Austedo improves quality of life in older adults with tardive dyskinesia

Austedo treatment appeared to improve involuntary movements and quality of life among older adults with tardive dyskinesia, according to results of a post hoc analysis of a long-term open-label extension study.

“Deutetrabenazine [Austedo; Teva Pharmaceuticals] is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor that has been approved by the [FDA] for the treatment of chorea associated with Huntington’s disease and for TD in adults,” Martha Sajatovic, MD, of the University Hospitals Cleveland Medical Center at Case Western Reserve University School of Medicine in Ohio, and colleagues wrote in The American Journal of Geriatric Psychiatry. “In two pivotal, 12-week, phase 3 clinical trials (ARM-TD and AIM-TD), deutetrabenazine showed clinically significant improvements in total motor Abnormal Involuntary Movement Scale (AIMS) scores with a favorable safety profile compared [with] placebo in participants with TD. Participants who completed either ARM-TD or AIM-TD were eligible to enroll in a single-arm, open-label extension study that evaluated long-term treatment of deutetrabenazine in participants with TD.”

Deutetrabenazine treatment was efficacious, safe and well-tolerated in the open-label extension study. Because data are sparse regarding the drug’s use among older patients with TD, Sajatovic and colleagues conducted the current post hoc analysis with data from the open-label follow-up extension study to investigate the long-term efficacy and safety of its use among older, as well as younger, patients with TD.

Across 76 centers in the U.S. and Europe, a total of 337 participants enrolled in the open-label extension study. Of these, 119 were aged younger than 55 years and 218 were aged 55 years or older. The intervention consisted of deutetrabenazune initiation at 12mg per day, titrated once per week by 6 mg per day using a response-driven dosing regimen until adequate dyskinesia control or a clinically significant adverse event occurred.

In the post hoc analysis, the researchers evaluated change and percent change from baseline in total motor AIMS score, response rates for 50% or greater AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC) and safety.

Mean deutetrabenazine dose was approximately 39.5mg per day among both groups after 3 years of open-label treatment. The researchers reported mean changes from baseline in total motor AIMS score of –6.7±0.62 and – 6.5±0.47 among younger and older participants, respectively. AIMS response of 50% or greater occurred among 76% of younger and 62% of older participants. A total of 67% of younger and 76% of older participants, as well as 64% of younger and 63% of older participants, achieved treatment success according to CGIC and PGIC, respectively. Both groups generally well tolerated deutetrabenazine.

“The finding that deutetrabenazine is efficacious among both younger and older participants remains clinically important for older patients,” Sajatovic and colleagues wrote. “Therefore, results from this analysis may encourage these patients to try deutetrabenazine and inform clinicians of suitable treatment options for older patients with TD.”