Abstract
BACKGROUND: Parkinson's disease (PD) is a progressive neurodegenerative disorder impacting the quality of life, with a notable prevalence worldwide, including China. Rotigotine, a silicone-based patch that transdermally delivers a dopamine agonist, has shown promise as a PD treatment option. OBJECTIVE: This study aimed to evaluate the safety and effectiveness of rotigotine in a real-world Chinese population. METHOD: This multicenter, prospective, noninterventional postmarketing surveillance study was conducted across 27 hospitals in China from March 2021 to June 2023. It included adult patients with early and advanced idiopathic PD, newly initiating rotigotine (includes receiving rotigotine up to four weeks prior to enrollment). Safety was assessed through treatment-emergent adverse drug reactions (ADRs), serious adverse events (AEs) (SAEs), and treatment discontinuations due to AEs. Effectiveness was evaluated using the Patient Global Impression of Change (PGIC), Wearing-Off Questionnaire-9 (WOQ-9), and PD Questionnaire-8 (PDQ-8). RESULTS: Of 829 enrolled patients, 803 were included in the safety set and 572 in the full analysis set. The study reported a safety profile consistent with previous studies, with the most common AE being application site pruritus. The incidence of ADRs was 17.6%, lower than in previous Chinese Phase 3 studies and a Japanese noninterventional study. Over half of the patients reported improvement in PD symptoms as per PGIC, and PDQ-8 scores indicated an overall improvement in quality of life, particularly in patients with advanced PD. CONCLUSIONS: This study reaffirms the safety and effectiveness of rotigotine in a real-world Chinese PD population, including both early and advanced stages, aligning with previous research findings.