Objective: To evaluate valbenazine’s effects on chorea across body regions in adults with Huntington’s disease (HD) using data from KINECT®-HD (NCT04102579).

Background: Once-daily valbenazine is approved to treat HD chorea and tardive dyskinesia. In this 12-week, phase 3 study, valbenazine (≤80 mg) significantly improved chorea versus placebo, as assessed using the Unified Huntington’s Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score. The TMC is a clinician-rated evaluation of chorea in seven body regions: face, buccal-oral-lingual region, trunk, and extremities (right and left, upper and lower).

Method: Post-hoc analyses were based on TMC body region scores (range for each item: 0 “absent” to 4 “marked/prolonged”) at the screening/baseline period (average of screening/baseline scores) and at the maintenance period (average of week 10/12 scores). For each item, score distributions and mean scores were evaluated by treatment group. Percentages of participants with score shifts from ≥2 (“mild/common” or “moderate/intermittent” or worse) at screening/baseline to ≤1 (“slight/intermittent” or better) at maintenance were calculated, along with numbers needed to treat (NNTs) and relative risks (RRs).

Results: Chorea was present in all body regions at screening/baseline, with similar mean item scores for placebo (n=61) and valbenazine (n=64) groups. In both treatment groups, baseline item scores ≥2 were found in >50% of participants for the extremities and trunk, and in ~30% of participants for face and buccal-oral-lingual region. A numerically greater percentage of those with scores ≥2 at screening/baseline had shifts to ≤1 at maintenance with valbenazine (range for all items: 33.3% to 47.8%) versus placebo (range: 10.4% to 24.2%). These shifts translated to NNTs (range: 3 to 6) and RRs (range: 1.8 to 4.2) favoring valbenazine, with statistical significance for each extremity (P<0.05 for all). All mean body region scores improved at maintenance, with numerically greater improvements for valbenazine for all items.

Conclusion: .In this post-hoc analysis of TMC data from KINECT-HD, greater chorea improvements were found with valbenazine across all body regions, and more participants had clinical improvements in each region with valbenazine. These analyses support the primary study endpoint and demonstrate consistent valbenazine benefit across body regions.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/valbenazine-improves-chorea-across-multiple-body-regions-in-adults-with-huntingtons-disease/