Objective: To characterize dyskinesia distribution by body region in subjects with tardive dyskinesia (TD) enrolled in a clinical trial of valbenazine, based on baseline Abnormal Involuntary Movement Scale (AIMS) item scores.

Background: KINECT 3 (NCT02274558) was a 6-week, randomized, double-blind, placebo-controlled trial of valbenazine (NBI-98854; 80 and 40 mg/day) in adults with TD and schizophrenia/schizoaffective disorder (SCHZ) or mood disorder. Concomitant treatment with a stable antipsychotic regimen was allowed. The primary efficacy measure was the change from baseline to Week 6 in the AIMS dyskinesia total score, which is the sum of scores for the 7 individual AIMS items that rate dyskinesia severity in different body regions.

Methods: Subjects entering KINECT 3 had a qualitative global assessment of “moderate” or “severe” TD based on screening videos. At baseline (and all subsequent study visits), subjects underwent a standardized, videotaped AIMS exam for scoring by 2 independent, blinded, central video raters. Consensus scoring between the central raters was required for each AIMS item (range, 0=none to 4=severe). AIMS baseline scores were analyzed by psychiatric diagnosis subgroup (SCHZ, mood); no statistical testing between subgroups was conducted.

Results: 225 subjects were included in this analysis (SCHZ, n=148; mood, n=77). AIMS dyskinesia total mean scores at baseline were 9.4 (range, 0-20) and 11.1 (range, 4-20) in the SCHZ and mood subgroups, respectively. The mean number of AIMS items/regions with a score ≥2 (mild severity or worse) was 3.1 (range, 0-7) in the SCHZ subgroup and 3.9 (range, 0-7) in the mood subgroup. In the SCHZ subgroup, >50% of subjects had an AIMS item score ≥2 in the following regions: jaw (57.3%), lips (54.7%). In the mood subgroup, >50% of subjects had an AIMS item score ≥2 in the following regions: tongue (72.7%), jaw (63.6%), lips (62.3%), upper extremities (51.9%), trunk (50.6%). In both subgroups, most subjects had some dyskinesia (AIMS item score ≥1) in ≥1 orofacial region and ≥1 non-orofacial region (SCHZ, 94.6%; mood, 96.1%).

Conclusions: The most pronounced TD movements were found in jaw/lips among subjects with SCHZ and in tongue/jaw/lips among subjects with a mood disorder. However, most subjects in both subgroups also had dyskinesia beyond the orofacial regions.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/tardive-dyskinesia-by-body-region-in-subjects-with-schizophreniaschizoaffective-disorder-or-mood-disorder-findings-from-the-kinect-3-study/