Long-term clinical, radiological, and safety outcomes during fingolimod treatment in relapsing–remitting multiple sclerosis: a real-world cohort from Saudi Arabia

Abstract Background Fingolimod, a sphingosine-1-phosphate receptor modulator, has demonstrated robust efficacy in relapsing–remitting multiple sclerosis (RRMS). However, real-world long-term data from Middle Eastern populations remain limited. This study aimed to describe long-term clinical, radiological, laboratory, and cardiac outcomes among Saudi patients with RRMS receiving fingolimod in routine clinical practice. A retrospective study was conducted at King Fahad Armed Forces Hospital, Jeddah, between 2013 and 2024. Adult RRMS patients treated with fingolimod 0.5 mg daily were stratified by treatment duration: < 5 years (Group I) and ≥ 5 years (Group II). Clinical, radiological, and safety data, including relapse status, MRI activity, laboratory abnormalities, and documented cardiac adverse events, were analyzed using independent-samples t-tests, Pearson’s χ 2 test, and Fisher’s exact test, as appropriate. Results Among 63 patients, 87.9% of short-term users and 76.7% of long-term users remained free of documented clinical relapse, with no significant difference between groups ( p = 0.24). Gadolinium-enhancing lesions were absent in 81.8% and 90.0% of short- and long-term users, respectively ( p = 0.35). Bradycardia was documented in 9.1% and 6.7%, respectively, while lymphopenia was observed in 87.9% and 93.3%. No fingolimod discontinuations were documented among the patients meeting the study eligibility criteria. Conclusion Fingolimod was associated with sustained effectiveness, no clinically significant cardiac abnormalities, and a favorable safety profile in Saudi RRMS patients over 10 years, aligning with international real-world evidence.