Foslevodopa/Foscarbidopa Improves Pain in People With Advanced Parkinson’s Disease Who Have Uncontrolled Motor Fluctuations: Interim Results From the Real-World ROSSINI Study
Jason Aldred1, Filip Bergquist2, Andrew Evans3, Sharon Hassin-Baer4, Robert A. Hauser5, Tove Henriksen6, Irene A. Malaty7, Tiago A. Mestre8, Pablo Mir9, Ramon Rodriguez10, Petra Schwingenschuh11, Mihaela Simu12, Pavnit Kukreja13, Marie O'Meara13, Juan Carlos Parra13, Megha Shah13, Lars Bergmann13, Wolfgang H. Jost14
1Selkirk Neurology & Inland Northwest Research, 2Department of Clinical Neuroscience, University of Gothenburg, 3Movement Disorders Program, Royal Melbourne Hospital, 4Movement Disorders Institute, Department of Neurology, Chaim Sheba Medical Center, Tel-Hashomer and Gray Faculty of Medical & Health Sciences, Tel-Aviv University, 5Department of Neurology, University of South Florida Parkinson’s Disease and Movement Disorders Center of Excellence, 6Department of Neurology, Movement Disorder Clinic, University Hospital of Bispebjerg, 7Department of Neurology, University of Florida, Fixel Institute for Neurological Diseases, 8Parkinson's Disease and Movement Disorders Clinic, Division of Neurology, Department of Medicine, University of Ottawa, 9Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología Clínica, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, 10Neurology One, 11Department of Neurology, Medical University of Graz, 12Department of Neurology, Victor Babes University of Medicine and Pharmacy, 13AbbVie Inc., 14Parkinson-Klinik Ortenau
Objective:
To evaluate change in Parkinson’s disease (PD)-related pain after initiation of 24-hour/day continuous subcutaneous infusion of foslevodopa/foscarbidopa (LDp/CDp).
Background:
Although clinical trials have demonstrated the efficacy of LDp/CDp in managing motor fluctuations in advanced PD (aPD), its effect on pain was not formally evaluated.
Design/Methods:
ROSSINI is a prospective, multicountry, real-world observational study (NCT06107426). Eligible patients were adults with levodopa-responsive aPD receiving LDp/CDp per local label. Cohort A included LDp/CDp-naive patients. This planned interim analysis of Cohort A evaluated 6-month change in treatment outcomes including PD-related pain, as assessed by King’s PD Pain Scale (KPPS; decrease in scores indicate improvement). KPPS data were analyzed using a mixed-effects repeated-measures model and based on the full analysis set, using observed cases.
Results:
Baseline characteristics (based on safety analysis set) reflected aPD and uncontrolled motor fluctuations (mean [SD]: age, 68.5 [9.5] years; PD duration, 12.6 [5.6] years; “Off,” 5.2 [0.6] hours/day; motor fluctuation duration, 6.4 [5.3] years). The KPPS total score was 21.1 (2.9) at baseline (n=95), with least squares (SE) mean change from baseline of −10.0 (1.6) at week 2 (n=84), −7.8 (1.8) at month 1 (n=66), −9.3 (1.7) at month 3 (n=78), and −9.1 (1.7) at month 6 (n=70; all P≤.001 vs baseline). The least squares (SE) mean change from baseline to month 6 was significant in 4 domains (chronic pain, −1.3 [0.4], P<.01; fluctuation-related pain, −3.9 [0.7], P≤.001; nocturnal pain, −2.6 [0.6], P≤.001; discoloration, −0.9 [0.4], P<.05) and 6 items (deep chronic pain, dyskinetic pain, “Off” dystonia, generalized “Off” period pain, burning sensation, difficulty turning in bed; all P<.05).
Conclusions:
LDp/CDp led to rapid and strong clinically significant improvements in PD-related pain that were sustained through 6 months, with improvements in KPPS total score exceeding the minimal clinically important difference threshold of 3.0 (Taghizadeh 2023). These findings suggest additional benefits of continuous dopaminergic stimulation.
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