Encore Presentations
Monday, November 13, 2023
01:00 PM–02:30 PM
Abstract
Valbenazine Improves Tardive Dyskinesia With or Without Concomitant Antipsychotic Therapy: A
Meta-Analysis of Three Long-Term Valbenazine Trials
Eduardo Dunayevich,1 Stephen R. Marder,2
Stewart A. Factor,3 Brittany Harbert,1Yumi Watanabe,4
Arline Nakanishi1
1.
Neurocrine
Biosciences, Inc., San Diego, CA, USA
2.
Department of Psychiatry and Behavioral Science,
UCLA David Geffen School of Medicine, Los Angeles, CA, USA
3.
Department of Neurology, Emory University School
of Medicine, Atlanta, GA, USA
4.
Mitsubishi Tanabe Pharma Corporation, Osaka,
Japan
ABSTRACT
Background: Valbenazine is a highly selective vesicular monoamine
transporter 2 inhibitor indicated for tardive dyskinesia (TD), a persistent and
potentially debilitating movement disorder associated with prolonged
antipsychotic exposure. Given the paucity of data regarding the course of TD in
patients no longer taking antipsychotics, a meta-analysis of 3 long-term valbenazine studies was conducted in subgroups with and
without concomitant antipsychotic use at baseline.
Methods:
KINECTTM-3 (NCT02274558), KINECTTM-4 (NCT02405091), and J‑KINECT
(NCT03176771) data were analyzed in study completers taking antipsychotics at baseline
(AP+) and those who were not (AP-). The Abnormal Involuntary Movement Scale
(AIMS) total score was used to measure TD severity at baseline, Wk48 (end of valbenazine treatment), and Wk52 (4 weeks after valbenazine withdrawal). The meta-analysis implemented a
random-effects model that weighted each study based on
inverse variance, adjusted for between-study variance.
Results:
Of 576 enrolled patients, 336 (58.3%) were study completers and included for
analysis: AP+ (n=269); AP- (n=67). Mean baseline AIMS scores ranged from
7.914.9 (AP+) and 10.914.5 (AP-). Mean changes from baseline in AIMS scores
indicated substantial TD improvements with valbenazine
at Wk48 (AP+, ‑6.1; AP-, -6.5) and return towards baseline severity at
Wk52 (AP+, -2.1; AP-, -1.4).
Conclusions:
Once-daily valbenazine treatment resulted in
substantial and sustained TD improvement through Wk48, with no meaningful
differences between AP+ and AP- subgroups. The return towards baseline severity
after valbenazine withdrawal shows TD is chronic and
often irreversible, even in patients no longer taking antipsychotics.
Continuous treatment with valbenazine may be
warranted irrespective of antipsychotic therapy.
Presenting Author
Brittany Harbert PharmDNeurocrine Biosciences, Inc.
Authors
Stephen Marder MD
UCLA David Geffen School of Medicine
Arline Nakanishi MS
Neurocrine Biosciences, Inc.
Eduardo Dunayevich MD
Neurocrine Biosciences, Inc.
Stewart Factor DO
Emory University School of Medicine
Yumi Watanabe PhD
Mitsubishi Tanabe Pharma Corporation