[Monoclonal antibodies in [corrected] development in [corrected] multiple sclerosis]. / Anticuerpos monoclonales en desarrollo en esclerosis múltiple.

ABSTRACT

INTRODUCTION: The last fifteen years have see the gradual appearance of a number of different drugs that have been shown to be effective as disease modifying therapies in multiple sclerosis. The opening and subsequent widening of the therapeutic armamentarium in multiple sclerosis will continue on a expanding course in the next few years due to the already known positive results of phase III clinical trials with orally administered molecules. Along with these, we have also seen the appearance of a group of drugs which, instead of being defined by their route of administration, are considered together as a consequence of their similar design: the monoclonal antibodies. CONTENTS AND METHODS: The principal safety and efficacy results of three of the monoclonal antibodies that have already obtained positive results in phase II studies will be reviewed in this paper alemtuzumab, rituximab / ocrelizumab, and daclizumab. For the preparation of this paper, information was obtained from already published articles and from the following web pages www.clinicaltrials.gov of the National Institute of Health of the U.S.A., the EMA (European Medicines Agency) web page and the Spanish Medicines Agency (Agencia Española del Medicamento) web page. CONCLUSIONS: Final results from the phase III clinical trials in progress are required to produce definitive statements on the efficacy and safety of the reviewed drugs. However, and subject to confirmation of the presently available data from phase II trials, it is likely that this group of drugs is to be placed one step beyond the currently available disease-modifying therapies in terms of efficacy, but with a safety pattern which will make careful monitoring of treated patients a mandatory requirement so as to obtain adequate risk/benefit profiles.