Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia

Authors

Martha Sajatovic, Case Western Reserve UniversityFollow

Author ORCID Identifier

Martha Sajatovic

Document Type

Article

Publication Date

3-1-2022

Abstract

Objectives: To assess long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) adult participants with tardive dyskinesia (TD). Design: Three-year, single-arm, open-label extension (OLE) study enrolling participants who completed the 12-week, pivotal ARM-TD or AIM-TD studies. Setting: Seventy-six centers in the United States and Europe. Participants: A total of 337 participants with TD (119 younger and 218 older). Intervention: Deutetrabenazine was initiated at 12 mg/day and titrated once weekly by 6 mg/day using a response-driven dosing regimen until adequate dyskinesia control was reached or a clinically significant adverse event occurred. Measurements: This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD. Results: After 3 years of open-label treatment, mean deutetrabenazine dose was ∼39.5 mg/day in both groups. Mean±SE changes from baseline in total motor AIMS score were –6.7 ± 0.62 and –6.5 ± 0.47 in younger and older participants, respectively (percent changes: –61.4% ± 4.10% and –54.6% ± 3.01%); 76% of younger and 62% of older participants achieved ≥50% AIMS response. Most younger and older participants achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%). Deutetrabenazine was generally well tolerated in both groups. Conclusions: Deutetrabenazine treatment was associated with sustained improvements in total motor AIMS score, treatment success, and improved quality of life, and was well tolerated in younger and older adults with TD in this 3-year OLE study.

Keywords

deutetrabenazine, efficacy, elderly, safety, tardive dyskinesia

Language

English

Publication Title

American Journal of Geriatric Psychiatry

Rights

© The Author(s) 2021. This is an Open Access work distributed under the terms of the Creative Commons Attribution Licence (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Recommended Citation

Sajatovic M, Finkbeiner S, Wilhelm A, Barkay H, Chaijale N, Gross N, Gordon MF. Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia. Am J Geriatr Psychiatry. 2022 Mar;30(3):360-371. doi: 10.1016/j.jagp.2021.08.003. Epub 2021 Aug 16. PMID: 34511333.