The effects of valbenazine on tardive dyskinesia in older and younger patients.

Abstract

ObjectiveTo evaluate the effects of once‐daily valbenazine (40 or 80 mg/d) in older and younger adults with tardive dyskinesia (TD).MethodsData were pooled from three 6‐week, randomized, double‐blind, placebo‐controlled (DBPC) studies (KINECT [NCT01688037], KINECT 2 [NCT01733121], and KINECT 3 [NCT02274558]) and two long‐term studies (KINECT 3 extension and KINECT 4 [NCT02405091]). Outcomes analyzed in older and younger participants (55 years or older and younger than 55 years, respectively) included Abnormal Involuntary Movement Scale (AIMS) response (threshold of greater than or equal to 50% improvement from baseline in total score [items 1 to 7]) and Clinical Global Impression of Change—Tardive Dyskinesia (CGI‐TD) response (score 2 or less [“very much improved” or “much improved”]). Safety assessments included treatment‐emergent adverse events (TEAEs).ResultsAt week 6 (end of DBPC treatment), the percentage of participants who met the AIMS response threshold was higher with valbenazine versus placebo in both subgroups: 55 years or older (80 mg/d, 39.7% [P < .001]; 40 mg/d, 28.6% [P < .01]; placebo, 9.7%); younger than 55 years (80 mg/d, 39.5% [P < .001]; 40 mg/d, 20.0% [P > .05]; placebo, 10.8%). The percentage of participants with CGI‐TD response was also higher with valbenazine versus placebo: 55 years or older (80 mg/d, 41.3% [P < .01]; 40 mg/d, 30.2% [P > .05]; placebo, 19.4%); younger than 55 years (80 mg/d, 39.5% [P < .05]; 40 mg/d, 35.3% [P < .05]; placebo, 18.5%). Responses at week 48 (end of long‐term treatment, combined doses) were as follows: 55 years or older (AIMS, 70.7%; CGI‐TD, 82.8%); younger than 55 years (AIMS, 58.7%; CGI‐TD, 72.3%). No significant differences between older and younger subgroups were found for AIMS or CGI‐TD response. No new safety signals or TEAEs of clinical concern were found in older participants who received long‐term treatment.ConclusionsValbenazine improved TD and was generally well tolerated in older and younger adults.