Objective: Compare real-world clinical outcomes of Parkinson’s disease (PD) patients with moderate/severe motor fluctuations and/or dyskinesia treated with oral medications compared to device-aided therapies.

Background: As PD progresses, patients experience increased motor fluctuations and/or dyskinesia, and optimization of oral regimens may become inadequate for symptom control. Management strategies for patients with advanced PD (aPD) vary as only a subset receive device-aided therapies, such as carbidopa-levodopa enteral suspension (CLES) or deep-brain stimulation (DBS), while many remain on complex oral regimens. Limited data are available on long-term real-world outcomes in patients who remain on oral treatment compared to those who switch to device-aided therapies; this study aims to assess the long-term clinical outcomes in these patients.

Method: We retrospectively reviewed the INFORM database of the University of Florida Norman Fixel Institute for Neurological Disease. Key inclusion criteria were 1) PD diagnosis >5 years, 2) moderate motor fluctuations/dyskinesia at least 25% of the day, and 3) treatment with levodopa ≥4 times/day or a levodopa equivalent dose >400 mg/day. Eligible patients were divided into two cohorts: those who “Continued” oral dopaminergic therapy and those who “Transitioned” to device-aided therapy (DBS or CLES). Quality of life (QoL) assessed by the Parkinson’s Disease Questionnaire (PDQ-39) from baseline to month (M) 12 is the primary objective. Key secondary objectives include comparisons of both cohorts’ change from baseline to M12 in UPDRS parts I–IV. Exploratory analyses include longer-term (>12M) analyses of motor and non-motor symptoms.

Results: At the time of preliminary analysis, baseline clinical characteristics of the patients were similar between cohorts. This analysis included 251 patient records in the “Continued” cohort (64.1% male, 90.4% white, mean age of 67 ± 10 years and PD duration of 9 ± 5 years [Table 1]) and 157 patients in the “Transitioned” cohort (70.1% male, 94.2% white, mean age of 64 ± 9.2 years and PD duration of 11.8 ± 5.5 years [Table 1]).

Conclusion: The study is ongoing and final results will provide insight into the disease burden and intervention of device-aided therapy in aPD patients with moderate/severe motor fluctuations or dyskinesia.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/clinical-outcomes-and-disease-burden-of-advanced-parkinsons-disease-patients-treated-with-oral-medication-vs-device-aided-therapies-preliminary-results-from-the-university-of-florida-regist/