Safety of Levodopa-Carbidopa Intestinal Gel in Advanced Parkinsonʼs Disease Patients: Interim Results of a U.S. Subset in the DUOGLOBE Observational Study

Abstract

Introduction: Levodopa-carbidopa intestinal gel (LCIG) (also known in the US as carbidopa-levodopa enteral suspension [CLES]) is a long-term treatment option for advanced Parkinson's disease (PD) patients and administered via percutaneous gastrojejunostomy (PEG-J) and an external pump. Objective of this interim analysis in a US patient subset in the DUOGLOBE observational study was to investigate routine clinical practice of PEG-J insertion, component replacements of the device and associated safety/tolerability.2834_A Figure 1. Percentage of patients with number of component replacements based on type of proceduralist performing the PEG-J insertion occurring in the first 6 months of treatment.2834_B Figure 2. Summary of treatment-emergent Serious Adverse Events occurring in the first 6 months of treatment in a US patient subsetMethods: DUOGLOBE is an ongoing observational multi-country study with a 3 year follow-up. This interim analysis included patients recruited at 19 US sites who had at least the PEG-J insertion procedure performed. The safety profile of these patients was investigated regarding the type of proceduralist performing the PEG-J insertion, type of tubing used, frequency of tube replacements and Serious Adverse Events (SAEs) reported. This interim analysis was not powered for comparison between groups due to limited number of patients. Results: Twenty-seven US patients were included in the interim analysis. 16 (59%) had PEG-J insertion performed by a gastroenterologist (GI) with 13 (81%) completing the first 6 months of the study. 11 subjects (41%) had an interventional radiologist (IR) perform the procedure with 8 (73%) completing the first 6 months of the study. Out of the entire US subset, 81.5% of patients had no tube replacements during the first 6 months with overall similar percentages of subjects with 0/1/2/3 tube replacements between the two types of proceduralists (GI: 0-75%, 1-25%, 2-0%, 3-0%; IR: 0-90.9%, 1-0%, 2-9.1%, 3-0%) during the first 6 months of the study (figure 1). Of the 5 tube replacements, 4 were performed by a GI using AbbVie proprietary tubing and 1 was performed by an IR using non-AbbVie tubing. The incidence of treatment-emergent SAEs is summarized in Table 1. Conclusion: In this interim analysis of the US subset of a multi-country observational study with CLES, limited by small patient numbers, GIs more frequently performed PEG-J insertion than IRs with similar percentage of subjects completing the first 6 months of the study. Frequency of tube replacements and AEs leading to drug withdrawn were similar between GIs and IRs.