Teva Unveils Real-World Data from IMPACT-TD Study at Psych Congress Elevate 2024

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., unveiled new interim results from the Phase 4 IMPACT-TD Registry study. These findings were presented at the 2024 Psych Congress Elevate Annual Meeting in Las Vegas, Nevada. The study underscores that tardive dyskinesia (TD) significantly affects patients' quality of life across multiple dimensions, including social, psychological, physical, and recreational aspects.

The IMPACT-TD Registry is the largest study of its kind, evaluating the holistic effects of TD over a three-year period. It also examines real-world treatment patterns and outcomes using once-daily AUSTEDO® XR and twice-daily AUSTEDO® tablets. According to Dr. Eric Hughes, Executive Vice President of Global R&D at Teva, the study aims to enhance understanding of TD's comprehensive impact and the effectiveness of available treatments.

The study is divided into two parts: Part A focuses on the progression of TD and its impact on patients' quality of life over time, while Part B evaluates outcomes related to treatment with AUSTEDO XR and AUSTEDO tablets. Clinician-reported data highlights the multidimensional impact of TD, even in patients with mild severity. The interim analysis included 286 patients with varying levels of TD severity. Key findings indicate that 98% of patients experience some impact on their quality of life due to TD. Moreover, 83% of patients report moderate to severe impact across various domains, including social (59%), psychological/psychiatric (70%), physical (53%), and vocational/educational/recreational (57%).

The study also revealed that 54% and 61% of patients with "very mild" and "mild" TD severity, respectively, experience moderate to severe impact on their quality of life. Patient-reported outcomes assessed using the novel IMPACT-TD PRO scale show that 59% of patients feel embarrassed in social situations, and 57% report that TD affects their ability to enjoy recreational activities. Additionally, 43% of patients indicated that TD impacts their sleep, and 38-42% reported physical limitations such as difficulty holding objects, doing chores, and exercising.

Dr. Richard Jackson, the study’s lead investigator and Assistant Clinical Adjunct Professor at the University of Michigan School of Medicine, emphasized the importance of understanding the broad impact of TD on various aspects of daily life. He noted that even mild TD movements could significantly affect social, psychological, physical, occupational, and recreational functioning. According to Dr. Jackson, it is crucial for clinicians to assess both the severity of TD movements and their impact on patients' lives.

The interim results also support the development and internal validation of the IMPACT-TD PRO scale, suggesting its efficacy in characterizing the multidimensional impact of TD in adults. Additionally, final results from the Phase 4 START study, which investigated real-world treatment outcomes with AUSTEDO, indicate that the 4-week Titration Kit helps patients find effective individualized doses. These findings align with the results observed in pivotal clinical trials, showing high adherence and patient satisfaction rates.

Further studies presented at the Psych Congress Elevate 2024 indicated that using benztropine off-label for TD could potentially harm patients and increase healthcare costs. This highlights the importance of appropriate treatment strategies for TD.

In summary, the IMPACT-TD Registry provides valuable insights into the multifaceted impact of TD and underscores the importance of effective treatment options. Teva Pharmaceuticals remains committed to developing meaningful solutions to improve outcomes for patients living with TD.