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Long-Term Deutetrabenazine Treatment Is Associated With Continued Improvement in Tardive Dyskinesia in the Completed 3-Year Open-Label Extension Study

Published online by Cambridge University Press:  10 May 2021

Robert A. Hauser ,
Hadas Barkay ,
Hubert H. Fernandez ,
Stewart A. Factor ,
Joohi Jimenez-Shahed ,
Nicholas Gross ,
Leslie Marinelli ,
Amanda Wilhelm ,
Mark Forrest Gordon  and
Juha-Matti Savola
...Show all authors
Robert A. Hauser
Affiliation:
University of South Florida, Parkinson’s Disease and Movement Disorders Center, Tampa, FL, USA
Hadas Barkay
Affiliation:
Teva Pharmaceutical Industries Ltd., Netanya, Israel
Hubert H. Fernandez
Affiliation:
Cleveland Clinic, Cleveland, OH, USA
Stewart A. Factor
Affiliation:
Emory University, Atlanta, GA, USA
Joohi Jimenez-Shahed
Affiliation:
Icahn School of Medicine at Mount Sinai, New York, NY, USA
Nicholas Gross
Affiliation:
Teva Pharmaceutical Industries Ltd., West Chester, PA, USA
Leslie Marinelli
Affiliation:
Teva Pharmaceutical Industries Ltd., West Chester, PA, USA
Amanda Wilhelm
Affiliation:
Teva Pharmaceutical Industries Ltd., West Chester, PA, USA
Mark Forrest Gordon
Affiliation:
Teva Pharmaceutical Industries Ltd., West Chester, PA, USA
Juha-Matti Savola
Affiliation:
Teva Pharmaceutical Industries Ltd., Basel, Switzerland
Karen E. Anderson
Affiliation:
Georgetown University, Washington, DC, USA
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Abstract

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Background

The 12-week ARM-TD and AIM-TD studies in tardive dyskinesia (TD) patients showed statistically significant improvements in TD symptoms with deutetrabenazine. The completed open-label extension (OLE) study (SD-809-C−20) evaluated long-term efficacy and safety of deutetrabenazine in TD.

Methods

Patients who completed ARM-TD or AIM-TD enrolled in the OLE study, with deutetrabenazine dose titrated based on dyskinesia control and tolerability. Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score was assessed by local site raters. Treatment success was evaluated locally as patients being “much improved” or “very much improved” on Clinical Global Impression of Change (CGIC).

Results

343 patients enrolled in the OLE study; 6 patients were excluded from analyses. At Week 54 (n=249; dose [mean±SE]: 38.7±0.66mg/day), mean change from baseline in AIMS score was –4.8±0.28; 66% of patients experienced treatment success. At Week 106 (n=194; dose: 39.3±0.75mg/day), mean change from baseline in AIMS score was –5.4±0.33; 65% of patients experienced treatment success. At Week 145 (n=160; dose: 39.4±0.83mg/day), mean change from baseline in AIMS score was –6.6±0.37; 73% of patients experienced treatment success. Treatment was generally well tolerated across 723 patient-years of exposure through Week 158, and exposure-adjusted incidence rates (incidence/patient-years) for akathisia/restlessness were 0.01, somnolence/sedation were 0.07, and symptoms which may represent parkinsonism or depression were 0.08 each.

Conclusions

Patients who received long-term treatment with deutetrabenazine achieved sustained improvement in AIMS scores. Findings from this open-label trial with response-driven dosing suggest the possibility of increasing benefit over time.

Funding

Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel

Type
Abstracts
Information
CNS Spectrums , Volume 26 , Issue 2 , April 2021 , pp. 162
Copyright
© The Author(s), 2021. Published by Cambridge University Press

Footnotes

Presenting Author: Robert A. Hauser