Study Supports Deutetrabenazine for Treatment of Chorea Associated with Huntington Disease
Deutetrabenazine is the only VMAT2 inhibitor approved by the FDA for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington disease.
Medication compliance rates with deutetrabenazine (Austedo; Teva Pharmaceuticals) were greater than 90% in the open-label extension period of the Alternatives for Reducing Chorea in Huntington’s Disease (ARC-HD) trial. The 3-year multicenter extension study evaluated the safety and tolerability of long-term treatment with deutetrabenazine tablets for chorea associated with Huntington disease (HD).
“Chorea is one of the most striking physical manifestations of Huntington’s disease that occurs in approximately 90% of HD patients,” Eran Harary, MD, SVP, global head of Specialty R&D at Teva, said in a press release. “As a disease that can have significant functional impact on patients’ and caregivers’ lives, we’re proud to share these new data to provide valuable insights for this community of patients and for those who provide care to them each day.”
Deutetrabenazine is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the FDA for the treatment of tardive dyskinesia (TD) in adults and for the treatment of chorea associated with HD. TD is a movement disorder with which patients may experience uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts.
Chorea can occur in approximately 90% of patients HD, and is characterized by involuntarily, random, and sudden twisting and/or writhing movements. The ARC-HD results showed that treatment with deutetrabenazine tablets had a safety and tolerability profile comparable with the first-HD randomized, placebo-controlled, 12-week study.
The analysis included 119 patients, of whom 82 completed the randomized, double-blind placebo-controlled First-HD trial, while 37 patients converted overnight from a stable tetrabenazine dose to deutetrabenazine with subsequent dose adjustments. The average mean daily dose of deutetrabenazine at the conclusion of the study was 45.7 mg.
The researchers measured the results by using the Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score. From baseline to week 8, among patients who rolled over from the pivotal study, there was a 4.5-point decrease in mean chorea scores and a 7.1-point decrease in mean TMS.
In patients who switched overnight from tetrabenazine, from baseline to Week 8 there was a 2.1-point drop in mean chorea scores and a 2.4-point decline in mean TMS. Decreases in TMC remained consistent for all patients across both cohorts from week 8 to week 145.
“These data provide important insight into the long-term use of deutetrabenazine for the treatment of chorea associated with Huntington’s disease, which can have a significant functional impact on people’s lives,” lead study author Samuel Frank, MD, associate professor of Neurology and director of HDSA Center of Excellence at Beth Israel Deaconess Medical Center, said in a press release. “Results of this study add to the safety and tolerability profile and support deutetrabenazine as a treatment choice for this progressive condition.”
The common adverse events found in both cohorts included fall, depression, anxiety, insomnia, somnolence, and akathisia, with no new safety concerns.
Teva Announces Results from 3-Year Study Assessing the Safety and Tolerability of AUSTEDO® (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease. Teva Pharmaceuticals. October 18, 2022. Accessed October 18, 2022. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-results-from-3-year-study-assessing-the-safety-and-tolerability-of-austedo-deutetrabenaz/