Objective: Continuous infusion of fosflevodopa/foscarbidopa is a promising treatment for patients with Parkinson’s disease (PD) and severe motor fluctuations unresponsive to conventional therapy. Patient selection and monitoring is critical for appropriate and cost-effective care.

Background: Foslevodopa/foscarbidopa is a soluble formulation of levodopa/carbidopa for the treatment of advanced PD, administered as a daily continuous subcutaneous infusion. Its safety and efficacy has been demonstrated in different phase III studies [1],[2], but real life studies are lacking. Wearable medical devices based on inertial sensors to quantify motor symptoms in patients with PD are now widely available and can help in monitoring and selecting patients for this type of treatment.

Method: Here we report data evaluating patients’ self-reported diaries and inertial sensor data in the first seven patients who received fosflevodopa/foscarbidopa infusion at the Parkinson Institute of Milan (ASST G.Pini-CTO, Italy), since its commercialization in Italy in February 2024. In addition to standard neurological evaluation and scales, the protocol included 1-week home monitoring with a wearable device (STAT-ON™) [3] before and after the start of the infusion. This device provides objective information on motor manifestations, such as bradykinesia, dyskinesia, ON-OFF fluctuations, freezing of gait, and gait parameters, falls, the quantity of movement, and postural activity. Additional in-hospital interventions included i) neuropsychological evaluation, ii) nutritional assessment, and iii) the study of autonomic function. Concomitant pharmacologic therapy as well as local and systemic side effects were also collected.

Results: All patients with continuous subcutaneous infusion report an increase in “good on time” troublesome fluctuations compared with conventional therapy, with a significant reduction of peak-dose dyskinesia. Symptom stratification based on wearable inertial sensors confirms symptom improvement.

Conclusion: Fosfcarbidopa/fosflevodopa is a safe and promising treatment option for patients with advanced PD. Home monitoring with wearable devices can support clinicians in understanding real-life daily motor status for appropriate patient selection and follow-up in the domestic setting, which is critical for future pharmacological and cost-effectiveness studies.

References: [1] Soileau MJ, Aldred J, Budur K, et al, Facheris MF, Hauser RA. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson’s disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022 Dec;21(12):1099-1109. doi: 10.1016/S1474-4422(22)00400-8.

[2] Aldred J, Freire-Alvarez E, Amelin AV, et al, Mochizuki H, Robieson WZ, Spiegel AM, Standaert DG, Talapala S, Facheris MF, Fung VSC. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023 Dec;12(6):1937-1958. doi: 10.1007/s40120-023-00533-1.

[3] Rodríguez-Martín D, Cabestany J, Pérez-López C, Pie M, Calvet J, Samà A, Capra C, Català A, Rodríguez-Molinero A. A New Paradigm in Parkinson’s Disease Evaluation With Wearable Medical Devices: A Review of STAT-ONTM. Front Neurol. 2022 Jun 2;13:912343. doi: 10.3389/fneur.2022.912343.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-comprehensive-at-home-and-in-hospital-work-up-of-patients-with-parkinsons-disease-receiving-fosflevodopa-fosfcarbidopa-continuous-subcutaneous-infusion/