Objective: To evaluate the efficacy of opicapone (OPC) in Parkinson’s disease (PD) patients with motor fluctuations being treated with different levodopa-containing treatment regimens.

Background: OPC, a once-daily catechol-O-methyltransferase inhibitor, was shown to be effective for end-of-dose motor fluctuations in PD patients in two large multinational trials [1, 2].

Method: Matching efficacy data from BIPARK-I and II [1, 2] were combined for the placebo (PLC) and OPC 50 mg groups. The studies had similar designs, eligibility criteria and methodologies. Primary efficacy endpoint was change from baseline in OFF-time based on patient diaries. Subgroup analyses were performed to evaluate the efficacy of OPC 50 mg in different levodopa-containing treatment regimens and potential differences between the defined subgroups (Table 1). Subgroup analyses were performed using an Analysis of Covariance model applied for primary efficacy endpoint.

Results: A total of 517 patients were included in the Full Analysis Set (FAS; patients treated with >/=1 dose and with >/=1 post-baseline OFF-time assessment; PLC, n=255; OPC 50 mg, n=262). Mean OFF-time reduction was greater when OPC 50 mg, in comparison with PLC, was added to any of the treatment regimens (Table 1; Figure 1A). In fact, for each treatment regimen, the increase in OFF-time reduction was approximately 2-fold greater with the addition of OPC 50 mg versus PLC (Table 1). OFF-time reduction was similar between each treatment regimen plus OPC 50 mg (Figure 1A). However, when comparing class effects, OFF-time reduction was greater when OPC 50 mg was added to levodopa only (without dopamine agonist [DA] or monoamine oxidase B inhibitors [MAO-Bi]), when compared with either levodopa plus MAO-Bi or levodopa plus DA (as determined from the respective PLC arms; Figure 1B).

Conclusion: OPC 50 mg showed an increased effect in reducing OFF-time either when used as first add-on to levodopa or when used in combination with levodopa regimens containing other anti-PD medications.

References: 1. Ferreira JJ, et al. Lancet Neurol. 2016;15:154–65. 2. Lees A, et al. JAMA Neurol. 2017;74:197–206.

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