Impact Of Valbenazine On Improvements In Health-Related Quality of Life (HRQoL) In Patients With Tardive Dyskinesia (TD): EQ-5D-5L Results From A Phase 4 Randomized Withdrawal Study (NCT03891862)
Author(s)
Michael Serbin, PharmD, MS, Justin Nedzesky, PharmD, MS, Edward Matson, BA, Sarah Gao, BS, MS, Morgan Bron, PharmD, MS, Roland Jimenez, BA.
Neurocrine Biosciences, Inc, San Diego, CA, USA.
Neurocrine Biosciences, Inc, San Diego, CA, USA.
OBJECTIVES: TD is a movement disorder associated with dopamine receptor-blocking agent exposure that can significantly impact HRQoL. A phase 4 study assessed persistence of effects of valbenazine, a VMAT2 inhibitor approved for treatment of TD and chorea associated with Huntington’s disease, versus placebo.
METHODS: Patients received open-label (OL) valbenazine up to 80 mg for 8 weeks, then were randomized to continue valbenazine or receive placebo for 8 weeks. HRQoL was assessed at baseline, Week 8, and Week 16 using EQ-5D-5L, which includes 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), scored from 1 (no problems) to 5 (unable to/extreme problems). Responses were transformed into a utility index (UI) score (range: 0-1). EQ-5D-5L also includes a visual analog scale (VAS) (range: 0-100; self-rated health measure); higher UI and VAS scores indicate better health status.
RESULTS: At baseline (n=127), mean scores were 1.91 for mobility, 1.69 self-care, 1.98 usual activities, 2.15 pain/discomfort, and 2.03 anxiety/depression; mean VAS and UI scores were 73.82 and 0.68, respectively. At Week 8 (OL end; n=122), differences from baseline for mobility (−0.27), self-care (−0.28), usual activities (−0.36), pain/discomfort (−0.34), VAS (4.70), and UI (0.08) scores significantly improved (all P<0.05). Anxiety/depression directionally improved (−0.12; P=0.167). During the double-blind, placebo-controlled treatment period, 59 patients received valbenazine and 59 received placebo. From Week 8 (randomization) to Week 16 (n=56), the placebo-adjusted differences for UI (0.09), mobility (−0.34), and anxiety/depression (−0.38) significantly improved in patients receiving valbenazine (all P<0.05). VAS (5.85; P=0.11), self-care (−0.23; P=0.07), usual activities (−0.08; P=0.61), and pain/discomfort (−0.27; P=0.15) scores were directionally improved in patients receiving valbenazine.
CONCLUSIONS: Patients receiving 8 weeks of OL valbenazine had improvements in HRQoL via the EQ-5D-5L. Patients randomized to valbenazine experienced continued improvements in all EQ-5D-5L items including significant improvements in mobility and anxiety/depression compared to patients randomized to placebo.
METHODS: Patients received open-label (OL) valbenazine up to 80 mg for 8 weeks, then were randomized to continue valbenazine or receive placebo for 8 weeks. HRQoL was assessed at baseline, Week 8, and Week 16 using EQ-5D-5L, which includes 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), scored from 1 (no problems) to 5 (unable to/extreme problems). Responses were transformed into a utility index (UI) score (range: 0-1). EQ-5D-5L also includes a visual analog scale (VAS) (range: 0-100; self-rated health measure); higher UI and VAS scores indicate better health status.
RESULTS: At baseline (n=127), mean scores were 1.91 for mobility, 1.69 self-care, 1.98 usual activities, 2.15 pain/discomfort, and 2.03 anxiety/depression; mean VAS and UI scores were 73.82 and 0.68, respectively. At Week 8 (OL end; n=122), differences from baseline for mobility (−0.27), self-care (−0.28), usual activities (−0.36), pain/discomfort (−0.34), VAS (4.70), and UI (0.08) scores significantly improved (all P<0.05). Anxiety/depression directionally improved (−0.12; P=0.167). During the double-blind, placebo-controlled treatment period, 59 patients received valbenazine and 59 received placebo. From Week 8 (randomization) to Week 16 (n=56), the placebo-adjusted differences for UI (0.09), mobility (−0.34), and anxiety/depression (−0.38) significantly improved in patients receiving valbenazine (all P<0.05). VAS (5.85; P=0.11), self-care (−0.23; P=0.07), usual activities (−0.08; P=0.61), and pain/discomfort (−0.27; P=0.15) scores were directionally improved in patients receiving valbenazine.
CONCLUSIONS: Patients receiving 8 weeks of OL valbenazine had improvements in HRQoL via the EQ-5D-5L. Patients randomized to valbenazine experienced continued improvements in all EQ-5D-5L items including significant improvements in mobility and anxiety/depression compared to patients randomized to placebo.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR191
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Mental Health (including addition), SDC: Neurological Disorders