Session Time: 1:45pm-3:15pm
Location: Agora 2 West, Level 2
Objective: To evaluate long-term efficacy of deutetrabenazine in patients with tardive dyskinesia (TD) by examining the change from baseline in Abnormal Involuntary Movement Scale (AIMS) scores and Clinical Global Impression of Change (CGIC).
Background: In the 12-week ARM-TD and AIM-TD pivotal studies evaluating deutetrabenazine for the treatment of TD, statistically significant improvements in TD symptoms were demonstrated, and there were low rates of overall adverse events and discontinuations associated with deutetrabenazine. The ongoing open-label extension study (SD-809-C-20) evaluates the long-term efficacy and safety of deutetrabenazine in patients with TD.
Method: Patients with TD who completed ARM-TD or AIM-TD could enroll in this open-label, single-arm study, titrating up to an individual optimal dose over 6 weeks to a maximum total daily dose of 48 mg/day on the basis of dyskinesia control and tolerability. The change from baseline in AIMS score was assessed by local site raters for this analysis. Treatment success according to clinical global assessment (patients “Much Improved” or “Very Much Improved” on CGIC) was evaluated.
Results: 343 patients enrolled in the extension study. At Week 54 (n=249; total daily dose [mean ± SE]: 38.6±0.66 mg), the mean change from baseline in AIMS score was -4.8±0.27; 65% of patients experienced treatment success. At Week 106 (n=169; total daily dose: 39.6±0.77 mg), the mean change from baseline in AIMS score was -5.6±0.34, and 65% experienced treatment success. At Week 132 (n=109; total daily dose: 39.7±0.97 mg), the mean change from baseline in AIMS score was -6.4±0.47, and 79% experienced treatment success. Treatment was generally well tolerated. There were 623 patient-years of exposure through Week 158, and exposure-adjusted incidence rates (incidence/patient-years) of adverse events of special interest were 0.01 for akathisia and restlessness, 0.07 for somnolence and sedation, 0.04 for parkinsonism, and 0.05 for depression.
Conclusion: Patients who received long-term treatment with deutetrabenazine achieved improvement in AIMS scores and treatment response rates that were indicative of clinically meaningful long-term benefit. Results from this open-label trial with individual dose titration suggest the possibility of increasing benefit over time.
To cite this abstract in AMA style:R. Hauser, H. Barkay, H. Fernandez, S. Factor, J. Jimenez-Shahed, N. Gross, M. Gordon, JM. Savola, K. Anderson. Long-Term Treatment With Deutetrabenazine Is Associated With Continued Improvement in Tardive Dyskinesia: Results From an Open-Label Extension Study [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/long-term-treatment-with-deutetrabenazine-is-associated-with-continued-improvement-in-tardive-dyskinesia-results-from-an-open-label-extension-study/. Accessed December 1, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-treatment-with-deutetrabenazine-is-associated-with-continued-improvement-in-tardive-dyskinesia-results-from-an-open-label-extension-study/