Objective: We present the results of our case series with continuous subcutaneous infusion (CSCI) produodopa in 2024, focusing on tolerability and efficacy, in line with clinical trial findings.

Background: CSCI is a novel treatment for advanced-stage Parkinson’s disease [1]. Since its approval by the Italian regulatory agency (AIFA) in 2024, we have adopted this therapy in our clinical practice.

Method: Twenty patients (6 females, 14 males) with levodopa-responsive PD and morning akinesia, meeting the Delphi panel criteria [2], were treated with 24-hour CSCI at individually optimized doses, determined during a 10-day hospitalization period. The primary objectives included assessing improvements in morning akinesia, evaluating changes in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS III and IV) and documenting any additional clinical observations.

Results: Between March and November 2024, we enrolled 20 patients with a mean age of 70 years (62–80), MMSE scores of 27/30 (25–30), disease duration of 10.4 years (5–17), and total daily levodopa intake of 806 mg (350–1200). Two patients discontinued treatment: one due to a depressive reaction and one due to a severe localized skin infection. The most frequent adverse events were mild non-serious infusion site reactions. All patients reported significant improvement in morning akinesia, however, 4 out of 18 patients still required oral medication for early morning administration. At three months, preliminary data showed global improvement in UPDRS III and IV scores compared to baseline. At the end of hospitalization, the mean CSCI infusion rates were 0.30 mL/h during the day (0.15–0.47) and 0.17 mL/h at night (0.15–0.30). Seven patients tested self-administered bolus doses (0.30 mL) but found them less effective than oral rescue therapy. Three patients temporarily suspended CSCI due to mild infusion site reactions: during the interruption, they reported improved therapeutic coverage with the same oral medication regimen used prior to CSCI initiation, suggesting a potential residual benefit of continuous infusion on oral pulsatile administration.

Conclusion: We confirm that in a real-life setting CSCI is a safe and efficacious treatment for patients with advanced PD.

References: [1] Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Jason Aldred et al.

[2] Developing consensus among movement disorder specialists on clinical indicators for identification and management of advanced Parkinson’s disease: a multi-country Delphi-panel approach. Angelo Antonini et al.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-life-experience-with-continuous-subcutaneous-foslevodopa-foscarbidopa-infusion-in-advanced-stage-of-parkinsons-disease-at-villa-margherita/