Objective: To evaluate changes in motor symptoms after safinamide initiation in Japanese patients with Parkinson’s disease (PD) in real-world clinical practice.

Background: Safinamide, a monoamine oxidase-B inhibitor, was approved in Japan in 2019. Randomized clinical trials have shown improvement in overall motor functions with safinamide [1, 2]. However, evidence from real-world clinical practice, particularly regarding its impact on individual motor symptom domains, remains limited.

Method: A Japanese post-marketing surveillance study was conducted to evaluate the safety and efficacy of safinamide following 24 weeks of treatment from October 2020 to December 2022. Patients who received safinamide first time were included. Motor symptoms were assessed by Unified Parkinson’s Disease Rating Scale (UPDRS) Part III. Subgroup analyses were stratified by age (<75 years / >=75 years) and concomitant anti-PD medications use (levodopa only / levodopa plus other anti-PD medications). Paired t-tests were used to compare between baseline and final evaluations.

Results: A total of 1,071 participants were enrolled, and 605 patients were included in the effectiveness analysis set (female: 57.5%, >= 75 years: 42.5%, mean UPDRS Part III total score: 27.9). In the overall population, mean change from baseline in UPDRS Part III total score at final evaluation was -4.7 (p<0.001). UPDRS Part III subitems were also significantly reduced at final evaluation (mean change from baseline: bradykinesia; -1.8, rigidity; -1.1, tremor; -0.7, and gait; -0.4, p<0.001 in all subitems). Subgroup analyses showed significant reduction in the UPDRS Part III total score and subitems across all age groups and concomitant anti-PD drug regimens (p<0.001).

Conclusion: In real-world clinical settings, motor function significantly improved after initiation of safinamide in patients with PD, including tremor and gait disturbances,　regardless of age or concomitant anti-PD medications.

References: [1] Cattaneo C, Sardina M, Bonizzoni E. Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson’s Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE. J Parkinsons Dis. 2016;6(1):165-173.
[2] Nomoto M, Ishida T, Koebis M, et al. Characteristics of wearing-off and motor symptoms improved by safinamide adjunct therapy in patients with Parkinson’s disease: A post hoc analysis of a Japanese phase 2/3 study. J Neurol Sci. 2022;434:120083.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/consistent-motor-benefit-of-safinamide-across-clinically-relevant-subgroups-in-japanese-patients-with-parkinsons-disease-a-24-week-real-world-study/