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Abstract Details

Treatment Responses with Long-Term Valbenazine in Patients with Tardive Dyskinesia
Movement Disorders
P6 - Poster Session 6 (12:00 PM-1:00 PM)
3-008
Valbenazine, a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of TD in adults. Valbenazine clinical trials used a more rigorous definition of response than previous TD trials, including ≥50% improvement in Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7) and score ≤2 (“much improved” or better) on the Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) or Patient Global Impression of Change (PGIC). Because participants who did not meet these thresholds still potentially experienced meaningful improvements, data from KINECT 4 (NCT02405091) were analyzed post hoc using wider ranges of response. 
To evaluate the range of responses in adults with tardive dyskinesia (TD) who received once-daily valbenazine for 48 weeks.
KINECT 4 included adults (18-85 years) with stable schizophrenia/schizoaffective disorder or mood disorder, TD for ≥3 months, and no/minimal risk of suicidality. Valbenazine was initiated at 40 mg and increased to 80 mg at Wk4 if tolerated; dosage was reduced to 40 mg after Wk4 if not tolerated. Response ranges at Wk48 were as follows: AIMS, ≥10% to 100% improvement; CGI-TD and PGIC, score ≤3 (“minimally improved” or better) or ≤2 (“much improved” or better). 
Among participants with an available assessment at Wk48 (N=103), 94.2% had ≥30% improvement and 86.4% had ≥50% improvement in AIMS total score. Response rates for remaining AIMS thresholds ranged from 9.7% (100% response) to 97.1% (≥10% response). Almost all participants had a global score ≤3: CGI-TD, 99.0%; PGIC, 98.1%. Most had a global score ≤2: CGI-TD, 92.2%; PGIC, 88.3%. 
After 48 weeks of once-daily valbenazine treatment, 97% of the participants had some AIMS response (≥10% improvement) with 9.7% reaching 100% AIMS response. Most participants (>98%) had a global rating of “minimally improved” or better, and >88% had a global rating of “much improved” or better.
Authors/Disclosures
Carlos Singer, MD (University of Miami)
PRESENTER
Dr. Singer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amneal. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Video Panel with CNS Ratings LLC. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Course Organiztion with Omniprex Scientific Medical Eduaction. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with Health Monitor Network. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Movement Disorders Society. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Workshop Moderator with International Neurotoxin Association Inc. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Lecturer with CME Outfitteres LLC.
Cynthia L. Comella, MD, FAAN (Rush University Medical Center) Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda Therapeutics. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck LTD. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan Inc. Dr. Comella has received personal compensation in the range of $0-$499 for serving as a Consultant for Merz. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. Dr. Comella has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Dr. Comella has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aeon. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz . Dr. Comella has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceutical. Dr. Comella has received publishing royalties from a publication relating to health care. Dr. Comella has received publishing royalties from a publication relating to health care.
Stephen Marder No disclosure on file
Khodayar Farahmand Mr. Farahmand has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc.
Roland Jimenez No disclosure on file