This Week in JAMA: Huntington's Patients Can Safely Switch to Austedo Tablets
This week in the Journal of the American Medical Association (JAMA) Neurology, results from the Phase III open-label, single-arm switch cohort of the Alternatives for Reducing Chorea in Huntington’s Disease (ARC-HD) study were published, and showed that patients can easily switch from ingesting tetrabenazine 3 times daily to the recently approved Austedo (deutetrabenzine) tablets twice daily.
HD is a genetic brain disorder of which primary symptoms include involuntary, random and sudden, twisting and/or writhing movements – also known as Chorea – and a variety of cognitive and mental health challenges. Damaged nerve cells in patients cause several areas of the brain to deteriorate.
While tetrabenazine has been considered efficacious overall for chorea control, tolerability concerns exist.
“Human-based research is critical to evolving our understanding of HD and to providing more options and meaningful treatments,” said Samuel Frank, M.D., principal investigator of the ARC-HD study and Director of the Huntington’s Disease Society of America Center of Excellence at Beth Israel Deaconess Medical Center in a press release.
Per the ARC-HD study, 53 HD patients were screened and 37 ambulatory patients with chorea associated with HD were enrolled. Each switched overnight from a stable, therapeutic tetrabenazine regimen to Austedo (deutetrabenazine).
Austedo, a small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), is intended to normalize the levels of neurotransmitters in the brain, and has already been approved in the United States for the treatment of chorea associated with Huntington’s disease. It was generally well-tolerated in the ARC-HD study and deemed safe overall.
After one week of Austedo treatment, investigators were permitted to adjust the weekly dosage to achieve optimal chorea control, if needed.
The study found that Austedo was well-tolerated with low rates of neuropsychotic adverse events. Further, Austedo treatment led to improvements in chorea control. Total maximal chorea score declined by a mean of 2.1 from baseline over the course of the 8 week study (P < .001).
“Chorea is a debilitating symptom of Huntington disease that can impact the safety, function and quality of life of many patients,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are pleased to share the ARC-HD study results to allow those physicians treating HD patients to increase their knowledge of Austedo.”
In April 2016, Rare Disease Report sat down with Frank to discuss the efficacy of SD-809 to treat chorea and dystonia in HD patients:
For more on Huntington’s Disease, be sure to follow RDR on Facebook and Twitter.