Effectiveness and Safety Profile of Fingolimod in Treating Omani Patients with Multiple Sclerosis: .

OBJECTIVES

This study aimed to evaluate the effectiveness and safety of fingolimod in Omani multiple sclerosis (MS) patients. Fingolimod is one of the oral drugs used to treat MS. However, there is limited information on its effectiveness and safety among the Omani population.

METHODS

This retrospective real-world study included 65 Omani MS patients who received fingolimod therapy from 2012 to 2021 at a single tertiary centre in Oman. Data were collected between August and November 2021. Various measures were used to evaluate the effectiveness and safety of fingolimod.

RESULTS

Out of 65 MS patients included in the study, 51 (79%) were female. The median duration of fingolimod use was 3.6 ± 2.5 years. The results of the last follow-up visit indicate that the median annualised relapse rate decreased by 84% and relapse-free rate (RFR) increased to 90%, with only a minimal (13%) increase in the expanded disability status. The median number of gadolinium-enhanced lesions in the brain and spine decreased significantly by 88% and 67%, respectively, while the new or enlarged T2 lesions in the brain significantly decreased by 62% (P < 0.050) over the treatment period. The most common side effect was bradycardia (32%). Patient age and age at treatment initiation were significant predictors of RFR (P < 0.050).

CONCLUSION

This study suggests that the effectiveness and safety profiles of fingolimod in Omani MS patients are similar to those determined by standard clinical trials and real-world retrospective studies.