Effects of Long-Term Deutetrabenazine Treatment in Patients with Tardive Dyskinesia and Underlying Psychiatric or Mood Disorders

Abstract

Deutetrabenazine is FDA-approved for the treatment of tardive dyskinesia (TD) in adults. In two 12-week pivotal trials (ARM-TD/AIM-TD), deutetrabenazine significantly improved Abnormal Involuntary Movement Scale (AIMS) scores and was well-tolerated. This post hoc analysis examined the efficacy and safety of long-term deutetrabenazine treatment in TD patients with comorbid psychiatric illness, including schizophrenia/schizoaffective disorder and mood disorders (bipolar/depression/other). Patients who completed ARM-TD or AIM-TD enrolled in the 3-year, open-label extension (OLE) study. Deutetrabenazine was titrated based on dyskinesia control and tolerability. Change from baseline in total motor AIMS score, Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and adverse events (AEs) were analyzed in subgroups by comorbid psychiatric illness. A total of 337 patients in the OLE study were included in the analysis: 205 patients with schizophrenia/schizoaffective disorder (mean age, 55years; 50% male; 6.4years since diagnosis; 92% taking DRA) and 131 patients with mood disorders (mean age, 60years; 35% male;4.6years since diagnosis; 50% taking DRA). At week 145, mean±SE dose was 40.4±1.1mg/day for schizophrenia/schizoaffective disorder (n=88) and 38.5±1.2mg/day for mood disorders (n=72). Mean±SE change from baseline in AIMS score at week 145 was -6.3±0.49 and -7.1±0.58, 56% and 72% achieved PGIC treatment success, and 66% and 82% achieved CGIC treatment success in schizophrenia/schizoaffective disorder and mood disorder patients, respectively. Overall AE incidence (exposure-adjusted incidence rates [incidence/patient-years]) was low: any, 1.02 and 1.71; serious, 0.10 and 0.12; leading to discontinuation, 0.07 and 0.05). Long-term deutetrabenazine treatment provided clinically meaningful improvements in TD-related movements, with a favorable safety profile, regardless of underlying comorbid psychiatric illness. Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.