Category: Drug-Induced Movement Disorders
Objective: To assess the clinical characteristics and overall disease management of adult patients receiving long-term valbenazine treatment for tardive dyskinesia (TD) in a real-world setting.
Background: TD is a persistent and often disabling involuntary movement disorder that is associated with long-term exposure to dopamine receptor blocking agents such as antipsychotics. The long-term efficacy of valbenazine, which was approved in 2017 for treating TD in adults, has been demonstrated in several prospective clinical trials. This multi-center, retrospective chart review will assess long-term valbenazine treatment for TD in a real-world setting.
Method: Data from up to 150 patient charts (at 15-20 US sites) will be extracted and entered into a validated electronic data capture (EDC) system. Adult patients (≥18 years) with a clinical diagnosis of DRBA-induced TD and ≥6 consecutive months of valbenazine treatment will be included. Data will be collected starting from one month or, if applicable, the last documented clinical visit prior to initial prescription with valbenazine up to the date of data abstraction. Data will be abstracted for the following items (both pre- and post-valbenazine treatment): socio-demographics, psychiatric and other comorbid conditions, concomitant medication use, duration/severity of TD, valbenazine treatment patterns, and health care resource utilization. Safety and tolerability will be assessed with adverse events. Changes over time in TD parameters will be evaluated with scatter plots and linear regression models, and predictors of treatment durability will be identified using Cox’s proportional hazards models. Outcome assessment will be conducted based on availability of patient data.
Results: Site enrollment is ongoing; interim data will be presented at the meeting.
Conclusion: This retrospective chart review aims to provide insights into the patient characteristics and disease management associated with long-term specific TD treatment in adult patients and to evaluate real-world decision-making and effects of long-term TD management.
To cite this abstract in AMA style:E. Goldberg, C. Yonan, N. Longo, H. Cratty, M. Nicosia, J. Sampalis, T. Carmack, S. Siegert, A. Angelov. Real-World Evaluation of Patient Characteristics and Disease Management in Long-Term Valbenazine Treatment in Adults with Tardive Dyskinesia [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/real-world-evaluation-of-patient-characteristics-and-disease-management-in-long-term-valbenazine-treatment-in-adults-with-tardive-dyskinesia/. Accessed December 5, 2023.
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