New Ingrezza Data Demonstrates Functional and Quality of Life Improvements in Patients With Tardive Dyskinesia

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Neurocrine Biosciences today announced new analyses from a phase 4 randomized withdrawal study (NCT03891862) showing participants with tardive dyskinesia who received continued treatment with valbenazine (Ingrezza) capsules demonstrated functional and health-related quality of life improvements. The analyses were presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research Conference in Montreal, Canada.¹

“Tardive dyskinesia can affect patients' daily lives, causing pain and anxiety and hindering the ability to perform self-care tasks and to participate in work, family, or social life," said Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences. "These unique analyses add to the expansive body of evidence demonstrating that Ingrezza treatment can significantly improve tardive dyskinesia patients' quality of life, addressing outcomes important to both patients and health care providers."

The analyses were conducted using data from 127 participants in a phase 4, double-blind, placebo-controlled, randomized withdrawal study. Participants received up to 80 mg of Ingrezza for 8 weeks, then they were randomized to either continue receiving Ingrezza (n=59) or to receive placebo (n=59) for an additional 8 weeks.

Investigators measured health-related quality of life (HRQoL) using the EuroQol 5-Dimension 5-Level (EQ-5D-5L), which assesses 5 dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. They also used a utility index, ranging from -0.573 to 1.0, and visual analog scale (EQ-VAS), ranging from 0 to 100, and found higher scores indicating better health status.

Functional impairment was measured using the 5-item Sheehan Disability Scale (SDS), which assessed 3 items: work/school (patient had to be working or attending school to be included), social life, and family/home life impairment. Scores were combined for an SDS total score for patients with work/school scores. Reductions in scores indicated improvement.

In the open-label portion of the study, participants receiving Ingrezza treatment for 8 weeks experienced significant improvements from baseline in multiple areas of HRQoL, including mobility (change from baseline: -0.27), self-care (-0.28), usual activities (-0.36), and pain/discomfort (-0.34). Those randomized to receive Ingrezza for an additional 8 weeks (week 16) saw continued improvements in all HRQoL dimensions, including significant improvements in mobility (placebo-adjusted difference from week 8: -0.34) and anxiety/depression (-0.38) compared with those receiving placebo.

In a separate analysis (Poster #PCR190), patients in the open-label portion of the same study receiving Ingrezza treatment for 8 weeks experienced significant improvements from baseline in work/school (change from baseline: -1.37), social life (-1.65), family/home life (-1.30), and SDS total score (-4.28). Those randomized to receive Ingrezza for an additional 8 weeks saw continued improvements in all domains, including significant improvements in social life (placebo-adjusted difference from week 8: -0.95) and family/home life (-0.89) compared with those receiving placebo.

These findings complement recently announced patient-reported outcome data from the phase 4 KINECT-PRO study of Ingrezza, the first study of its kind to specifically measure and report clinically meaningful improvements in the impact of tardive dyskinesia.² Additionally, recent 48-week remission data on Ingrezza show it has high efficacy in inducing tardive dyskinesia remission, with 59.2% of participants achieving remission after 48 weeks of treatment.³

"These findings further establish Ingrezza as a highly effective long-term treatment option for individuals living with tardive dyskinesia, regardless of their underlying psychiatric condition, including schizophrenia, schizoaffective disorder, or mood disorder," said Roberts.³

References

1. Neurocrine Biosciences presents data adding to the growing body of evidence demonstrating functional and quality of life improvements in patients with tardive dyskinesia. News release. May 16, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-data-adding-to-the-growing-body-of-evidence-demonstrating-functional-and-quality-of-life-improvements-in-patients-with-tardive-dyskinesia-302457312.html

2. 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. Accessed May 16, 2025. https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-reports-patient-reported-outcome-data

3. Kuntz L. New 48-week remission data on Ingrezza for the treatment of tardive dyskinesia. Psychiatric Times. March 20. 2025. https://www.psychiatrictimes.com/view/new-48-week-remission-data-on-ingrezza-for-the-treatment-of-tardive-dyskinesia