Foslevodopa/Foscarbidopa Treatment for Advanced Parkinson Disease Associated with Significant Quality of Life Improvements According to Interim Analysis of Clinical Trial Data

Patients with advanced Parkinson disease (aPD) treated with foslevodopa/foscarbidopa (ABBV-951, AbbVie; North Chicago, IL), a soluble formulation of levodopa/carbidopa prodrugs delivered as a 24-hour/day continuous subcutaneous infusion, reported significant quality of life improvements according to interim analysis of clinical trial (NCT03781167) data. These results were presented at the 2023 European Academy of Neurology (EAN) meeting. 

Interim analysis from the phase 3, open-label, 52-week, single-arm clinical safety/tolerability trial included levodopa-responsive idiopathic PD patients who were ≥ 30 y and had ≥ 2.5 hours of average daily “Off” time prior to study enrollment. Participants reported quality of life aspects using the Parkinson’s Disease Questionnaire-39 (PDQ-39), which includes a summary index total score and 8 domain scores. A paired sample t-test was used to compare changes in PDQ-39 scores from baseline through 52 weeks of treatment. Significant improvements were found in the PDQ-39 mean (SD) summary index score (-6.8 [13.56], P≤.001), and in the subdomains of mobility (-10.2 [20.63], P≤.001), activities of daily living (-10.1 [20.35], P≤.001), stigma (-7.4 [22.47], P≤.001), and bodily discomfort (-11.7 [21.49], P≤.001). Additionally, results indicate the overall safety of foslevodopa/foscarbidopa, with infusion site events being the most commonly reported adverse events (infusion site erythema [51.2%], nodule [27.9%], cellulitis [23.0%]).

This study was supported by AbbVie Inc.