Abstract Details

Title Dose Patterns for Long-Term Deutetrabenazine Treatment in Patients With Tardive Dyskinesia by Baseline Abnormal Involuntary Movement Scale Item 8 Score

Topic Movement Disorders

Presentation(s) P9 - Poster Session 9 (5:30 PM-6:30 PM)

Poster/Presentation
Number 5-001

Objective This post hoc analysis examined dosing patterns by severity of tardive dyskinesia (TD) according to baseline Abnormal Involuntary Movement Scale (AIMS) item 8 score.

Background The mechanism of TD is complex, and TD medications typically require fine-tuning of doses. Deutetrabenazine is FDA-approved to treat TD in adults. Based on results from the 12-week pivotal trials (ARM-TD and AIM-TD), deutetrabenazine showed significant reductions in total motor AIMS scores with deutetrabenazine compared with placebo.

Design/Methods Patients who completed the pivotal 12-week studies, ARM-TD and AIM-TD, were eligible for the 3-year open-label extension study. Deutetrabenazine was initiated at 12 mg/day and titrated weekly by 6 mg/day for 6 weeks based on dyskinesia control and tolerability. Subgroups were defined by baseline AIMS item 8 scores 0/1/2 or 3/4. Total daily dose categories and treatment exposure over time were evaluated.

Results 336 patients were analyzed (scores 0/1/2, n=117; 3/4, n=219). At Week 15, proportions of patients by deutetrabenazine total daily dose (mg) for scores 0/1/2 and 3/4, respectively, were: <24, 10% and 3%; ≥24-≤36, 41% and 48%; >36-≤48, 49% and 49%. At Week 145, proportions by total daily dose (mg) for scores 0/1/2 and scores 3/4 were: <24, 9% and 3%; ≥24-≤36, 42% and 38%; >36-≤48, 47% and 55%; >48, 2% and 4%. For scores 0/1/2, mean±SE total daily dose (mg) at Week 15 and Week 145, respectively, was 36.9±1.04 (n=108) and 37.9±1.44 (n=64). For scores 3/4, mean±SE total daily dose (mg) at Week 15 and Week 145, respectively, was 39.2±0.65 (n=186) and 40.5±0.99 (n=97).

Conclusions Patients with TD benefit from response-driven titration and arrival to optimal deutetrabenazine doses >24 mg/day regardless of baseline severity of abnormal movements. These findings highlight the importance of patient-driven titration until adequate movement control is achieved while maintaining safety/tolerability in TD treatment.

Authors/Disclosures
Nayla Chaijale PRESENTER	Nayla Chaijale has received personal compensation for serving as an employee of Teva Pharmaceuticals.
	No disclosure on file
Stacy Finkbeiner	Stacy Finkbeiner has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Amanda Wilhelm, PhD	Dr. Wilhelm has received personal compensation for serving as an employee of Teva Pharmaceuticals .
Jessica K. Alexander, PhD (Jazz)	Jessica K. Alexander has received personal compensation for serving as an employee of Teva Pharmaceuticals. Jessica K. Alexander has received stock or an ownership interest from Teva Pharmaceuticals.
Nayla Chaijale	Nayla Chaijale has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Mark F. Gordon, MD, FAAN (Teva Pharmaceuticals)	Dr. Gordon has received personal compensation for serving as an employee of Teva. Dr. Gordon has stock in Teva.

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