Neurocrine Biosciences, Inc. (Nasdaq: NBIX) recently presented data from over 300 patients with tardive dyskinesia treated with INGREZZA® (valbenazine) capsules, revealing significant improvements in functional, social, emotional, and health-related quality of life. These findings, drawn from Phase 3 and 4 studies, demonstrated broad positive effects on patients’ daily functioning, emotional well-being, and adherence to antipsychotic treatments in real-world settings. The data were shared at the 2024 Psych Congress in Boston.
“Tardive dyskinesia impacts many facets of life beyond the physical symptoms of movement disorder, affecting social and emotional well-being,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “These findings represent one of the largest efforts to date to examine the comprehensive impact of treating tardive dyskinesia with INGREZZA, showing substantial improvements across areas that matter to both patients and clinicians.”
Phase 3 Study: INGREZZA’s Impact on Function and Emotional Well-Being
Data from the Phase 3 KINECT®-3 and KINECT®-4 studies involved 252 patients and used the Tardive Dyskinesia Impact Scale (TDIS) to measure tardive dyskinesia symptoms from baseline through Week 48. Improvements were observed across all assessed items, including self-consciousness, embarrassment, mouth noises, and unwanted attention. Notably, scores in areas like self-consciousness, embarrassment, and mouth noises improved by over one point from baseline, indicating a meaningful impact of INGREZZA on patients’ physical and socio-emotional health.
Phase 4 Study: Health-Related Quality of Life (HRQOL) Gains
In a double-blind, placebo-controlled Phase 4 study with 127 patients, INGREZZA was associated with improvements in health-related quality of life (HRQOL) measures, such as mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These gains, as measured by the EQ-5D-5L, were significant after 16 weeks of treatment and maintained during the treatment period, although scores returned to baseline following a 4-week washout period.
Real-World Data: Improvements in Function, Independence, and Antipsychotic Adherence
A real-world survey of 78 U.S. clinicians managing 164 patients highlighted the functional and emotional burdens of tardive dyskinesia. Most patients (93.9%) showed improvement in tardive dyskinesia symptoms with INGREZZA, impacting functional ability (95.1%), emotionality, social interactions, and activities of daily living. Additionally, 87.8% of patients reported increased independence, and more than half of those with available data on antipsychotic adherence (52.2%) experienced improvement.
Additional Insights from Psych Congress 2024 Posters
Neurocrine Biosciences presented additional findings at the 2024 Psych Congress:
- Long-term remission of tardive dyskinesia with valbenazine (Poster #98)
- Efficacy of once-daily valbenazine in patients with dysphagia or swallowing difficulties (Poster #114)
- Trends in managing tardive dyskinesia among U.S. psychiatry clinicians (Poster #48)
- Comparative effect sizes of valbenazine in treating tardive dyskinesia and Huntington’s disease chorea
These findings underscore the broad impact of INGREZZA on tardive dyskinesia management, offering new insights into treatment outcomes that extend beyond symptom reduction to enhancing overall patient well-being.
