Objective:

To evaluate global improvements and psychiatric status in patients with tardive dyskinesia (TD) who received long-term treatment with valbenazine, a highly selective VMAT2 inhibitor approved for TD.

Background:

Effective and comprehensive TD treatment requires reducing patients’ abnormal involuntary movements without compromising their psychiatric stability. This can be especially challenging when patients have complex psychiatric conditions that require multiple medications.

Design/Methods:

KINECT 3 and KINECT 4 study participants received valbenazine (40 or 80 mg, once-daily) for 48 weeks; concomitant medications needed to manage medical and psychiatric conditions were allowed. Data from these studies were pooled and analyzed by participants’ primary psychiatric diagnosis: schizophrenia/schizoaffective disorder (“SCHZ”) or mood disorder (“MD”). The percentages of participants who met the threshold for global response (rating of “much improved” or better) for the Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC) were analyzed at Week 48. Psychiatric symptom scales included: Positive and Negative Syndrome Scale (PANSS) and Calgary Depression Scale for Schizophrenia (CDSS) [SCHZ subgroup]; Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) [MD subgroup]; Columbia-Suicide Severity Rating Scale [all participants].

Results:

After 48 weeks of valbenazine, >75% of participants in the SCHZ subgroup met response thresholds per clinician assessment (CGI-TD=79.7%) and self-report (PGIC=78.0%). Mean changes from baseline (CFB) to Week 48 for PANSS scores (positive symptoms [-0.7], negative symptoms [‑0.6], general psychopathology [-1.9], total [-3.2]) and CDSS total score (-0.5) indicated maintenance of psychiatric stability throughout valbenazine treatment. The MD subgroup achieved similar rates of global response (CGI-TD=77.6%, PGIC=84.5%), with mean CFB in YMRS total score (-1.0) and MADRS total score (+0.3) indicating maintenance of psychiatric stability. No emergence of suicidal ideation/behavior was observed.

Conclusions:

Patients with TD who received long-term treatment with once-daily valbenazine met rigorous thresholds for clinician- and self-reported global improvement without compromising their psychiatric stability.