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Academia Mexicana de Neurología, A.C.

2014, Number 6

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Rev Mex Neuroci 2014; 15 (6)

Open label, extension-of-PRO-3209 trial to assess efficacy and safety of Probioglat® (glatiramer acetate) in Mexican patients with relapsing-remitting multiple sclerosis. Interim report of the first 12 months of treatment (Study PRO-4109).

López-Ruiz M, Ruiz-Sandoval JL, Barroso-Rodríguez NS, Cantú-Brito CG, Violante-Villanueva JA, Molina-Pérez A, Revilla-Beltri J

Language: Spanish
References: 18
Page: 307-314
PDF size: 175.27 Kb.


ABSTRACT

Objectve: To evaluate the efficacy and safety of Probioglat® by the occurrence of multiple sclerosis (MS) relapses, changes in disability, the emergence and evolution of demyelinating lesions viewed on magnetic resonance imaging (MRI), and the occurrence of adverse events in patients with relapsing-remitting multiple sclerosis (RRMS).
Methods: A multicenter, open, non-comparative, longitudinal and prospective study in patients from a previous study (Study PRO-3209) and new patients. Patients received Probioglat® 20 mg subcutaneously daily for a period of 24 months; this report presents the results of the first year of treatment of Study PRO-4109.
Results: A total of 54 patients were included and 8 patients discontinued the study; 39 patients were from the previous study (PRO-3209) and 15 were new patients. The mean age was 34 years and 30 of the patients were women. Twelve patients (22%, 95% CI: 14.5 to 38.2) had MS relapses; the annualized relapse rate was 0.29 (IC 95%: 0.14 a 0.44). The Expanded Disability Status Scale (EDSS) scores had no notable changes from baseline to 12 months. The mean change was -0,046 (standard deviation: 0.92). The demyelinating active lesions identified by gadolinium-contrasted MRI scans (Gad+) tended to decrease in size and intensity. The number of Gad+ lesions decreased significantly from baseline to 12 months (p = 0.0011, paired t-test). Thirty-seven patients (68.5%) presented at least one adverse event during the study. Injection site reaction was the most frequent adverse event, which was reported in 16 patients (29.6%), followed by depression in 11 patients (20.4%) and fatigue in other 9 patients (16.6%).
Conclusions: The interim analysis of the study found that the administration of Probioglat® in a daily subcutaneous dose of 20 mg in Mexican patients with RRMS for 12 months showed beneficial effect: reduced EM relapses, decreased the progression of disability and the number of new demyelinating lesions. The treatment was also safe and well-tolerated. However, it’s recommended completing 24 months of treatment to obtain final results.


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