Efficacy and Safety of Levodopa/Entacapone/Carbidopa Combination in the Treatment of Advanced Parkinson's Disease – Prospective ELEGANCE Study

LCIG vs. LECIG 

Compared to the standard intestinal gel of levodopa/carbidopa (LCIG), the bioavailability of levodopa in LECIG is higher due to the presence of entacapone. Increased bioavailability of levodopa allows for a 20–35% reduction in its dose while achieving the same effective plasma level. 

Thus, LECIG represents a new therapeutic option for patients with advanced-stage Parkinson's disease and motor complications that can no longer be adequately compensated with optimized oral/transdermal medication. 

Assessment of PD Symptoms 

Parkinson's disease includes a variety of motor and non-motor symptoms. The effort to quantify these symptoms led to the creation of the first unified scale for PD assessment in the 1980s, known as the Unified Parkinson's Disease Rating Scale (UPDRS), which formed the basis for the MDS-UPDRS scale published in 2001 and is currently one of the most used scales for evaluating PD symptoms. The ELEGANCE study also utilizes it. 

Design of the ELEGANCE Study

ELEGANCE is an international prospective non-interventional observational study being conducted in 16 countries. Participation is offered to all adult patients with advanced PD with severe motor fluctuations and hyperkinesia or dyskinesia despite optimized oral or transdermal medication who have been prescribed the LECIG combination as part of routine clinical practice. De novo patients as well as those switching from another infusion therapy can be included. The planned total number of participants across all countries is 300. Patients will then be monitored for 24 months or until the study ends. Data collection began in July 2021 with a recruitment end date planned for July 2022, study completion in the second quarter of 2024, and interim reports in between. 

Study Objectives 

The primary objective is to evaluate the long-term efficacy and safety of LECIG over 24 months. Efficacy assessments will include the impact on motor symptoms (changes in OFF functional state from baseline to month 24 – motor complications of PD expressed on the MDS-UPDRS IV scale) and motor aspects of daily living (MDS-UPDRS II scale), required levodopa dose, use of other PD treatments, clinical and patient overall impression of therapy, and patient satisfaction with the treatment. Adverse events will be monitored for safety assessment. 

Secondary objectives include the occurrence of non-motor symptoms (change from baseline on the non-motor symptoms scale, PD sleep scale, and non-motor aspects of daily living, MDS-UPDRS lb scale score), quality of life (PDQ-8 and PDQ-39 questionnaires), healthcare resource utilization (PD complications leading to hospitalization, issues with medication or devices). 

Conclusion 

The data from the ELEGANCE study will provide valuable information on the real-world effectiveness and safety of long-term LECIG treatment. It will also offer insights from the patient's perspective and the impact on healthcare resource utilization, which can help shape future clinical decisions and therapeutic approaches. 

(lexi) 

Sources:  
1. Jost W., Dafsari H., Ebersbach G., Warnecke T. ELEGANCE – a prospective non-interventional study of the long-term effectiveness and safety of levodopa–entacapone–carbidopa intestinal gel (LECIG) in patients with advanced Parkinson's disease in routine care. Clin Neurophysiol 2022; 137: e61, doi: 10.1016/j.clinph.2022.01.112.
2. Baláž M. New MDS-UPDRS scale in quantifying Parkinson's disease symptoms. Neurology for Practice 2011; 12 (Suppl. G): 16. Available at: www.neurologiepropraxi.cz/pdfs/neu/2011/92/06.pdf
3. Baláž M. MDS-UPDRS scale in patients with Parkinson's disease. Neurology for Practice 2011; 12 (Suppl. G): 18–27. Available at: www.neurologiepropraxi.cz/pdfs/neu/2011/92/07.pdf 
4. Nevrlý M. Intestinal gel levodopa/entacapone/carbidopa (LECIG) in the treatment of Parkinson's disease. proLékaře.cz, 31. 3. 2022. Available at: www.prolekare.cz/tema/parkinsonova-choroba/detail/intestinalni-gel-levodopa-entakapon-karbidopa-lecig-v-lecbe-parkinsonovy-nemoci-130465