Objective: To assess clinically meaningful improvements in tardive dyskinesia (TD) by evaluating changes in abnormal movements by body region after long-term valbenazine (VBZ) treatment.

Background: The anatomical distribution and severity of TD can be variable. The efficacy of VBZ in TD was established based on mean improvements in the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7). However, because the AIMS is not a linear scale, such results provide limited information about which body regions were most affected. Therefore, shift analyses by body region were conducted using AIMS data from the KINECT 4 (NCT02405091) study.

Methods: Adults with TD and stable schizophrenia/schizoaffective disorder or mood disorder received 48 weeks of open-label VBZ followed by a drug-free washout period (4 weeks). Stable regimens of concomitant psychiatric medications were allowed. Once-daily VBZ was initiated at 40 mg, with escalation to 80 mg after 4 weeks based on tolerability and clinical assessment of TD. Shift analyses were conducted for each AIMS item, as scored by site raters. These included the shift from moderate/severe (score ≥3) at baseline to none/minimal/mild (score ≤2) after treatment (Wk48) or washout (Wk52).

Results: A total of 94 participants receiving valbenazine 40mg (n=20) or 80mg (n=74) had available AIMS data at Wk48. In this group, body regions which had the most participants with a baseline score ≥3 were lips (n=59) and tongue (n=56), followed by jaw (n=48), upper extremities (n=48), face (n=38), lower extremities (n=27), and trunk (n=26). The percentage of participants shifting to a score ≤2 at Wk48 was 100% for lips, jaw, upper extremities, and lower extremities. Shift rates for the remaining body regions were as follows (40mg, 80mg): face (100%, 97%), tongue (100%, 98%), trunk (88%, 89%). At Wk52, shift rates decreased across all items (40mg, 80mg): face (56%, 59%), lips (33%, 60%), jaw (50%, 55%), tongue (27%, 44%), upper extremities (63%, 50%), lower extremities (20%, 64%), trunk (50%, 56%).

Conclusions: Most participants (88-100%) who had moderate/severe abnormal movements at baseline had none-to-mild movements in all body regions after 48 weeks of VBZ treatment. A loss of effect was seen after washout, suggesting that patients may require ongoing VBZ therapy to maintain TD improvements.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effects-of-long-term-valbenazine-on-tardive-dyskinesia-by-body-region-shift-analyses-of-kinect-4-study-results/