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Valbenazine shows sustained improvement in tardive dyskinesia
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Once-daily treatment with valbenazine resulted in 6-week and sustained improvements in tardive dyskinesia in adults with a mood disorder, according to recent study findings.
In 2017, the FDA approved valbenazine (Ingrezza, Neurocrine Biosciences) for tardive dyskinesia (TD).
“The efficacy and safety of valbenazine were demonstrated in two 6-week, double-blind, placebo-controlled trials,” Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, University Health Network, and colleagues wrote. “While both studies conducted a priori analyses of efficacy by underlying diagnosis, neither study was designed or powered for statistical testing within the mood diagnosis subgroup.”
Using pooled data from these two studies, researchers conducted a post hoc analysis to further characterize this patient population of adults with a mood disorder and examine the effects of once-daily valbenazine on TD.
The investigators used Abnormal Involuntary Movement Scale (AIMS) total score, Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC) to evaluate efficacy. Change in AIMS total score was evaluated from baseline to week 6 in the pooled double-blind population (KINECT 2 and 3; n = 114), and from baseline to weeks 8, 16, 32, 48 and 52 in the long-term population (KINECT 3; n =77). They also examined safety.
Analysis revealed that mean improvements in AIMS total score from baseline to week 6 were significantly greater in the valbenazine group — both the 40-mg and 80-mg per day doses — than in the placebo group. In addition, participants with mood disorders demonstrated continued improvements throughout 48 weeks of treatment with valbenazine; however, there was some loss of treatment effect at 52 weeks, according to the results.
McIntyre and colleagues also found that more patients with mood disorders in the pooled double-blind population had an AIMS response (more than a 50% total score improvement from baseline) with valbenazine 80 mg than with placebo at week 6 (37.5% vs. 11.9%; P < .01). Overall, 46.5% of mood participants had an AIMS response after receiving long-term treatment with valbenazine 40 mg or 80 mg.
Treatment with valbenazine also resulted in significantly greater global improvements in mean CGI-TD scores at week 6 compared with placebo, but not in PGIC response.
Valbenazine was generally well tolerated, according to the findings. There were no unexpected treatment-emergent adverse events, worsening in psychiatric symptoms or suicidality emergence among participants taking valbenazine.
“Future research should endeavor to evaluate the risk of TD in patients with mood disorders who are exposed to antipsychotics, particularly those with multiple risk factors for TD, such as women with comorbid medical conditions (eg, type 2 diabetes) and older patients,” the researchers wrote. “In addition, the long-term safety and efficacy of TD treatments in these populations should be further investigated.” – by Savannah Demko
Disclosures: McIntyre reports consulting fees from Neurocrine Biosciences and speaker/consultant fees from Allergan, AstraZeneca, Bristol-Myers Squibb, Janssen Ortho, Lundbeck, Otsuka, Pfizer, Purdue, Shire, Sunovion and Takeda. He also reports grant support from the Brand and Behavior Research Foundation, Canadian Institutes for Health Research, the National Natural Science Foundation of China and Stanley Medical Research Institute. Please see the study for all other authors’ relevant financial disclosures.