Sustained Improvements in Motor and Non-Motor Symptoms in Advanced Parkinson’s Disease Patients Treated with Carbidopa Levodopa Enteral Suspension in a ‘Real-World’ Study: Interim Results of the Multinational DUOGLOBE Study With at Least 24 Months Follow-Up
Jason Aldred1, David Standaert2, Norbert Kovacs3, Francesco Pontieri4, Paul Bourgeois5, Thomas Davis6, Esther Cubo Delgado7, Marieta Anca-Herschkovitsch8, Robert Iansek9, Mustafa Siddiqui10, Michaela Simu11, Lars Bergmann12, Pavnit Kukreja12, Weining Robieson12
1Selkirk Neurology, 2Univ of Alabama - Dept of Neurology, 3University of Pécs, 4Sapienza University of Rome, 5AZ Groeninge, 6Vanderbilt University Medical Center, Vanderbilt University, 7Hospital Universitario Burgos, 8Edith Wolfson Medical Center- Holon-Israel, 9Kingston Centre, Monash Health, 10Wake Forest School of Medicine, 11Victor Babes University of Medicine and Pharmacy, 12AbbVie Inc.
Objective:
Evaluate the effect of carbidopa levodopa enteral suspension (CLES) on motor and nonmotor symptoms in a multi-country observational study in advanced Parkinson’s disease (PD) patients treated with LCIG in routine clinical practice.
Background:
CLES has established benefit in reducing both motor and non-motor symptoms, but prospective long-term data on the effect of CLES on dyskinesia symptoms and associated effects on QoL and caregiver burden in a real-world setting are limited.
Design/Methods:
DUOGLOBE is a prospective multinational observational study (including US sites) of CLES naïve patients treated as part of routine clinical practice with 3-years follow-up planned (NCT02611713). Assessments included “Off” time, Unified Dyskinesia Rating Scale (UDysRS), Non-Motor Symptoms Scale (NMSS), sleep symptoms (PD Sleep Scale-2, PDSS-2), Quality of Life (8-item PD questionnaire, PDQ-8), and Serious Adverse Events (SAEs). Interim outcomes from baseline up to month (M) 24 are presented.
Results:
In this interim analysis, 196 patients were included (62% male, 78% ≥65 years old; 51% ≥10 years’ PD duration). Mean (SD) LCIG treatment duration was 711 (368) days with a median daily CLES infusion of 16.0 h/d. Significant improvements (mean change from baseline to M24) were observed in “Off” time (-3.7 h/d; 95% CI -4.3 to -3.1; p<.001), UDysRS total scores (-7.9; 95% CI -12.5 to -3.2; p=.001), NMSS total scores (-22.2; 95% CI -30.7 to -13.7;  p<.001), PDSS-2 total score (-5.8; 95% CI -8.2 to -3.3; p<.001), and QoL (-5.8; 95% CI -10.0 to -1.5; p=.009). Overall, 52% of patients experienced SAEs, 23% (n=45) of patients discontinued the study due to AEs as primary reason.
Conclusions:
This interim analysis shows sustained real-world long-term improvements with CLES in routine clinical practice on motor and non-motor symptoms in advanced PD patients. Safety was consistent with the established CLES profile.