This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
Background: Valbenazine (INGREZZA) is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for tardive dyskinesia (TD). Since the distribution and severity of TD can be heterogeneous, Abnormal Involuntary Movement Scale (AIMS) data from a Phase 3 trial (KINECT 3, NCT02274558) were analyzed to explore the effects of valbenazine on TD by body region.
Methods: Adults with TD were randomized (1:1:1) to once-daily valbenazine (80 mg or 40 mg), or placebo. For each AIMS item, the percentage of subjects who improved (shifted) from a moderate/severe rating (score ≥3) at baseline to a mild/minimal/none rating (score ≤2) at Week 6 was analyzed descriptively.
Results: The numbers of subjects with an AIMS item score ≥3 at baseline were: face (n=16), lips/perioral (n=36), jaw (n=60), tongue (n=57), upper extremities (n=15), lower extremities (n=14), neck/shoulders/hips (n=28). In these participants, the percentages who met the shift criteria were (valbenazine 80 mg, valbenazine 40 mg, placebo): face (33%, 50%, 17%), lips/perioral (100%, 73%, 46%), jaw (86%, 77%, 46%), tongue (61%, 55%, 16%); upper extremities (100%, 50%, 71%); lower extremities (88%, 67%, 67%); neck/shoulders/hips (55%, 80%, 29%).
Conclusions: In subjects with scores ≥3 in individual AIMS items at baseline, both doses of valbenazine (80 and 40 mg/day) were associated with greater TD improvement relative to placebo in 6 out of 7 body regions. While the primary outcome (AIMS total mean score change from baseline) demonstrated the efficacy of valbenazine in an overall study population, this shift analysis may be more appropriate for understanding individual patient responses.