Caratterizzare il rischio di eventi avversi gravi durante il sequencing dei trattamenti nei pazienti con Sclerosi Multipla: analisi di coorte basata sul Registro Italiano Sclerosi Multipla.

During the last years, there has been a paradigm shift in the treatment of multiple sclerosis (MS) thanks to the availability of a broad spectrum of immune therapies, with distinct mechanisms of action, risk- profiles and side-effects. However, the identification of an ‘optimal choice’ for individual patients must consider not only treatment efficacy and adherence but also, the Adverse Events profile. This choice has become increasingly complex, especially with regard to the common clinical scenario of various sequential treatment possibilities that may be associated with additive, though different, effects on immune system. This study aims to provide an overview of the risk related to different treatment sequencies, trying to provide, for each treatment decision, individual risk stratification and consequent pharmacovigilance that needs to be maintained. The study will be conducted by extracting and analyzing the data present in the Italian Multiple Sclerosis Register collected from its establishment to 1st May 2020; we will then assess the incidence of adverse events, particularly infections, lymphopenia (grade III-IV) and malignancies, estimate the time to adverse event and the comparative safety of the different therapeutic approaches.

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