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Abstract Details

Sustained Treatment Response with Long-Term Valbenazine in Patients with Tardive Dyskinesia
Movement Disorders
P11 - Poster Session 11 (11:45 AM-12:45 PM)
5-012
To assess patterns of treatment response in patients with tardive dyskinesia (TD) who received once-daily valbenazine in a 48-week clinical trial (KINECT 4 [NCT02405091]).
Valbenazine is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of TD, a persistent and potentially disabling movement disorder associated with prolonged exposure to antipsychotics and other dopamine receptor blocking agents. 

Data from KINECT 4 treatment completers (participants who reached the Week 48 visit) were analyzed post hoc. Analyses were conducted at Week 8 (first study visit after dose-optimization period) and Week 48 (end of treatment) using the following thresholds: ≥50% and ≥70% improvement from baseline in Abnormal Involuntary Movement Scale (AIMS) total score; rating of “much improved” or “very much improved” (score ≤2) on Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC).

Of 167 participants in KINECT 4, 103 (62%) were treatment completers and included for analysis. The proportion of these participants who met AIMS response thresholds at Weeks 8 and 48, respectively, were as follows: ≥50% improvement (39% and 86%); ≥70% improvement (17% and 52%). Of 40 participants with AIMS ≥50% improvement at Week 8, 95% also met this threshold at Week 48 (“sustained response”). Of 63 participants with <50% AIMS improvement at Week 8, 81% achieved the ≥50% response threshold at Week 48. The proportion of participants meeting thresholds for global response increased from Week 8 to Week 48 for CGI-TD (from 50% to 92%) and PGIC (from 53% to 88%).

Post hoc analyses of KINECT 4 data showed that the proportion of participants meeting rigorous treatment response thresholds increased over time. After 48 weeks of treatment with once-daily valbenazine, >80% of participants demonstrated robust improvements in TD, as assessed using the AIMS (≥50% improvement), CGI-TD (score ≤2), and PGIC (score ≤2).

Authors/Disclosures
Eric Jen (Neurocrine Biosciences, Inc.)
PRESENTER
Eric Jen has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc.
No disclosure on file
No disclosure on file
No disclosure on file
Scott Siegert Mr. Siegert has received personal compensation for serving as an employee of Neurocrine Biosciences. Mr. Siegert has stock in Neurocrine Biosciences.
Eduardo Dunayevich, MD Eduardo Dunayevich has received personal compensation for serving as an employee of Neurocrine Biosciences. Eduardo Dunayevich has stock in Neurocrine Biosciences.