Impact of carbidopa-levodopa enteral suspension on quality of life and activities of daily living in patients with advanced Parkinson’s Disease: Results from a pooled meta-analysis (P3.8-033)

Objective: To evaluate short-term and long-term impact of carbidopa-levodopa enteral suspension (CLES) on quality of life (QoL) and activities of daily living (ADL) in patients with advanced Parkinson’s Disease (APD).

Background: In addition to the clinical trials, there is emerging data from open label real-world observational studies on the safety and efficacy of CLES. Outcomes evaluates in these studies include motor symptoms, non-motor symptoms, QoL, ADL amongst others. A meta-analysis approach allows for pooling data across multiple studies to comprehensively evaluate the impact of drug on relevant patient-centric outcomes.

Design/Methods: Published trials and observational studies examining the efficacy of CLES were identified from EMBASE, MEDLINE, Derwent Drug File, and BIOSIS Previews up to September 7, 2017. Outcomes of interest for this analysis include: (i) QoL (PDQ-8, PDQ-39, EQ-5D VAS, EQ-5D), and ADL (UPDRS-II)The pooled mean change from baseline (CFB) with 95% confidence interval (CI) was estimated for each 3-month interval up to 24 months by a random-effects model. Heterogeneity was evaluated using I² and Q-statistic.

Results: A total of 27 studies (4 clinical trials and 23 observational studies) evaluating a total of 1,562 patients with advanced PD were included in this analysis. All outcomes of interest showed statistically significant improvement within 1–3 months of starting CLES. Improvement in PD-related QoL was sustained up to a period of 2 years after CLES initiation [For PDQ-39: CFB_{10–12months} = −8.6(−6.58,−10.62); CFB_{22–24months} = −7.74(−3.07,−12.40). Improvement in ADL was sustained up to a period of 2 years after CLES initiation [For UPDRS-II_OFF: CFB_{10–12months} = −5.36(−2.03,−8.70); CFB_{22–24months} = −3.88(−2.42,−5.34)]. Results were robust to the exclusion of studies driving heterogeneity.

Conclusions: CLES leads to improvement in QoL and ADL measures in APD patients that are consistent across a broad range of studies and persist for up to 2 years. Future analyses will evaluate correlation with other outcomes.

Disclosure: Dr. Standaert has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Serina Therapeutics, Abbvie Inc., the Michael J. Fox Foundation for Parkinson Research, The International Parkinson Disease and Movement Disorder Society, The Parkinson Foundation, the National Institutes of Health, Oregon Health Sciences University, Voyager Therapeutics, Blue Rock Therapeutics, Clintrex LLC, Revivo Therapeutics, Sanofi-Adventis Research and Development, and US Department of Justice. Dr. Standaert has received license feed payments, royalties, or contractual rights from McGraw Hill, Inc. Dr. Standaert has received research support from Abbvie, Inc., Avid Radiopharmaceuticals, the American Parkinson Disease Association, the Michael J. Fox Foundation for Parkinson Research, Alabama Department of Commerce, the Bachmann-Strauss Dystonia; Parkinson Foundation, and NIH grants. Dr. Patel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pharmerit International. Dr. Patel has received research support from Pharmerit International and AbbVie. Dr. Snedecor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pharmerit International. Dr. Snedecor has received research support from AbbVie, Inc. Dr. Thakkar has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received consulting fees from Abbvie. Dr. Jalundhwala has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie. Dr. Jalundhwala holds stock and/or stock options in AbbVie which sponsored research in which Dr. Jalundhwala was involved as an investigator. Dr. Kukreja has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Kukreja holds stock and/or stock options in AbbVie Inc which sponsored research in which Dr. Kukreja was involved as an investigator. Dr. Kukreja holds stock and/or stock options in AbbVie Inc. Dr. Kratochvil has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pharmerit International . Dr. Kratochvil has received research support from Pharmerit International, which has received study funding from AbbVie for conducting the Study. Dr. Bao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Inc. Dr. Bao holds stock and/or stock options in AbbVie, Inc., which sponsored research in which Dr. Bao was involved as an investigator. Dr. Pahwa has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, ACADIA, Acorda, Adamas, Cynapsus, Global Kinetics, Ionis, Lundbeck, Neurocrine Biosciences, St. Jude Medical, Sunovion, Teva Neuroscience, UCB and US World Meds. Dr. Pahwa has received personal compensation in an editorial capacity for Abbvie, ACADIA, Acorda, Adamas, Cynapsus, Global Kinetics, Ionis, Lundbeck, Neurocrine Biosciences, St. Jude Medical, Sunovion, Teva Neuroscience, UCB and US World Meds. Dr. Pahwa has received research support from Abbvie, ACADIA, Acorda, Adamas, Cynapsus, Global Kinetics, Ionis, Lundbeck, Neurocrine Biosciences, St. Jude Medical, Sunovion, Teva Neuroscience, UCB and US World Meds. Received research grants from Abbott, AbbVie, Acorda, Adamas, BMS, Boston Scientific, Cala Health, Cavion, Cynapsus, Intec, Jazz, Kyowa, Lilly, National Parkinson Foundation, NIH/NINDS, Parkinson Study Group, Pfizer, Prexton, Roche, Sunovion and US WorldMeds.