Clinical Efficacy and Safety of Fingolimod in Relapsing-Remitting Multiple Sclerosis : A 10-Year Single-Centre Retrospective Observational Study

Abstract

Background: Fingolimod is an oral disease-modifying therapy approved for the treatment of highly active relapsing forms of multiple sclerosis (MS). Real-world data remain essential for assessing its long-term effectiveness and safety in routine clinical practice. Objective: The study aims to evaluate the clinical and radiological effectiveness, as well as the safety and tolerability, of fingolimod in patients with multiple sclerosis treated at a tertiary neurology centre. Methods: This retrospective observational study included 14 patients with multiple sclerosis who had received fingolimod for at least 15 months at the Department of Neurology, Mohammed V Military Teaching Hospital, Rabat, Morocco, between March 2014 and March 2024. Demographic, clinical, radiological, and laboratory data were collected to assess treatment effectiveness, safety, and tolerability. Results: Relapsing-remitting multiple sclerosis (RRMS) was the predominant phenotype (85.7%), whereas 14.3% of patients had secondary progressive multiple sclerosis (SPMS). After fingolimod initiation, 92.9% of patients achieved an annualised relapse rate (ARR) of ≤0.5 relapses per year, and the mean Expanded Disability Status Scale (EDSS) score decreased from 3.00 ± 1.77 before fingolimod treatment to 1.54 ± 1.51 during follow-up. MRI findings remained stable in 13 of 14 patients ; only one patient developed a new non-enhancing lesion associated with minimal corpus callosum atrophy after 63 months of treatment. Fingolimod was well tolerated, with no first-dose cardiovascular events, allergic reactions, ECG abnormalities, or OCT abnormalities. Lymphopenia occurred in all patients, whereas mild, transient hepatic cytolysis was observed in two cases. All patients were seropositive for varicella-zoster virus (VZV), and no cases of progressive multifocal leukoencephalopathy (PML) were identified. Conclusion: Fingolimod was associated with sustained clinical and radiological effectiveness in this real-world cohort, including reduced relapse activity and lower disability scores during follow-up. Although treatment was generally well tolerated, regular clinical, laboratory, ophthalmological, and cardiovascular monitoring remains essential for supporting long-term safety.