Interim Analysis of a Patient-Reported Impact Measure in the IMPACT-TD Registry

Abstract: Background: The IMPACT-TD Patient Reported Outcome (IMPACT-TD PRO) scale is a newly developed patient questionnaire to assess the multidimensional impact of tardive dyskinesia (TD) on the patients’ quality of life. Methods: The IMPACT-TD study is a real-world, ongoing, phase 4, 3-year longitudinal observational study of patients with TD. For the registry part of the IMPACT-TD study, data are collected approximately every 3 months for a total of 13 visits. Patients aged ≥18 years with a score of ≥2 on ≥1 item of the Abnormal Involuntary Movement Scale and probable TD or, alternatively, who are receiving vesicular monoamine transporter 2 inhibitor therapy were included. The IMPACT-TD PRO scale was developed to assess the multidimensional impact of TD. Results: This interim analysis includes characterization of 286 patients (mean age, 51.8 years; 50% female; 56% White) with varied TD severity (Patient Global Impression of Severity of TD [n=264]); 34% mild, 36% moderate, 12% severe, 8% very severe) at the time of enrollment. As assessed with the IMPACT-TD PRO (n=264), the activities most impacted by TD (reported by patients as mild, moderate, or severe) were embarrassment in social situations (59%) and ability to enjoy the things they do for fun (57%). 43% of patients reported that TD impacts their sleep. Patients also reported physical impacts of TD and included the ability to hold things, do chores, and exercise (range, 38%−42%). Conclusion: In this large, inclusive study, patients reported a range of multidimensional impacts of TD with greatest impact on psychosocial aspects of life.Short Description: The IMPACT-TD study is an ongoing, observational study of patients with tardive dyskinesia (TD) and includes a multidimensional patient reported outcome assessment. Based on an interim analysis, a majority of the patients experienced an impact of TD on the social aspects of their lives; almost 60% reported embarrassment in social situations and/or that TD impacted their ability to enjoy the things they do for fun. Many patients reported that TD impacted their physical activities (38%−42%).Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.