Estudio comparativo con asignación aleatoria y evaluador ciego para determinar el efecto sobre las Moléculas de Adhesión Celular Vascular Solubles (sVCAM) del Interferón Beta 1a biogenérico de producción mexicana contra un Interferón Beta 1a de producción internacional en pacientes con Esclerosis Múltiple Remitente-Recurrente (EMRR)

Introduction: Due to the fact that the multiple sclerosis is an autoimmune disease characterized by the presence of multifocal areas of demyelinization in the nervous central system, the Interferon Beta 1a has been outlined as the viable treatment for this suffering, especially of the relapsing-remitting type. Objective: To compare two INF b 1a of different brands measuring their effect on the induction of them sVCAM-1. Material and methods: The effect of two different sources of Interferon Beta 1a (INF β 1a) on the soluble Vascular Cell Adhesion Molecules (sVCAM-1) in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) was compared. Patients were randomized to receive either, INF β 1a (12 MUI, sc) from a standard international source, or INF β 1a from a Mexican source (same dose), three times weekly during 12 weeks. Serum sVCAM-1 levels were measured before and several weeks after treatment. Quality of life was also assesses before and three months after treatment. Results: sVCAM-1 levels were increased after treatment more than 60% in both groups. Adverse events were similar for both INF β 1a brands. Conclusion: Safety profiles and effect on serum sVCAM-1 were similar for both groups; no differences were found regarding gender, age, baseline or final disease status. This is the first worldwide study to compare the cellular immunologic effect of the international INF β 1a versus a biogeneric.