Objective: To evaluate the opicapone (OPC) associated patient’s odds ratio (OR) in relative OFF-time reduction.

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 evaluating the associated patient’s OR in relative OFF-time reduction, in each treatment group, at different cut-offs, namely >=25%, >=50%, >=75% and 100% (OFF-time free). Statistical analysis was performed by a pairwise Cochran-Mantel-Haenszel test stratified by study.

Results: In total, 535 patients were randomized; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. The proportion of OFF-time responders for 50mg-OPC was higher than placebo for all different cut-offs, reaching statistical significance for both >=25 (p=0.0002) and >=50% (p=0.0223) relative OFF-time reduction. PLC proportion of responders ranged from 38.0% (>=25%) to 4.7% (100%). OPC-50mg proportion of responders ranged from 54.6% (>=25%) to 8.0% (100%) and presented an OR to placebo ranging from 1.94 (>=25%) to 1.75 (100%).

Conclusion: OPC 50 mg once-daily was associated with significant improvements of motor fluctuations across a range of responses considered clinically meaningful and with 75% increased odds of becoming OFF-time free in relation to placebo.

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/opicapone-odds-ratio-in-relative-off-time-reduction-a-post-hoc-analysis-from-combined-bipark-i-and-ii-data/