No Evidence of Disease Activity After Fingolimod Treatment: A Three-Year Real-World Comparison of Pre- and Post-Treatment Outcomes in Multiple Sclerosis

Abstract

Background: Real-world data on fingolimod effectiveness in multiple sclerosis (MS) remain valuable, particularly in switch cohorts and across phenotypes. Methods: We conducted a retrospective single-center observational study including MS patients with RRMS or SPMS who received fingolimod and had complete symmetric 3-year pre- and 3-year post-treatment clinical follow-up data. Outcomes included changes in annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) over the 3-year pre/post periods, and the proportion achieving NEDA-3 during the 3-year on-treatment period. Results: A total of 657 patients were analyzed (596 RRMS; 61 SPMS). In RRMS, ARR decreased from 0.34 +/- 0.39 in the 3 years pre-treatment to 0.08 +/- 0.20 in the 3 years on fingolimod (p < 0.001), and mean EDSS changed from 1.48 +/- 1.27 to 1.43 +/- 1.36 (p = 0.152). In SPMS, ARR changed from 0.61 +/- 0.52 to 0.27 +/- 0.32 (p < 0.001), while EDSS increased from 5.08 +/- 1.01 to 6.10 +/- 1.31 (p < 0.001). NEDA-3 was achieved by 415/596 (69.6 %) RRMS patients and 10/61 (16.4 %) SPMS patients during the 3-year on-treatment period. Conclusion: In this real-world switch cohort, fingolimod was associated with a marked reduction in relapse activity in RRMS, while disability worsening persisted in SPMS. NEDA-3 rates differed substantially by phenotype, supporting phenotype-specific expectations and the value of real-world risk stratification.