Teva Presents New Tardive Dyskinesia Data at Psych Congress 2024 from the IMPACT-TD Registry, Revealing Differences in Patient Experience Based on Underlying Psychiatric Condition
Teva Pharmaceuticals announced new interim results from the Phase 4 IMPACT-TD Registry study, revealing key differences in tardive dyskinesia (TD) experiences between patients with psychotic and mood disorders. The study, the largest of its kind, showed that fewer patients with psychotic disorders (36%) received TD diagnoses compared to those with mood disorders (50%), despite similar AIMS scores.
The study also presented real-world patient experience data with AUSTEDO XR, showing that 87% reported satisfaction with the medication, and 74% reported improvement in their extra movements. The registry highlighted that TD significantly impacts quality of life regardless of underlying mental health conditions.
Teva Pharmaceuticals ha annunciato nuovi risultati preliminari dallo studio del Registro IMPACT-TD di Fase 4, rivelando differenze significative nelle esperienze di discinesia tardiva (TD) tra pazienti con disturbi psicotici e dell'umore. Lo studio, il più grande nel suo genere, ha mostrato che meno pazienti con disturbi psicotici (36%) hanno ricevuto diagnosi di TD rispetto a quelli con disturbi dell'umore (50%), nonostante punteggi AIMS simili.
Lo studio ha anche presentato dati sull'esperienza reale dei pazienti con AUSTEDO XR, mostrando che l'87% ha riportato soddisfazione con il farmaco, e il 74% ha riportato un miglioramento dei loro movimenti involontari. Il registro ha evidenziato che la TD impatta significativamente sulla qualità della vita indipendentemente dalle condizioni di salute mentale sottostanti.
Teva Pharmaceuticals anunció nuevos resultados interinos del estudio del Registro IMPACT-TD en Fase 4, revelando diferencias clave en las experiencias de discinesia tardiva (TD) entre pacientes con trastornos psicóticos y del estado de ánimo. El estudio, el más grande de su tipo, mostró que menos pacientes con trastornos psicóticos (36%) recibieron diagnósticos de TD en comparación con aquellos con trastornos del estado de ánimo (50%), a pesar de tener puntajes AIMS similares.
El estudio también presentó datos sobre la experiencia real de los pacientes con AUSTEDO XR, mostrando que el 87% informó satisfacción con el medicamento, y que el 74% reportó una mejora en sus movimientos involuntarios. El registro subrayó que la TD impacta significativamente en la calidad de vida, independientemente de las condiciones de salud mental subyacentes.
테바 제약은 4단계 IMPACT-TD 레지스트리 연구의 새로운 중간 결과를 발표하며, 정신병 및 기분 장애 환자 간의 지체성 운동장애(TD) 경험에서 주요 차이를 밝혔습니다. 이 연구는 같은 종류의 가장 큰 연구로, 정신병 장애가 있는 환자 중 36%만이 TD 진단을 받았으며, 기분 장애가 있는 환자 중 50%는 TD 진단을 받았습니다, AIMS 점수가 유사함에도 불구하고요.
이 연구는 또한 AUSTEDO XR을 사용하는 환자들의 실제 경험 데이터를 보여주었는데, 87%가 약물에 대한 만족감을 보고하였고, 74%는 추가적인 움직임의 개선을 보고하였습니다. 레지스트리는 TD가 기저 정신 건강 상태와 관계없이 삶의 질에 상당한 영향을 미친다는 점을 강조했습니다.
Teva Pharmaceuticals a annoncé de nouveaux résultats intermédiaires de l'étude du registre IMPACT-TD en phase 4, révélant des différences clés dans les expériences de dyskinésie tardive (TD) entre les patients atteints de troubles psychotiques et de troubles de l'humeur. L'étude, la plus grande de son genre, a montré que moins de patients avec des troubles psychotiques (36%) ont reçu un diagnostic de TD par rapport à ceux ayant des troubles de l'humeur (50%), malgré des scores AIMS similaires.
L'étude a également présenté des données sur l'expérience réelle des patients avec AUSTEDO XR, montrant que 87% ont rapporté une satisfaction avec le médicament, et que 74% ont signalé une amélioration de leurs mouvements involontaires. Le registre a souligné que la TD impacte de manière significative la qualité de vie, indépendamment des problèmes de santé mentale sous-jacents.
Teva Pharmaceuticals hat neue Zwischenresultate aus der Phase-4-IMPACT-TD-Registerstudie bekannt gegeben, die wesentliche Unterschiede in den Erfahrungen mit tardiven Dyskinesien (TD) zwischen Patienten mit psychotischen und affektiven Störungen aufdeckten. Die Studie, die größte ihrer Art, zeigte, dass weniger Patienten mit psychotischen Störungen (36%) eine TD-Diagnose erhielten als Patienten mit affektiven Störungen (50%), obwohl die AIMS-Werte ähnlich waren.
Die Studie präsentierte auch Daten zur realen Erfahrung von Patienten mit AUSTEDO XR und zeigte, dass 87% der Patienten Zufriedenheit mit dem Medikament berichteten und 74% eine Verbesserung ihrer unkontrollierten Bewegungen anzeigten. Das Register hob hervor, dass TD die Lebensqualität unabhängig von den zugrunde liegenden psychischen Gesundheitszuständen erheblich beeinträchtigt.
- 87% of patients reported satisfaction with AUSTEDO XR medication
- 74% of patients reported improvement in extra movements with AUSTEDO XR
- 98% of respondents found AUSTEDO XR easy to use
- 95% of patients agreed they would continue taking AUSTEDO XR
- Lower TD diagnosis rate in psychotic disorder patients (36%) vs mood disorder patients (50%) despite similar symptoms
- High burden of TD on quality of life across all patient groups
Insights
The IMPACT-TD Registry study reveals critical insights into Tardive Dyskinesia (TD) treatment disparities and patient outcomes. The significant diagnosis gap between psychotic disorder patients (36%) and mood disorder patients (50%) despite similar symptom severity is particularly concerning, suggesting potential healthcare access or diagnostic bias issues.
The real-world effectiveness data for AUSTEDO XR is promising, with 87% patient satisfaction and 74% reporting improvement in movements. These outcomes, combined with the 98% ease-of-use rating, indicate strong potential for improved medication adherence. The study's findings about TD's impact on quality of life across both psychotic and mood disorder patients (86% vs 80% reporting moderate to severe impact) emphasizes the critical need for early detection and intervention.
The demographic differences between patient groups, particularly the higher representation of Black patients and younger individuals in the psychotic disorder cohort, warrant attention for targeted healthcare interventions and equity initiatives.
- IMPACT-TD Registry, the largest study evaluating holistic effects of tardive dyskinesia (TD), highlights that there is a high burden of TD on quality of life regardless of a person’s underlying mental health condition
- Registry revealed fewer patients with psychotic disorders (
36% ) received TD diagnoses compared to those with mood disorders (50% ) - Teva continues to further innovations in mental health and progress real-world data to improve treatment optimization
TEL AVIV, Israel and PARSIPPANY, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, revealing differences between TD 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 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. These findings are being presented at the Psych Congress 2024 taking place from October 29 – November 2 in Boston, MA.
“Tardive dyskinesia is underdiagnosed and often little-understood while presenting a major negative impact on all aspects of a patient’s life. Our latest research is part of Teva’s efforts to build better outcomes, as we seek to improve the day-to-day lives of the patients we serve,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “As we continue driving meaningful innovation and lead efforts to tackle mental health equity gaps in care, we are steadfastly committed to understanding the experience of those who are living with TD and look forward to additional insights as we continue this registry.”
The 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 study includes adult patients identified to have TD, but a formal TD diagnosis was not required to participate.
The IMPACT-TD findings revealed:
- Fewer people with a psychotic disorder had received a diagnosis of TD compared to those with mood disorders (
36% vs50% ), despite having similar mean AIMS scores (8.7 vs 8.0), a longer median time since the first recognition of movements (5.5 vs 3.8 years), and a longer median time since the first use of an antipsychotic (16 vs 10 years) - In the study, patients with a psychotic disorder (n=135) compared to those with a mood disorder (n=141) were younger (mean age 48 vs 55.5), more likely to be Black or African American (
36% vs9% ), and male (62% vs38% ) - The impact of TD on the lives of patients in the study was similar in both groups, with clinicians reporting moderate or severe impact of
86% for those with a psychotic disorder and80% for those with mood disorders
“It is critical for people with psychotic disorders to get the treatment that they need. In the past several years, antipsychotic medicines use has increased, leading to an increased risk of developing TD,” said Rakesh Jain, MD, MPH, Clinical Professor of Psychiatry, Texas Tech University School of Medicine – Permian Basin. “Taken together, the results of this physician- and patient-reported data reveal the need to more closely monitor patients suffering from mental health conditions for signs of TD so that they can be treated early and effectively.”
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 satisfaction with the medication overall74% reported that their extra movements improved with AUSTEDO XR- More than
76% agreed that a reduction in their extra movements had improved their comfort in social settings and their emotional well-being, and more than half of patients agreed that a reduction in their extra movements had improved their overall physical health and work or school/life balance since starting the medication - Almost all respondents (
98% ) reported that AUSTEDO XR was easy to use and incorporate into daily routines and agreed that they would continue to take it (95% )
Currently more than 57 million Americans are living with a mental illness, 14 million of whom are living with a serious mental health condition.1 For those taking certain mental health medications, one in four may experience the onset of TD, an often-overlooked chronic movement disorder that can have a physical, emotional and psychological impact on patients.2,3 Both TD and HD chorea can pose significant challenges to patients’ every day lives as simple tasks like eating, talking and walking can be impacted.
About Tardive Dyskinesia (TD)
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.4,5,6
About Chorea Associated with Huntington’s Disease (HD)
HD is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately
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 U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.
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 TD.
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; and other factors discussed in our Quarterly Report on Form 10-Q for the second 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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- U.S. Department of Health and Human Services. (n.d.). Mental illness. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/mental-illness.
- Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. J Clin Psychiatry. 2017;78(3): e264-e278.
- Hansen TE, Brown WL, Weigel RM, Casey DE. Underrecognition of tardive dyskinesia and drug-induced parkinsonism by psychiatric residents. Gen Hosp Psychiatry. 1992;14(5):340-344.
- Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258.
- Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.
- Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed May 4, 2023.
- Huntington’s Disease. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/health-information/disorders/huntingtons-disease#toc-what-is-huntington-s-disease-. Accessed May 15, 2023.
- Thorley, E. M., Iyer, R. G., Wicks, P., Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., & Carlozzi, N. E. (2018). Understanding How Chorea Affects Health-Related Quality of Life in Huntington Disease: An Online Survey of Patients and Caregivers in the United States. The patient, 11(5), 547–559. https://doi.org/10.1007/s40271-018-0312-x.
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FAQ
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