EUROPEAN JOURNAL OF NEUROLOGY
Volume 24, Supplement 1, June 2017
Abstracts of the 3rd Congress of the European Academy of Neurology
Amsterdam, The Netherlands
Observational cohort study on safety and efficacy of copamer (a new brand-generic
Glatiramer acetate) 40mg in Iranian patients with RRMS
R. Abolfazli1, S. Pournourmohammadi2, S. Samadzadeh1,A.R. Shamshiri3, J. Alaghehmandi2
1Amiralam hospital, 2Zahravi Pharmaceutical Company, Tehran, Iran, Islamic Republic of, 3School of
Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Objective: The aim of this study is to evaluate the safety, tolerability and efficacy of a brand-generic Glatiramer acetate (GA) 40 mg, in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) over a 12-month period.
Methods: A non-interventional cohort study was conducted on 185 patients who had a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria (2010), besides who were ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.5, and whose treatment by GA 40mg/ml was just started. Adverse drug reactions (ADR), relapse rate, MRI parameters and EDSS were evaluated over one year.
Results: of 185 enrolled patients, 170 patients completed the study. The mean value of EDSS at the time of screening was 1.97±0.75 and 100% of subjects had experienced one relapse during one year before screening. The most common ADRs were local pain (45.4%) and erythema (38.9%). The immediate post injections reaction were dyspnea (10.3%), anxiety (9.7%), palpitation (8.1%), urticaria (5.4%), Flushing (3.24%), chest pain (2.16%), throat constriction (0.54%). The percentage of relapse-free patients at month 12 was 87% compared to 77% and the annual relapse rate was 0.134 compared to 0.301 reported on Copaxon®. Increased in EDSS was found in 20% of subjects and new T2 and GAD enhancing lesions were found in 34.7% and 9.4%, respectively. Treatment failure were 1.6% and 4.3% according to Modified Rio- and Rio-scores, respectively.
Conclusion: Copamer® 40 mg is safe, well tolerated and effective in Iranian patients with RRMS and it is fully substitutable for Copaxone®.