Abstract Details

Title Treatment Responses with Long-Term Valbenazine in Patients with Tardive Dyskinesia

Topic Movement Disorders

Presentation(s) P6 - Poster Session 6 (12:00 PM-1:00 PM)

Poster/Presentation
Number 3-008

Objective To evaluate the range of responses in adults with tardive dyskinesia (TD) who received once-daily valbenazine for 48 weeks.

Background 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.

Design/Methods 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).

Results 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%.

Conclusions 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 nothing to disclose.
Cynthia L. Comella, MD, FAAN (Rush University Medical Center)	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 Vima. 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.
	No disclosure on file
Khodayar Farahmand	Mr. Farahmand has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc.
	No disclosure on file

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