The data support the need to raise awareness of involuntary movements from possible tardive dyskinesia and the importance of properly screening and diagnosing patients.
Stanley Caroff, MD
Results from the RE-KINECT study (NCT03062033) of a real-world population suggest those with a psychiatric disorder are frequently impacted by tardive dyskinesia (TD) and can ultimately have reduced quality of life as a result.1,2
Of the 739 eligible patients in RE-KINECT, 204 (27.6%) had clinician-confirmed possible TD. Patients without involuntary movements or with non-TD involuntary movements were assigned to Cohort 1 (n = 535) while those with involuntary movements confirmed by clinician as possible TD were placed in Cohort 2 (n = 204).
Published in the Journal of Clinical Psychopharmacology by Stanley Caroff, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, and colleagues, the data showed that patient-rated EuroQol 5-Dimensions 5-Level (EQ-5D-5L) assessment scores were significantly lower—and thus, worse—health state visual analog scale scores in Cohort 2 versus Cohort 1 (66.8% vs 69.7%, respectively; P = .0002). Cohort 2 also reported worse utility index scores in comparison with Cohort 1 (0.71 vs 0.76, respectively; P <.0175).
Compared with Cohort 1, patients in Cohort 2 were significantly older (P <.0001), more likely to have schizophrenia or schizoaffective disorder (P <.0001) and a longer lifetime exposure to antipsychotics (P <.0001), and less likely to be working or studying, based on clinician perception (P = .00100).
"The real-world data from the RE-KINECT study are valuable for informing treatment decisions in clinical practice and demonstrate the importance of assessing the impact of involuntary movements from possible tardive dyskinesia on quality of life and daily functioning," Cardiff said in a statement.2
Correlation between clinician- and patient-rated severity of possible TD movements was significant in each of the 4 body regions, for maximum severity in each region, and for total number of affected regions (P <.001 for all correlations). Additionally, based on clinician and patient ratings, respectively, 52.9% and 63.6% of Cohort 2 patients had involuntary movements in 2 or more body regions.
The research demonstrated that among the 204 patients with clinician-confirmed possible TD, 75.5% of them affirmed they felt self-conscious or embarrassed about involuntary movements that they could not control. In addition, patient-rated assessments showed 40% of patients (n = 44) with possible TD reported that involuntary movements had “some” or “a lot” of impact on their ability to continue usual activities.
While there was no statistically significant difference between cohorts for patient-reported overall health status, more than 50% of patients in both cohorts (Cohort 1, n = 325; Cohort 2, n = 121) were most worried or concerned about mental health and reported spending the most time managing this condition. Data showed that there was a significantly higher percentage of Cohort 2 patients (26%, n = 53) who were worried about movement disorders (TD or non-TD) than cohort 1 (P <.0001), and more Cohort 2 patients reported spending the most time managing this condition (P <.0001).
RE-KINECT was a prospective real-world screening study, conducted with support from Neurocrine Biosciences, that assessed the presence and impact of possible TD and described the associated disease burden in a cohort of patients with 1 or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of 3 months or more. Patient characteristics such as location, severity of involuntary movements, and impact of possible RD on health-related quality of life, including using the EQ-5D-5L questionnaire were all assessed at baseline. Involuntary movements in general body regions such as the head/face, neck/trunk, upper/lower limbs, as well as possible TD, were all evaluated in each patient.
Health-related QoL assessments such as EQ-5D-5L used 5 domains, each scored on a scale of 1 (“no problems”) to 5 (“unable to perform”). Patients also were assessed on the Sheehan Disability Scale (SDS), which contains 5 domains and measures disability and impairment in patients on scores of 0 (“not at all”) to 10 (“extremely”).
"When screening and diagnosing patients with possible tardive dyskinesia, it may be informative to ask patients whether involuntary movements from possible tardive dyskinesia have had any impact on their ability to continue usual activities, be productive, take care of oneself, or socialize,” Caroff continued. “It is important to include assessments from patients and caregivers on a patient's ability to perform daily activities as there is clearly a negative social impact of the stigmatizing movements of tardive dyskinesia.”
1. Neurocrine Biosciences announces new data published from the largest real-world screening study, RE-KINECT, demonstrating that movements consistent with tardive dyskinesia occur frequently and can reduce quality of life in patients with psychiatric disorders [news release]. San Diego, CA: Neurocrine Biosciences. Published May 7, 2020. Accessed May 19, 2020. prnewswire.com/news-releases/neurocrine-biosciences-announces-new-data-published-from-the-largest-real-world-screening-study-re-kinect-demonstrating-that-movements-consistent-with-tardive-dyskinesia-occur-frequently-and-can-reduce-quality-of-life-in-patient-301055244.html
2. Caroff SN, Yeomans K, Lenderking WR, et al. RE-KINECT A prospective study of the presence and healthcare burden of tardive dyskinesia in clinical practice settings. J Clin Psychopharmacol. 2020;40(3):259—268. doi: 10.1097/JCP.0000000000001201.