Fingolimod in multiple sclerosis: insights into drug survival and discontinuation factors

Over 300,000 individuals with multiple sclerosis (MS) have been treated with fingolimod. While clinical trials confirm its efficacy, real-world data are crucial to evaluate drug discontinuation rates and optimize prescribing practices.

This study assesses fingolimod drug survival in MS patients and identifies factors associated with its discontinuation.

A retrospective observational study was conducted at an MS outpatient clinic in São Paulo, Brazil. MS diagnosis based on McDonald 2017 criteria and prior or current fingolimod use were inclusion criteria. Demographic and clinical data, including treatment duration and discontinuation reasons, were extracted from medical records. Statistical analyses used chi-square, Mann-Whitney, or Fisher tests, with p < 0.05 considered significant.

Among 243 patients (median age: 37 years; 71 % female), 104 (42.8 %) discontinued fingolimod after a median of 33 months. One-year and five-year drug survival rates were 84 % and 50 %, respectively. Lack of efficacy was the main discontinuation reason (68 patients, 65 %), primarily due to clinical relapses (54 %) or radiological findings (35 %). Patients who discontinued were younger (34 vs. 40 years, p < 0.01) and more often female (79 % vs. 65 %, p = 0.023). Safety concerns accounted for 20 discontinuations (19 %), including infections (30 %), hepatotoxicity (30 %), and teratogenicity concerns (25 %).

Fingolimod demonstrated a five-year median survival in this Brazilian cohort, aligning with European and U.S.

Male patients with up-to-date vaccinations and good liver health may benefit most from fingolimod treatment.