Objective: To assess the efficacy and safety of deutetrabenazine (DTB) in reducing the severity of the abnormal involuntary movements of tardive dyskinesia (TD) based on the individual body region scores that comprise the Abnormal Involuntary Movement Scale (AIMS).

Background: The AIMS is often used in clinical trials to assess the severity of TD. The first seven items of the AIMS score assess abnormal movements in the face, lips and perioral area, jaw, tongue, upper extremities, lower extremities, and the trunk (neck, shoulders, hips), and are scored from 0 (no movements) to 4 (severe movements). A decrease in score reflects reduced abnormal involuntary movements and improvement of TD. DTB significantly reduced overall AIMS score (items 1–7) in patients with TD in two randomized, double-blind, placebo (PBO)-controlled trials compared with PBO: ARM-TD (DTB: –3.0 vs PBO: –1.6, P=0.019) and AIM-TD (DTB 36 mg/day: –3.3; DTB 24 mg/day: –3.2 vs PBO: –1.4; P≤0.003 for both); it was generally well tolerated.

Methods: The change in AIMS score from baseline to Week 12 was analyzed for each body region using a mixed model for repeated measures for all randomized patients who had a centrally read baseline AIMS score ≥6, received study drug, and had at least one post-baseline AIMS assessment. Pooled analysis and individual study results from both studies are presented here.

Results: Pooled analysis of ARM-TD and AIM-TD indicate significant improvements from baseline to Week 12 with DTB treatment (n=152) compared with PBO (n=107) in six of seven AIMS components: lips and perioral area (DTB: –0.5 vs PBO: –0.2; P=0.001); jaw (–0.5 vs –0.3; P=0.017); tongue (–0.7 vs –0.4; P=0.004); upper extremities (–0.4 vs –0.1; P=0.001); lower extremities (–0.4 vs –0.2; P=0.02); neck, shoulders and hips (–0.3 vs –0.1; P=0.013). In the ARM-TD study, improvements were seen in six of the seven AIMS body regions with DTB treatment. In the AIM-TD study, improvements were seen in all seven AIMS body regions with DTB 24 and 36 mg/day. Muscles of facial expression showed improvement only in the AIM-TD study, as compared with a slight worsening in the ARM-TD study.

Conclusions: DTB treatment improved all body regions assessed by the AIMS. This suggests that DTB is useful for the treatment of TD in multiple body areas.

Presented at: APA annual meeting; May 20–24, 2017; San Diego, CA, USA

« Back to 2017 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-deutetrabenazine-by-body-region-score-of-the-abnormal-involuntary-movement-scale-in-tardive-dyskinesia-arm-td-and-aim-td-studies/