Deutetrabenazine for tardive dyskinesia and chorea associated with Huntington’s disease: a review of clinical trial data

References

• Bordelon YM. Clinical neurogenetics: Huntington disease. Neurol Clin. 2013;31(4):1085–1094.
   PubMed Web of Science ®Google Scholar
• Lerner PP, Miodownik C, Lerner V. Tardive dyskinesia (syndrome): current concept and modern approaches to its management. Psychiatry Clin Neurosci. 2015;69(6):321–334.
   PubMed Web of Science ®Google Scholar
• Reiner A, Dragatsis I, Dietrich P. Genetics and neuropathology of Huntington’s disease. Int Rev Neurobiol. 2011;98:325–372.
   PubMed Web of Science ®Google Scholar
• Huntington Study Group, Frank S, Testa CM, et al. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. JAMA. 20165;316(1):40–50.
   PubMed Web of Science ®Google Scholar
• Jankovic J, Roos RAC. Chorea associated with Huntington’s disease: to treat or not to treat? Mov Disord. 2014;29(11):1414–1418.
   PubMed Web of Science ®Google Scholar
• Waln O, Jankovic J. An update on tardive dyskinesia: from phenomenology to treatment. Tremor Other Hyperkinet Mov (NY). 2013;3.
   PubMedGoogle Scholar
• Haddad MS, Cummings JL. Huntington’s disease. Psychiatr Clin North Am. 1997;20(4):791–807.
   PubMed Web of Science ®Google Scholar
• Zutshi D, Cloud LJ, Factor SA. Tardive syndromes are rarely reversible after discontinuing dopamine receptor blocking agents: experience from a university-based movement disorder clinic. Tremor Other Hyperkinet Mov (NY). 2014;4:266.
   PubMedGoogle Scholar
• Mahmoudi S, Levesque D, Blanchet PJ. Upregulation of dopamine D3, not D2, receptors correlates with tardive dyskinesia in a primate model. Mov Disord. 2014 Aug;29(9):1125–1133.
   PubMed Web of Science ®Google Scholar
• Mestre TA. Chorea. Continuum (Minneap Minn). 2016 Aug;22(4 Movement Disorders):1186–1207.
   Google Scholar
• Xenazine® (tetrabenazine) (prescribing information). Copenhagen, Denmark: Lundbeck; 2017.
   Google Scholar
• Austedo® (deutetrabenazine) tablets [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA, Inc; 2017.
   Google Scholar
• Bhidayasiri R, Fahn S, Weiner WJ, et al. Evidence-based guideline: treatment of tardive syndromes: report of the guideline development subcommittee of the american academy of neurology. Neurology. 2013;81(5):463–469.
   PubMed Web of Science ®Google Scholar
• Caroff SN, Hurford I, Lybrand J, et al. Movement disorders induced by antipsychotic drugs: implications of the CATIE schizophrenia trial. Neurol Clin. 2011;29(1):127–148.
   PubMed Web of Science ®Google Scholar
• Carbon M, Hsieh CH, Kane JM, et al. Tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. J Clin Psychiatry. 2017;78(3):e264–e278.
   PubMed Web of Science ®Google Scholar
• Dhir A, Schilling T, Abler V, et al. Estimation of epidemiology of tardive dyskinesia incidence and prevalence in the United States. The American Academy of Neurology Annual Meeting; 2017 Apr 22–28; Boston, MA, USA.
   Google Scholar
• Maher AR, Maglione M, Bagley S, et al. Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis. JAMA. 2011;306(12):1359–1369.
   PubMed Web of Science ®Google Scholar
• Maglione M, Maher AR, Hu J, et al. Off-label use of atypical antipsychotics: an update. Rockville, MD: Report No.:11-EHC087-EF.; 2011. eng. (AHRQ Comparative Effectiveness Reviews).
   Google Scholar
• Loughlin AM, Lin N, Abler V, et al. Tardive dyskinesia among patients using antipsychotic medications in customary clinical care in the United States. PLoS One. 2019;14(6):e0216044.
   PubMed Web of Science ®Google Scholar
• Bhidayasiri R, Jitkritsadakul O, Friedman JH, et al. Updating the recommendations for treatment of tardive syndromes: a systematic review of new evidence and practical treatment algorithm. J Neurol Sci. 2018;389:67–75.
   PubMed Web of Science ®Google Scholar
• Scorr LM, Factor SA. VMAT2 inhibitors for the treatment of tardive dyskinesia. J Neurol Sci. 2018;389:43–47.
   PubMed Web of Science ®Google Scholar
• Wimalasena K. Vesicular monoamine transporters: structure-function, pharmacology, and medicinal chemistry. Med Res Rev. 2011;31(4):483–519.
   PubMed Web of Science ®Google Scholar
• Vergo S, Johansen JL, Leist M, et al. Vesicular monoamine transporter 2 regulates the sensitivity of rat dopaminergic neurons to disturbed cytosolic dopamine levels. Brain Res. 2007;1185:18–32.
   PubMed Web of Science ®Google Scholar
• Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003–2010.
   PubMed Web of Science ®Google Scholar
• Claassen DO, Carroll B, De Boer LM, et al. Indirect tolerability comparison of deutetrabenazine and tetrabenazine for Huntington disease. J Clin Mov Disord. 2017;4:3.
   PubMedGoogle Scholar
• Huntington Study Group. Tetrabenazine as antichorea therapy in Huntington disease: a randomized controlled trial. Neurology. 2006;66(3):366–372.
   PubMed Web of Science ®Google Scholar
• Neurocrine Biosciences I. Ingrezza™ (valbenazine) capsules [prescribing information]: neurocrine biosciences, Inc. San Diego, CA; Apr 2017 [cited 2017 Jun 29]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf
   Google Scholar
• Grigoriadis DE, Smith E, Hoare SRJ, et al. Pharmacologic characterization of valbenazine (NBI-98854) and its metabolites. J Pharmacol Exp Ther. 2017 Jun;361(3):454–461.
   PubMed Web of Science ®Google Scholar
• O’Brien CF, Jimenez R, Hauser RA, et al. NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: a randomized, double-blind, placebo-controlled study. Mov Disord. 2015;30(12):1681–1687.
   PubMed Web of Science ®Google Scholar
• Seeberger LC, Hauser RA. Valbenazine for the treatment of tardive dyskinesia. Expert Opin Pharmacother. 2017;18(12):1279–1287.
   PubMed Web of Science ®Google Scholar
• Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a Phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017;174(5):476–484.
   PubMed Web of Science ®Google Scholar
• Factor SA, Remington G, Comella CL, et al. The effects of valbenazine in participants with tardive dyskinesia: results of the 1-year kinect 3 extension study. J Clin Psychiatry. 2017;78(9):1344–1350.
   PubMed Web of Science ®Google Scholar
• Factor S, Kane J, Marder S, et al. Effects of long-term valbenazine on tardive dyskinesia and patient-reported outcomes: results from the KINECT 4 study (P4.078). Neurology. 2018;90(15Supplement):P4.078.
   Google Scholar
• Frank S, Stamler D, Kayson E, et al. Safety of converting from tetrabenazine to deutetrabenazine for the treatment of chorea. JAMA Neurol. 2017;74:977–982.
   PubMed Web of Science ®Google Scholar
• Citrome L. Deutetrabenazine for tardive dyskinesia: a systematic review of the efficacy and safety profile for this newly approved novel medication-what is the number needed to treat, number needed to harm and likelihood to be helped or harmed?. Int J Clin Pract. 2017;71(11).
   Web of Science ®Google Scholar
• Stamler D, Brown F, Bradbury M The pharmacokinetics of extended release SD-809, a deuterium-substituted analogue of tetrabenazine. Movement Disorders Meeting; 2013 Jun 16–20; Sydney, Australia.
   Google Scholar
• Tarsy D, Baldessarini RJ. Tardive dyskinesia. Annu Rev Med. 1984;35:605–623.
   PubMed Web of Science ®Google Scholar
• Savitt D, Jankovic J. Tardive syndromes. J Neurol Sci. 2018;389:35–42.
   PubMed Web of Science ®Google Scholar
• Frank S, Vaughan C, Stamler D, et al. The long-term safety of deutetrabenazine for chorea in Huntington disease: a preliminary analysis. International Congress of Parkinson’s Disease and Movement Disorders; 2017 Jun 4–8; Vancouver, BC, Canada.
   Google Scholar
• Frank S, Stamler D, Sung V, et al. Deutetrabenazine effect on total motor score in patients with Huntington disease (First-HD). American Academy of Neurology Annual Meeting; 2016 Apr 15–21; Vancouver, BC, Canada.
   Google Scholar
• Sung V, Claassen DO, Edmondson MC, et al. Comparable neuropsychiatric safety observed with deutetrabenazine treatment and placebo in patients with Huntington disease (First-HD). US Psychiatric and Mental Health Congress; 2016 Oct 21–24; San Antonio, TX, USA.
   Google Scholar
• Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;5:595–604.
   Google Scholar
• Anderson KE, Stamler D, Davis MD, et al. Long-term deutetrabenazine treatment response in tardive dyskinesia by concomitant dopamine-receptor antagonists and baseline comorbidities. American Psychiatric Association Annual Meeting; 2018 May 5–9; New York, NY, USA.
   Google Scholar
• Jimenez-Shahed J, Fernandez HH, Stamler D, et al. Deutetrabenazine is associated with an improvement in involuntary movements in patients with tardive dyskinesia (TD) as seen by the high proportion of responders to deutetrabenazine treatment in the AIM-TD study. American Academy of Neurology Annual Meeting; 2017 Apr 22–28; Boston, MA, USA.
   Google Scholar
• Jimenez-Shahed J, Factor SA, Ondo WG, et al. Deutetrabenazine is associated with an improvement in involuntary movements in patients with tardive dyskinesia (TD) as seen by the high proportion of responders to treatment in the ARM-TD study. US Psychiatric and Mental Health Congress; 2016 Oct 21–24; San Antonio, TX, USA.
   Google Scholar
• Anderson KE, Factor SA, Davis MD, et al. Addressing involuntary movements in tardive dyskinesia (AIM-TD): effect of fixed-dose deutetrabenazine by baseline comorbidities. American Academy of Neurology Annual Meeting; 2017 Apr 22–28; Boston, MA, USA.
   Google Scholar
• Jimenez-Shahed J, Fernandez HH, Stamler D, et al. Deutetrabenazine treatment response by concomitant dopamine-receptor antagonists in the Phase III, randomized, double-blind, placebo-controlled AIM-TD trial in tardive dyskinesia (TD). International Congress of Parkinson’s Disease and Movement Disorders; 2017 Jun 4–8; Vancouver, BC, Canada.
   Google Scholar
• Factor SA, Anderson KE, Stamler D, et al. Effect of deutetrabenazine on quality of life in patients with tardive dyskinesia in AIM-TD, a 12-week double-blind, placebo-controlled study. International Congress of Parkinson’s Disease and Movement Disorders; 2017 Jun 4–8; Vancouver, BC, Canada.
   Google Scholar
• Hauser RA, Fernandez HH, Stamler D, et al. 45 Long-term treatment with deutetrabenazine is associated with continued improvement in tardive dyskinesia: results from an open-label extension study. CNS Spectr. 2019;24(1):200–201.
   PubMedGoogle Scholar
• Fernandez HH, Stamler D, Davis MD, et al. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019. Epub ahead of print. DOI:10.1136/jnnp-2018-319918.
   PubMedGoogle Scholar
• Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for the treatment of tardive dyskinesia: results from an open-label, long-term study. American Psychiatric Association Annual Meeting; 2017 May 20–24; San Diego, CA USA.
   Google Scholar
• Anderson KE, Stamler D, Davis MD, et al. Long-term treatment with deutetrabenazine improves quality of life in patients with tardive dyskinesia as assessed by a modified dystonia scale. American Psychiatric Association Annual Meeting; 2018 May 5–9; New York, NY, USA.
   Google Scholar
• Fernandez HH, Davis MD, Factor SA, et al. Improvements in clinical global impression of change with deutetrabenazine treatment in tardive dyskinesia from the ARM-TD and AIM-TD studies. Psych Congress Annual Meeting; 2017 Sep 16–19; New Orleans, LA, USA.
   Google Scholar
• Farber R, Sparta D, Gauthier M, et al. Tardive dyskinesia: patient and caregiver perspectives on signs, symptoms, and impact. Psych Congress Annual Meeting; 2017 Sep 16–19; New Orleans, LA, USA.
   Google Scholar
• Chang FC, Fung VS. Clinical significance of pharmacogenomic studies in tardive dyskinesia associated with patients with psychiatric disorders. Pharmgenomics Pers Med. 2014;7:317–328.
   PubMedGoogle Scholar
• Sung VW, Iyer RG, Gandhi SK, et al. Physician perceptions of pharmacologic treatment options for chorea associated with Huntington disease in the United States. Curr Med Res Opin. 2018;34(4):643–648.
   PubMed Web of Science ®Google Scholar
• Rodrigues FB, Duarte GS, Costa J, et al. Tetrabenazine versus deutetrabenazine for huntington’s disease: twins or distant cousins? Mov Disord Clin Pract. 2017;4(4):582–585.
   PubMed Web of Science ®Google Scholar