Abstract Details

Older patients (≥55 years) taking a dopamine receptor blocking agent (e.g., antipsychotic) have an increased risk for TD. Valbenazine, a selective and potent vesicular monoamine transporter 2 (VMAT2) inhibitor, is the only approved TD treatment with no required dosing adjustments based on age.

To assess treatment outcomes with once-daily valbenazine in elderly patients (≥65 years) with tardive dyskinesia (TD).

Data from two 48-week studies (KINECT 3-extension, KINECT 4) were pooled and analyzed by age (≥65 and <65 years). Analyses based on Abnormal Involuntary Movement Scale (AIMS) total score included mean change from baseline (CFB); clinically meaningful response (≥30% improvement [AIMS-30%]); and protocol-defined response (≥50% improvement [AIMS-50%]). Additional analyses included response thresholds for Clinical Global Improvement-Tardive Dyskinesia and Patient Global Impression of Change as follows: rating of “minimally improved” or better (score ≤3) at Week 48 (CGI-TD≤3, PGIC≤3); rating of “much improved” or “very much improved” (score ≤2) at Week 48 (CGI-TD≤2, PGIC≤2).

Treatment outcomes were generally robust in both subgroups. In participants ≥65 years, pooled AIMS results indicated substantial improvements in TD movements with valbenazine 40 mg (n=8) and 80 mg (n=20): mean CFB (-6.4 and -9.8 [for 40 and 80 mg, respectively]); AIMS-30% (75% and 95%); AIMS-50% (75% and 85%). CGI-TD and PGIC response rates indicated that clinician- and patient-reported global improvements were also substantial in elderly study participants: CGI-TD≤3 (88% and 100% [for 40 and 80 mg, respectively]); CGI-TD≤2 (88% and 95%); PGIC≤3 (88% and 100%); PGIC≤2 (75% and 90%).

These are the first analyses to evaluate the long-term effects of any approved TD treatment in patients ≥65 years. Results indicate that in an elderly population, once-daily treatment with valbenazine for 48 weeks resulted in clinically meaningful and substantial TD improvements that were comparable to (or better than) those in the younger cohort.