Objective: The REONPARK study aims to evaluate COMT inhibitors (COMTi) effectiveness and tolerability in alleviating motor complications associated with L-dopa treatment in Parkinson’s disease (PD) patients with early motor fluctuations (EMF, signs of end-of-dose motor fluctuations within ≤2 years) in clinical practice.

Background: In PD, COMTi usage extend the elimination half-life of levodopa and reduce peak-trough variations, contributing to optimize the dose of levodopa and stabilize plasma levels [1]. Although evidence indicates comparable COMTi efficacy in reducing off-time and increasing on-time in both patients with recent and long-standing motor fluctuations, some studies suggest a benefit of earlier initiation of COMTi [2-6].

Method: REONPARK study is a Spanish COMTi registry for PD patients treated with L-dopa/DDCI and EMF. Presenting here an interim analysis up to 6 months post COMTi initiation.

Results: One hundred and thirty-one evaluable patients (mean±SD: 65.2±10 years old; 5.1±3.2 years PD duration; 472.9±196 mg/daily L-dopa/DDCI; MDS-UPDRS III:22.5±14.3; MDS-UPDRS IV:2.9±2.1) initiated COMTi (99.3% opicapone; 0.7% entacapone). After 6 months the motor symptoms and motor complications (fluctuations and dyskinesias) were reduced [Table 1]. Mean OFF time decreased from 3.9±2.6h at baseline to 1.9±2.4h (p<0.001) after 6 months [Figure 1]. Meanwhile, OFF severity seems to be reduced since the functional impact of the fluctuations was reduced, (from baseline 1.5±0.9 to 0.8±0.9, p<0.001 at 6 months) and patients experiencing no impact increased from 11.54% to 46.77% [Figure 2]. After 6 months, a significant decrease was observed for PDQ-8 (from 6.1±5.1 to 5.2±5.0, (p=0.044) and for WOQ-19 (from 5.1±2.3 to 3.0±2.4, p<0.001).

Conclusion: COMTi (mainly opicapone) treatment demonstrated a reduction on OFF time and motor complications, improving the functional impact of fluctuations after 6 months of treatment in real-world practice.

Table 1

Figure 1

Figure 2

References: 1. Expert Rev Neurother 2021(9):1019-1033.
2. Mov Disord. 2020;35(suppl 1):444
3. Ebersbach GR, O; Ferreira, J; Costa, R. Rocha J.F , Magalhães, D; Soares-da-Silva, P. . Efficacy and Safety of Opicapone in Parkinson’s Disease Patients According to Duration of Motor Fluctuations: Post-Hoc Analysis of BIPARK-I and II. In: MDS Virtual Congress 2020.
4. Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P (2019) Long-term efficacy of opicapone in fluctuating Parkinson’s disease patients: a pooled analysis of data from two phase 3 clinical trials and their open-label extensions. Eur J Neurol 26(7):953-960.
5. Nissinen H, Kuoppamaki M, Leinonen M, Schapira AH (2009) Early versus delayed initiation of entacapone in levodopa-treated patients with Parkinson’s disease: a long-term, retrospective analysis. Eur J Neurol 16(12):1305-1311.
6. Rocha JF, Ebersbach G, Lees A et al (2021) The Added Benefit of Opicapone When Used Early in Parkinson’s Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II. Front Neurol 12754016.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/comt-inhibitors-clinical-experience-in-early-motor-fluctuations-six-months-analysis-of-reonpark-study/