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ABSTRACT
Background: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson’s disease (PD) patients.
Methods: Patients previously received levodopa for ≥6 months as monotherapy/in combination with another dopamine-agonist (DA). Primary variable: Unified PD Rating Scale (UPDRS) Part-II change from baseline to end-of-observation-period (EOP).
Results: 91 younger/99 older patients started rotigotine; 68 younger/62 older patients completed the study. Most switched from levodopa+another DA. Addition of rotigotine as first DA was more common in older patients (20.2% vs.15.4%). Mean ± SD rotigotine-exposure: 6.1 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose.
At EOP, improvement in mean UPDRS-II was greater in younger patients (p = 0.0289). UPDRS-II responder-rate (≥20% decrease in UPDRS-II score) was higher in younger patients (42.3% vs. 25.9%). Improvement across age groups was similar on PD Sleep Scale-2 and Clinical Global Impressions-Improvement Scale. Adverse drug reactions (ADRs), and discontinuations because of ADRs, were more common among older patients. There were no new safety signals.
Conclusions: Despite low rotigotine doses, when added to levodopa/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.
Acknowledgments
The authors thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. The authors acknowledge Nicole Meinel, PhD, CMPP (Evidence Scientific Solutions, London, UK) for writing assistance, funded by UCB Pharma (Brussels, Belgium), Elisabeth Dohin, MD (UCB Pharma, Brussels, Belgium) and Karin Annoni, MD (UCB Pharma, Milan, Italy) for scientific and medical input into the data analyses and interpretation, and Suzannah Ryan, PhD (former employee of UCB Pharma, Dublin, Ireland) for publication coordination. The authors thank Javier Alcazar Perez, MD (former employee of UCB Pharma, Madrid, Spain) for his contributions to the running of the study and analysis of the data. This data was previously presented at the 21st International Congress of Parkinson’s Disease and Movement Disorders, June 4–8 2017; Vancouver, Canada.
Declaration of Interest
D Woitalla has received personal compensation from UCB Pharma, GlaxoSmithKline, Orion Pharma, Zambone, Bial, Bayer, and AbbVie for consulting services. M-G Ceravolo has received personal compensation from UCB Pharma for consulting services. KR Chaudhuri has received research support from UCB Pharma, AbbVie, and Britannia Pharma between 2006–2011. They have also received consultancy fees/honoraria from UCB Pharma, AbbVie, US WorldMeds, Otsuka, Mundipharma, and Britannia. They furthermore act as a consultant/advisor for AbbVie (2010–present), Britannia (2009–present), Mundipharma (2012–present), UCB Pharma (2010–present) and receive funding for speaker activities for AbbVie, Britannia, Mundipharma, UCB Pharma, Zambon, and Medtronic. They also receive educational grants from AbbVie, Britannia, Medtronic, and UCB Pharma and grants/honoraria from the NIHR, Parkinson’s UK, the European Union, AbbVie, Britannia, Medtronic, and UCB Pharma. Finally, this author also holds a patent for a product referred to in the CME/CPD program that is marketed by a commercial organization; and is currently participating in, designing, or running a clinical trial (within the past 2 years) for Toledo, Neupark, PANDA, and the Newron PDGF study. L Joeres and J-C Schuller are salaried employees of UCB Pharma and receive stock options from their employment. M Asgharnejad is a former employee of UCB Pharma (Raleigh, NC) who received stock options from her employment. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. One referee declares that they have acted as a consultant for UCB Pharma in 2012.
Author contributions
Dirk Woitalla, Antoine Dunac, Ali Safavi, Maria-Gabriella Ceravolo, Juan Carlos Gomez Esteban, Nicola Pavese, and K. Ray Chaudhuri were study investigators and were involved in data collection. Mahnaz Asgharnejad, Lars Joeres, and Jan-Christof Schuller were involved in the design of the study. Jan-Christof Schuller performed the data analysis. All authors contributed to data interpretation. All authors were involved in the critical review/revision of manuscript drafts and approved the final version.
Supplemental Materials
Supplemental data for this article can be accessed here.