Treatment Response for Tardive Dyskinesia Expected With Daily Valbenazine

Patterns of improvement can be expected for patients with Tardive Dyskinesia (TD) while taking once daily valbenazine, according to a post-hoc analysis of a long-term study.

The information was presented virtually in a poster presentation at this weekend’s Psych Congress Elevate virtual meeting.

“Once daily valbenazine resulted in substantial mean improvements in AIMS (Abnormal Involuntary Movement Scale) double score. While this type of overall improvement demonstrates efficacy, it does not always reflect patient’s individual experiences,” said Chirag Shah, PharmD, Neurocrine Biosciences, Inc., San Diego, CA, USA.

Researchers analyzed data from the long-term valbenazine study KINECT 4, which employed the Abnormal Involuntary Movement Scale (AIMS) to map the impact of valbenazine on TD and characterize different sets of TD improvement.

Participants were adults aged 18 to 85 years with a diagnosis of neuroleptic-induced TD for three or more months before screening, diagnosis of schizophrenia/schizoaffective disorder or mood disorder, and a stable psychiatric and medical status. Diagnosis of schizophrenia/schizoaffective disorder or mood disorder, and diagnosis of neuroleptic-induced TD were defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM).

Participants received 40mg of valbenazine once daily for a 4-week period, which could be escalated to 80mg if there was no response following 4 weeks. KINECT 4 had a 48-week open-label treatment period.

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Participants were analyzed at weeks 4, 8, 12, 24, 36, and 48 to map improvements (decreases) or worsening or symptoms (increases) based on the on the minimal clinically important difference (MCID) for AIMS score.

Based on analyzation, participants were divided into groups of early sustained strong response (≥50% improvement by Week 4 sustained through all check ins); early sustained response (≥30% improvement by Week 4 sustained through all check ins); early response (≥30% improvement at Week 4 and Week 48); delayed response (≥30% improvement at Week 8 and Week 48); and late response (≥30% improvement at Week 12 or later and Week 48). Poor or no response was classified by none of the other groups.

More than 95% of participants saw improvement at weeks 24, 36, and 48. A total of 61.4% of participants saw remission and 46.8% saw sustained remission, though patients reached remission at varied times.

“Together these data indicate that patterns of TD improvement with valbenazine may vary, but clinically meaningful, sustained and or robust treatment responses can be expected with long term treatment,” Dr. Shah concluded.

—Erin McGuinness

Reference

Correll, Christoph U., Carmack, Tara, Shah, Chirag, Lundt, Leslie. Patterns of Improvement with Valbenazine in Patients with Tardive Dyskinesia. Poster presented at the Psych Congress Elevate; June 11-13, 2021; Virtual