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

Neurology and Therapy, vol. 15, pp. 2073–2095

Abstract

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.

Authors 11

1. Tobias Warnecke corresponding

   University of Münster · Klinikum Osnabrück

   Affiliation as printed

   Department of Neurology and Neurorehabilitation, Klinikum Osnabrück-Academic Teaching Hospital of the University of Münster, Am Finkenhügel 1, 49076, Osnabrück, Germany. tobias.warnecke@klinikum-os.de

2. Anton Adriaan van der Plas Aachen

   Alrijne Ziekenhuis

   Affiliation as printed

   Alrijne Hospital Leiderdorp, Simon Smitweg 1, 2353 GA, Leiderdorp, Netherlands

3. Petra Schwingenschuh

   Medical University of Graz

   Affiliation as printed

   Department of Neurology, Medical University of Graz, Auenbruggerplatz 22, 8036, Graz, Austria

4. Anders Johansson

   Karolinska Institutet

   Affiliation as printed

   Department of Clinical Neuroscience, Karolinska Institutet, NKS A8:06, 171 76, Stockholm, Sweden

5. Mihaela Adriana Simu

   Victor Babeș University of Medicine and Pharmacy Timișoara

   Affiliation as printed

   Department of Neurology, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania

6. Marie O’Meara

   AbbVie (United States)

   Affiliation as printed

   AbbVie Inc., North Chicago, IL, USA

7. Resmi Gupta

   AbbVie (United States)

   Affiliation as printed

   AbbVie Inc., North Chicago, IL, USA

8. Bjoern Fritz

   AbbVie (United States)

   Affiliation as printed

   AbbVie Inc., North Chicago, IL, USA

9. Lars Bergmann

   AbbVie (United States)

   Affiliation as printed

   AbbVie Inc., North Chicago, IL, USA

10. Juan Carlos Parra

    AbbVie (United States)

    Affiliation as printed

    AbbVie Inc., North Chicago, IL, USA

11. Martin Südmeyer

    Düsseldorf University Hospital · Klinikum Ernst von Bergmann

    Affiliation as printed

    Department of Neurology, Klinikum Ernst Von Bergmann, Charlottenstrasse 72, 14467, Potsdam, Germany

    Department of Neurology, University Hospital Düsseldorf, Moorenstrasse 5, 40225, Düsseldorf, Germany