TY - JOUR
T1 - Characterizing treatment effects of valbenazine for tardive dyskinesia
T2 - Additional results from the KINECT 3 study
AU - Correll, Christoph U.
AU - Cutler, Andrew J.
AU - Kane, John M.
AU - McEvoy, Joseph Patrick
AU - Liang, Grace S.
AU - O'Brien, Christopher F.
N1 - Funding Information:
a consultant/advisor to or received honoraria from Alkermes, Allergan, Angelini, Gerson Lehrman Group, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, Medavante, Medscape, Neurocrine, Otsuka, Pfizer, Rovi, Sunovion, Takeda, and Teva; provided expert testimony for Bristol-Myers Squibb, Janssen, and Otsuka; served on a Data Safety Monitoring Board for ROVI, Lundbeck, and Pfizer; and received grant support from Janssen and Takeda. Dr Cutler has received research support from AbbVie, Alkermes, Allergan, AstraZeneca, Bristol-Meyers Squibb, Forum, Janssen/J&J, Eli Lilly, Lundbeck, Novartis, Otsuka, Pfizer, Reckitt Benckiser, Sunovion, Takeda, and Vanda; served as a consultant for AbbVie, Alkermes, Allergan, AstraZeneca, Bristol-Myers Squibb, Forum, Janssen/J&J, Jazz, Eli Lilly, Lundbeck, Novartis, Otsuka, Pfizer, Sunovion, Takeda, Teva, and Vanda; and served as a speaker for Alkermes, Allergan, AstraZeneca, Bristol-Myers Squibb, Janssen/J&J, Jazz, Eli Lilly, Lundbeck, Novartis, Otsuka, Pfizer, Sunovion, Takeda, Teva, and Vanda. Dr Kane has been a consultant/ advisor to or received honoraria from Alkermes, Allergan, Eli Lilly, EnVivo Pharmaceuticals (Forum), Genentech, Lundbeck. Intracellular Therapies, Janssen/J&J, Neurocrine, Otsuka, Pierre Fabre, Reviva, Roche, Sunovion, Takeda, and Teva; received grant support from Janssen/J&J and Otsuka; and is a shareholder in Vanguard Research Group and LB Pharmaceuticals. Dr McEvoy has received consulting fees, honoraria, and/or grants from Alkermes Inc, Avanir, Boehringer Ingelheim, Neurocrine, Otsuka, and Teva. Drs Liang and O’Brien are full-time employees of Neurocrine Biosciences, Inc, which sponsored the study described here, and report having equity in the company.
Publisher Copyright:
© Copyright 2018 Physicians Postgraduate Press, Inc.
PY - 2019/1
Y1 - 2019/1
N2 - Background: In the KINECT 3 (NCT02274558; October 2014 to September 2015) study, valbenazine efficacy in tardive dyskinesia (TD) was demonstrated based on mean changes from baseline in the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7). Data from this study were analyzed further to provide a more clinically meaningful interpretation of the primary AIMS results. Methods: The study included adults who had a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or any mood disorder and also met DSM-IV criteria for neuroleptic-induced TD. Study participants received 6 weeks of double-blind treatment with valbenazine (40 or 80 mg/d) or placebo. Post hoc AIMS analyses, based on available data, included Cohen d effect sizes, response analyses with odds ratios (ORs) and numbers needed to treat (NNTs), and shift analyses. Results: At week 6 (N = 202), medium-to-high effect sizes were found for mean improvements in AIMS total score (40 mg/d, d = 0.52; 80 mg/d, d = 0.89). For AIMS total score responses of ≥ 10% to ≥ 70% improvement from baseline, statistical significance was found for valbenazine 80 mg/d versus placebo (P ≤.01), with ORs (range, 3.0-10.3) and NNTs (range, 3-9) indicating clinical relevance. For response per AIMS item (score ≤ 1 at week 6), significant differences between valbenazine (both doses or 80 mg/d) and placebo were found in the lips, jaw, tongue, and upper extremities. In participants who had an AIMS item score ≥ 1 at baseline, the percentage with a ≥ 1-point improvement at week 6 (shift) was significantly higher with valbenazine (40 and/or 80 mg/d) versus placebo in all 7 body regions. Conclusions: Consistent with primary published results for KINECT 3, these supplemental analyses indicate that participants treated with valbenazine (40 or 80 mg/d) had statistically significant and clinically relevant improvements in TD severity both overall and in specific body regions.
AB - Background: In the KINECT 3 (NCT02274558; October 2014 to September 2015) study, valbenazine efficacy in tardive dyskinesia (TD) was demonstrated based on mean changes from baseline in the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7). Data from this study were analyzed further to provide a more clinically meaningful interpretation of the primary AIMS results. Methods: The study included adults who had a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or any mood disorder and also met DSM-IV criteria for neuroleptic-induced TD. Study participants received 6 weeks of double-blind treatment with valbenazine (40 or 80 mg/d) or placebo. Post hoc AIMS analyses, based on available data, included Cohen d effect sizes, response analyses with odds ratios (ORs) and numbers needed to treat (NNTs), and shift analyses. Results: At week 6 (N = 202), medium-to-high effect sizes were found for mean improvements in AIMS total score (40 mg/d, d = 0.52; 80 mg/d, d = 0.89). For AIMS total score responses of ≥ 10% to ≥ 70% improvement from baseline, statistical significance was found for valbenazine 80 mg/d versus placebo (P ≤.01), with ORs (range, 3.0-10.3) and NNTs (range, 3-9) indicating clinical relevance. For response per AIMS item (score ≤ 1 at week 6), significant differences between valbenazine (both doses or 80 mg/d) and placebo were found in the lips, jaw, tongue, and upper extremities. In participants who had an AIMS item score ≥ 1 at baseline, the percentage with a ≥ 1-point improvement at week 6 (shift) was significantly higher with valbenazine (40 and/or 80 mg/d) versus placebo in all 7 body regions. Conclusions: Consistent with primary published results for KINECT 3, these supplemental analyses indicate that participants treated with valbenazine (40 or 80 mg/d) had statistically significant and clinically relevant improvements in TD severity both overall and in specific body regions.
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U2 - 10.4088/JCP.18m12278
DO - 10.4088/JCP.18m12278
M3 - Article
C2 - 30695293
AN - SCOPUS:85060790243
SN - 0160-6689
VL - 80
JO - Diseases of the Nervous System
JF - Diseases of the Nervous System
IS - 1
ER -
