(#150) Valbenazine Improves Tardive Dyskinesia in Patients Regardless of Ethnicity or Race: Post Hoc Analyses of Long-Term Data from the KINECT® 4 Study

Abstract: Once-daily valbenazine is approved for tardive dyskinesia (TD) and chorea associated with Huntington's disease. In KINECT® 4 (K4: NCT02405091), early and sustained TD improvements were found in participants who received up to 48 weeks of valbenazine (40 or 80 mg). To assess the efficacy and safety of valbenazine based on self-reported ethnicities and races, data from K4 study participants who completed 48 weeks of treatment (N=103) were analyzed in the following subgroups: Hispanic/Latino, any race (n=43); non-Hispanic (NH) non-White (n=21: Black/African-American [n=20], Asian/Pacific Islander or other [n=1]); and NH White (n=39). At Week 48, mean changes from baseline (± standard error) in the Abnormal Involuntary Movement Scale total score (sum of items 1-7) were as follows: Hispanic/Latino (-10.5±0.6); NH non-White (-10.0±1.0); NH White (-10.7±0.9). The percentages of participants who were "much improved" or "very much improved" at Week 48 on the Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD score ≤2) and the Patient Global Impression of Change (PGIC score ≤2) were as follows: Hispanic/Latino (97.7% and 93.0% for CGI-TD and PGIC, respectively); NH non-White (100.0% and 81.0%); NH White (82.1% and 87.2% ). The incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to discontinuation were generally comparable across subgroups. These post hoc analyses support the long-term efficacy and safety findings that have been reported in the overall K4 population. Clinicians can have confidence in the safety and efficacy of valbenazine when treating patients of various ethnicities and races.

Short Description: Valbenazine, a uniquely selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of adults with tardive dyskinesia (TD) and chorea associated with Huntington's disease. The long-term KINECT® 4 trial demonstrated substantial and sustained TD improvements in participants who received 48 weeks of treatment. Post hoc analyses by ethnicity and race indicate substantial and clinically meaningful TD improvements with valbenazine across these subgroups, with no notable differences in safety/tolerability.

Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.