Patients Reported Improvement in Quality of “OFF” time, Severity of Non-Motor Fluctuations, and Medication Satisfaction in the OPTI-ON Study
Peter LeWitt1, Olga Klepitskaya2, Michael Serbin2, Eric Jen2, Stacey Rattana3, Jeffrey Trotter3, Grace Liang2
1Wayne State University School of Medicine and Henry Ford Hospital, 2Neurocrine Biosciences, Inc., 3Worldwide Clinical Trials
Objective:
To describe patient-reported outcomes (PROs) from the Opicapone Treatment Initiation Open-Label Study (OPTI-ON).
Background:
Opicapone is an oral, once-daily, selective catechol-O-methyltransferase (COMT) inhibitor used as adjunctive treatment to carbidopa/levodopa (CD/LD) in patients with Parkinson’s disease (PD) experiencing “OFF” episodes. The aim of the OPTI-ON study was to evaluate “real-world” patient characteristics, treatment patterns, and safety/tolerability of opicapone use in the US.
Design/Methods:
OPTI-ON was a prospective, open-label, single-arm, multicenter, observational, longitudinal (6-month) study of patients with PD experiencing “OFF” episodes who were prescribed opicapone adjunctive to CD/LD. PROs including the Patient Global Impression of Severity in the “OFF” state (PGI-S OFF), Patient Global Impression of Change (PGI-C), Non-Motor Fluctuations PGI-S (NMFs PGI-S), and Medication Satisfaction Questionnaire (MSQ) were obtained at baseline (BL) and throughout follow-up.
Results:
Overall, 164 patients completed the study. On the PGI-S OFF, more patients rated their “OFF” time symptom severity as none or very mild at 3 months (21.2%) and 6 months (20.4%) compared to BL (10.3%). For the PGI-C, 29.8% and 23.5% of patients were much or very much improved at months 3 and 6, respectively. On the NMFs PGI-S, fewer patients scored markedly to most extremely affected with NMFs at 6 months (3.2%) compared to BL (11.9%). On the MSQ, 42.3% of patients were very or extremely satisfied with their opicapone treatment at 6 months versus 14.2% with their treatment regimen at BL.
Conclusions:
After 6 months of opicapone treatment, patients reported improvement on the PGI-S OFF and PGI-C, reduced NMF severity on the NMFs PGI-S, and increased satisfaction on the MSQ. In addition to decreasing the duration of “OFF” episodes as shown in Phase 3 clinical studies, these results suggest once-daily opicapone may improve the quality of “OFF” time, more effectively manage motor fluctuations and NMFs in PD, and increase patients’ satisfaction with their PD treatment regimen.