Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage

Background: The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5h/day in 'off' state) Parkinson's disease (PD). Objective: To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging. Methods: Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8mg/24h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16mg/24h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS IIIII; statistical tests are exploratory. Results: Data were available for 2057 patients (HY 1:262; HY 2:1230; HY 3:524; HY 4:41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS IIIII scores vs patients at lower HY stages. Rotigotine improved UPDRS IIIII versus placebo for each individual HY stage (p<0.05 for each HY stage), with treatment differences increasing with increasing HY stages. Similar results were observed for UPDRS II and UPDRS III. Conclusions: This post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1-4).