Impact of Valbenazine on Improvements in Disability and Functional Impairment in Patients With Tardive Dyskinesia (TD): Sheehan Disability Scale (SDS) Results From a Phase 4 Randomized Withdrawal Study (NCT03891862)
Author(s)
Michael Serbin, PharmD, MS, Justin Nedzesky, PharmD, MS, Sarah Gao, BS, MS, Morgan Bron, PharmD, MS, Edward Matson, BA, Roland Jimenez, BA.
Neurocrine Biosciences, Inc, San Diego, CA, USA.
Neurocrine Biosciences, Inc, San Diego, CA, USA.
OBJECTIVES: Tardive dyskinesia (TD) is a movement disorder associated with dopamine receptor-blocking agent exposure that can significantly impact functioning. A phase 4 study assessed persistence of effects of valbenazine, a VMAT2 inhibitor approved for 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 either continue valbenazine or receive placebo for 8 weeks. The 5-item SDS assessed disability and functional impairment over the past week at baseline, Week 8, and Week 16. Three items assessed work/school, social life, and family/home life impairment and were scored independently (0 [not impaired] to 10 [extremely impaired]) and combined (0 to 30). Two items assessed days lost or underproductive.
RESULTS: Baseline mean scores were 3.7 (n=60) work/school, 4.2 (n=127) social life, 3.5 (n=127) family/home life, and 11.2 total (n=60), indicating mild-moderate disruption. Mean lost (n=126) and underproductive days (n=127) were 1.0 and 1.4, respectively. At Week 8 (end of OL), the differences for work/school (−1.37; n=43), social life (−1.65; n=122), family/home life (−1.30; n=122), and total (−4.28; n=43) scores and days underproductive (−0.45; n=120) significantly improved from baseline (all P<0.05). Days lost were directionally improved (−0.32; n=119; P=0.06). During the double-blind, placebo-controlled treatment period, 59 patients received valbenazine and 59 received placebo. From Week 8 (randomization) to Week 16, the placebo-adjusted differences for family/home life (−0.89; n=56) and social life (−0.95; n=56) scores significantly improved in patients receiving valbenazine (both P<0.05). Changes in work/school score, total score, days lost, and days unproductive were nonsignificant.
CONCLUSIONS: Patients receiving 8 weeks OL valbenazine had improvements in functioning and disability, evidenced by reduced SDS scores. Patients randomized to valbenazine experienced continued improvements in all SDS domains, including significant enhancements in social life and family/home life compared to those randomized to placebo.
METHODS: Patients received open-label (OL) valbenazine up to 80 mg for 8 weeks then were randomized to either continue valbenazine or receive placebo for 8 weeks. The 5-item SDS assessed disability and functional impairment over the past week at baseline, Week 8, and Week 16. Three items assessed work/school, social life, and family/home life impairment and were scored independently (0 [not impaired] to 10 [extremely impaired]) and combined (0 to 30). Two items assessed days lost or underproductive.
RESULTS: Baseline mean scores were 3.7 (n=60) work/school, 4.2 (n=127) social life, 3.5 (n=127) family/home life, and 11.2 total (n=60), indicating mild-moderate disruption. Mean lost (n=126) and underproductive days (n=127) were 1.0 and 1.4, respectively. At Week 8 (end of OL), the differences for work/school (−1.37; n=43), social life (−1.65; n=122), family/home life (−1.30; n=122), and total (−4.28; n=43) scores and days underproductive (−0.45; n=120) significantly improved from baseline (all P<0.05). Days lost were directionally improved (−0.32; n=119; P=0.06). During the double-blind, placebo-controlled treatment period, 59 patients received valbenazine and 59 received placebo. From Week 8 (randomization) to Week 16, the placebo-adjusted differences for family/home life (−0.89; n=56) and social life (−0.95; n=56) scores significantly improved in patients receiving valbenazine (both P<0.05). Changes in work/school score, total score, days lost, and days unproductive were nonsignificant.
CONCLUSIONS: Patients receiving 8 weeks OL valbenazine had improvements in functioning and disability, evidenced by reduced SDS scores. Patients randomized to valbenazine experienced continued improvements in all SDS domains, including significant enhancements in social life and family/home life compared to those randomized to placebo.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR190
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Mental Health (including addition), SDC: Neurological Disorders