Real-world data of opicapone in patients with Parkinson's disease experiencing motor fluctuations: the OPTIMO study.

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PurposeEvaluate the outcomes of opicapone as an add-on treatment to levodopa/DDCI in patients with Parkinson's disease (PD) and motor fluctuations (MF) in a real-world setting.MethodsObservational, retrospective, and post-authorization study in patients with PD and MF treated with opicapone at 16 Spanish Movement Disorders centers.ResultsOf 245 patients included (55.9% men; mean [standard deviation] age: 67.7 [10.4] years), 41.9 and 33.6% presented rigid-akinetic and tremor-dominant phenotypes, respectively; 43.8% had a history of dyskinesias. Patients started treatment with 50 mg/day opicapone 8.3 (5.3) years after diagnosis. At initiation, the mean levodopa dose was 620.7 (313.7) mg/day. According to the PGI-C (available in 178 patients), 74.2% of patients reported clinical improvement in MF, without worsening of dykinesias in 64.6%. Clinical improvement of MF with stable/improved dyskinesias was similar between PD phenotypes (p = 0.327). Opicapone reduced the percentage of patients experiencing wearing-off phenomena (98.0% vs. 61.6%), delayed-on (10.2% vs. 5.3%; p = 0.010), no-on (6.5% vs. 2.9%; p = 0.027), and non-motor fluctuations (21.6% vs. 15.1%; p = 0.010). Furthermore, the off-time decreased (143.3 vs. 67.9 min/day; p ConclusionThis study demonstrates that opicapone added to levodopa improves motor function and reduces MF without significantly enhancing dyskinesia intensity, along with a tolerable profile. Moreover, there were no differences regarding clinical improvement among PD phenotypes.

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