Objective: REONPARK study is an observational study conducted in Spain aimed at evaluating COMT inhibitors (iCOMT) tolerability and effectiveness in alleviating motor complications associated with L-dopa treatment in Parkinson’s disease (PD) patients with early motor fluctuations (signs of end-of-dose motor fluctuations within ≤2 years) in clinical practice.

Background: In PD, the usage of iCOMT extends the half-life of levodopa and reduces peak-trough variations, contributing to optimize the dose of levodopa and stabilize plasma levels [1]. Available iCOMTs include opicapone, entacapone and tolcapone. Although evidence indicates comparable iCOMT efficacy in reducing off-time and increasing on-time in patients with recent or long-standing motor fluctuations, some studies suggest a benefit of earlier initiation of iCOMT [2-5]. The MDS-UPDRS part IV is essential for quantifying the severity and clinical impact of these fluctuations.

Method: This interim analysis describes the effect of 12-months iCOMT treatment on the MDS‑UPDRS Part IV, with a particular focus on changes in motor fluctuations.

Results: In 89 evaluable patients (age [mean±SD] 64.6±10.2 years old; time since diagnosis 4.8±3.1 years; mean daily levodopa dose 463.8±191.7 mg/day; 98.9% initiating opicapone and 1.1% entacapone), the mean MDS-UPDRS IV score was 4.5±1.9 at baseline. After 12 months of treatment with iCOMT, a reduction of motor complications (fluctuations and dyskinesias) was observed, with the score decreasing by 1.45 points (p<0.001) to 3.0±2.7. Time spent in the OFF state (MDS-UPDRS part IV item 4.3) improved substantially: 36.4% of patients reported no OFF‑time after 12 months on iCOMT (Figure 1). Similarly, the functional impact of motor fluctuations (MDS-UPDRS part IV item 4.4) improved, with an increased proportion of patients reporting no impact (47.7%) after 12 months (Figure 2).

Conclusion: In real‑world clinical practice, the use of iCOMT (mainly opicapone) was associated with an improvement in time spent in OFF state and in the functional impact of motor fluctuations after up to 12 months of treatment. These improvements positively influence patients’ ability to perform daily activities and might be considered clinically meaningful for their overall quality of life.

Figure 1

Figure 2

References: 1. Jenner P. Expert Rev Neurother 2021(9):1019-1033.
2. 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.
3. 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.
4. 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.
5. 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/improvement-in-time-spent-in-off-state-and-in-the-functional-impact-of-motor-fluctuations-after-initiation-with-comt-inhibitors-in-parkinsons-disease-patients-with-early-wearing-off-results/