Assessment of safety and effectiveness of oral multiple sclerosis medication

To assess the effectiveness and safety profile of the new disease modifying drugs (fingolimod, teriflunomide, and dimethyl fumarate) at a local hospital in Riyadh, Saudi Arabia.

This is a retrospective cohort, where institutional review board approval was granted in December 2015. The study was conducted at King Abdulaziz Medical City Research Center, Riyadh, Saudi Arabia. Demographic variables (age, gender, disease onset, and duration on medication), clinical variables (medication side effects and radiological findings), in addition to relapse frequency per year was collected.

Fifty-seven patients' records were retrieved from the pharmacy and included in the analysis. Eight patients were on teriflunomide, 5 patients on dimethyl fumarate and 44 patients on fingolimod were enrolled. The patients' average age was 32.5 years with female gender representing 63% the study population. Annual relapse rates were 0.24, 0.34, and 0.5 per patient per year for those taking fingolimod, dimethyl fumarate, and teriflunomide, correspondingly, lymphopenia (91.4%), neutropenia (23%), and bradycardia (16%) were the most reported side effects for fingolimod therapy.

The study results were able to capture the effectiveness rate for the targeted treatment in the studied population, with the frequency of incidence of side effects. However, as these results cannot be generalized for the entire Saudi population.