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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
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.

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

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
Martha Sajatovic, 5110
PRESENTER
Martha Sajatovic, 5110 has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alkermes, Otsuka, Janssen, Myriad, Health Analytics, Frontline Medical Communications. The institution of Martha Sajatovic, 5110 has received research support from Nuromate, Otsuka, Alkermes, International Society for Bipolar Disorders (ISBD), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Patient-Centered Outcomes Research Institute (PCORI). Martha Sajatovic, 5110 has received publishing royalties from a publication relating to health care.
Amanda Wilhelm Amanda Wilhelm has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Stacy Finkbeiner No disclosure on file
Hadas Barkay Hadas Barkay has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Nayla Chaijale Nayla Chaijale has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Nicholas Gross, MS Nicholas Gross, MS has nothing to disclose.
Mark Forrest Gordon, MD, FAAN (Teva Pharmaceuticals) Dr. Gordon has received personal compensation for serving as an employee of Teva. Dr. Gordon has stock in Teva.