Background <p>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.</p> Methods <p>Consecutive patients starting LDp/CDp at seven centers were followed for 6&#xa0;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.</p> Results <p>We enrolled 108 patients (mean age 64.7&#xa0;years; mean disease duration 12.9&#xa0;years). After FDR correction, MDS-UPDRS Parts I and IV improved at 3 and 6 months; Part II improved at 3&#xa0;months only, and Part III showed no clear change. PDQ-39 was largely unchanged except for significant improvement in bodily discomfort at 3&#xa0;months. Forty-three patients (39.8%) discontinued LDp/CDp mostly within 90&#xa0;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, <i>p</i> &lt; 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.</p> Conclusions <p>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.</p>

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Real-world outcomes and early discontinuation of foslevodopa/foscarbidopa in Parkinson’s disease

  • Takashi Tsuboi,
  • Katsuo Kimura,
  • Kensuke Ikenaka,
  • Toru Baba,
  • Keita Matsuura,
  • Yuta Kajiyama,
  • Daiki Kamiyama,
  • Takashi Uematsu,
  • Katsuya Abe,
  • Keita Kakuda,
  • Hiroyuki Takenaka,
  • Koichi Miyashita,
  • Akiko Saito,
  • Masahito Mihara,
  • Akihiro Shindo,
  • Takafumi Hasegawa,
  • Yasuyoshi Kimura,
  • Fumiaki Tanaka,
  • Nobutaka Hattori,
  • Masahisa Katsuno,
  • Noriko Nishikawa

摘要

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.