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Psych Congress  

Analysis of AIMS Global Judgment Components (Items 8–10) in Patients With TD: Results From the ARM-TD and AIM-TD Studies


Hadas Barkay, PhD – Teva Pharmaceuticals; Amanda Wilhelm, PhD – Teva Pharmaceuticals; Rolf Hansen, PhD – Teva Pharmaceuticals; Maria Wieman, MPH – Teva Pharmaceuticals; Nicholas Gross, MS – Teva Pharmaceuticals; Juha-Matti Savola, MD, PhD – Teva Pharmaceuticals

Teva Pharmaceuticals

Background: Tardive dyskinesia (TD) is a debilitating, often-irreversible hyperkinetic movement disorder that impairs patients’ abilities to perform daily activities. Deutetrabenazine was FDA-approved to treat TD based on the pivotal ARM-TD and AIM-TD studies.

Methods: ARM-TD and AIM-TD were 12-week, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of deutetrabenazine in the treatment of TD. Here we present the effect of deutetrabenazine on Abnormal Involuntary Movement Scale (AIMS) items 8–10 (severity of abnormal movements; incapacitation due to abnormal movements; awareness of abnormal movements; score: 0 [none] to 4 [severe] for each item) in ARM-TD and AIM-TD.

Results: 89 patients (43 placebo, 46 deutetrabenazine) from ARM-TD and 153 (56 placebo, 97 deutetrabenazine) from AIM-TD were analyzed. In ARM-TD, AIMS item 8 (mean±standard error) change from baseline was –0.8±0.14 for placebo and –1.1±0.13 for deutetrabenazine (difference –0.2; P=0.195). There were no score differences for AIMS items 9-10. In AIM-TD, item 8 scores were improved by –0.6±0.12, –1.0±0.13, and –1.1±0.12 after placebo, 24 mg/day (difference –0.4; P=0.02), and 36 mg/day (difference –0.4; P=0.011). Item 9 scores were improved by –0.5±0.12, –1.0±0.14, and –0.9±0.13 after placebo, 24 mg/day (difference –0.5; P=0.004), and 36 mg/day (difference –0.4; P=0.012). Item 10 scores were improved by –0.5±0.14, –0.9±0.15, and –0.9±0.14 after placebo, 24 mg/day (difference –0.4; P=0.037), and 36 mg/day (difference –0.4; P=0.045).

Conclusion: TD patients receiving deutetrabenazine 24 and 36 mg/day doses showed AIMS 8–10 score improvements at Week 12, suggesting reduced severity of, less incapacitation from, and increased awareness of abnormal movements.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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