THE EFFICACY OF SAFINAMIDE IN IMPROVING MOTOR SYMPTOMS AND THE QUALITY OF LIFE IN KOREAN PATIENTS WITH MOTOR FLUCTUATIONS

초록

Background: We aimed to evaluate Safinamide as add-on therapy, improving motor symptoms as well as patients’ quality of life. This study was specifically designed to investigate the efficacy of safinamide maintained without escalating the dose of levodopa and dopamine agonist during the treatment period. Methods: This study was a multi-center, prospective study in Korean population who experienced motor fluctuations with ≥1.5 hours of “off” time throughout the day, and take levodopa 3 or more times a day. The dose of levodopa and dopamine agonist at baseline can be maintained without escalation during the 18-week treatment period. All subjects initially took Safinamide 50mg/day for the first 2 weeks and 100mg/day afterwards. Subjects unable to tolerate 100mg/day dosage within 4 weeks were excluded from this study. For the efficacy analysis, data from the subject diary and questionnaire examination (PDQ-39, MDS-UPDRS part 3 and part 4, KPPS, MMSE) were collected at baseline and at week 18. Safety assessment consists of determining and recording all adverse events(AEs). Results: At week 18, the co-primary outcomes - daily “off” time and PDQ-39 scores – demonstrated significant improvement from baseline (p <0.001). Furthermore, Safinamide significantly improved the change from baseline in MDS-UPDRS part 3 and 4, as well as daily “on” time (p <0.001). Particularly, each domain (Bradykinesia, Tremor, Rigidity score) in MDS-UPDRS part 3 demonstrated a significant improvement from baseline. The assessment of pain using KPPS also significantly decreased at week 18 compared to baseline (p = 0.013). 80 patients (40.2%) reported TEAEs with the majority being mild (39.2%). SAE was reported in 4 patients (2.01%). Conclusions: Over the 18-week period, Safinamide at 100mg/day demonstrated significant improvement in reducing the total MDS-UPDRS part 3 score during “on” time and improving the quality of life for patients. Furthermore, Safinamide at 100mg/day was generally well-tolerated in Korean patients who have motor fluctuations.