Abolfazli,S. Pournourmohammadi,S. Samadzadeh,A.R. Shamshiri, J. Alaghehmandi۲
EUROPEAN JOURNAL OF NEUROLOGY
Volume ۲۴, Supplement ۱, June ۲۰۱۷
Abstracts of the ۳rd 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) ۴۰mg in Iranian patients with RRMS
R. Abolfazli۱, S. Pournourmohammadi۲, S. Samadzadeh۱,A.R. Shamshiri۳, J. Alaghehmandi۲
۱Amiralam hospital, ۲Zahravi Pharmaceutical Company, Tehran, Iran, Islamic Republic of, ۳School 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) ۴۰ mg, in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) over a ۱۲-month period.
Methods: A non-interventional cohort study was conducted on ۱۸۵ patients who had a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria (۲۰۱۰), besides who were ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of ۰-۵.۵, and whose treatment by GA ۴۰mg/ml was just started. Adverse drug reactions (ADR), relapse rate, MRI parameters and EDSS were evaluated over one year.
Results: of ۱۸۵ enrolled patients, ۱۷۰ patients completed the study. The mean value of EDSS at the time of screening was ۱.۹۷±۰.۷۵ and ۱۰۰% of subjects had experienced one relapse during one year before screening. The most common ADRs were local pain (۴۵.۴%) and erythema (۳۸.۹%). The immediate post injections reaction were dyspnea (۱۰.۳%), anxiety (۹.۷%), palpitation (۸.۱%), urticaria (۵.۴%), Flushing (۳.۲۴%), chest pain (۲.۱۶%), throat constriction (۰.۵۴%). The percentage of relapse-free patients at month ۱۲ was ۸۷% compared to ۷۷% and the annual relapse rate was ۰.۱۳۴ compared to ۰.۳۰۱ reported on Copaxon®. Increased in EDSS was found in ۲۰% of subjects and new T۲ and GAD enhancing lesions were found in ۳۴.۷% and ۹.۴%, respectively. Treatment failure were ۱.۶% and ۴.۳% according to Modified Rio- and Rio-scores, respectively.
Conclusion: Copamer® ۴۰ mg is safe, well tolerated and effective in Iranian patients with RRMS and it is fully substitutable for Copaxone®.