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, F�鶹��ýӳ�� (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

�鶹��ýӳ��

�鶹��ýӳ��