Objective: To assess the long-term outcomes of once-daily valbenazine (VBZ) on tardive dyskinesia (TD) using a formal assessment (Abnormal Involuntary Movement Scale [AIMS]) in participants who were early responders based on self-report (Patient Global Impression of Change [PGIC]) or clinician judgment (Clinical Impression of Change-Tardive Dyskinesia [CGI-TD]).

Background: VBZ, approved for treating TD in adults, has been evaluated in several long-term studies, including KINECT 3 (NCT02274558) in which participants received VBZ (40 or 80 mg) for up to 48 weeks.

Method: Data from KINECT 3 (40 or 80 mg [once-daily], 6-week double-blind, placebo-controlled [DBPC] period; 42-week double-blind extension) were analyzed post hoc. Long-term outcomes included mean change of AIMS total score from baseline to Week 48 (CFB) and AIMS response (≥50% total score improvement from baseline) at Week 48. These AIMS outcomes were assessed in participants who reached an “early improvement” threshold, defined as a PGIC or CGI-TD score of 1 (“very much improved”), 2 (“much improved”), or 3 (“minimally improved”) at Week 2 (first post-baseline visit) of the DBPC period.

Results: Of 143 participants who received 48 weeks of VBZ (40 or 80 mg), 72 (50%) achieved early PGIC improvement (score ≤3 at Week 2); 61 (43%) achieved early CGI-TD improvement (score ≤3 at Week 2). After 48 weeks of treatment, mean AIMS total score CFB in participants with early PGIC improvement was similar to those who did not reach the early PGIC improvement threshold (-4.1 vs -3.5). Mean AIMS total score CFB in participants with early CGI-TD improvement was similar to those who did not achieve early CGI-TD improvement (-4.2 vs -3.5 ). AIMS response at Week 48 was also similar in those who achieved early PGIC and CGI-TD improvement (40% and 42%, respectively) compared to those who did not achieve early PGIC and CGI-TD improvement (39% and 38%, respectively).

Conclusion: Results from this long-term VBZ trial indicate that many participants achieved early patient- and clinician-reported improvement at Week 2. AIMS outcomes at Week 48 demonstrated long-term reductions in TD severity regardless of early response. More research is needed to understand the association between early improvement and long-term treatment effects, but early non-improvement based on subjective measures may not be predictive of long-term treatment failure.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-outcomes-in-patients-with-tardive-dyskinesia-who-were-early-responders-with-valbenazine/