Objective: To characterize different patterns of improvement with valbenazine (VBZ) in patients with tardive dyskinesia (TD) using Abnormal Involuntary Movement Scale (AIMS) data from KINECT 4 (NCT02405091), a long-term study of the approved TD medication, VBZ.

Background: TD is a persistent and potentially disabling movement disorder associated with prolonged antipsychotic exposure. In clinical trials, VBZ efficacy was based on mean changes from baseline (BL) in AIMS total score, but these overall changes may not reflect patients’ individual experiences.

Method: Post hoc analyses were conducted in 158 patients who received once-daily VBZ (40 or 80 mg) for up to 48 weeks and had ≥1 post-BL AIMS assessment. Based on the minimal clinically important difference (MCID) for AIMS total score, patients with a ≥2-point decrease (improvement) or increase (worsening) were analyzed by visit (Wks 4, 8, 12, 24, 36, 48 [or last visit]). Based on the MCID for clinically meaningful response and protocol-defined response (≥30% and ≥50% AIMS total score improvement from BL, respectively), patterns of response were defined as follows: early/sustained/strong (≥50% improvement by Wk4 through Wk48); early/sustained (≥30% by Wk4 through Wk48); early (≥30% at Wk4 and Wk48); delayed (≥30% at Wk8 and Wk48); late (≥30% at Wk12 or later and Wk48); poor/none (none of the 5 response groups). Based on Schooler-Kane criteria, remission was defined as absence of TD (score≤2 [mild or better] in ≤1 AIMS item and ≤1 for all other items) at last study visit or last 2 visits (sustained remission).

Results: The percentage of patients with AIMS ≥2-point improvement increased from Wk4 (57.0%) to Wk48 (97.1%); 2.9% had ≥2-point worsening at Wk48. Response results were as follows: early/sustained/strong (10.8%), early/sustained (14.6%), early (3.2%), delayed (29.1%), late (27.8%), poor/none (14.6%). 62.0% and 48.1% of patients met the criteria for remission and  sustained remission, respectively.

Conclusion: Patterns of improvement may vary but robust and long-term TD improvements can be expected with once-daily VBZ. Patients responding within 4 weeks may be likely to maintain that response throughout treatment. Others may require ≥8 weeks of treatment before responding, but with long-term outcomes that are comparable to “early responders”. Some patients may achieve TD remission within 1 year of VBZ treatment. Previously presented at the APA Annual Meeting (May 1-3, 2021).

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MDS Abstracts - https://www.mdsabstracts.org/abstract/patterns-of-improvement-with-valbenazine-in-patients-with-tardive-dyskinesia/