Objective: To evaluate the association of patients’ perception of Parkinson’s Disease (PD) symptoms improvement (as assessed by Patient Global Impression of Change, PGIC) could be associated with other efficacy endpoints (UPDRS-III, OFF- and ON-time).

Background: Opicapone (OPC), a novel once-daily COMT inhibitor, has shown to be effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) [1,2].

Methods: Patient-level data from matching treatment arms in BIPARK-I and II studies were combined for the placebo (PLC) and OPC-50mg groups. The studies had similar designs, eligibility criteria and methods. Eligible patients were male or female, aged 30-83 years, with a 3-year diagnosis of idiopathic PD, Hoehn and Yahr 1-3 at ON-state, receiving levodopa treatment for at least 1-year and experiencing end-of-dose motor fluctuations. In both studies the primary efficacy endpoint was the change from baseline in absolute OFF-time based on patient diaries. An exploratory post-hoc analysis was performed for evaluating how and if PGIC rated by the end of double-blind (DB) was associated with UPDRS-III, OFF- and ON-time outcomes. PGIC was partitioned into responders (those who finished DB and indicated any improvement), no change (those who finished DB and indicated no change) and non-responders (those who finished DB and indicated any worsening). UPDRS-III, OFF- and ON-time outcomes were depicted for each PGIC responder status.

Results: A total of 464 patients were randomized to PLC (n=232) and OPC-50mg (n=232) completed PGIC rating at the end of DB period. From these, 53% (PLC) and 66% (OPC-50mg) were responders. For PLC and OPC-50mg, respectively, PGIC responders presented a change from baseline of -113 and -154 mins in OFF-time, -4.7 and -4.6 points in UPDRS-III and +90 and +104 mins in ON-time without dyskinesia. In contrast, PGIC non-responders presented a change from baseline of 88 and -7 mins in OFF-time, 0.0 and +1.4 points in UPDRS-III and -40 and -11 mins in ON-time without dyskinesia for PLC and OPC-50mg, respectively.

Conclusions: A positive association between PGIC and objective efficacy outcomes was observed, suggesting that improvement on those outcome measures was clinically significant from the patients perspective.

References: 1. Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P, et al. Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol 2016;15:154-165. 2. Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, et al. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol 2017;74:197-206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/relationship-between-patient-global-impression-of-change-and-other-efficacy-endpoints-in-parkinsons-disease-a-post-hoc-analysis-from-combined-bipark-i-and-ii/