Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study.

Background: The aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month period. A noninterventional cohort study was conducted on 185 patients. The patients had a confirmed and documented diagnosis of relapsing-remitting multiple sclerosis as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by glatiramer acetate 40 mg/mL was just started.

Methods: Adverse drug reactions, relapse rate, magnetic resonance imaging parameters, and Expanded Disability Status Scale score were evaluated over 1 year.

Results: Of 185 enrolled patients from 21 different cities, 170 completed the study. The mean (SD) Expanded Disability Status Scale score was 1.97 (0.75) at the time of screening. The mean age was 33 years with an average of 4-year multiple sclerosis history, and 83% were women. Hepatic disorder and depression were the most frequent medical history. The most common adverse drug reactions were local pain (45.4%) and erythema (38.9%). The immediate postinjection reactions included dyspnea (10.3%), anxiety (9.7%), palpitation (8.1%), urticaria (5.4%), flushing (3.24%), chest pain (2.16%), and throat constriction (0.54%). The percentage of relapse-free patients at Month 12 was 87%, and the annual relapse rate was 0.134. An increase in the Expanded Disability Status Scale score was observed in 20% of patients, and new T2 and gadolinium-enhancing lesions were found in 34.7% and 9.4%, respectively. The rate of treatment failure was 1.6% and 4.3% according to the Modified Rio and Rio scores, respectively.

Conclusions: The 40 mg brand-generic glatiramer acetate product was well tolerated in this selected group of Iranian patients with relapsing-remitting multiple sclerosis, and patient adherence was favorable over 1 year. ( Curr Ther Res Clin Exp . 2018; 79:XXX-XXX).