Objective: To evaluate the real-world effectiveness of carbidopa/levodopa enteral suspension (CLES) in patients with advanced Parkinson’s disease (PD) in real world at home setting in USA.

Background: While CLES has been available in multiple countries since 2004, it was approved in USA in 2015. The effect of CLES on PD-related motor and non-motor symptoms has been studied through robust clinical trials(1-4) and observational studies(5-6). Real-world evidence has been often examined in European settings, and the evidence from the US settings is now emerging.

Method: PROviDE is a US-based prospective, longitudinal observational study. All patients who received a prescription for CLES were eligible to participate. Patients were evaluated at baseline and at months 3, 6, 12, 18, 24, 30, 36 after treatment initiation. Patients completed a battery of self-reported outcome measures via telephone-call or a web-survey. The outcomes included number of hours of off-time and dyskinesia per day; quality of life, sleep, fatigue, treatment satisfaction, freezing of gait, and impact of dyskinesia on activity of daily living were measured using self-reporting, PDQ-8, PDSS-2, PROMIS-fatigue, TQSM, FOGQ-sa, and PDYS-26 respectively. This interim analysis focuses on the 3 month effectiveness of CLES. Unadjusted comparisons were made vs. baseline using paired t-tests and Wilcoxon signed rank tests.

Results: The baseline demographic and clinical characteristics are reported [Table1]. Compared to baseline, patients were observed to have significant reduction in self-reported off-time (mean ± SD: -3.05 ± 3.27 hours/day; p<0.0001). The patients also were observed to have a significant improvement in dyskinesia, quality of life, sleep, freezing of gait, and treatment satisfaction [Table 2]. There was also an improvement in fatigue and impact of dyskinesia on activities of daily living; however the change was not statistically significant at 3 months.

Conclusion: This study provides data from one of the largest US-specific cohorts of CLES patients in real-world settings. Evidence suggests that CLES improves patient-centered outcomes within 3 months of treatment initiation. Future analyses will include adjusted treatment effect for potential confounders and data for the complete study population.

References: 1. Olanow, C.W. et al., 2014. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson’s disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurology, 13(2), pp.141–149. 2. Slevin, J.T. et al., 2015. Long-term safety and maintenance of efficacy of levodopa-carbidopa intestinal gel: an open-label extension of the double-blind pivotal study in advanced Parkinson’s disease patients. Journal of Parkinson’s disease, 5(1), pp.165-174. 3. Fernandez, H.H. et al., 2015. Levodopa-carbidopa intestinal gel in advanced Parkinson’s disease: Final 12-month, open-label results. Movement disorders, 30(4), pp.500–509. 4. Standaert, D.G. et al., 2017. Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson’s Disease. Movement Disorders Clinical Practice, 4(6), pp.829–837. 5. Antonini, A. et al., 2017. Levodopa-carbidopa intestinal gel in advanced Parkinson’s: Final results of the GLORIA registry. Parkinsonism & related disorders, 45, pp.13–20. 6. Pålhagen, S.E. et al., 2016. Levodopa-carbidopa intestinal gel (LCIG) treatment in routine care of patients with advanced Parkinson’s disease: An open-label prospective observational study of effectiveness, tolerability and healthcare costs. Parkinsonism & related disorders, 29, pp.17–23.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/evaluating-the-real-world-effectiveness-of-carbidopa-levodopa-enteral-suspension-cles-on-patients-with-advanced-parkinsons-disease-in-usa-interim-evidence-from-the-provide-study/