Abstract Details

Title Quality of Life Effects of Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa in People with Parkinson's

Topic Movement Disorders

Presentation(s) P9 - Poster Session 9 (8:00 AM-9:00 AM)

Poster/Presentation
Number 3-003

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.

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.

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.

Authors/Disclosures
Leonard Verhagen Metman, MD, PhD (Northwestern University) PRESENTER	Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi Tanabe. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerevel. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers.
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center)	Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allevion. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Photopharmics. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sun Biopharma. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Biohaven. The institution of Dr. Pahwa has received research support from EIP. The institution of Dr. Pahwa has received research support from Amneal. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theranexus. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Voyager. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Annovis. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Praxis. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB.
Thomas E. Kimber, PhD, FRACP (Royal Adelaide Hospital)	Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Seqiris. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Kimber has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer.
Okeanis Vaou, MD, FAAN (UT Health San Antonio)	An immediate family member of Dr. Vaou has received personal compensation for serving as an employee of Acadia Pharmaceutical. An immediate family member of Dr. Vaou has received personal compensation for serving as an employee of Sage. Dr. Vaou has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic . Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for medtronic. An immediate family member of Dr. Vaou has stock in Takeda and Acadia, Sage. The institution of Dr. Vaou has received research support from Medtronic.
Jaclyn C. Homola, PharmD (AbbVie)	Dr. Homola has received personal compensation for serving as an employee of AbbVie. Dr. Homola has stock in AbbVie.
Lars Bergmann	Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
Jia Jia, PhD	Mr. Jia has received personal compensation for serving as an employee of Abbvie.
Megha Shah	Megha Shah has received personal compensation for serving as an employee of AbbVie. Megha Shah has stock in AbbVIe .
Jason L. Aldred, MD, FAAN (Selkirk Neurology)	Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quadralynx. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Adamas. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Atara. The institution of Dr. Aldred has received research support from Takeda. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Theravance. The institution of Dr. Aldred has received research support from Triplet Therapeutics. The institution of Dr. Aldred has received research support from UCB. The institution of Dr. Aldred has received research support from Cerevel . The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from Athira. The institution of Dr. Aldred has received research support from IRL. The institution of Dr. Aldred has received research support from NeuroDerm.