Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To evaluate the efficacy of opicapone (OPC) in levodopa-treated Parkinson’s Disease (PD) patients with or without baseline presence of dyskinesia (BPDys).
Background: OPC, a once-daily COMT inhibitor, proved effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) , .
Method: Patient-level data from matching treatment arms in BIPARK-I and II were combined in placebo (PLC) and OPC-50mg groups. Studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria , . Key secondary endpoints included analysis of responders (>1 hour OFF-time reduction or >1 hour ON-time increase). A post-hoc analysis was performed to evaluate OPC-50mg and PLC efficacies in levodopa-treated PD patients according to BPDys (assessed by UPDRS question 32).
Results: In total, 535 patients were randomized; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. 47% (PLC) to 50% (OPC-50mg) of patients reported BPDys. Mean placebo-adjusted OFF-time reduction was -50.5min (p=0.0080) and -67.3min (p=0.0005) for OPC-50mg patients with and without BPDys. There was ~65% more OFF-time reduction in PLC patients with BPDys than in those without. A higher-than-PLC proportion of OPC-50mg-receiving patients with BPDys achieved OFF- (67.9% vs. 50.8%; p<0.0060) and ON-time (65.6% vs. 45.1%; p=0.0011) responders’ endpoint. Consistently, a higher-than-PLC proportion of OPC-50mg-receiving patients with absence of dyskinesia achieved OFF- (67.2% vs. 47.4%; p=0.0010) and ON-time (61.1% vs. 45.9%; p=0.0115) responders’ endpoint.
Conclusion: Opicapone was effective regardless of baseline presence of dyskinesia.
References:  Ferreira et al., Lancet Neurology 2016; 15(2):154-165.  Lees et al., JAMA Neurol. 2017; 74(2):197-206.
To cite this abstract in AMA style:A. Lees, J. Ferreira, A. Antonini, H. Reichmann, R. Costa, D. Magalhães, J. Rocha, P. Soares-da-Silva. Efficacy of opicapone in Parkinson’s disease patients according to baseline presence of dyskinesia: a post-hoc analysis from combined BIPARK-I and II [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-parkinsons-disease-patients-according-to-baseline-presence-of-dyskinesia-a-post-hoc-analysis-from-combined-bipark-i-and-ii/. Accessed December 10, 2023.
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