Levodopa-Entacapone-Carbidopa Intrajejunal Infusion in Advanced Parkinson's Disease - Interim Analysis of the ELEGANCE Study

Abstract

Background: Levodopa-entacapone-carbidopa intestinal gel (LECIG) was introduced in 2018 as a device-aided therapy for advanced Parkinson's disease (PD).

Objectives: The ELEGANCE study (NCT05043103) is gathering real-world data on long-term efficacy, safety and patient-reported outcomes with LECIG from 13 European countries. This article reports data from the planned interim analysis.

Methods: The study enrolled patients prescribed LECIG as part of routine clinical care. We evaluated patients at V1 before starting LECIG treatment (in seven patients V1 data were obtained retrospectively), and thereafter at V2 (3-6 months) or V3 (6-12 months).

Results: This analysis includes 167 patients from 37 centers. Three patients from this analysis set (1.8%) discontinued the study. Mean (±SD) daily OFF-time hours (MDS-UPDRS IV item 4.3) were substantially reduced by 3.47 ± 3.56 h at V2 (baseline: 5.15 ± 3.05; P < 0.0001). Similarly, MDS-UPDRS part IV total scores were reduced by 4.24 ± 4.08 at V2 (baseline: 10.77 ± 3.83); (P = 0.0001) and MDS-UPDRS part II scores by 3.63 ± 7.76 at V2 (baseline: 20.65 ± 8.17; P = 0.0004). PDSS-2 total scores were sustainably improved (reduction of 7.38 ± 10.72 at V2 [baseline: 25.21 ± 10.62]; P < 0.0001), as was the PDQ-8 summary index score indicating an improvement in quality of life (QoL) (reduction of 13.3 ± 19.05 at V2 [baseline: 46.34 ± 20.09]; P < 0.0001). For all parameters improvements were maintained at V3. Patient-reported satisfaction with the LECIG pump was high. Most adverse events were related to the procedure or the device.

Conclusions: Routine use of LECIG for up to 12 months provided sustained control of motor symptoms, and was well tolerated with a positive impact on QoL and high patient satisfaction.

Keywords: advanced Parkinson's disease; carbidopa intestinal gel; clinical practice; entacapone; levodopa.

Figure 1

Daily hours of OFF time by visit. Data are mean ± 95% confidence interval.

Figure 2

Radar plot indicating the mean values per visit of the clinically meaningful sleep subdomains from the PDSS‐2 score. A scale from 0 to 4 is used with lower numbers associated with better outcome. Items were grouped according to the APOMORPHEE study: overall quality of night's sleep (item 1), sleep onset and maintenance insomnia (items 2 and 3), nocturnal restlessness (items 4 and 5), nocturnal psychosis (items 6 and 7), nocturia (items 8 and 9), nocturnal motor symptoms (items 10–13), sleep refreshment (item 14), and daytime dozing (item 15).