How to Use Valbenazine for Elderly Adults With Tardive Dyskinesia
How should clinicians initiate, assess, and monitor valbenazine treatment in adults aged 65 years and older with tardive dyskinesia?
Older adults exposed to antipsychotics and other dopamine receptor blocking agents have elevated tardive dyskinesia risk and may experience gait, swallowing, respiratory, and functional consequences from abnormal movements. This guide applies to psychiatrically stable adults aged 65 years and older with established tardive dyskinesia and summarizes the long-term valbenazine treatment approach and monitoring framework described in the article.
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Confirm that the patient matches the studied population
Use this approach in adults aged 65 years and older with a DSM diagnosis of neuroleptic-induced tardive dyskinesia present for at least 3 months before screening. The study population also had schizophrenia, schizoaffective disorder, or a mood disorder and was psychiatrically stable before study entry, for example with a Brief Psychiatric Rating Scale score below 50 at screening.
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Review exclusion-level clinical issues before treatment
The trial excluded patients with an active, clinically significant, and unstable medical condition within 1 month before screening, a comorbid movement disorder more prominent than tardive dyskinesia, or significant risk for active suicidal ideation, suicidal behavior, or violent behavior. These factors limit how directly the study findings apply and should be reviewed before following this treatment pathway.
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Stabilize concomitant medications before starting
Concomitant medications for medical and psychiatric conditions were allowed, including first-generation and second-generation antipsychotics, antidepressants, and anticholinergics. In the studies, dosing, dosing frequency, and medication starts or stops were not changed within 30 days before screening, so interpret this treatment approach in the context of recent medication stability.
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Start once-daily valbenazine using the studied dosing approach
Long-term treatment used once-daily valbenazine at 40 mg or 80 mg. In KINECT 4, treatment started at 40 mg for 4 weeks and then escalated to 80 mg based on efficacy and tolerability; in both studies, patients unable to tolerate 80 mg could reduce to 40 mg, and those unable to tolerate 40 mg were discontinued.
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Establish a baseline movement severity measure
Assess tardive dyskinesia severity with the Abnormal Involuntary Movement Scale total score using the sum of items 1 through 7 before treatment. In this analysis, baseline AIMS total score was approximately 12 in both age groups, providing a reference point for judging change over time.
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Reassess early response by Week 8
Check AIMS response by Week 8 because clinically meaningful improvement was already present by that time in older adults. In participants aged 65 years and older, mean AIMS change at Week 8 was -4.5, which exceeded the estimated minimal clinically important difference of -2 points; 58.0% achieved at least 30% improvement and 40.0% achieved at least 50% improvement from baseline.
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Use defined response thresholds to judge benefit
Interpret AIMS change using the article's explicit response thresholds: at least 30% improvement from baseline as a clinically meaningful response and at least 50% improvement as the protocol-defined response threshold. Also assess global improvement with CGI-TD and PGIC, using a score of 2 or less as response, meaning much improved or very much improved.
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Continue treatment and reassess over months, not just weeks
Do not judge long-term effectiveness only from the earliest visit, because response rates increased over time in the elderly subgroup. By Week 24, 88.5% had at least 30% AIMS improvement and 65.4% had at least 50% improvement, and by Week 48 these rates were 89.3% and 82.1%, with mean AIMS change of -8.8.
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Monitor tolerability and persistence closely
Track treatment-emergent adverse events throughout treatment, with particular attention to somnolence, urinary tract infection, dizziness, and falls in older adults. Overall treatment-emergent adverse events and serious treatment-emergent adverse events were not significantly different from younger adults, but discontinuation due to a treatment-emergent adverse event was higher in the elderly subgroup at 25.5% versus 13.3%.
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Monitor psychiatric status and other movement adverse effects during follow-up
Follow psychiatric symptom scales appropriate to the underlying diagnosis and monitor for akathisia or parkinsonism during valbenazine treatment. In the elderly subgroup, PANSS, CDSS, YMRS, MADRS, BARS, and SAS changes were minimal over time, indicating maintenance of psychiatric stability and no emergence or worsening of akathisia or drug-induced parkinsonism in these analyses; the discussion notes that if parkinsonism symptoms appear, valbenazine dosing should be reduced.
Clinical Considerations
- These findings come from post hoc pooled analyses of 2 trials and the elderly subgroup was small, with 55 participants aged 65 years and older.
- Generalizability is limited because participants had to be psychiatrically stable before study entry and certain medically or behaviorally unstable patients were excluded.
- No conclusions can be drawn about dose effects because dosing in KINECT 4 was determined by site investigators based on tolerability and treatment response.
- Potential selection bias from study dropouts should be considered, especially because discontinuations due to treatment-emergent adverse events were more frequent in elderly participants.
Bottom Line
In psychiatrically stable adults aged 65 years and older with tardive dyskinesia, once-daily valbenazine can produce clinically meaningful improvement by Week 8 that often deepens through 24 to 48 weeks, but older patients need close tolerability monitoring because adverse-event discontinuations are more common.
