Levodopa-entacapone-carbidopa intestinal gel in advanced Parkinson's disease: an analysis of interim data for Romanian patients enrolled in the ELEGANCE study.

Levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion is a device-aided therapy (DAT) for advanced Parkinson's disease (APD). ELEGANCE (NCT05043103) is a multinational observational study gathering real-world data on long-term efficacy, safety and patient-reported outcomes with LECIG. Here we report the experience of 69 patients (41%) in the ELEGANCE interim analysis cohort (n = 167) from Romanian tertiary centers. The following outcomes were recorded: reduction in daily OFF time and time spent with dyskinesia (based on MDS-UPDRS part IV, questions 4.3 and 4.1, respectively), scores for MDS-UPDRS part II, treatment-emergent adverse events (AEs), non-motor symptoms (NMS), quality of life (QoL), patients' perceptions of the device and, from visit (V) 2, patient and clinician global impression of improvement (PGI-I and CGI-I). Mean daily OFF time was significantly improved from baseline at V2 (3-6 months of treatment) and V3 (6-12 months) to < 2 h per day. The most common AE was device dislocation (6 patients, 8.7%). One patient experienced an AE that required treatment withdrawal. There were improvements in scores for NMS Scale domains, notably sleep parameters and gastrointestinal function, and in Parkinson's Disease Sleep Scale 2. Clinically meaningful improvements in QoL measures were observed. PGI-I and CGI-I scores showed substantial improvement. Patient-reported satisfaction with the pump was high. LECIG treatment for up to one year of APD patients at Romanian centers provided effective control of motor symptoms and was well tolerated, with few discontinuations. Additional benefit was observed on some NMS, in particular sleep, and in QoL.