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

Purpose Evaluate 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. Methods Observational, retrospective, and post-authorization study in patients with PD and MF treated with opicapone at 16 Spanish Movement Disorders centers. Results Of 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 < 0.001). After 4.8 (3.6) months of treatment, scores in UPDRS Parts II-IV significantly decreased, suggesting additional improvements in daily activities and motor function. The mean daily time with dyskinesias did not increase after initiating opicapone. Mild adverse events were observed in 21 (8.3%) patients. Conclusion This 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.