RE-KINECT, A REAL-WORLD, PROSPECTIVE TARDIVE DYSKINESIA SCREENING STUDY: AN EVALUATION OF BASELINE CHARACTERISTICS IN OLDER PATIENTS

Abstract

Introduction Older age is a risk factor for developing tardive dyskinesia (TD), a persistent movement disorder associated with prolonged exposure to antipsychotics. In older patients, TD symptoms may appear after shorter antipsychotic treatment. RE-KINECT (NCT03062033), a real-world study of outpatients prescribed antipsychotics, was designed to identify the presence of drug-induced involuntary movements consistent with TD (i.e., “possible TD”) and to characterize the impact of these movements on health-related quality of life. Baseline data from RE-KINECT were analyzed to explore the patient experience of possible TD and how it affects functioning in older adults (≥55 years). Methods Adults with ≥3 months of lifetime exposure to antipsychotics and ≥1 psychiatric disorder were recruited. The presence of possible TD was based on clinicians’ observation and assessment of involuntary movements in 4 body regions (head/face, trunk/neck, upper extremities, and lower extremities). Patients were categorized into Cohort 1 (without visible movements or possible TD) or Cohort 2 (with visible movements and confirmed by clinician as consistent with possible TD). Baseline outcomes for all patients included demographics, clinical history, patient-reported health status (score range, 0 [“no health problems”] to 10 [“health as bad as you can imagine”]), and the patient-reported EuroQoL 5-Dimensional 5-Level questionnaire (EQ-5D-5L; domain score range, 1 [no problems or symptoms] to 5 [extreme problems or symptoms]). Clinicians also assessed the location and severity (ratings, “none”, “some”, or “a lot”) of abnormal movements in Cohort 2 patients. Exploratory statistical testing was conducted between older adults (≥55 years) in Cohorts 1 and 2. Results Of the 738 patients enrolled in the study, the results of those ≥55 years (N=300, 41%) are presented here. Within this subgroup, 114 (38%) had clinician-confirmed possible TD (Cohort 2) and 186 (62%) had no visible movements or had movements that were inconsistent with TD (Cohort 1). In Cohort 2 patients, the highest frequencies of severe abnormal movements (severity rating: “a lot”) were observed in the head/face (25%) and upper extremities (14%). Cohort 2 patients were less likely to be married, more likely to live in care homes, and were more likely to have longer lifetime exposure to antipsychotics than Cohort 1 patients (Table). More patients in Cohort 2 had schizophrenia or schizoaffective disorder, while those in Cohort 1 were more likely to have a mood disorder. Patients in Cohort 2 also had slightly higher mean EQ-5D-5L scores at baseline in four EQ-5D-5L domains, suggesting a somewhat greater impact on health-related quality of life, particularly in the domain of self-care. Conclusions Results from this real-world sample of older psychiatric outpatients suggest that the greater risk and severity of TD in this population may be associated with more limited support systems and reduced quality of life, which are separate from the effects of age itself. This research was funded by This research was fully funded by Neurocrine Biosciences, Inc.