Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results.
Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
DE · Author affiliation · country only
Parkinson-Klinik Ortenau, Wolfach, Germany. w.jost@parkinson-klinik.de.Location evidence
Gothenburg, SE · Author affiliation
Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.Location evidence
Melbourne, AU · Author affiliation
The Royal Melbourne Hospital, Parkville, VIC, Australia.Location evidence
IL · Author affiliation · country only
Movement Disorders Institute, Department of Neurology, Sheba Medical Center, Tel- Hashomer, Israel.Location evidence
Tel Aviv, IL · Author affiliation
Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.Location evidence
Tampa, US · Author affiliation
University of South Florida, Tampa, FL, USA.Location evidence
Copenhagen, DK · Author affiliation
Movement Disorder Clinic, University Hospital of Bispebjerg, Copenhagen, Denmark.Location evidence
US · Author affiliation · country only
Department of Neurology, Fixel Institute for Neurological Diseases, University of Florida, Gainesville, FL, USA.Location evidence
Ottawa, CA · Author affiliation
Division of Neurology, Department of Medicine, The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.Location evidence
Sevilla, ES · Author affiliation
Unidad de Trastornos del Movimiento, Servicio de Neurología, Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Spain.Location evidence
Universidad, ES · Author affiliation
Unidad de Trastornos del Movimiento, Servicio de Neurología, Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Spain.Location evidence
Centro, ES · Author affiliation
Centro de Investigación Biomédica en Red Sobre Enfermedades Neurodegenerativas, Instituto de Salud Carlos III, Madrid, Spain.Location evidence
Madrid, ES · Author affiliation
Centro de Investigación Biomédica en Red Sobre Enfermedades Neurodegenerativas, Instituto de Salud Carlos III, Madrid, Spain.Location evidence
Orlando, US · Author affiliation
Neurology One, University of Central Florida, Orlando, FL, USA.Location evidence
Graz, AT · Author affiliation
Department of Neurology, Medical University of Graz, Graz, Austria.Location evidence
Timişoara, RO · Author affiliation
Department of Neurology, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania.Location evidence
North Chicago, US · Author affiliation
AbbVie Inc., North Chicago, IL, USA.Location evidence
Spokane, US · Author affiliation
Selkirk Neurology & Inland Northwest Research, Spokane, WA, USA.Location evidence
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Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease
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Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
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Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
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Original abstract
INTRODUCTION: Foslevodopa/foscarbidopa (LDp/CDp) is a nonsurgical 24-h continuous subcutaneous infusion for patients with advanced Parkinson's disease (aPD) and motor fluctuations uncontrolled on oral medications. We present the first multicountry real-world data from routine clinical practice. METHODS: ROSSINI (NCT06107426) is an ongoing 3-year multicountry, prospective, observational study of adults with aPD who are LDp/CDp-naïve (cohort A) or transitioning from LDp/CDp open-label extension studies (NCT04379050/NCT04750226, cohort B). For this interim analysis, the primary endpoint was change from baseline to 6 months in OFF time [Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV (MDS-UPDRS-IV) modified item 4.3]. Safety was assessed by monitoring adverse events (AEs). Interim results for 105 cohort A patients enrolled ≥ 6 months by March 24, 2025 are presented only; cohort B results were limited (n = 5). Mixed-effects models for repeated measurements (continuous outcomes) were utilized, adjusted for country. RESULTS: Cohort A patients had a mean (SD) age of 68.5 (9.5) years, PD duration of 12.1 (5.3) years, and least squares mean (SE) OFF time of 5.2 (0.6) h at baseline. Patients on LDp/CDp showed statistically significant reductions (95% CI) in OFF time [(- 2.8 h (- 3.6, - 1.9), P ≤ .001, n = 47/40 at baseline/month 6], dyskinesia time [- 1.8 h (- 2.6, - 0.9), P ≤ 0.001], MDS-UPDRS-III [- 5.0 (- 8.2, - 1.9), P = 0.002], Parkinson's Disease Sleep Scale-2 [- 5.2 (- 8.0, - 2.4), P ≤ .001], and 39-item Parkinson's Disease Questionnaire [PDQ-39, - 5.6 (- 9.2, - 2.0), P = .002] from baseline to month 6. Freezing of Gait Questionnaire, Gastrointestinal Dysfunction Scale in PD, and King's PD Pain Scale likewise showed statistically significant decreases (P < .05). Overall, 58 (55.2%) reported ≥ 1 AE, primarily nonserious and mild-to-moderate (12.4% serious, 17.1% severe), with hallucinations and infusion site events the most frequently reported events (5.7% each). CONCLUSIONS: ROSSINI demonstrates reductions in motor fluctuations and nonmotor symptoms, and increased quality of life in patients with aPD after 6 months of LDp/CDp treatment. The safety profile was consistent with clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT06107426.