Improvement in Morning Akinesia After Foslevodopa/Foscarbidopa Treatment was Associated with Significantly Improved Motor Fluctuations, Activities of Daily Living, and Quality of Life in People with Parkinson’s Disease
Rajesh Pahwa1, Sara Dhanani2, Okeanis Vaou3, Diego Santos Garcia4, Bruno Bergmans5, Lars Bergmann6, Linda Harmer6, Resmi Gupta6, Megha Shah6, Thomas Kimber7, Angelo Antonini8
1University of Kansas Medical Center, Kansas City, KS, USA, 2Banner Sun Health Research Institute, Sun City, AZ, USA, 3University of Texas Health Science Center at San Antonio, San Antonio, TX, USA, 4Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain, 5AZ St-Jan Brugge, Brugge, Belgium and Ghent University Hospital, Ghent Belgium, 6AbbVie Inc., North Chicago, IL, USA, 7Royal Adelaide Hospital, Adelaide, SA, Australia, 8Padua University, Padua, Italy
Objective:
Assessment of morning akinesia (MA) association with motor complications, activities of daily living (ADL), quality of life (QoL), and sleep in patients with advanced Parkinson’s disease (PD) receiving continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp).
Background:
MA is one of the most common motor complications in PD, is often an early symptom, and can significantly impair QoL. LDp/CDp 24-hour/day CSCI demonstrated clinically meaningful improvements in MA in 12-week, active-controlled, double-blind, randomized (NCT04380142) and 52-week, single-arm, open-label (NCT03781167) phase 3 clinical trials.
Design/Methods:
A post hoc longitudinal approach differentiated LDp/CDp-treated patients with baseline MA pooled from the 12-week active-controlled, 52-week open-label, and a 96-week open-label extension of the active-controlled (NCT04750226; cutoff 14-Sep-2022) trials who demonstrated Continued MA from those who woke up in the “ON” state (Without MA) at Week 12 (wk-12). Efficacy parameters were evaluated via two-sample t-test.
Results:
Of the N=93 pooled patients with baseline MA, n=69 (74.2%) changed to Without MA while n=24 (25.8%) patients Continued MA at wk-12. No strong predictors or major differences in baseline characteristics/demographics between groups were observed. Significant differences (*P≤.05, **P≤.01, ***P≤.001) between Without MA versus Continued MA were observed in the mean (SD) change from baseline “ON” Time without Dyskinesia (5.2 [3.81]***, 1.8 [4.42]), “OFF” Time (-4.4 [3.00]***, -0.2 [3.72]), “ON” Time without Troublesome Dyskinesia (4.6 [2.78]***, 0.6 [3.67]), ADL (via MDS-UPDRS Part II, -4.5 [7.39]**, 0.2 [4.82]), and in QoL via PDQ-39 Summary Index (-9.2, [15.59]*, -1.0 [13.10]). While not significant between groups (P=.0645), the Without MA group demonstrated numerically higher clinically meaningful PDSS-2 Total Score improvement (-9.6 [11.15], -4.2 [11.47]). Previously reported overall safety data indicates LDp/CDp is generally well tolerated.
Conclusions:
Patients receiving LDp/CDp who changed to waking in the “ON” state experienced: more “ON” Time and less “OFF” Time throughout the day, improved QoL, and increased ability to participate in ADL.
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