Session Information
Date: Saturday, October 6, 2018
Session Title: Drug-Induced Movement Disorders
Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: To assess the long-term effects of once-daily valbenazine on tardive dyskinesia (TD).
Background: Valbenazine has been evaluated in several long-term TD studies, including the KINECT 4 (NCT02405091) trial in which participants received open-label treatment for up to 48 weeks.
Methods: KINECT 4 included adults with TD who had a diagnosis of schizophrenia/schizoaffective disorder or mood disorder. Valbenazine dosing was initiated at 40 mg, with escalation to 80 mg at Week 4 based on clinical assessment of TD and tolerability. A dose reduction back to 40 mg was allowed if the 80-mg dose was not tolerated (80/40mg group). Analyses based on the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7, assessed by site raters) included: mean total score change from baseline to Week 48; and response, defined as ≥50% total score improvement from baseline. Analyses based on the Patient Global Impression of Change (PGIC: range, 1 [very much improved] to 7 [very much worse]) included: mean score at Week 48; and response, defined as a patient self-rating of “1=very much improved” or “2=much improved”.
Results: Of the 167 enrolled participants, 103 completed the study and had available AIMS and PGIC data at Week 48. The main reason for discontinuation prior to Week 48 was adverse events (15.6%). For AIMS total score, mean changes from baseline to Week 48 indicated clinician-rated TD improvements in all dose groups: 40 mg, 10.2; 80 mg, 11.0; 80/40 mg, -7.2. AIMS response was found in 86.4% of the completer population: 40 mg, 90.0% [18/20]; 80 mg, 89.2% [66/74]; 80/40 mg, 55.6% [5/9]. Mean PGIC scores at Week 48 indicated patient-rated global improvements in all dose groups: 40 mg, 1.6; 80 mg, 1.7; 80/40 mg, 2.0. PGIC response was found in 88.3% of completers: 40 mg, 90.0% [18/20]; 80 mg, 89.2% [66/74]; 80/40 mg, 77.8% [7/9].
Conclusions: Consistent with previous trials, substantial clinician- and patient-reported improvements were observed in adults with TD receiving once-daily valbenazine for up to 48 weeks.
To cite this abstract in AMA style:
C. Singer, C. Comella, K. Farahmand, J. Burke, R. Jimenez, S. Siegert. Assessing the Effectiveness of Valbenazine in the Treatment of Tardive Dyskinesia as Determined by the AIMS and PGIC: Results from the KINECT 4 Trial [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/assessing-the-effectiveness-of-valbenazine-in-the-treatment-of-tardive-dyskinesia-as-determined-by-the-aims-and-pgic-results-from-the-kinect-4-trial/. Accessed June 14, 2025.« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/assessing-the-effectiveness-of-valbenazine-in-the-treatment-of-tardive-dyskinesia-as-determined-by-the-aims-and-pgic-results-from-the-kinect-4-trial/