Objective: To evaluate the impact of disease duration on the efficacy of opicapone (OPC) in levodopa-treated Parkinson’s Disease (PD) patients with motor fluctuations.

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) [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]. An exploratory post-hoc analysis was performed to evaluate the influence of disease duration on efficacy outcomes (change from baseline in OFF-/ON-time). Applied linear regression’s slope was statistically tested for deviation from zero and linearity.

Results: In total, 1027 patients were randomized to BIPARK-I and II and 522 patients took a dose of study medication; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. One patient in each group was excluded from disease duration analysis as there was no matched-patient. OFF-/ON-time magnitude of responses was not influenced by disease duration (non-significant linear regression).

Conclusion: Disease duration appears to have no impact in the magnitude of response.

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/influence-of-disease-duration-in-the-efficacy-response-of-parkinsons-disease-patients-with-motor-fluctuations-post-hoc-analysis-from-combined-bipark-i-and-ii/