Objective: To evaluate the impact of demographic characteristics in the efficacy response of levodopa-treated Parkinson’s Disease (PD) patients with motor fluctuations.

Background: Opicapone (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 demographic characteristics [i.e., age, gender, race (Caucasian vs. Asian), weight and Body Mass Index (BMI)] in efficacy outcomes (i.e., change from baseline in OFF-/ON-time). Linear regression was applied and the slope was statistically tested for deviation from zero.

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)]. Neither OFF- nor ON-time magnitude of responses were influenced by age, gender, race, weight and BMI at baseline. Linear regression applied was found to be non-significant for both treatment arms and all variables analyzed.

Conclusion: Demographic characteristics (i.e., age, gender, race, weight and BMI) do not appear to impact either OFF- or ON-time magnitude of responses in a clinical study setting.

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