Ingrezza Treatment for Tardive Dyskinesia Improved Functional, Social, Emotional, and Health-Related Quality of Life Measures
Treatment with Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) was associated with improvements in functional, social, emotional, and health-related quality of life measures for people with tardive dyskinesia (TD). The findings of 3 separate analyses of clinical study and survey data were presented at the 2024 Psych Congress.
The first of analysis utilized data from 252 participants from the phase 3 KINECT-3 (NCT02274558) and KINECT-4 (NCT02405091) clinical studies, who received either placebo (n=71) or Ingrezza (n=181). Change in TD symptom impact from baseline to week 48 was assessed according to the 11-item Tardive Dyskinesia Impact Scale (TDIS). Participants who received Ingrezza experienced consistent improvements across each of these 11 items, demonstrating the efficacy of Ingrezza for physical and socio-emotional symptom domains.
At baseline, items with the greatest impact of TD were self-consciousness (mean score, 1.99), embarrassment (1.89), mouth noises (1.80), unwanted attention (1.74), and writing (1.29). After 48 weeks, participants experienced an improvement (mean change) in the following:
- Self-consciousness (-1.24)
- Embarrassment (-1.19)
- Mouth noises (-1.05)
- Unwanted attention (-1.00)
- Writing (-0.78)
The second analysis utilized data from a phase 4, randomized, double-blind, placebo-controlled clinical study (NCT03891862) evaluating the persistence of effects of Ingrezza treatment for 127 participants. After an 8-week treatment period, participants were randomly assigned to receive either Ingrezza or placebo for an additional 8 weeks, followed by a 4-week washout period.
After the treatment period (Week 16, n=56), participants showed significant improvements in each of the 5 dimensions of the health-related quality of life (HRQOL) EQ-5D-5L scale (mobility, self-care, unusual activities, pain/discomfort, and anxiety/depression), as well as improvements per a utility index (UI) and visual analog scale (VAS). After the washout period, these scores returned to or near baseline.
The third analysis assessed the effect of ≥2 months of Ingrezza treatment on burden of diagnosed TD with ≥1 follow-up visit. This analysis utilized data from a web-based survey and chart extraction from 78 clinicians caring for 164 patients with TD.
Regardless of TD severity (mild-to-moderate TD, 82.9%; severe TD, 12.2%), 93.9% of participants experienced an improvement:
- 87.8% of all patients showed improvements in independence
- Among patients with impacts on functional ability (95.1%; n=156), 94.2% showed improvements in functional status.
- The most commonly impacted areas of functional ability were emotionality, socialization, activities of daily living, and mouth/throat function.