Objective: To evaluate the type and timing of occurrence of treatment-emergent adverse events (AEs) in people with advanced Parkinson’s disease (PD) following up to one year of treatment with LECIG by analysis of interim data from the ELEGANCE study (NCT05043103) for a total of 167 patients.

Background: ELEGANCE is a large, ongoing non-interventional registry study (NCT05043103) that is collecting ‘real-world’ safety, efficacy and patient-reported outcomes data across 13 countries over 2 years from advanced PD patients treated with LECIG in routine clinical practice. LECIG, a device-aided therapy for advanced PD, was introduced in 2018 and is now approved in multiple European countries. The inclusion of entacapone in the formulation increases the bioavailability of levodopa allowing a reduced dose of levodopa to be given in a smaller volume while still achieving effective plasma levodopa levels.¹

Method: Study participants are advanced PD patients with severe motor fluctuations and hyperkinesia or dyskinesia despite optimised PD therapy who have been prescribed LECIG as part of routine clinical care. Treatment-emergent AEs, including serious AEs, that occurred at any time during the course of LECIG treatment were reported. For this analysis, information on the type of AE and timing of occurrence were evaluated for up to one year of treatment.

Results: Overall, the occurrence of AEs was low. For all time points evaluated, the most common AEs related to the procedure (stoma site inflammation or infection) or the infusion device (device dislocation or occlusion; Table 1). Diarrhoea, a known AE that may occur in up to 10% of patients treated with oral entacapone¹, occurred in only 1/167 patients within the first week and 3/167 patients between 3–12 months. In each case these events were infectious in origin and unrelated to LECIG treatment. No case resulted in treatment discontinuation and all patients recovered following antibiotic treatment. Visual hallucination occurred in 2/167 patients over one year of LECIG treatment.

Conclusion: These data suggest that LECIG treatment for up to one year is generally well tolerated by patients with advanced PD. As has been observed with levodopa–carbidopa intestinal gel infusion, the most frequent AEs are associated with the procedure or the device.

Table 1

References: 1. Comtan Summary of Product Characteristics.
2. Antonini A, et al. Parkinsonism Relat Disord. 2017:45:13-20.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/timing-and-type-of-adverse-events-following-long-term-treatment-with-levodopa-entacapone-carbidopa-intestinal-gel-lecig-infusion-data-from-the-elegance-interim-analysis/