Safety And Pharmacodynamics Comparative Study To Evaluate The Effect Of Glatiramer Acetate (Probioglat((R)) And Copaxone((R))) Study Drug And Reference Over Response Th1, Th2 And Svcam In Patients With Relapsing-Remitting Multiple Sclerosis

INTRODUCTION: Glatiramer acetate is a treatment approved in relapsing remitting multiple sclerosis (RRMS).OBJECTIVE: To evaluate the effect of study glatiramer acetate on CD4 + T lymphocytes levels with Th1 and Th2 phenotype compared with the reference glatiramer acetate in patients with RRMS for 4 months.METHODS: Multicenter, comparative, longitudinal and prospective blinded investigator. Patients were randomized to one of two glatiramer acetate in a 1: 1 ratio. Patients were invited to continue treatment for 24 additional months.RESULTS: A total of 51 patients were included: 28 (55%) were female, mean age of 35 years, 26 to group test glatiramer acetate and 25 to the reference group. There were no significant differences in age, gender and baseline clinical characteristics between groups. Comparing baseline against the end of treatment, it was observed in both groups decreased serum levels of IFN. (Th1 response) and an increase in levels of IL-10 (Th2 response). Probioglat((R)) generated a Th2 response (anti-inflammatory) comparable to Copaxone((R)). The results over sVCAM levels showed few change after drug treatment of both test and for the reference. Antibodies anti-glatiramer acetate was observed in one patient treated with reference glatiramer acetate. Adverse events associated with the use of both drugs are also comparable in frequency and severity.CONCLUSION: The immune response generated by both molecules is similar, suggesting bioequivalence, at least in these parameters, for both compounds.