Scholarlink

Introduction <p>Foslevodopa/foscarbidopa (LDp/CDp) is a continuous 24-h subcutaneous infusion therapy for advanced Parkinson’s disease (aPD). Clinical trials have demonstrated the efficacy and safety of LDp/CDp; however, real-world evidence is limited.</p> Methods <p>This retrospective multi-country cohort study used data recorded by AbbVie’s patient support program (PSP) nurses during routine interactions with patients with aPD on LDp/CDp (December 2023–February 2025). Patients were followed until earliest of treatment discontinuation or database lock. Patients who started therapy during the study period were included without a pre-defined follow-up duration or standardized scheduled visits.</p> Results <p>A total of 2590 patients (38.3% female) were followed on average for 141.1&#xa0;days. During follow-up, mean LDp/CDp base infusion rate was 0.36 (SD = 0.14) mL/h, equivalent to 62.0 (SD = 23.6) mg/h. During the optimization period (mean = 5.4&#xa0;days), infusion rates generally increased from initial recorded dose to optimization, then remained stable. Among participants with available effectiveness data, 60.0% and 83.0% reported 0&#xa0;h/day of “Off” and dyskinesia symptoms, respectively, in the first month post-optimization; with similar observations over time. 61.1% of patients were assessed as handling the pump well and 80.5% as applying skin care well during the optimization period; both increased post-optimization. The most common reason for discontinuation was infusion site events (5.1%). Exploratory results indicated that younger patients (&lt; 65&#xa0;years) with shorter disease duration (&lt; 10&#xa0;years), managed the system better and had more favorable discontinuation outcomes compared to the total population.</p> Conclusion <p>This study describes real-world use of LDp/CDp in patients with aPD demonstrating that a stable infusion rate was achieved within 5.4&#xa0;days and provides initial observations on effectiveness. Data completeness varied substantially across variables due to the non-mandatory nature of data collection within the PSP and variable follow up duration. Ongoing efforts to improve data completeness and standardization will support future analyses and enhance understanding of real-world use of LDp/CDp and patient’s experience.</p> Clinical Trial Registration <p>The study is registered on ClinicalTrials.gov under NCT06937034.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Observational Retrospective Cohort of Patient Support Program Data on Practical Experiences of Treatment with Foslevodopa/Foscarbidopa in Advanced Parkinson’s Disease: The ORCHESTRA Study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年6月20日

查看全文
  • Tobias Warnecke,
  • Anton Adriaan Van der Plas,
  • Petra Schwingenschuh,
  • Anders Johansson,
  • Mihaela Simu,
  • Marie O’Meara,
  • Resmi Gupta,
  • Bjoern Fritz,
  • Lars Bergmann,
  • Juan Carlos Parra,
  • Martin Südmeyer

摘要

Introduction

Foslevodopa/foscarbidopa (LDp/CDp) is a continuous 24-h subcutaneous infusion therapy for advanced Parkinson’s disease (aPD). Clinical trials have demonstrated the efficacy and safety of LDp/CDp; however, real-world evidence is limited.

Methods

This retrospective multi-country cohort study used data recorded by AbbVie’s patient support program (PSP) nurses during routine interactions with patients with aPD on LDp/CDp (December 2023–February 2025). Patients were followed until earliest of treatment discontinuation or database lock. Patients who started therapy during the study period were included without a pre-defined follow-up duration or standardized scheduled visits.

Results

A total of 2590 patients (38.3% female) were followed on average for 141.1 days. During follow-up, mean LDp/CDp base infusion rate was 0.36 (SD = 0.14) mL/h, equivalent to 62.0 (SD = 23.6) mg/h. During the optimization period (mean = 5.4 days), infusion rates generally increased from initial recorded dose to optimization, then remained stable. Among participants with available effectiveness data, 60.0% and 83.0% reported 0 h/day of “Off” and dyskinesia symptoms, respectively, in the first month post-optimization; with similar observations over time. 61.1% of patients were assessed as handling the pump well and 80.5% as applying skin care well during the optimization period; both increased post-optimization. The most common reason for discontinuation was infusion site events (5.1%). Exploratory results indicated that younger patients (< 65 years) with shorter disease duration (< 10 years), managed the system better and had more favorable discontinuation outcomes compared to the total population.

Conclusion

This study describes real-world use of LDp/CDp in patients with aPD demonstrating that a stable infusion rate was achieved within 5.4 days and provides initial observations on effectiveness. Data completeness varied substantially across variables due to the non-mandatory nature of data collection within the PSP and variable follow up duration. Ongoing efforts to improve data completeness and standardization will support future analyses and enhance understanding of real-world use of LDp/CDp and patient’s experience.

Clinical Trial Registration

The study is registered on ClinicalTrials.gov under NCT06937034.