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Newly shared top-line phase 4 data demonstrates clinically meaningful and sustained effects of Ingrezza capsules on the physical, social, and emotional impacts experienced with tardive dyskinesia.
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Neurocrine Biosciences has announced top-line data from the phase 4 study, KINECT-PRO, demonstrating clinically meaningful and sustained effects of valbenazine (Ingrezza) capsules on the physical, social, and emotional impacts experienced by patients living with tardive dyskinesia (TD), regardless of TD severity or underlying psychiatric conditions. KINECT-PRO is the first study to show patient-reported impact of a vesicular monoamine transporter 2 inhibitor on TD using multiple clinically validated scales.1
"Tardive dyskinesia can significantly impact many aspects of patients' lives, including daily activities, work or school attendance and social interactions," said Eiry W. Roberts, MD, Chief Medical Officer, Neurocrine Biosciences. "The data from the KINECT-PRO trial, which was designed to follow typical clinical practice, show that patients and clinicians observed substantial reduction in the impact and severity of TD, as well as improvement in overall quality of life with use of Ingrezza. Importantly, patients reported significant improvements across measures regardless of their underlying psychiatric conditions or the baseline severity of their TD involuntary movement symptoms."
Ingrezza is approved by the US Food and Drug Administration for the treatment of adults with TD and the treatment of chorea associated with Huntington disease.2
In the KINECT-PRO study, 59 patients were enrolled and received once-daily Ingrezza (40 mg, 60 mg, or 80 mg) for up to 24 weeks; 52 patients completed the week 24 visit. There were comparable numbers of patients across TD severity (mild vs moderate/severe) and underlying psychiatric condition subgroups (schizophrenia or schizoaffective disorder vs bipolar disorder or major depressive disorder).
The primary objective of this study was to evaluate changes in patient-reported physical and socio-emotional impacts of TD, changes in work, family, social life, and overall sense of health and well-being during treatment with Ingrezza. Self-reported outcome measures provide a more complete perspective on a patient's experience of living with TD and the broad range of improvements that occurred following treatment with Ingrezza.
These outcomes were measured at weeks 4, 8, 16, and 24 on multiple scales, including the Tardive Dyskinesia Impact Scale, the Sheehan Disability Scale, and the EQ Visual Analogue Scale. The secondary objective was to evaluate clinician- and patient-reported changes in TD severity as measured by the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change–TD, and Clinical Global Impression of Severity–TD.
Results showed significant and sustained improvements from baseline on all 3 patient-reported outcome measures, including patients with mild or moderate/severe TD, with improvements observed as early as 4 weeks at the lowest dose of 40 mg. AIMS scores also showed sustained reductions in involuntary movements, regardless of TD severity or underlying psychiatric condition. The safety and tolerability were consistent with the Ingrezza’s known profile, with no new concerns identified.
The results of KINECT-PRO will be shared at upcoming scientific conferences.
If you are interested in learning more about how best to manage tardive dyskinesia, learn more from experts from Real Psychiatry:
-Examples of Quality of Life Improvement for Patients With Tardive Dyskinesia
-Challenges in Treating Tardive Dyskinesia: How to Have Productive Conversations With Patients
References
1. Neurocrine Biosciences reports patient-reported outcome data from KINECT-PRO™ study for Ingrezza® (valbenazine) capsules in tardive dyskinesia: significant and clinically meaningful improvements in functionality and quality of life measures. News release. February 27, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-patient-reported-outcome-data-from-kinect-pro-study-for-ingrezza-valbenazine-capsules-in-tardive-dyskinesia-significant-and-clinically-meaningful-improvements-in-functionality-and-quality-of-lif-302387896.html
2. Duerr HA. Ingrezza sprinkle capsules received FDA approval for tardive dyskinesia in adults. Psychiatric Times. April 30, 2024. https://www.psychiatrictimes.com/view/ingrezza-sprinkle-capsules-received-fda-approval-for-tardive-dyskinesia-in-adults