TY - JOUR
T1 - An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients
AU - Krüger, Rejko
AU - Lingor, Paul
AU - Doskas, Triantafyllos
AU - Henselmans, Johanna M.L.
AU - Danielsen, Erik H.
AU - de Fabregues, Oriol
AU - Stefani, Alessandro
AU - Sensken, Sven Christian
AU - Parra, Juan Carlos
AU - Onuk, Koray
AU - Yegin, Ashley
AU - Antonini, Angelo
N1 - Funding Information:
Financial support for this study, as well as funding for the article processing charges and open access fee associated with this manuscript, was provided by AbbVie Inc., North Chicago, IL, USA. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. Rejko Kr?ger, Paul Lingor, Triantafyllos Doskas, Johanna Henselmans, Erik H. Danielsen, Oriol de Fabregues, Alessandro Stefani, Koray Onuk, and Angelo Antonini acquired and interpreted the data and reviewed and critiqued the manuscript throughout the editorial process. Sven-Christian Sensken, Juan Carlos Parra, and Ashley Yegin were responsible for original research project conception and design, and reviewed and critiqued the manuscript throughout the editorial process. Juan Carlos Parra also performed statistical analysis. Data included in this manuscript were previously presented at the 20th International Congress of Parkinson?s Disease and Movement Disorders, June 19?21, 2016, in Berlin, Germany, at the 11th International Congress on Non-Motor Dysfunctions in Parkinson?s Disease and Related Disorders, October 6?8, 2016, in Ljubljana, Slovenia, as well as at the Austrian Parkinson Society (?PG) Annual Meeting, October 20?22, 2016, in Graz, Austria. Medical writing assistance was provided by Kelly M. Cameron, PhD, of JB Ashtin, who, on behalf of AbbVie Inc., helped prepare the first draft and implemented author revisions throughout the editorial process. Support for this assistance was funded by AbbVie Inc. Rejko Kr?ger was a study investigator. He has received research grants from the German Research Council (DFG: KR2119/8-1), the Michael J Fox Foundation, the Fritz Thyssen Foundation (10.11.2.153), the Federal Ministry for Education and Research (BMBF, NGFNplus; 01GS08134), the Fonds National de Recherche Luxembourg (FNR; PEARL and NCER-PD), and from the European Union?s Horizon 2020 research and innovation program under grant agreement No. 692320 (TWINNING; Centre-PD). He has received speakers? honoraria and/or travel grants from UCB Pharma, AbbVie, Takeda Pharmaceuticals, St Jude, and Medtronic. Paul Lingor was a study investigator and received speaker honoraria and/or travel grants from AbbVie, Licher MT, Medtronic, BayerVital, and Zambon. His research has been supported by the German Research Council (DFG), the Michael J Fox Foundation, and the Else Kr?ner-Fresenius Stiftung. Triantafyllos Doskas was a study investigator, and has received speaker/consulting honoraria from Merck, Novartis, Teva, Actellion, and Genesis. Erik H Danielsen was a study investigator and has no other conflicts of interest to disclose. Alessandro Stefani was a study investigator and has no other conflicts of interest to disclose. Johanna Henselmans was a study investigator and did not receive any personal funding from AbbVie over the past year. Oriol de Fabregues was a study investigator and has received speaker honoraria from AbbVie and Zambon; he reports no other financial conflicts of interest. Sven-Christian Sensken is an employee of AbbVie Deutschland GmbH & Co KG. Juan Carlos Parra is an employee of AbbVie Inc, and holds AbbVie stock and/or stock options. Koray Onuk is an employee of AbbVie Inc, and holds AbbVie stock and/or stock options. Ashley Yegin is an employee of AbbVie Inc, and holds AbbVie stock and/or stock options. Angelo Antonini has received honoraria for consulting services and symposia from AbbVie. This study was funded by AbbVie Inc. AbbVie participated in the study design, research, data collection, analysis, and interpretation of data, writing, reviewing, and approving the manuscript for publication. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study. The clinical study report synopsis is available on AbbVie.com. Requests for additional trial data can be made at http://abbvie.com. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. To view enhanced content for this article go to http://www.medengine.com/Redeem/4998F0605DE851C0.
Publisher Copyright:
© 2017, The Author(s).
PY - 2017/7/1
Y1 - 2017/7/1
N2 - Introduction: Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8. Results: The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event. Conclusion: This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG. Funding: AbbVie Inc.
AB - Introduction: Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8. Results: The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event. Conclusion: This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG. Funding: AbbVie Inc.
KW - Activities of daily living
KW - Levodopa–carbidopa intestinal gel
KW - Parkinson’s disease
KW - Percutaneous endoscopic gastrojejunostomy
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=85021143613&partnerID=8YFLogxK
U2 - 10.1007/s12325-017-0571-2
DO - 10.1007/s12325-017-0571-2
M3 - Article
C2 - 28631218
AN - SCOPUS:85021143613
SN - 0741-238X
VL - 34
SP - 1741
EP - 1752
JO - Advances in Therapy
JF - Advances in Therapy
IS - 7
ER -