Abstract Details

Title Global Improvements and Psychiatric Stability in Adults with Tardive Dyskinesia: Post Hoc Analyses of Two Long-Term Valbenazine Studies

Topic Movement Disorders

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 5-010

Objective To evaluate global improvements and psychiatric status in patients with tardive dyskinesia (TD) who received long-term treatment with valbenazine, a highly selective VMAT2 inhibitor approved for TD.

Background Effective and comprehensive TD treatment requires reducing patients’ abnormal involuntary movements without compromising their psychiatric stability. This can be especially challenging when patients have complex psychiatric conditions that require multiple medications.

Design/Methods KINECT 3 and KINECT 4 study participants received valbenazine (40 or 80 mg, once-daily) for 48 weeks; concomitant medications needed to manage medical and psychiatric conditions were allowed. Data from these studies were pooled and analyzed by participants’ primary psychiatric diagnosis: schizophrenia/schizoaffective disorder (“SCHZ”) or mood disorder (“MD”). The percentages of participants who met the threshold for global response (rating of “much improved” or better) for the Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC) were analyzed at Week 48. Psychiatric symptom scales included: Positive and Negative Syndrome Scale (PANSS) and Calgary Depression Scale for Schizophrenia (CDSS) [SCHZ subgroup]; Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) [MD subgroup]; Columbia-Suicide Severity Rating Scale [all participants].

Results After 48 weeks of valbenazine, >75% of participants in the SCHZ subgroup met response thresholds per clinician assessment (CGI-TD=79.7%) and self-report (PGIC=78.0%). Mean changes from baseline (CFB) to Week 48 for PANSS scores (positive symptoms [-0.7], negative symptoms [-0.6], general psychopathology [-1.9], total [-3.2]) and CDSS total score (-0.5) indicated maintenance of psychiatric stability throughout valbenazine treatment. The MD subgroup achieved similar rates of global response (CGI-TD=77.6%, PGIC=84.5%), with mean CFB in YMRS total score (-1.0) and MADRS total score (+0.3) indicating maintenance of psychiatric stability. No emergence of suicidal ideation/behavior was observed.

Conclusions Patients with TD who received long-term treatment with once-daily valbenazine met rigorous thresholds for clinician- and self-reported global improvement without compromising their psychiatric stability.

Authors/Disclosures
Olga Klepitskaya, MD, FAAN (Neurocrine Biosciences, Inc) PRESENTER	Dr. Klepitskaya has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Klepitskaya has or had stock in Neurocrine Biosciences.
Andrew Cutler	Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for AbbVie. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Alkermes. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Axsome. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Boehringer Ingelheim. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Bristol Myers Squibb. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Delpor. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for 4M Therapeutics. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Intra-Cellular Therapies. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for J&J. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Jazz Pharma. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Lundbeck. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for MapLight Therapeutics. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Neumora. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Neurocrine. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Noven. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Otsuka. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Relmada. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Supernus. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Teva. Andrew Cutler has received personal compensation in the range of $0-$499 for serving as a Consultant for Tris Pharma. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for COMPASS Pathways. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Freedom Biosciences. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for AbbVie. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Alkermes. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Axsome. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Intra-Cellular Therapies. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for J&J. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Lundbeck. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Neurocrine. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Noven. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Otsuka. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Supernus. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Teva. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Tris Pharma. Andrew Cutler has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Vanda Pharmaceuticals. Andrew Cutler has stock in 4M Therapeutics. Andrew Cutler has stock in Relmada.
	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.
	No disclosure on file

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