Objective: To assess the real-world (RW) effectiveness of continuous subcutaneous infusion of foslevodopa/foscarbidopa (LDp/CDp) over a 12-month follow-up.

Background: LDp/CDp is a continuous 24-hour subcutaneous infusion of levodopa and carbidopa prodrugs approved for the treatment of advanced Parkinson’s disease. RW data on its effectiveness remain limited, particularly in countries such as France.

Method: This is a prospective observational single-arm study conducted in 32 centers in France. 250 patients are planned to be included with study visits performed at baseline, at months 6 (M6) and 12 (M12). Primary endpoint is change at M12 in quality of life assessed by PDQ-8. Other secondary endpoints include changes in ON and OFF time and clinical global impression (CGI-C). Interim analysis relies on the patients included and treated for 6 months at the time of cut off.

Results: Among 127 PD patients who initiated the LDp/CDp more than 6 months ago, 83 completed the M6 visit and were included in the analysis, 28 patients discontinued the treatment before M6 (including insufficient efficacy, n=12, adverse events, n=9, death, n=2) and 16 with no PDQ-8 evaluation at M6 were not included in the analysis.

Among the 83 patients, 50 (60.2%) were male. The mean (± SD) age was 69.0 ± 9.4 years, mean disease duration was 13.2 ± 5.0 years. Mean delay between diagnosis and onset of motor fluctuations was 6.5 ± 4.6 years. Thirty-eight patients (45.8%) had been previously treated with continuous subcutaneous apomorphine infusion. Initiation of LDp/CDp occurred predominantly in the hospital setting (73.5%), and 70 patients (85.4%) were receiving at least one concomitant antiparkinsonian medication.

At baseline patients experienced a mean ON time without dyskinesia of 6.8 ± 3.7 hours and a mean OFF time of 4.4 ± 2.9 hours. The mean CGI score was 4.6 ± 1.3.

At M6, ON time without dyskinesia increased by 3.2 ± 4.3 hours and OFF time decreased by 2.8 ± 2.8 hours. In addition, CGI score improved by 2.2 ± 1.0 points, with 65.4% of patients rated as much improved or very much improved.

Conclusion: This interim analysis of the first French RW study assessing the effectiveness of LDp/CDp demonstrated numerical improvements in ON and OFF times and in Clinical Global Impression. The clinical meaningfulness of these preliminary findings will be confirmed in the final analysis of the full study cohort.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effectiveness-and-use-of-foslevodopa-foscarbidopa-in-advanced-parkinson-disease-in-real-life-setting-in-france-envol-study-interim-analysis/