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Abstract Details

Long-term Motor and Non-Motor Symptom Benefits in Patients With Advanced Parkinson’s Disease Treated With Levodopa-Carbidopa Intestinal Gel: Final Analysis of the 36-Month DUOGLOBE Real-world Multinational Observational Study
Movement Disorders
P1 - Poster Session 1 (9:00 AM-5:00 PM)
272
Evaluate the long-term effectiveness and safety of levodopa-carbidopa intestinal gel (LCIG) during routine clinical practice in patients with advanced Parkinson's disease (PD).
In clinical trials, LCIG reduced motor and non-motor symptoms in patients with advanced PD. Prospective, long-term data on LCIG use in a real-world setting are limited.
DUOGLOBE (NCT02611713) was an observational, multinational (including US sites), prospective study enrolling LCIG-naïve patients treated in routine clinical practice with a 3-year follow-up. The change in patient-reported “Off” time was the primary outcome. Additional assessments included Unified Dyskinesia Rating Scale (UDysRS), Non-Motor Symptom Scale (NMSS), Parkinson’s Disease Sleep Scale (PDSS-2), health-related quality of life (HR-QoL; Parkinson’s disease Questionnaire 8 [PDQ-8]), Modified Caregiver Strain Index (MCSI), and serious adverse events (SAEs). Final outcomes at month (M) 36 are presented.
Among 195 patients, baseline "Off" time, UDysRS, and NMSS total scores showed substantial disease burden. Overall, 89 patients completed the 3-year follow-up. About one-third of patients were treated with LCIG monotherapy or LCIG with only supplemental oral levodopa. The mean total LCIG dose was stable across all time points. Significant improvements were sustained through M36 in patient-reported “Off” time (P<.001), UDysRS (P<.05), PDSS-2 (P<.001), and NMSS total scores (P<.01). Patient-reported HR-QoL and MCSI scores were significantly improved through M24 (P<.01) and M30 (P<.05), respectively. About half of discontinuations were primarily due to non-safety reasons; 31% of patients who discontinued the study did continue LCIG. The most common SAEs were falls and (worsening of) PD (4.1% [n=8]). Device-related issues were reported by 11.8% of patients (n=23).
In this final analysis from the first fully prospective, 3-year, real-world study of LCIG, patients with advanced PD treated with LCIG exhibited significant and sustained improvements in motor and non-motor symptoms that were maintained for 3 years. Safety was consistent with the established LCIG safety profile.
Authors/Disclosures
Lars Bergmann, MD (Abbvie GmbH & Co)
PRESENTER 		Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
No disclosure on file
Norbert Kovacs Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie.
No disclosure on file
Jason L. Aldred, MD, FAAN (Selkirk Neurology) Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $0-$499 for serving as a Consultant for Quadralynx. 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 Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 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 $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $500-$4,999 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 $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 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 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 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 NeuroDerm. The institution of Dr. Aldred has received research support from PhotoPharma. The institution of Dr. Aldred has received research support from Lilly.
Paul M. Bourgeois, MD Dr. Bourgeois has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABBVIE.
Thomas L. Davis, MD Dr. Davis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Davis has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Parkinson Foundation.
Esther Cubo Delgado, MD, PhD, FAAN (Fundacion Burgos Investigacion Salud CIF G09254616) Dr. Cubo Delgado 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. Cubo Delgado has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Zambon. Dr. Cubo Delgado has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. The institution of Dr. Cubo Delgado has received research support from Spanish health ministry. The institution of Dr. Cubo Delgado has received research support from European union grant.
Marieta Anca-Herschkovitsch, MD (Edith Wolfson Medical Center- Holon-Israel) Marieta Anca-Herschkovitsch, MD has nothing to disclose.
No disclosure on file
Mustafa S. Siddiqui, MD, FAAN Dr. Siddiqui has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Boston Scientific Neuromodulation. Dr. Siddiqui has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. The institution of Dr. Siddiqui has received research support from Boston Scientific Neuromodulation. The institution of Dr. Siddiqui has received research support from Abbvie. The institution of Dr. Siddiqui has received research support from National Institute of Health .
Mihaela A. Simu, MD, PhD (University of Medicine and Pharmacy Timisoara) Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis PHarma . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Romania. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for TEVA. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Bayer. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for UCB. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis Pharma. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Johnson &Johnson. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofy Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Abbvie . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Abbvie. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Johnson&Johnson. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson & Johnson . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Abbvie. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for UCB. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ewopharma A G. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen.
Pavnit Kukreja, PharmD (AbbVie) Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
Omar Ladhani Omar Ladhani has received personal compensation for serving as an employee of AbbVie. Omar Ladhani has received stock or an ownership interest from AbbVie.
Jia Jia, PhD Mr. Jia has received personal compensation for serving as an employee of Abbvie.
David G. Standaert, MD, PhD, FAAN (Univ of Alabama - Dept of Neurology) Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Inc. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CVS/Pharmacy. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll Biopharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for F. Hoffman LaRoche. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from National Institutes of Health. The institution of Dr. Standaert has received research support from F. Hoffman LaRoche. Dr. Standaert has received publishing royalties from a publication relating to health care. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with National Institutes of Health. Dr. Standaert has a non-compensated relationship as a Chair, Scientific Advisory Board with American Parkinson Disease Association that is relevant to AAN interests or activities.