Teva Presents First Real-World Data from the IMPACT-TD Registry Study at Psych Congress Elevate 2024
Teva Pharmaceuticals presented interim results from the Phase 4 IMPACT-TD Registry study at Psych Congress Elevate 2024, revealing that tardive dyskinesia (TD) significantly impacts patients' quality of life. The study involves 286 patients and shows that 98% of them experience TD's effects in daily life, with 83% facing moderate to severe impacts. Key findings include that TD affects social, psychological, and physical aspects even in mild cases. The study also evaluated the effectiveness of AUSTEDO XR and AUSTEDO tablets in treating TD.
- 98% of patients experience TD impact, showing the extensive nature of the condition.
- 83% of patients face moderate to severe quality of life impacts due to TD.
- Data supports the effectiveness of the once-daily AUSTEDO XR and twice-daily AUSTEDO tablets in real-world scenarios.
- High adherence and patient satisfaction rates were observed with AUSTEDO doses in the START study.
- The IMPACT-TD PRO scale was validated to effectively assess TD impact.
- TD significantly impacts quality of life across various domains for 98% of patients.
- Benztropine use off-label for TD may result in potential harm and increased costs.
- 54% and 61% of patients with very mild or mild TD severity still experience moderate to severe impact on quality of life.
- A significant portion of patients reported negative effects on social interactions, physical activities, and sleep.
Insights
The IMPACT-TD Registry study, as presented by Teva Pharmaceuticals, sheds considerable light on the multidimensional impact of tardive dyskinesia (TD) across various domains of patients' lives. This comprehensive study provides a thorough real-world analysis of TD's effects, emphasizing that even mild cases can significantly impair quality of life. It's noteworthy that the study utilized well-established scales like the AIMS (Abnormal Involuntary Movement Scale) and CGIS-TD (Clinical Global Impression of Severity of TD), which validate its methodology and outcomes.
The findings are substantial for the medical community because they highlight the need for a more holistic approach to treating TD. Doctors and clinicians should be aware of TD's far-reaching effects beyond physical symptoms, extending to social, psychological and vocational aspects. This understanding may drive more personalized treatment plans that address these wider dimensions, potentially leading to better patient outcomes and adherence to prescribed therapies like AUSTEDO.
For a retail investor, these results are promising as they underscore the effectiveness and comprehensive benefits of AUSTEDO. It strengthens Teva's position in the market for TD therapies and could support future growth in this segment. Observing how these findings influence prescribing behaviors and patient satisfaction can offer insights into the drug's market potential.
Teva Pharmaceuticals' announcement from the IMPACT-TD Registry study holds significant implications for the company’s financial outlook. The real-world data reinforcing the effectiveness of AUSTEDO in improving quality of life for TD patients could bolster the drug’s market position. Given that AUSTEDO is a critical asset in Teva’s portfolio, these findings might positively affect sales and revenue growth in the coming years.
High adherence and patient satisfaction rates mentioned in the study are particularly impactful. These factors often translate into sustained prescription rates and repeat sales, which are vital for financial stability and growth. Moreover, the study's extensive nature and robust findings may enhance Teva's credibility in the pharmaceutical market, potentially leading to greater market penetration and competitive advantage.
Investors should monitor subsequent quarterly earnings reports to assess how these findings are translating into financial performance. Any increase in prescription rates or market share for AUSTEDO will likely be reflected in future revenue figures. Evaluating Teva’s strategic initiatives to leverage these positive results will also be important for long-term investment decisions.
The data from the IMPACT-TD Registry study provides valuable insights into the market dynamics of TD treatments. The study's revelations regarding the multidimensional impact of TD, even in mild cases, underscore a significant unmet need in the market. This positions AUSTEDO favorably as a comprehensive treatment option, which could influence prescribing patterns and patient preferences.
Understanding TD's broad impact can help refine market strategies for Teva, focusing on education and awareness campaigns that emphasize the drug's holistic benefits. The study supports the notion that effective treatment extends beyond just mitigating physical symptoms, showcasing AUSTEDO's value in improving overall quality of life. Such positioning can differentiate AUSTEDO from competing therapies and enhance its market appeal.
For retail investors, it's vital to consider how Teva plans to leverage these findings in its marketing and sales efforts. Effective communication of the drug's comprehensive benefits could drive higher adoption rates and market share, providing a solid foundation for sustained revenue growth in this therapeutic area.
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Nearly
98% of patients experience quality of life impact as a result of tardive dyskinesia (TD) including social, psychological, physical and recreational aspects of daily living - Data highlight for the first time that TD has a multidimensional impact on patients including those with mild TD severity
- IMPACT-TD Registry is the largest-ever study of its kind evaluating the holistic effects of TD over three years along with real-world treatment patterns and outcomes with once-daily AUSTEDO® XR (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO® (deutetrabenazine) tablets
“TD can be a devastating setback for those who have achieved mental stability with their psychiatric medication,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “These interim findings from IMPACT-TD Registry, the largest study of its kind, reveal the profound effect that TD can have on a patient’s life, beyond the clinic. Understanding the full impact of TD and how approved treatment options for TD, like once-daily AUSTEDO XR and twice-daily AUSTEDO, can help treat the condition is critical to improving outcomes for patients and is a driving force in our unwavering commitment to developing meaningful solutions for them.”
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 (Part A), as well as outcomes related to treatment with once-daily AUSTEDO XR and twice-daily AUSTEDO (Part B).
Clinician-reported TD severity and impact is assessed using the IMPACT-TD scale, the AIMS (Abnormal Involuntary Movement Scale) and the CGIS-TD (Clinical Global Impression of Severity of 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:
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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, including social (59% ), psychological/psychiatric (70% ), physical (53% ) and vocational/educational/recreational (57% ) -
54% and61% 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 (IMPACT-TD Patient-Reported Outcome) scale. Patient-reported findings, as assessed with the IMPACT-TD PRO, show:
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59% and57% 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 -
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-42% of patients reported experiencing the physical impact of TD, including on their ability to hold things, do chores and exercise
“These data provide a clearer understanding as to how the abnormal movements of TD significantly impact the daily functioning of patients that cannot be gleaned from looking solely at the severity of the movements,” said Richard Jackson, MD, an Assistant Clinical Adjunct Professor in the University of Michigan School of Medicine’s Department of Psychiatry and the study’s lead investigator. “TD can impact all domains of daily functioning including social, psychological, physical, occupational and recreational aspects of daily living even when the abnormal movements appear to be mild. This emphasizes the need for all clinicians to assess not only the severity of a patient’s TD movements but the impact those movements can have on all aspects of life. Continuing to understand the multifaceted impact of TD and finding ways to alleviate these burdens is crucial to supporting patients on their TD journey.”
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 (HCRU) 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.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3
About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the
INDICATIONS AND USAGE
AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.
Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.
Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>
Please see accompanying full Prescribing Information, including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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1 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs.
2 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.
3 Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed May 4, 2023.
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FAQ
What is the impact of tardive dyskinesia on patients' quality of life according to the IMPACT-TD Registry study?
How does TD affect patients with mild severity according to the IMPACT-TD study?
What are the findings related to AUSTEDO in the IMPACT-TD Registry study?
What percentage of patients reported embarrassment in social situations due to TD?
How does benztropine use affect TD patients?
