PETAH TIKVA (dpa-AFX) - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, revealing differences between tardive dyskinesia patients with a psychotic disorder and those with a mood disorder.
The IMPACT-TD Registry is the largest study of its kind evaluating the holistic effects of tardive dyskinesia (TD), showing real-world treatment patterns and outcomes with once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO (deutetrabenazine) tablets. Teva also announced interim data from a patient-reported survey describing early, real-world experience with AUSTEDO XR.
The company noted that two-part IMPACT-TD study is a three-year longitudinal observational study evaluating how TD progresses and impacts a patient's quality of life, as well as outcomes related to treatment with once-daily AUSTEDO XR and twice-daily AUSTEDO.
The IMPACT-TD findings revealed that fewer individuals with a psychotic disorder received a diagnosis of tardive dyskinesia (TD) compared to those with mood disorders, at rates of 36% versus 50%, despite having similar mean AIMS scores (8.7 for psychotic disorders versus 8.0 for mood disorders). Patients with psychotic disorders also had a longer median time since the first recognition of movements (5.5 years compared to 3.8 years) and since the first use of an antipsychotic (16 years versus 10 years).
In the study, patients with psychotic disorders (n=135) were generally younger, with a mean age of 48, compared to 55.5 for those with mood disorders (n=141).
Additionally, a higher proportion of patients with psychotic disorders identified as Black or African American (36% versus 9%) and were more likely to be male (62% versus 38%). The impact of TD on the lives of patients was reported to be similar in both groups, with clinicians indicating a moderate or severe impact in 86% of patients with psychotic disorders and 80% of those with mood disorders.
Teva also presented findings on real-world patient experience with AUSTEDO XR from a non-interventional, prospective, cross-sectional survey, which included adults with TD or Huntington's disease (HD) chorea who were prescribed the medication. The survey explored patient-reported ease of use, effectiveness and satisfaction.
In this interim analysis of data from 131 respondents, 87% reported overall satisfaction with the medication. Additionally, 74% indicated that their extra movements improved with AUSTEDO XR. More than 76% agreed that the reduction in their extra movements enhanced their comfort in social settings and contributed to their emotional well-being. Over half of the patients also felt that this reduction positively affected their overall physical health and work or school/life balance since starting the medication. Almost all respondents (98%) found AUSTEDO XR easy to use and incorporate into their daily routines, and 95% expressed that they would continue taking it.
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