American Journal of Geriatric Psychiatry | 2019
GLOBAL IMPROVEMENTS IN TARDIVE DYSKINESIA AND PATIENT SATISFACTION WITH VALBENAZINE IN OLDER AND YOUNGER PATIENTS: RESULTS FROM AN OPEN-LABEL, ROLLOVER STUDY
Abstract
Introduction Older adults have an increased risk of developing tardive dyskinesia (TD), a persistent and often debilitating movement disorder that is associated with antipsychotic treatment. Valbenazine is currently approved to treat TD in adults of all ages, with no dose adjustment required for older patients. Valbenazine has been evaluated in 2 long-term Phase III studies (KINECT 3, KINECT 4) in which adults with TD (18 to 85 years) received once-daily treatment (40 or 80 mg) for up to 48 weeks. Completers from these studies were eligible to enter a long-term, open-label rollover study (NCT02736955) in which global improvements and patient satisfaction were assessed. Data from the rollover study were analyzed post hoc to further investigate the long-term effects of valbenazine in participants categorized by age ( Methods Completers from KINECT 3 or KINECT 4 were re-initiated at 40 mg following washout of prior valbenazine treatment. Dose was escalated after 4 weeks to 80 mg based on tolerability and clinical assessment of TD. Reduction to 40 mg was allowed if 80 mg was not tolerated; participants unable to tolerate 40 mg were discontinued from the study. The study was designed to include 72 weeks of treatment, but few participants reach Week 60 and none reach Week 72 because valbenazine became commercially available. Both doses of valbenazine (40 and 80 mg) were pooled. Analyses were conducted at Week 48 and end-of-treatment (EOT), based on the last available post-baseline value. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD: range, 1 [normal/not at all ill] to 7 [extremely ill]) and Patient Satisfaction Questionnaire (PSQ: range, 1 [very satisfied] to 5 [very dissatisfied]). All outcomes were analyzed descriptively in age subgroups (younger, Results The study included 51 younger participants (mean age, 47.9 years; range, 34-54 years) and 109 older participants (mean age, 62.5 years; range, 55-83 years). A total of 56 participants reached the Week 48 visit ( Conclusions A clinician-based global assessment indicated ongoing, meaningful TD improvements with once-daily valbenazine in both younger and older adults. Patient satisfaction rates remained high, even in patients treated for >1 year. These results, along with the safety results presented separately at this meeting, indicate that valbenazine is an effective long-term treatment for TD. This research was funded by This research was fully funded by Neurocrine Biosciences, Inc.