888 Percutaneous Gastrojejunostomy Tubing Utilization and Safety With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson’s Disease Patients: Interim Results of the Long-Term DUOGLOBE "Real-World" Observational Study

Abstract

INTRODUCTION: Levodopa-carbidopa intestinal gel (LCIG, carbidopa-levodopa enteral suspension [CLES] in the US) administered via percutaneous gastrojejunostomy (PEG), a jejunal (J) extension tube and an external pump is a long-term treatment option for patients with advanced Parkinson’s disease (aPD). Limited data exists on PEG-J component utilization and replacements during LCIG treatment in a ‘real-world’ setting. This interim analysis investigated the routine clinical practice of PEG-J insertion and component replacements of the device and associated safety. METHODS: DUOGLOBE is an ongoing multinational observational study with 3-year follow-up. This interim analysis included patients who had the PEG-J insertion procedure from 55 global sites. The type of tubing used, frequency of and reasons for tube replacements, and Serious Adverse Events (SAEs) were assessed. This analysis was not powered for statistical comparisons. RESULTS: This interim dataset had 188 patients with PEG-J tube placement (mean duration of PEG-J exposure: 515.8 days); 178 patients with PEG-J tubing manufacturer data were included in this analysis. At initial PEG-J tube placement, 83% (n = 148) of patients received AbbVie-proprietary tubing and 17% (n = 30) received non-AbbVie tubing. Most patients 79% (n = 141) did not require a PEG-J replacement. Patients needing any PEG-J replacement was similar between AbbVie and non-AbbVie tubing (22% and 17%); 5% of patients (n/N = 7/148) with AbbVie tubing required 2 PEG-J replacements (n/N = 0/30 for non-AbbVie tubing). In the first 12 months, Kaplan-Meier estimates demonstrated that 84% of patients did not require a tube replacement with AbbVie tubing (non-AbbVie tubing, 89%). The most common reasons for the first PEG-J replacement for AbbVie tubing was a routine, preplanned procedure (6%), PEG-J dislocation (4%), occlusion and leaking (each 2%), and other (5%); for non-AbbVie tubing PEG-J dislocation (10%) was the only reported reason. Overall, 38% of patients experienced an SAE who had AbbVie tubing (n = 56) and 47% for non-AbbVie tubing (n = 14). Gastrointestinal (GI)-related SAEs were reported in patients [n(%)] with AbbVie tubing [8(5%)] and non-AbbVie tubing [6(20%)]; 1 (1%) and 2 (7%) patients discontinued due to a GI-related AE, respectively. CONCLUSION: This interim analysis of patients in a multinational observational study with LCIG demonstrated that most patients did not require PEG-J tube replacements in a real-world setting and safety was similar to the known safety profile of LCIG.