Real-world outcomes and early discontinuation of foslevodopa/foscarbidopa in Parkinson's disease.
Real-world outcomes and early discontinuation of foslevodopa/foscarbidopa in Parkinson's disease.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
Nagoya, JP · Author affiliation
Department of Neurology, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, 466-8550, Japan. tsuboi.takashi.z9@f.mail.nagoya-u.ac.jp.Location evidence
Yokohama, JP · Author affiliation
Department of Neurology, Yokohama City University Medical Center, Yokohama, Japan.Location evidence
Osaka, JP · Author affiliation
Department of Neurology, The University of Osaka Graduate School of Medicine, Suita, Japan.Location evidence
Suita, JP · Author affiliation
Department of Neurology, The University of Osaka Graduate School of Medicine, Suita, Japan.Location evidence
JP · Author affiliation · country only
Department of Neurology, National Hospital Organization Sendai Nishitaga Hospital, Sendai, Japan.Location evidence
Kurashiki, JP · Author affiliation
Department of Neurology, Kawasaki Medical School, Kurashiki, Japan.Location evidence
Tokyo, JP · Author affiliation
Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.Location evidence
Wako, JP · Author affiliation
Neurodegenerative Disorders Collaborative Laboratory, RIKEN Center for Brain Science, Wako, Japan.Location evidence
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Original abstract
BACKGROUND: Continuous subcutaneous foslevodopa/foscarbidopa (LDp/CDp) infusion is an emerging device-aided therapy for advanced Parkinson's disease (PD), but real-world evidence on multidomain outcomes and treatment persistence remains limited. METHODS: Consecutive patients starting LDp/CDp at seven centers were followed for 6 months. Outcomes were the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the 39-item Parkinson's Disease Questionnaire (PDQ-39). Longitudinal changes were analyzed using linear mixed-effects models with false discovery rate (FDR) correction. Treatment discontinuation was evaluated using Kaplan-Meier estimates and Cox proportional hazards models, with sensitivity and exploratory analyses. RESULTS: We enrolled 108 patients (mean age 64.7 years; mean disease duration 12.9 years). After FDR correction, MDS-UPDRS Parts I and IV improved at 3 and 6 months; Part II improved at 3 months only, and Part III showed no clear change. PDQ-39 was largely unchanged except for significant improvement in bodily discomfort at 3 months. Forty-three patients (39.8%) discontinued LDp/CDp mostly within 90 days, primarily due to insufficient efficacy or adverse events. Longer disease duration was associated with discontinuation in the core multivariable Cox model (HR 1.11 per year, 95% CI 1.04-1.18, p < 0.001), with similar results in sensitivity analyses. Exploratory analyses showed a suggestive association between PDQ-39 Summary Index and discontinuation, with domain-level associations for emotional well-being, stigma, social support, and cognition. CONCLUSIONS: In routine care, LDp/CDp was associated with improvements across several MDS-UPDRS domains, although early discontinuation was common. Baseline disease duration and patient-reported quality-of-life dimensions may help identify support needs during the early initiation phase.