Âé¶¹´«Ã½Ó³»­

Âé¶¹´«Ã½Ó³»­

Explore the latest content from across our publications

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Long-term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia
Movement Disorders
P6 - Poster Session 6 (12:00 PM-1:00 PM)
3-005

To assess the long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) patients with tardive dyskinesia (TD).

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.
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. 
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.
Deutetrabenazine treatment was associated with sustained improvements in AIMS score and was well tolerated in both younger and older TD patients. 
Authors/Disclosures

PRESENTER
No disclosure on file
Amanda Wilhelm Amanda Wilhelm has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Stacy Finkbeiner No disclosure on file
No disclosure on file
Nayla Chaijale Nayla Chaijale has received personal compensation for serving as an employee of Teva Pharmaceuticals.
No disclosure on file
Mark F. Gordon, MD, FÂé¶¹´«Ã½Ó³»­ (Teva Pharmaceuticals) Dr. Gordon has received personal compensation for serving as an employee of Teva. Dr. Gordon has stock in Teva.