Over 300,000 individuals with multiple sclerosis (MS) have received fingolimod treatment (English and Aloi, 2015), (T Ziemssen et al., 2021). In the LONGTERMS extension study, 45 % of patients relapse-free after ten years of follow-up and only 5 % of patients discontinued the drug due to safety concerns (Cohen et al., 2019).

Although real-world data on fingolimod supports a favorable safety profile and moderate relapse control, data specific to Latin America is limited, as only 3.4 % of patients in the LONGTERMS study were from this region (Cohen et al., 2019). Furthermore, the increasing availability of disease-modifying therapies underscores the need for studies identifying predictors of drug discontinuation, as some discontinuations may be preventable through optimized patient selection. In 2012, fingolimod was approved in Brazil for the treatment of relapsing-remitting multiple sclerosis (RRMS), with over 10 disease-modifying drugs (DMDs) available in the country; however, there are still no specific brazilian studies on the drug survival of fingolimod and its underlying causes.

This study aims to assess the median drug survival of fingolimod in a Latin American cohort and compare it with prior real-world data. Additionally, it seeks to identify predictors and causes of drug discontinuation to guide optimal patient selection for fingolimod treatment in MS.