Quality of Life Effects of Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa in People with Parkinson's
Leonard Verhagen Metman1, Rajesh Pahwa2, Thomas Kimber3, Okeanis Vaou4, Jaclyn Homola5, Lars Bergmann5, Jia Jia5, Megha Shah5, Jason Aldred6
1Northwestern University, Chicago, IL, USA, 2University of Kansas Medical Center, Kansas City, KS, USA, 3Royal Adelaide Hospital, Adelaide, SA, Australia, 4University of Texas Health Science Center at San Antonio, San Antonio, TX, USA, 5AbbVie Inc., North Chicago, IL, USA, 6Selkirk Neurology & Inland Northwest Research, Spokane, WA, USA
Objective:
To determine the effect of continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp) for 24-hours/day for 12 weeks on people with Parkinson’s (PwP) quality of life measured via Parkinson’s Disease Questionnaire-39 (PDQ-39) subdomains.
Background:
A prior 52-week open-label LDp/CDp CSCI phase 3 trial (NCT03781167) demonstrated significant improvement in the PDQ-39 subdomains of Activities of Daily Living (ADLs), Mobility, Bodily Discomfort (BD), Stigma, and the Summary Index. In a 12-week double-blind phase 3 trial comparing LDp/CDp CSCI and oral levodopa-carbidopa immediate-release (LD/CD-IR) tablets (NCT04380142), numerical PDQ-39 Summary Index improvements were observed in LDp/CDp- versus oral-treated patients. However, the hierarchical testing procedure utilized prevented claiming statistical significance by stopping at a higher-ranked endpoint, despite nominal P values observed at <.05.
Design/Methods:
This post hoc study analyzes the PDQ-39 subdomain results from the above-mentioned 12-week trial. PDQ-39 subdomain change from baseline to final were analyzed both within and between treatment groups. P values are nominal and not corrected for multiplicity.
Results:
Compared to the oral LD/CD-IR arm (n=59), LDp/CDp CSCI treatment (n=45) led to improvements in the PDQ-39 subdomains of Mobility (LS mean of difference [SE]: -6.70 [3.09]*) and Stigma (-5.28 [2.61]*) with the nominal P value of *≤.05. Significant within-group improvements were seen in oral-treated patients for the PDQ-39 Social Support subdomain (mean [SD]: 3.55 [10.53]*, n=47); and in LDp/CDp-treated patients (n=45) for subdomains of Mobility (-8.00 [18.19]**), ADLs (-8.98 [21.36]**), Stigma (-9.03 [20.58]**), and BD (-6.67 [18.51]*) at *P≤.05 or **P≤.01. Soileau et al. reported the 12-week trial safety was generally consistent with other levodopa-containing medicines and subcutaneous therapies.
Conclusions:
This post hoc analysis shows improvements in Mobility and Stigma versus the oral arm with a nominal P value of ≤.05. And, the statistically significant within-group improvements versus baseline in four PDQ-39 subdomains of LDp/CDp-treated patients are consistent with the 52-week open-label trial results.