Huntington Disease Health Index accurate for patient-reported changes in symptom burden
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Key takeaways:
- The Huntington Disease Health Index was used for patient-reported symptom burden in KINECT-HD trial.
- The HD-HI detected improvements in disease burden at week 10 and week 12.
CHICAGO – The Huntington Disease Health Index was an accurate, clinically meaningful tool for participants in the KINECT-HD trial to report symptomatic disease burden changes when treated with valbenazine, according to a recent study.
“The Huntington Disease Health Index is a disease-specific, patient-reported outcome measure [that] was designed to measure clinically meaningful changes in Huntington disease-related burden in response to therapeutic interventions,” Chad Heatwole, MD, MS, director of the University of Rochester Center for Health and Technology, stated during his presentation at the International Association of Parkinsonism and Related Disorders World Congress.
Researchers sought to describe results of the Huntington Disease Health Index (HD-HI), a measurement tool to assess symptomatic burden of the disease in the phase 3 KINECT-HD clinical trial.
Heatwole and colleagues applied the HD-HI during the study, a 12-week randomized, double-blind controlled trial featuring a 4-week screening period as well as a 2-week follow-up that included 135 adults randomized to receive valbenazine (n = 64) or placebo (n = 61). Mean HD-HI scores were collected at baseline then at 10- and 12-week intervals and analyzed as exploratory endpoints. Post hoc exploratory analyses further evaluated changes from baseline in the HD-HI and its subscales.
According to results, HD-HI detected improvements in disease burden in response to valbenazine across most of the scale’s 13 subscales at both week 10 (Wk10) and week 12 (Wk12); however, no changes in HD-HI total score were noted at both week 10 and week 12.
Participants administered valbenazine demonstrated numerical improvements in mobility (Wk10: -6.3 vs -4.1; Wk12: -4.2 vs -2.7), abnormal movements (Wk10: -12.2 vs -9.6; Wk12: -11.2 vs -4.3) and upper extremity function (Wk10: -7.2 vs -1.6; Wk12: -7.2 vs 1.4). Least squares (LS) mean changes from baseline to Wk12 in the HD-HI abnormal movements subscale were -11.1 for valbenazine and -4.4 for placebo, with an LS mean difference between treatment groups of -6.7.
“This suggests that the HD-HI is and was a sensitive assessment of disease burden, Heatwole said. “The sensitivity of HD-HI in KINECT-HD supports the appropriateness of using this [patient reported outcome] in future clinical trials of HD therapies.”