Characterizing a Parkinson's Disease Population Inadequately Controlled by Oral Therapy: Baseline Characteristics of the Phase 3 Clinical Program for Foslevodopa/Foscarbidopa
Per Odin1, Rajesh Pahwa2, Jill Farmer3, Thomas Kimber4, Bruno Bergmans5, Eric Freire Alvarez6, K Ray Chaudhuri7, Resmi Gupta8, Connie H. Yan8, Lars Bergmann8, Pavnit Kukreja8, Angelo Antonini9
1Lund University, Lund, Sweden, 2University of Kansas Medical Center, Kansas City, KS, USA, 3Global Neurosciences Institute, Pennington, NJ, USA, 4Royal Adelaide Hospital, Adelaide, Australia, 5AZ St-Jan Brugge-Oostende AV, Bruges, Belgium and Ghent University Hospital, Ghent, Belgium, 6University General Hospital of Elche, Elche, Spain, 7King's College Hospital, London, UK, 8AbbVie Inc., North Chicago, IL, USA, 9University of Padua, Padua, Italy
Objective:
The aim of this analysis was to characterize the patient populations of two pivotal clinical trials with foslevodopa/foscarbidopa (LDP/CDP, also referred to as ABBV-951), an investigational drug for Parkinson’s Disease (PD).
Background:
While identification of advanced PD (aPD) continues to be a challenge, new tools have emerged to help clinicians determine if patients have reached aPD. Recently, a validated tool known as MANAGE-PD was launched to help clinicians identify suboptimal PD symptom control and categorize patients with advancing PD as either controlled, inadequately controlled possibly needing treatment optimization, or potentially eligible for device-aided therapies (DATs).
Design/Methods:
This post-hoc analysis evaluated the baseline characteristics of patients enrolled in two ABBV-951 phase 3 studies (one double-blind/double-dummy, NCT04380142; and one open-label safety, NCT03781167). Additionally, in the open-label study, the MANAGE-PD criteria (section 1 and 2) was applied to the participants prospectively, which may further validate the use of the tool in identifying patients eligible for DATs.
Results:
In the double-blind (n=141) and open-label (n=244) studies, the percentages of participants at baseline in the 55-74 age category were 66.7% and 73.4%, that had daily off time >3 hours were 97.2% and 88.1%, that had a 0-3 Hoehn and Yahr stage were 96.5% and 94.7%, and had time to occurrence of motor fluctuations as >3 years of 73.0% and 77.5%, respectively. Based on the MANAGE-PD categorization, in the open label-study all patients were considered to be inadequately controlled with the current treatment regimen, with 14.8% possibly benefitting from current treatment optimization, and 85.2% as potentially benefitting from DAT.
Conclusions:
The vast majority of patients from the pivotal trials in the LDP/CDP clinical program were consistent with populations characterized as ‘advanced’ and eligible for a DAT such as ABBV-951, which was substantiated using the MANAGE-PD categorization, adding to the validation of this tool.