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.
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.
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.
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.
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.
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.