Objective: To assess the long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) patients with tardive dyskinesia (TD).
Background: TD is an involuntary movement disorder that is more prevalent in older patients. Deutetrabenazine is FDA approved for treatment of TD in adults based on 2 pivotal phase 3 studies in patients with baseline Abnormal Involuntary Movement Scale (AIMS) score ≥6 (ARM-TD and AIM-TD), which demonstrated significant improvements in AIMS score versus placebo over 12 weeks.
Method: Patients who completed ARM-TD or AIM-TD were enrolled in a single-arm open-label extension (OLE) study. This post hoc analysis assessed change and percent change from baseline in AIMS score, response rates for ≥50% AIMS improvement, Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and safety in younger (<55 years) and older (≥55 years) patients.
Results: 343 participants enrolled in the OLE, including 124 younger patients and 219 older patients. At Week 145, mean ±SE total deutetrabenazine dose was 39.3 ±1.37 mg/day and 39.3 ±1.05 mg/day in younger and older patients, respectively. At Week 145, mean ±SE changes from baseline in AIMS score were –6.7 ±0.61 and –6.4 ±0.47 in younger and older patients, respectively (percent changes of –60.9% ±4.06% and –53.8% ±3.06%, respectively); the majority of younger and older patients achieved treatment success per CGIC (66% and 76%) and PGIC (both 63%), and 75% of younger and 61% of older patients achieved ≥50% AIMS response. Deutetrabenazine was generally well tolerated in both groups. Exposure-adjusted incidence rates (incidence/patient-years) were <0.01 and 0.02 for akathisia, 0.07 and 0.06 for somnolence and sedation, 0.04 and 0.11 for parkinson-like events, and 0.06 and 0.09 for depression in younger and older patients, respectively.
Conclusion: Deutetrabenazine treatment was associated with sustained improvements in AIMS score and was well tolerated in both younger and older TD patients.
To cite this abstract in AMA style:M. Sajatovic, A. Wilhelm, S. Finkbeiner, H. Barkay, N. Chaijale, N. Gross, M. Gordon. Long-term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/long-term-safety-and-efficacy-of-deutetrabenazine-in-younger-and-older-patients-with-tardive-dyskinesia/. Accessed December 5, 2023.
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