Use of fingolimod in patients with relapsing remitting multiple sclerosis in Kuwait

Abstract Background Post-marketing studies are important to confirm what was established in clinical trials, and to assess the intermediate and long-term efficacy and safety. Objective To assess efficacy and safety of fingolimod in multiple sclerosis (MS) in Kuwait. Methods We retrospectively evaluated MS patients using the MS registries in 3 MS clinics. Relapsing remitting MS patients according to revised 2010 McDonald criteria who had been treated with fingolimod for at least 12 months were included. Primary endpoint was proportion of relapse-free patients at last follow-up. Secondary endpoints were mean change in EDSS and proportion of patients with MRI activity (gadolinium-enhancing or new/enlarging T2 lesions). Results 76 patients met the inclusion criteria. Mean age and mean disease duration were 34.43 and 7.82 years respectively. Mean duration of exposure to fingolimod was 18.50 months. Proportion of relapse-free patients was 77.6% at last follow-up. Mean EDSS score significantly improved (2.93 versus 1.95; p < 0.0001) while 17.1% of patients continued to have MRI activity versus 77.6% at baseline ( p < 0.0001). Four patients stopped fingolimod due to disease breakthrough ( n = 3) and lymphadenitis ( n = 1). Conclusion Fingolimod is safe and effective in reducing clinical and radiological disease activity in relapsing remitting MS patients. Our results are comparable to reported results of phase III studies.