Real-world use of fingolimod in patients with relapsing remitting multiple sclerosis: a retrospective study using the national multiple sclerosis registry in Kuwait.

Abstract

Fingolimod is an oral sphingosine-1-phosphate-receptor modulator, which has demonstrated efficacy in clinical trials and has recently been approved for multiple sclerosis (MS) treatment in Kuwait. Post-marketing studies are important to demonstrate real-life efficacy and safety. The objective of this study was to examine the efficacy and safety of fingolimod treatment in a clinical setting. Using the national Kuwait MS registry, relapsing remitting MS patients who had been prescribed fingolimod for≥6months were retrospectively identified. Three-monthly clinical evaluations and 6-monthly magnetic resonance imagings (MRIs) were performed. Patient status pre- and post-treatment was compared using chi-square and Student t-tests. A total of 175 patients were included: 75.4% female (n=132); mean age 33.3±9.2years; mean disease duration 7.2±5.2years; mean fingolimod use 21.7±9.1months. Most had used previous disease-modifying therapy (78.9%; n=138), mainly interferons (66.9%; n=117). Twenty-three patients (11.4%) discontinued/withdrew fingolimod; of whom eight had relapses. The proportion of relapse-free patients improved significantly (86.3% vs. 32.6%; p<0.001), while the proportion of patients with MRI activity decreased (18.3.6% vs. 77.7%; p<0.001). Mean expanded disability status scale (EDSS) score at the last visit improved when compared with pre-treatment (2.26±1.49 vs. 2.60±1.44; p=0.03). Forty-three (24.6%) patients experienced adverse events; headaches and lymphopenia were the most commonly reported adverse events. Fingolimod treatment was associated with reduced relapse and MRI activity, and an improved EDSS score. Discontinuation/withdrawal rates and adverse events were low. Fingolimod presents a promising treatment for MS in Kuwait.