Teva presents first real-world data from IMPACT-TD Registry study

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, reinforcing that TD has a wide-reaching, multidimensional impact on patients’ quality of life. These interim findings from the IMPACT-TD study were presented at the 2024 Psych Congress Elevate Annual Meeting, taking place from May 30 – June 2 in Las Vegas, Nevada. The two-part IMPACT-TD study is a 3-year longitudinal observational study evaluating how TD progresses over time and impacts a patient’s quality of life, as well as outcomes related to treatment with once-daily AUSTEDO XR and twice-daily AUSTEDO. Clinician-reported TD severity and impact is assessed using the IMPACT-TD scale, the AIMS and the CGIS-TD scale. The interim analysis includes 286 patients with varying levels of TD severity and highlights, for the first time, that clinicians reported that TD has a multidimensional impact, even on patients with mild TD severity. Clinician-reported IMPACT-TD findings show that 98% of patients experience the impact of TD in some aspect of their quality of life; 83% of patients experience moderate to severe impact across various quality of life domains; 54% and 61% of patients with “very mild” and “mild” TD severity based on CGIS-TD, respectively, experience moderate to severe impact on their quality of life; Patient-reported TD impact is assessed using the novel IMPACT-TD PRO scale. Patient-reported findings, as assessed with the IMPACT-TD PRO, show that 59% and 57% of patients reported that TD caused embarrassment in social situations and impacted their ability to enjoy the things they do for fun, respectively; 43% of patients reported that TD impacts their sleep; 38-42% of patients reported experiencing the physical impact of TD, including on their ability to hold things, do chores and exercise. Also presented at Psych Congress Elevate 2024 were data supporting the development and internal validation of the IMPACT-TD PRO scale, suggesting that the questionnaire can effectively and reliably characterize the multidimensional impact of TD in adult patients. Final results from the TD cohort of the Phase 4 START study, which investigated real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit. These full START results show that the titration kit successfully helped patients with TD find individualized therapeutic AUSTEDO doses with effectiveness similar to that observed in the pivotal clinical trials, with high adherence and patient satisfaction rates. Findings from a retrospective study comparing healthcare resource utilization in patients with TD treated with benztropine versus non-treated patients with TD suggest that benztropine can result in potential harm and increased cost for the patient if used off-label for the treatment of TD.