Neurocrine Biosciences has unveiled promising top-line results from their phase 4 KINECT-PRO study, marking a significant advancement in tardive dyskinesia (TD) treatment. The study demonstrates that valbenazine (Ingrezza) capsules deliver sustained clinical benefits across multiple patient-reported outcomes, regardless of TD severity or underlying psychiatric conditions.
Patient-Reported Outcomes and Study Design
The groundbreaking KINECT-PRO trial enrolled 59 patients who received once-daily Ingrezza at doses of 40 mg, 60 mg, or 80 mg for up to 24 weeks, with 52 patients completing the full study duration. The trial design reflected typical clinical practice conditions and utilized multiple validated assessment scales to measure treatment impact.
Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, emphasized the study's significance: "Tardive dyskinesia can significantly impact many aspects of patients' lives, including daily activities, work or school attendance and social interactions. The data from the KINECT-PRO trial 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."
Comprehensive Assessment Measures
The study employed multiple evaluation tools to capture the full spectrum of treatment benefits:
- Tardive Dyskinesia Impact Scale
- Sheehan Disability Scale
- EQ Visual Analogue Scale
- Abnormal Involuntary Movement Scale (AIMS)
- Patient Global Impression of Change-TD
- Clinical Global Impression of Severity-TD
Key Findings and Clinical Impact
Significant improvements were observed across all assessment measures starting as early as week 4, even at the lowest dose of 40 mg. The benefits were sustained throughout the 24-week study period and were consistent across patient subgroups, including:
- Patients with mild TD
- Patients with moderate/severe TD
- Individuals with schizophrenia or schizoaffective disorder
- Patients with bipolar disorder or major depressive disorder
The AIMS scores demonstrated sustained reductions in involuntary movements, confirming the clinical efficacy of the treatment. Importantly, the safety and tolerability profile remained consistent with previous findings, with no new safety concerns identified.
Treatment Context and Significance
Ingrezza, currently FDA-approved for treating adults with TD and chorea associated with Huntington disease, represents an important therapeutic option in the movement disorder space. As the first study to demonstrate patient-reported impacts of a vesicular monoamine transporter 2 inhibitor in TD treatment, KINECT-PRO provides valuable insights into the real-world effectiveness of the medication.
The comprehensive nature of the improvements observed in the study, spanning physical, social, and emotional domains, underscores the potential of Ingrezza to address the full spectrum of TD's impact on patients' lives. These findings are particularly significant given the often-debilitating nature of TD and its effects on patients' daily functioning and quality of life.
