Introduction: Ocrelizumab is a humanised monoclonal antibody that targets the CD20 antigen on B cells. It has recently been approved by the US (Food and Drug Administration) and European health agencies (European Medicines Agency) for the treatment of multiple sclerosis (MS) and is the first drug marketed for both relapsing-remitting MS (RRMS) and primary progressive MS (PPMS). The clinical trials conducted for both the relapsing forms (OPERA I/II) and the progressive forms of the disease (ORATORIO) have demonstrated its efficacy. The aim of this review is to address the main aspects of the efficacy and safety of ocrelizumab in MS.
Development: Using PubMed, a literature review was conducted of studies published at the ECTRIMS 2017 Congress and of active studies in ClinicalTrials. In order to evaluate the efficacy and safety of ocrelizumab in MS, both randomised clinical trials and their extension and follow-up studies were reviewed, and information about its safety obtained from monitoring programmes of the Food and Drug Administration and European Medicines Agency was included.
Conclusions: Ocrelizumab is the first drug that has been shown to be able to significantly slow disability progression at 12 and 24 weeks in patients with PPMS. It is also effective in controlling clinical and radiological activity in patients with RRMS forms, and it is approved and indicated for both phenotypes of the disease. To date, the safety profile of ocrelizumab matches that observed in clinical trials, without any unexpected alerts.
Title: Ocrelizumab: eficacia y seguridad en la esclerosis multiple.
Introduccion. El ocrelizumab es un anticuerpo monoclonal humanizado contra el antigeno CD20 de las celulas B. Ha sido aprobado recientemente por las agencias sanitarias estadounidense (Food and Drug Administration) y europea (European Medicines Agency) para el tratamiento de la esclerosis multiple (EM), y supone el primer farmaco comercializado tanto para la EM remitente recurrente (EMRR) como para la EM primariamente progresiva (EMPP). Los ensayos clinicos, tanto para formas recurrentes (OPERA I/II) como para las formas progresivas de la enfermedad (ORATORIO), han demostrado su eficacia. El objetivo de esta revision es abordar los principales aspectos de eficacia y seguridad del ocrelizumab en la EM. Desarrollo. Se ha realizado una revision bibliografica a traves de PubMed de trabajos publicados en el congreso ECTRIMS 2017 y de estudios activos en ClinicalTrials. Con el fin de evaluar la eficacia y seguridad del ocrelizumab en la EM, se han revisado ensayos clinicos aleatorizados, asi como sus estudios de extension y de seguimiento, y se ha incluido informacion sobre seguridad de los programas de monitorizacion de la Food and Drug Administration y la European Medicines Agency. Conclusiones. El ocrelizumab es el primer farmaco que ha demostrado poder frenar de forma significativa la progresion de la discapacidad en 12 y 24 semanas en pacientes con EMPP. Es tambien eficaz en el control de la actividad clinica y radiologica en pacientes con formas de EMRR, y su aprobacion e indicacion engloban ambos fenotipos de la enfermedad. Hasta ahora, el perfil de seguridad del ocrelizumab se ajusta a lo observado en los ensayos clinicos, sin alertas inesperadas.