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

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


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


1. Arnon R. The development of Cop 1 (Copaxone), an innovative drug for the treatment of multiple sclerosis: personal reflections. Immunol Lett 1996; 50(1–2): 1–15.

2. Schrempf W, Ziemssen T. Glatiramer acetate: mechanisms of action in multiple sclerosis. Autoimmun Rev 2007; 6(7): 469–475.

3. Blanchette F, Neuhaus O. Glatiramer acetate: evidence for a dual mechanism of action. J Neurol 2008; 255 (Suppl 1): 26–36.

4. Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP et al. Copolymer 1 reduces relaps rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology 1995; 45(7): 1268–1276.

5. Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe) study: a randomised, double-blind, placebo-controlled trial. Lancet 2009; 374(9700): 1503–1511.

6. Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ. The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 1994; 21(1): 9–14.

7. Ziemssen T, Hoffman J, Apel R, Kern S. Effects of glatiramer acetate on fatigue and days of absence from work in the first time treated relapsing-remitting multiple sclerosis. Health Qual Life Outcomes 2008; 6: 67.

8. Berger JF, Houff S. Opportunistic infections and other risks with newer multiple sclerosis therapies. Ann Neurol 2009; 65(4): 367–377.

9. Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR et al. Comparison of subcutaneuos interferon-beta 1b with glatiramer acetate in patients with relapsing multiple sclerosis (the Rebif vs Glatiramer acetate in Relapsing MS Disease (Regard study): a multicentre, randomised, parallel, open - label trial. Lancet Neurol 2008; 7(10): 903–914.

10. O’Connor P, Fillipi M, Arnason B, Comi G, Cook S, Goodin D et al. 250 microg or 500 microg interferon beta 1b versus 20 mg glatiramer acetate in relapsing- remitting multiple sclerosis: a prospective randomised, multicentre study. Lancet Neurol 2009; 8(10): 889–897.

11. Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K et al. Efficacy of treatment of MS with IFNB-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurol 2009: 72(23): 1976–1983.

12. Ziemssen T, Kumpfel T, Klinkert WEF, Neuhas O, Hohlfeld R. Glatiramer acetate specific T-helper 1 and 2 type cell lines produce BDNF: Implications for multiple sclerosis therapy. Brain 2002; 125(11): 2381–2391.

13. Heesen C, Nawrath L, Reich C. Fatigue in multiple sclerosis: an example of cytokine mediated sickness behaviour? J Neurol Neurosurg Psychiatry 2006; 77(1): 34–39.

Paediatric neurology Neurosurgery Neurology

Article was published in

Czech and Slovak Neurology and Neurosurgery

2011 Issue 4

Most read in this issue
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.


Don‘t have an account?  Create new account