Long-Term Effectiveness and Safety of LCIG in Romania. 3-year Results from a Prospective, Observational Study (DUOGLOBE)

Background: Levodopa-carbidopa intestinal gel (LCIG) is an established treatment for patients with advanced Parkinson’s disease (APD). Improvement of motor and non-motor symptoms, as well as the quality of life has been proven in clinical trials. Prospective long-term data in routine clinical practice are limited. Objective: To assess the effectiveness and safety of LCIG over a 36-month prospective follow-up in Romania, as part of the DUOGLOBE international non-interventional study. Methods: DUOGLOBE (DUOdopa/Duopa in Patients with APD – a GLobal OBservational Study Evaluating Long-Term Effectiveness; NCT02611713) was a long-term observational study in patients with APD receiving LCIG as part of their treatment strategy in routine clinical care. Prospective data up to 36 months from LCIG initiation were collected in the study. The primary objective assessed the change in OFF time from baseline to 36 months. Results: Of the total number of 195 patients enrolled worldwide, 51 patients were included in 6 movement disorder centers in Romania. In these patients, LCIG was initiated after a median disease duration of 8.1 years (1.6– 19.7). The need for concomitant anti-PD medication decreased within one month after LCIG initiation and remained stable for up to 36 months. The OFF time was significantly reduced by LCIG treatment at all timepoints vs baseline (p< 0.001) (mean change standard deviation, SD at final visit: − 3.4 ± 2.8 hours). Improvement of dyskinesia was recorded at 36 months (mean change SD of the Unified Dyskinesia Rating Scale at final visit − 9.0 16.54, p=0.006). Improvements in non-motor symptoms and quality of life were consistent from Day 1 throughout the study. Safety was consistent with the well-established LCIG profile and with the global study results (serious adverse events SAEs): 49.0% of patients discontinued the therapy (27.5% due to SAEs). Conclusion: DUOGLOBE provides long-term data on routine practice in Romania and consistent LCIG benefits in patients with APD. Keywords: DUOGLOBE, non-interventional study, LCIG, Romania, Parkinson’s disease, real-world evidence