Objective: Characterize the relationship between foslevodopa/foscarbidopa infusion rate and infusion site reaction (ISR) score in patients with Parkinson’s disease (PD)

Background: As PD progresses, motor symptoms are no longer well controlled by oral levodopa medication due to a progressively narrower therapeutic window.  Foslevodopa/foscarbidopa is an investigational drug being developed for the treatment of PD that provides continuous therapeutic levels of levodopa.  However, foslevodopa/foscarbidopa daily dose requirements are variable and patient specific.  Since the systemic safety profile of levodopa is well established, the current analysis investigates the relationship between infusion site reaction (ISR) severity score and foslevodopa/foscarbidopa infusion rate.

Method: ISR severity score based on the infusion site evaluation scale was collected from a 52-week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of foslevodopa/foscarbidopa in subjects with PD.  The ISR severity score is a 7-point scale where a change of 1 point indicates a change in the severity of ISR. The ISR severity score was correlated with foslevodopa/foscarbidopa infusion rate. A poisson model with square root link was found to most adequately describe the ISR scores. 241 patients with Parkinson’s disease were included in the analysis.

Results: When a typical high foslevodopa/foscarbidopa infusion rate to a low rate (95%ile to 5%ile) was compared, the estimated increase in the ISR score was 0.28. This was not considered clinically meaningful since the ISR scale is intended to differentiate reactions based on a full point change.

Conclusion: While patients with PD require a wide range of foslevodopa/foscarbidopa infusion rates that are individualized on a patient basis, the current data suggests that patients on the high end of the infusion rate range will not have a clinically meaningful difference in ISR severity score compared to a patient on the lower end of the infusion rate range.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/foslevodopa-foscarbidopa-subcutaneous-infusion-shows-similar-infusion-site-reaction-severity-score-across-range-of-infusion-rates-in-patients-with-parkinsons-disease/