Objective: To evaluate the incidence of treatment-emergent adverse events (TEAEs) in levodopa-treated Parkinson’s Disease (PD) patients with motor fluctuations and taking opicapone (OPC).

Background: OPC is a once-daily COMT inhibitor that proved effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) [1],[2].

Method: Patient-level data from matching treatment arms in BIPARK-I and II were combined in placebo (PLC) and OPC-50mg groups. The studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria [1],[2]. Safety was assessed by incidence of TEAEs, laboratory parameters, ECGs and vital signs. An exploratory post-hoc analysis was performed to evaluate the incidence of TEAEs according to baseline disease severity (assessed as modified Hoehn and Yahr, H&Y).

Results: Of the 1027 patients randomized to BIPARK-I and II, 522 patients took a dose of relevant study medication (OPC-50mg n=265, PLC n=257) and were included in this analysis. H&Y>=2.5 patients represented ~57% of both OPC-50mg and PLC groups. Overall, 64.2% of OPC-50mg patients reported any TEAE compared to 57.2% in PLC. There was a comparable incidence of TEAEs for both H&Y<2.5-matched patients (66.4% vs. 63.2% for OPC-50mg and PLC groups) and H&Y>=2.5-matched patients (62.5% vs. 52.4% for OPC-50mg and PLC groups). The most frequently occurring TEAE was dyskinesia in both subgroups.

Conclusion: Opicapone appears to be well-tolerated in both 2.5<=H&Y and H&Y<2.5 patients.

References: [1] Ferreira et al., Lancet Neurology 2016; 15(2):154-165. [2] Lees et al., JAMA Neurol. 2017; 74(2):197-206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/incidence-of-treatment-emergent-adverse-events-in-parkinsons-disease-patients-according-to-baseline-disease-severity-post-hoc-analysis-from-double-blind-combined-bipark-i-and-ii-data/