Neurocrine Biosciences, Inc. (Nasdaq: NBIX) showcased findings from the long-term KINECT®-4 study, revealing that nearly 60% of participants achieved remission from tardive dyskinesia after 48 weeks of treatment with once-daily INGREZZA® (valbenazine) capsules. This research, titled “Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment” (Poster #98), was presented at the 2024 Psych Congress in Boston.
“Tardive dyskinesia is a persistent and irreversible condition, and effective long-term treatment can significantly improve the lives of patients already dealing with underlying psychotic and mood disorders,” stated Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “Our clinical studies have demonstrated clinically meaningful and sustained improvements in tardive dyskinesia with INGREZZA, and these remission results contribute to the growing evidence of its robust efficacy.”
This post hoc analysis utilized data from 103 participants who completed the final Week 48 visit in the open-label KINECT-4 trial. Remission was defined as achieving a score of 1 or less (indicating “none” or “minimal”) across all body regions on the Abnormal Involuntary Movement Scale (AIMS). Shifts to remission were determined by a maximum score of 2 (“mild”), 3 (“moderate”), or 4 (“severe”) at baseline, with scores of 1 or less at Week 48.
The results indicated significant remission rates among participants:
- 59.2% (61 out of 103) of participants scored 1 or less on each AIMS item at Week 48.
- In the 40 mg dose group, 65.0% (13 out of 20) achieved remission, while 57.8% (48 out of 83) in the 80 mg dose group did the same.
- 10% (10 out of 103) of participants experienced complete resolution, with an AIMS total score of 0.
- Among the 4 participants with a maximum item score of 2 at baseline, 50.0% (2 out of 4) reached the remission threshold.
- Of the 56 participants who had a maximum item score of 3 at baseline, 64.3% (36 out of 56) achieved remission.
- From the 43 participants with a maximum item score of 4 at baseline, 53.5% (23 out of 43) reached the remission threshold.
Additional Presentations at Psych Congress 2024
Neurocrine Biosciences also presented several other studies at the Psych Congress, including:
- Once-Daily Valbenazine for Tardive Dyskinesia or Huntington’s Disease Chorea in Patients with Dysphagia or Swallowing Difficulties (Poster #114)
- A Multi-Year Survey on United States Psychiatry Clinicians: Trends in Managing Patients with Tardive Dyskinesia (Poster #48)
- Item Response Theory (IRT) Analyses of the Tardive Dyskinesia Impact Scale (TDIS) (Poster #28)
- Impact of Valbenazine on Physical, Psychological, and Functional Health in Patients with Tardive Dyskinesia: Results from EQ-5D-5L Health State Scores after 16 Weeks of Treatment (Poster #29)
- Real-World Improvements in Quality of Life and Functional Status of Valbenazine-Treated Patients with Tardive Dyskinesia: Insights from a 2024 Chart Extraction and Clinician Survey of 164 Patients (Poster #27)
- Treatment Effect Sizes of Once-Daily Valbenazine for Tardive Dyskinesia and for Chorea Associated with Huntington’s Disease: A Post Hoc Analysis of Phase 3 Clinical Trial Data
These findings further underscore the potential of INGREZZA in effectively managing tardive dyskinesia and enhancing patient quality of life.
