Tags

Type your tag names separated by a space and hit enter

Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study.
J Clin Psychiatry. 2018 12 18; 80(1)JC

Abstract

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.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02274558.

Authors+Show Affiliations

75-59 263rd St, Glen Oaks, NY 11004. ccorrell@northwell.edu. Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, USA. Department of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA. Center for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, Manhasset, New York, USA.Meridien Research, Tampa, Florida, USA.Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, USA. Department of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.Neurocrine Biosciences, Inc, San Diego, California, USA.Neurocrine Biosciences, Inc, San Diego, California, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30695293

Citation

Correll, Christoph U., et al. "Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study." The Journal of Clinical Psychiatry, vol. 80, no. 1, 2018.
Correll CU, Cutler AJ, Kane JM, et al. Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. J Clin Psychiatry. 2018;80(1).
Correll, C. U., Cutler, A. J., Kane, J. M., McEvoy, J. P., Liang, G. S., & O'Brien, C. F. (2018). Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. The Journal of Clinical Psychiatry, 80(1). https://doi.org/10.4088/JCP.18m12278
Correll CU, et al. Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. J Clin Psychiatry. 2018 12 18;80(1) PubMed PMID: 30695293.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. AU - Correll,Christoph U, AU - Cutler,Andrew J, AU - Kane,John M, AU - McEvoy,Joseph P, AU - Liang,Grace S, AU - O'Brien,Christopher F, Y1 - 2018/12/18/ PY - 2018/04/03/received PY - 2018/11/08/accepted PY - 2019/1/30/entrez PY - 2019/1/30/pubmed PY - 2019/10/15/medline JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 80 IS - 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02274558. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/30695293/Characterizing_Treatment_Effects_of_Valbenazine_for_Tardive_Dyskinesia:_Additional_Results_From_the_KINECT_3_Study_ L2 - http://www.psychiatrist.com/JCP/article/Pages/2019/v80/18m12278.aspx DB - PRIME DP - Unbound Medicine ER -