Long-Term Treatment With Deutetrabenazine Is Associated With Continued Improvement in Tardive Dyskinesia (TD): Results From an Open-Label Extension Study (S4.009)

Objective: To evaluate long-term efficacy of deutetrabenazine in patients with tardive dyskinesia (TD) by examining response rates from baseline in Abnormal Involuntary Movement Scale (AIMS) scores. Updated results of the responder analysis are reported here. Background: In the 12-week ARM-TD and AIM-TD studies, the percentage of patients achieving ≥50% and ≥70% response was higher in the deutetrabenazine-treated group than the percentage of patients in the placebo group, and there were low rates of overall adverse events and discontinuations associated with deutetrabenazine. Design/Methods: Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted or started deutetrabenazine 12 mg/day, titrating up to a maximum total daily dose of 48 mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration and a long-term maintenance phase (ongoing through Week 158). The cumulative proportion of AIMS responders from baseline was assessed; response rates for at least 50% and 70% improvement from baseline for each patient were evaluated. AlMS score was assessed by local site raters for this analysis. Results: 343 patients enrolled in the extension study. At Week 54 (n=250; total daily dose [mean ± standard error]: 38.6±0.66 mg), 48% of patients achieved ≥50% response and 24% achieved ≥70% response. At Week 106 (n=169; total daily dose: 39.6±0.77 mg), 55% of patients achieved ≥50% response, and 30% achieved ≥70% response. At Week 145, (n=77; total daily dose: 39.2±1.12 mg), 74% of patients achieved ≥50% response and 52% achieved ≥70% response. Treatment was generally well tolerated. Exposure-adjusted incidence rates (EAIRs) of common AEs were headache (0.04, somnolence (0.06), anxiety (0.07), and depression (0.05). Conclusions: Patients who received long-term treatment with deutetrabenazine achieved response rates that were indicative of clinically meaningful long-term treatment benefit. Disclosure: Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Acorda Therapeutics, Academy for Continued Healthcare Learning, Acadia Pharmaceuticals, Inc., Adamas Pharmaceuticals, AstraZeneca, ApoPharma, Back Bay Life Science, Biotie Therapies, Bracket, Cerecor, Inc., ClearView Healthcare Partners, ClinicalMind Medical and Therapeutic Communications, CNS Ratings, LLC., Cowen and Company, Cynapsus Therapeutics, DDB Health LLC, Decision Resources Group (DRG), Eli Lilly & Company, eResearch Technology, Inc., Expert Connect, Extera Partners, GE Healthcare, Health Advances, HealthLogix, Health and Wellness Partners, Huron Consulting Group, Impax Laboratories, Impel Neuropharma, Intec Pharma Ltd., Jazz Pharmaceuticals, Kashiv Pharma LLC, Kyowa Kirin Pharmaceutical Development, Ltd., LCN Consulting, LifeMax, Life Sciences, Lundbeck LLC, The Lockwood Group, MEDACorp, Medscape, Medtronic, Michael J. Fox Foundation, Mitsubishi Tanabe Pharmaceuticals, Movement Disorder Society, National Institutes of Health (NIH), Neurocea LLC, Neurocrine Biosciences, Neuroderm, Neuropore Therapies, Orbes Medical Group, Outcomes Insights, Parkinson Study Group, Peerview Press, Pennside Partners, Pfizer, Inc., Pharma Two B, Ltd, Phase Five Communications, Prescott Medical Group, Prexton Therapeutics, Prilenia Development Ltd., Projects in Knowledge, Putnam Associates, Quintiles, RMEI Medical Education for Better Outcomes, SAI Med Partners LLC, Sarepta Therapeutics, Schlesinger Associates, Scion Neurostim, LLC, Seagrove Partners, LLC, Slingshot Insights, Sunovion Pharmaceuticals, Inc., Sun Pharma, Teva Pharmaceutical Industries, US WorldMeds, Vista Research, WebMD, Windrose Consulting Group. Dr. Hauser has received royalty, license fees, or contractual rights payments from the University of South Florida. Dr. Hauser has received research support from AbbVie Inc., Acorda Therapeutics, AstraZeneca, Axovant Sciences , Biogen Inc., Cavion, Enterin Inc., Impax Laboratories, LLC., Intec Pharma Ltd, Jazz Pharmaceuticals, NeuroDerm Ltd., Lundbeck, Michael J Fox Foundation for Parkinson’s Research, F. Hoffman-La Roche, Dart NeuroScience LLC, Prexton Therapeutics, Revance Therapeutics Inc., Sunovion Pharmaceuticals. Dr. Barkay has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Fernandez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prime Education Inc. International Parkinson and Movement Disorders Society, Carling Communications, Medscape, Vindico, AbbVie, Biogen, Blackthorn, Inventiv, Kyowa Hakko Kirin, Medscape, Voyager, Sunovion, and Pfizer Pharmaceuticals. Dr. Fernandez has received royalty, license fees, or contractual rights payments from Demos Publishing, Cambridge University Press. Dr. Fernandez has received research support from Abbvie, Biotie/Acorda Therapeutics, Michael J. Fox Foundation, Movement Disorders Society, NIH/NINDS, Parkinson Study Group, Rhythm, Sunovion. Dr. Factor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine, Lundbeck, Teva, Avanir, Sunovion, Adamas, Prexton, Biogen. Dr. Factor has received research support from Ipsen, Medtronics, Teva, US World Meds, Sunovion, Solstice, Vaccinex, Voyager, CHDI Foundation, Michael J. Fox Foundation, NIH. Dr. Jimenez Shahed has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with St. Jude Medical/Abbott, Medtronic, Teva, Bracket, Nuvelution, Sunovion,. Dr. Jimenez Shahed has received research support from Biotie/Accorda, Medtronic, St. Jude Medical/Abbott, Eli Lilly & Company, Wilsons Therapeutics. Dr. Gross, MS has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Savola has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals International. Dr. Anderson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Scientific Advisor: North American study Co-Principal Investigator for LEGATO-HD, Global Principal Investigator for AIM-TD, and Global Co-Principal Investigator for ARM-TD. Site Principal Investigator for Pride-HD, First-HD, ARC-HD: Teva. Scientific Advisor, Site Principal Investigator for ENROLL-HD: CHDI Foundation. Scientific Advisor: Prana. Site Principal Investigator: Vaccinex. Consultant to the NeuroNext 105 study: Azevan, salary support from the Griffin Foundation. She has also received honoraria from Vindico Medical Education.