Abstract Details

Title Effects of Concomitant Medication Use on Tardive Dyskinesia Outcomes in Long-Term Valbenazine Trials

Topic Movement Disorders

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-035

Objective To evaluate the effects of concomitant medications on treatment outcomes in long-term valbenazine trials.

Background The efficacy and safety of valbenazine, a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating tardive dyskinesia (TD) in adults, have been demonstrated in shorter- and long-term trials. Concomitant medications (e.g., antipsychotics, antidepressants, anticholinergics) needed to manage psychiatric conditions were allowed in the valbenazine clinical trials.

Design/Methods Data were pooled from two phase 3 trials, KINECT 3 (NCT02274558) and KINECT 4 (NCT02405091), in which participants received up to 48 weeks of once-daily valbenazine (40 or 80 mg). Outcomes included Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7) mean change from baseline (CFB) to Week 48 and AIMS response (≥50% total score improvement). Concomitant medication subgroups were defined as: antipsychotic (yes, no); antipsychotic type (atypical only, typical or both [typical+atypical]); antidepressant (yes, no); anxiolytic (benzodiazepines+others: yes, no); anticholinergic (yes, no). Subgroup categories were not mutually exclusive.

Results Of 304 participants, 85.5% were taking antipsychotics, 64.5% antidepressants, 30.3% anxiolytics, and 32.2% anticholinergics. AIMS total score CFB was significantly improved in all subgroups (P<0.05 versus baseline): antipsychotic (yes, -7.6; no, -8.0), antipsychotic type (atypical only, -7.9; typical or both [typical+atypical], -5.8); antidepressant (yes, -8.3; no, -6.3); anxiolytic (yes, -8.4; no, -7.3); anticholinergic (yes, -6.1; no, -8.3). There was a greater proportion of participants achieving AIMS response (≥50% total score improvement) for all “yes” compared to “no” subgroups, except for anticholinergics (antipsychotics: yes, 68.9%; no, 53.6%; antidepressants: yes, 70.5%; no, 57.9%; anxiolytics: yes, 72.4%; no, 63.6%; anticholinergics: yes, 51.9%; no, 72.4%).

Conclusions

Results from long-term valbenazine trials indicate sustained TD improvements in patients taking different concomitant medications.

Authors/Disclosures
Cynthia L. Comella, MD, FAAN (Rush University Medical Center) PRESENTER	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.
Carlos Singer, MD (University of Miami)	Dr. Singer has nothing to disclose.
	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
Scott Siegert	Mr. Siegert has received personal compensation for serving as an employee of Neurocrine Biosciences. Mr. Siegert has stock in Neurocrine Biosciences.

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