Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double‐blind, placebo‐controlled study (J‐KINECT). Issue 11 (17th September 2022)

• Record Type: Journal Article
• Authors: Horiguchi, Jun; Watanabe, Koichiro; Kondo, Kazuoki; Iwatake, Atsushi; Sakamoto, Hajime; Susuta, Yutaka; Masui, Hideaki; Watanabe, Yumi
• Is Part Of: Psychiatry and clinical neurosciences. Volume 76:Issue 11(2022)
• Page Start: 560
• Page End: 569
• Publication Date: 2022-09-17
• Subjects: abnormal involuntary movement scale -- randomized controlled trial -- tardive dyskinesia -- valbenazine -- vesicular monoamine transporter 2; Psychiatry -- Periodicals; Neurology -- Periodicals; 616.89
• DOI: 10.1111/pcn.13455
• Languages: English
• ISSNs: 1323-1316

Abstract

Abstract : Aim: Valbenazine is approved in the US for treatment of tardive dyskinesia (TD); however, efficacy/safety data in Asian populations are lacking. We assessed the efficacy/safety of valbenazine in Japanese patients. Methods: This phase II/III, multicenter, randomized, double‐blind, placebo‐controlled study (NCT03176771) included adult psychiatric patients with TD, who were randomly allocated to receive placebo or valbenazine (once‐daily 40‐ or 80‐mg) for a 6‐week, double‐blind period, after which the placebo group was switched to valbenazine for a 42‐week extension. The primary endpoint was change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Week 6; clinical global impression of improvement of TD (CGI‐TD) was also assessed. Results: Of 256 patients, 86, 85, and 85 were allocated to the 40‐mg valbenazine, 80‐mg valbenazine, and placebo groups, respectively. Least‐squares mean (95% confidence interval) change from baseline in AIMS score at Week 6 was −2.3 (−3.0 to −1.7) in the valbenazine 40‐mg group, −3.7 (−4.4 to −3.0) in the 80‐mg group, and −0.1 (−0.8 to 0.5) in the placebo group; both treatment groups showed statistically significant improvements vs. placebo. Patients switched to valbenazine at Week 6 showed similar improvements in AIMS scores, which were maintained to Week 48. Improvements in CGI‐TD scores were observed for both treatment groups vs. placebo. Incidence of adverse events was highest in the 80‐mg group; common events included nasopharyngitis, somnolence, schizophrenia worsening, hypersalivation, insomnia, and tremor. Conclusion: The efficacy/safety profile of valbenazine was similar to that of previous clinical trials, supporting its use for TD treatment in Japanese patients.