹; I. Kontrová ¹; M. Hladíková ¹; I. Okáčová ¹; Y. Benešová ¹
Authors‘ workplace: Neurologická klinika LF MU a FN Brno ¹; CEITEC (Středoevropský technologický institut), MU, Brno ²
Published in: Cesk Slov Neurol N 2011; 74/107(4): 447-454
Category: Original Paper

Overview

This extensive study of multiple sclerosis (MS) aims to evaluate the influence of glatiramer acetate (Copaxone^®) on relapse rate, disease progression and changes in fatigue and quality of life (QoL) parameters in order to strengthen the profile of this immunomodulator through focusing on lesser-known but important clinical aspects. Glatiramer acetate is an effective long-term treatment for relapsing-remitting MS (RRMS), reducing relapse rate and stabilizing disease progression. The study covered the years 2006–2010 with a cohort consisting of 766 patients (n = 766) with RRMS. However, not all of them had complete records, which is reflected in the numbers of patients in specific subgroups. Patients received subcutaneous glatiramer acetate 20 mg once daily and were subsequently followed up for 13 months. Our study evaluated demographic data, annual relapse rate, EDSS progression, and QoL and fatigue scale questionnaires. The project was approved by the local ethics committees. Statistical significance was tested by T-test at a level of p<0.05. The average annual relapse rate (A-RR) was 1.8 before treatment and 0.46 after one year’s treatment. EDDS values were on average 2.63 before treatment, and 2.54 after 1 year’s treatment. QoL questionnaire results showed improvements in family relations, health concerns, tiredness and conservation of energy (p <0.01). The fatigue impact scale questionnaire disclosed statistically significant improvement for certain factors, such as flexibility, social isolation, working abilities, motivation, mental concentration and lesser rest requirement (p < 0.01–0.04). We conclude that significantly reduced A-RR and non-significant EDSS improvement were basic results confirming the efficacy of glatiramer acetate in this clinical observational study. Statistically significant improvement in various factors in QoL and fatigue impact scale questionnaires support the notion of a wider clinical impact for glatiramer acetate treatment in daily practice.

Key words:
multiple sclerosis – glatiramer acetate – treatment efficacy and safety

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