Objective: To assess patients’ impression of treatment benefit from deutetrabenazine (DTB) for the treatment of tardive dyskinesia (TD).

Background: In TD, patients’ perception of benefit can be assessed with patient-reported outcome measures such as the Patient Global Impression of Change (PGIC), a 7-point Likert scale used in clinical trials of various conditions. Patients with TD often have underlying psychiatric illnesses, such as psychotic (schizophrenia and schizoaffective disorder) or mood disorders (depression and bipolar disorder). The PGIC may not be an optimal assessment for patients with psychotic disorders due to commonly associated lack of awareness of their condition and cognitive impairment, which can lead to impaired recognition of symptoms. However, it can still provide important information on the perception of benefit in patients with TD with mood disorders.

Methods: Pooled results from the two 12-week trials, ARM-TD and AIM-TD (24 and 36 mg/day doses), are presented. PGIC ratings at each visit were analyzed using the Cochran-Mantel-Haenszel test. Results were stratified by baseline comorbidities: psychotic disorders (schizophrenia/schizoaffective disorder) and mood disorders (bipolar disorder/depression/other). Treatment success was defined as “much improved” or “very much improved” at Week 12.

Results: 161 patients (DTB: 93; placebo [PBO]: 68) had a psychotic disorder; among these, 38 (41%) were ”much improved” or “very much improved” at Week 12 with DTB treatment compared with 22 (32%) given PBO (P=0.379). Of the 97 patients with a mood disorder (DTB: 59; PBO: 38), 28 (47%) DTB patients were “much improved” or “very much improved” compared with 10 (26%) PBO patients (P=0.003). Patients in this group were almost 3 times as likely to report treatment success with DTB compared with PBO (odds ratio=2.8). DTB was generally well tolerated in both studies.

Conclusions: TD patients with underlying mood disorders were more likely to perceive treatment success with DTB than with PBO. These results corroborate clinicians’ perception of improvement in TD symptoms, as assessed by the Clinical Global Impression of Change, and add to the overall knowledge of DTB’s efficacy.

Presented at: APA annual meeting; May 20–24, 2017; San Diego, CA, USA

« Back to 2017 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/evaluation-of-patient-reported-outcomes-in-tardive-dyskinesia-patients-with-underlying-psychotic-and-mood-disorders-in-the-arm-td-and-aim-td-trials/