Objective: To assess a potential threshold for remission of tardive dyskinesia (TD) during treatment with once-daily valbenazine, a uniquely selective vesicular monoamine transporter 2 inhibitor.

Background: Valbenazine is approved for TD and chorea associated with Huntington’s disease. In an open-label study of TD (KINECT^® 4 [NCT02405091]), valbenazine treatment resulted in substantial mean improvements from baseline (BL) to Week 48 (end of treatment) in the Abnormal Involuntary Movement Scale (AIMS) total score (40 mg, -10.2; 80 mg, -11.0). These findings warrant further investigation, including the potential remission of TD symptoms during valbenazine treatment.

Method: Derived from the Schooler-Kane criteria for TD, a potential threshold for remission was defined as an AIMS item score of ≤1 (“none” or “minimal”) in each of the 7 body regions (items 1-7). Among participants who reached the Week 48 visit (“completers”), the percentage who met the remission threshold was analyzed by dose (40 mg, 80 mg) and by psychiatric diagnosis (schizophrenia or schizoaffective disorder [SCHZ], mood disorder [MOOD]). Participants who had a dose reduction from 80 to 40 mg were categorized as 40 mg. Mean AIMS total score (sum of items 1-7) was also analyzed by dose at BL and Week 48 in participants who met the remission threshold.

Results: Valbenazine dosing and psychiatric diagnoses in the completer population (N=103) were as follows: 80 mg (71.8% [n=74]), 40 mg (28.2% [n=29]), SCHZ (68.9% [n=71]), MOOD (31.1% [n=32]). Among the 103 completers, 61 (59.2%) met the threshold for remission (score ≤1 in all 7 AIMS items) at Week 48: 40 mg, 58.6% (17/29); 80 mg, 59.5% (44/74). Mean values for AIMS total score at BL (80 mg, 15.1 [range: 6-23]; 40 mg, 12.4 [6-22]) and Week 48 (80 mg, 2.5 [0-7]; 40 mg, 2.1 [0-6]) indicated substantial TD improvements with both valbenazine doses. Among the 71 completers who had a SCHZ diagnosis, 41 (57.7%) met the threshold for remission; among 32 completers with a MOOD diagnosis, 20 (62.5%) achieved remission.

Conclusion: A majority of participants who received 48 weeks of once-daily valbenazine reached a potential threshold for remission of TD while on treatment, regardless of dose or psychiatric diagnosis. The threshold for remission used in this analysis could be applied to clinical settings and/or used in future research as a potential treatment goal for TD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/remission-of-tardive-dyskinesia-in-patients-receiving-long-term-valbenazine-treatment/