Fingolimod (Gilenya, Novartis pharmaceuticals) is the first oral disease-modifying therapy for reducing the frequency of clinical relapses and delaying disability progression in patients with relapsing-remitting multiple sclerosis (RRMS). In this study, we aimed to evaluate the outcome of Saudi patients with active RRMS treated with fingolimod.
We conducted a retrospective multicenter observational study at the King Abdulaziz Medical City in Jeddah and Riyadh, Saudi Arabia. The inclusion criteria consisted of patients 18 years and older who were diagnosed with RRMS according to the revised McDonald criteria who are currently receiving or received fingolimod treatment in the past for a minimum of 6 months.
A total of 100 patients were treated with fingolimod. The mean ± SD duration of the disease was 9.23 ± 6.63 years. The mean ± SD duration of using fingolimod was 32.00 ± 24.83 months. The mean ± SD baseline expanded disability status scale (EDSS) score was 2.95 ± 2.58. The mean ± SD EDSS score at last follow-up was 2.95 ± 2.65. The mean ± SD annualized relapse rate was significantly reduced from 1.24 ± 1.39 at baseline to 0.43 ± 1.15 at the last follow-up (P = 0.001). In addition, radiological activity was significantly improved at follow-up magnetic resonance imaging studies when compared with the baseline.
Our multicenter study provides further evidence for the efficacy of fingolimod in reducing clinical and radiological disease activity in patients with RRMS. The reduction in relapse rate, stabilization of the EDSS score, and improvement in magnetic resonance imaging images were similar to other observational studies conducted in different countries worldwide. Fingolimod seems to be well tolerated for our multiple sclerosis population.