The VMAT2 inhibitor marketed as Austedo by Teva Pharmaceuticals was associated with clinically meaningful long-term treatment benefit in patients with tardive dyskinesia, showing higher response rates than those observed in short-term trials.
Dieter Schultewolter, MD
Teva Pharmaceuticals recently presented data on its tardive dyskinesia agent deutetrabenazine (Austedo) at the 2019 Psych Congress, suggesting that the vesicular monoamine transporter 2 (VMAT2) inhibitor is associated with long-term, persistent efficacy.
The data, collected from a cohort of 343 patients who completed the ARM-TD and AIM-TD studies (treatment, n = 232; placebo, n = 111), ultimately showed that those treated over the course of 80 weeks achieved higher response rates compared to positive short-term study results.
In the currently ongoing trial at Week 54 (n = 250), 48% of patients achieved ≥50% response, and 24% achieved ≥70% response. At Week 106 (n = 169), 55% of patients achieved ≥50% response, and 30% achieved ≥70% response. At Week 132 (n = 108), 61% of patients achieved ≥50% response, and 40% achieved ≥70% response.
Data presented also included the study design of a randomized withdrawal study which will seek to evaluate deutetrabenazine’s persistence of therapeutic effect in adults with tardive dyskinesia. Dieter Schultewolter, MD, Global Medical Affairs Lead, Central Nervous System, Teva, told NeurologyLive that tardive dyskinesia “is a debilitating, often irreversible, hyperkinetic movement disorder resulting from exposure to dopamine-receptor antagonists,” and that the “results of the randomized withdrawal analysis may provide clinical evidence to inform tardive treatment decisions.”
NeurologyLive spoke with Schultewolter about the key takeaways from these data as well as how they inform the use of the agent.
Dieter Schultewolter, MD: Improvement was observed in the long-term use of deutetrabenazine following patients for up to 132 weeks in an open-label study of response-driven dosing of deutetrabenazine in the treatment of tardive dyskinesia. Dosing was relatively stable over time, and exposure-adjusted incidence rates of AEs were comparable to or lower than those observed with short-term deutetrabenazine treatment and placebo. This 3-year, open-label clinical study is the longest known study to date in tardive dyskinesia.
These data indicate that results seen in the controlled clinical trials of deutetrabenazine were sustained with long-term treatment and stable dosing. Proportions of patients with ≥50% and ≥70% improvements in AIMS [Abnormal Involuntary Movement Scale] score and CGIC [Clinical Global Impression of Change] score increased over time, with a stable dose of ~39 mg/day. For a patient, these results suggest the possibility of increasing improvement over time in the treatment of tardive dyskinesia.
The results seen in the controlled clinical trials of deutetrabenazine on the abnormal movements of tardive dyskinesia were observed through week 132. Mean AIMS scores decreased from baseline over time for patients remaining in the study and the proportion of patients with ≥50% and ≥70% improvements in the AIMS score increased over time.
These clinical data represent the longest follow-up of patients receiving treatment for tardive dyskinesia, with 132 weeks of open-label clinical study. Importantly, the results suggest the possibility of improvement over time with stable dosing of deutetrabenazine.
Transcript edited for clarity.
Teva to Present New Data on AUSTEDO® (deutetrabenazine) Tablets at Psych Congress 2019 [press release]. Jerusalem, Israel, and Parsippany, NJ: Teva Pharmaceuticals; Published October 2, 2019. businesswire.com/news/home/20191002005195/en/Teva-Present-New-Data-AUSTEDO%C2%AE-deutetrabenazine-Tablets. Accessed October 18, 2019.