Abstract Details

Title Long-Term Efficacy and Safety of Deutetrabenazine in Patients With Tardive Dyskinesia by Concomitant Dopamine-Receptor Antagonist Use

Topic Movement Disorders

Presentation(s) P6 - Poster Session 6 (5:30 PM-6:30 PM)

Poster/Presentation
Number 5-001

Background TD is an involuntary movement disorder that can result from exposure to DRAs. Deutetrabenazine demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores in the 12-week pivotal trials (ARM-TD/AIM-TD).

Objective

This post hoc analysis assessed the long-term efficacy and safety of deutetrabenazine in patients with tardive dyskinesia (TD) by baseline dopamine-receptor antagonist (DRA) use.

Design/Methods

Patients who completed ARM-TD or AIM-TD enrolled in the 3-year, open-label extension (OLE) study, with deutetrabenazine dose titrated based on dyskinesia control and tolerability. Change from baseline in total motor AIMS score, Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and adverse event (AE) rates were analyzed in subgroups by baseline DRA use.

Results

Of 337 patients in the OLE study, 254 were taking DRAs at baseline (mean age, 56y; 48% male; 6.0y since diagnosis) and 83 were not (mean age, 60y; 31% male; 4.9y since diagnosis). Mean±SE dose at Wk145 was 39.9±1.0mg/day in patients taking DRAs (n=108) and 38.5±1.5mg/day in patients not taking DRAs (n=53). At Wk145, mean±SE change from baseline in AIMS score was –6.1±0.43 and –7.5±0.71; 64% and 62% achieved PGIC treatment success; and 69% and 81% achieved CGIC treatment success, respectively. Overall AE incidence was low (exposure-adjusted incidence rates [incidence/patient-years]: any, 1.08 and 1.97; serious, 0.10 and 0.12; leading to discontinuation, 0.06 and 0.05).

Conclusions

This analysis suggests that deutetrabenazine for long-term treatment of TD is beneficial, with a favorable safety profile, regardless of concomitant DRA use.

Authors/Disclosures
Nayla Chaijale PRESENTER	Nayla Chaijale has received personal compensation for serving as an employee of Teva Pharmaceuticals.
	No disclosure on file
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)	Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Global Kinetics Consulting (GKC). Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion Neurostim LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tolmar Inc.. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inhibikase. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pharma 2 B. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Therapeutics. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ovid Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AgeX Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avanex. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MDCE Suzhou. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedRhythms. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PDNeurotechnology. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Tremor Research Support Group. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tris Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Ameal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sunovion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Inhibikase. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. Dr. Hauser has stock in Revance Therapeutics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Artizan Biosciences. The institution of Dr. Hauser has received research support from Parkinsons & Movement Disorder Alliance. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Aeon Biopharma. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Bukwang Pharmaceutical Co., Ltd.. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Cynapsus Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Impax Labratories. The institution of Dr. Hauser has received research support from Integrative Research Labratories Sweden. The institution of Dr. Hauser has received research support from Lundbeck, Inc.. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuraly Inc.. The institution of Dr. Hauser has received research support from Neurocrine Biosciences. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Pharma Two B Ltd.. The institution of Dr. Hauser has received research support from Revance Therapeutics. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Sanofi Pharmaceuticals. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from SunPharma. The institution of Dr. Hauser has received research support from UCB BioPharma. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)	Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Fernandez has received research support from Biogen. The institution of Dr. Fernandez has received research support from Michael J Fox Founda. The institution of Dr. Fernandez has received research support from Roche. The institution of Dr. Fernandez has received research support from Parkinson Foundation. The institution of Dr. Fernandez has received research support from UCB. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
Stewart A. Factor, DO, FAAN (Emory University School of Medicine)	Dr. Factor has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Factor has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. The institution of Dr. Factor has received research support from Biohaven. The institution of Dr. Factor has received research support from Voyager. The institution of Dr. Factor has received research support from Neurocrine. The institution of Dr. Factor has received research support from Supernus. The institution of Dr. Factor has received research support from Prelinia. The institution of Dr. Factor has received research support from Medtronics. The institution of Dr. Factor has received research support from Boston Scientific. The institution of Dr. Factor has received research support from Sun Pharmaceuticals Advanced Research Company. The institution of Dr. Factor has received research support from Aspen. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care. Dr. Factor has received publishing royalties from a publication relating to health care.
Joohi Jimenez Shahed, MD (Icahn School of Medicine at Mount Sinai)	Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bracket Global LLC. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alpha Omega. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RegenXBio. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BlueRock Therapeutics. Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PhotoPharmics. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Emalex. The institution of Dr. Jimenez Shahed has received research support from Michael J Fox Foundation. The institution of Dr. Jimenez Shahed has received research support from Amneal. The institution of Dr. Jimenez Shahed has received research support from Annovis. The institution of Dr. Jimenez Shahed has received research support from SAGE. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Faculty with Movement Disorders Society. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Faculty with American Academy of Neurology. Dr. Jimenez Shahed has received personal compensation in the range of $500-$4,999 for serving as a Grant Reviewer with Parkinson Foundation. Dr. Jimenez Shahed has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant on Research Grant with Florida Atlantic University. Dr. Jimenez Shahed has received personal compensation in the range of $0-$499 for serving as a Speaker with Tourette Association of America. Dr. Jimenez Shahed has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with NACCME.
	No disclosure on file
	No disclosure on file
Amanda Wilhelm, PhD	Dr. Wilhelm has received personal compensation for serving as an employee of Teva Pharmaceuticals .
Mark F. Gordon, MD, FAAN (Teva Pharmaceuticals)	Dr. Gordon has received personal compensation for serving as an employee of Teva. Dr. Gordon has stock in Teva.
Juha M. Savola, MD, PhD (Spark Therapeutics, Inc)	Dr. Savola has received personal compensation for serving as an employee of Teva Pharmaceuticals. Dr. Savola has received intellectual property interests from a discovery or technology relating to health care.
Karen E. Anderson	Ms. Anderson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for teva. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AskBio. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for novartis. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Biogen. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. The institution of Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Ms. Anderson has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for neurocrine. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medscape. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for atheneum. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GLG. Ms. Anderson has received personal compensation in the range of $500-$4,999 for serving as a scientific advisor with CHDI.