Rapid and significant tardive dyskinesia (TD) symptom control1,2
AUSTEDO significantly reduced AIMS total score by 3.3 points from baseline in the 36 mg/day arm (vs 1.4 with placebo) at Week 12 (P=0.001)1,2
Change in AIMS Total Score From Baseline to Week 12 (N=222)1,2
AIMS, Abnormal Involuntary Movement Scale; LS, least squares.
71% of patients taking AUSTEDO 36 mg/day saw reductions in their uncontrolled movements3,4
Psychiatric scale scores generally remained stable2-4
- In the pivotal studies, patients’ preexisting psychiatric stability was maintained through 12 weeks*
- See patient demographics from the studies
Patients may see a response with AUSTEDO as early as 2 weeks (exploratory analysis)2
AIM-TD was a 12-week, placebo-controlled, fixed-dose trial in adults with TD. Patients were randomized 1:1:1:1 to 12 mg/day AUSTEDO, 24 mg/day AUSTEDO, 36 mg/day AUSTEDO, or placebo. Treatment duration included a 4-week dose escalation period and an 8-week maintenance period. The primary efficacy endpoint was change in the AIMS total score from baseline to Week 12 in the 36 mg/day arm vs placebo. Patients were 52% female and 48% male. Average age was 57 years. Mean baseline AIMS total scores in the 4 study arms were 9.5 (placebo), 9.6 (12 mg/day), 9.4 (24 mg/day), and 10.1 (36 mg/day).1-3
*Evaluations performed using: 1. The Hospital Anxiety and Depression Scale (HADS), a self-report questionnaire that offers an efficient way to screen patients for psychological comorbidities, showed no worsening at Week 12 in AIM-TD and ARM-TD; 2. The Columbia-Suicide Severity Rating Scale (C-SSRS), a measure used to identify and assess individuals at risk for suicide, was assessed at any visit during the 12-week randomized trials (AIM-TD and ARM-TD).2-4
In the longest TD study to date (open-label extension, non-blinded)
Rapid TD symptom control as early as 2 weeks† with sustained results observed through ~3 years3,5,6
AIMS Score Reduction in the RIM-TD Study3,6
Mean dose at Week 145 was similar for younger and older patients (>39 mg/day).7§
†Symptom control defined as change in AIMS total score observed as early as Week 2 in placebo-controlled studies.3
‡Mean total dose.3
§<55 years of age=younger; ≥55 years of age=older.7
Growing percentage of patients achieved ≥50% AIMS score improvement over time6
Patients With ≥50% Reduction in AIMS Total Score6
At Week 145:
67% of patients saw
42% of patients saw
Stable dosing over time: average dose was ~39 mg/day from Week 15 through Week 145.
A majority of patients and physicians reported symptoms as “much improved” or “very much improved” at Week 145 (CGIC and PGIC)3
Adverse events were comparable to those in the pivotal trials. 3% of patients in the long-term study did not complete the study due to lack of efficacy.3,6
The mean overall compliance rate was ~90% at 3 years.3||
||Overall compliance based on pill counts.3
See more results from the RIM-TD study.
RIM-TD was a single-arm, open-label extension study of patients from the 2 placebo-controlled trials, AIM-TD and ARM-TD. Patients who opted to roll over completed a 1-week washout and then started AUSTEDO at 12 mg/day, which was titrated by 6 mg/day weekly to identify a dose that adequately controlled TD and was tolerated by the patient.8
Open-label AUSTEDO with response-driven dosing9
Significant and meaningful control of TD symptoms at Week 12 with AUSTEDO1,10
Response-driven dosing with a mean dose of 38.3 mg/day at the end of the treatment period1
- AUSTEDO® (deutetrabenazine) tablets significantly reduced AIMS total score by 3.0 points (vs 1.6 in the placebo arm) at Week 12 (P=0.019)1,10
Change in AIMS Total Score From Baseline to Week 12 (N=113; P=0.019)10
in AIMS score with AUSTEDO vs placebo
ARM-TD was a randomized, double-blind, placebo-controlled, phase 2/3 trial to evaluate the efficacy, safety, and tolerability of AUSTEDO in patients with TD. The primary efficacy endpoint was change in the AIMS total score from baseline to Week 12. Among the total population, 83% of patients were taking an antipsychotic drug at baseline. Patients were evenly distributed in terms of gender and the average age was 55 years. The mean AIMS total score at baseline was 9.7 in the AUSTEDO group and 9.6 in the placebo group.1,3,10
CGIC, Clinical Global Impression of Change; DRA, dopamine-receptor antagonist; PGIC, Patient Global Impression of Change.
REFERENCES: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 3. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 4. Anderson KE, Stamler D, Davis MD, et al. Supplementary appendix. Lancet Psychiatry. 2017;4(suppl 1):1-4. doi:10.1016/S2215-0366(17)30236-5 5. Marder SR, Singer C, Lindenmayer J-P, et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019:39(6):620-627. 6. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999. doi:10.3389/fneur.2022.773999 7. Sajatovic M, Finkbeiner S, Wilhelm A, et al. Long-term safety and efficacy of deutetrabenazine in younger and older patients with tardive dyskinesia. Am J Geriatr Psychiatry. Published online August 15, 2021. doi:10.1016/j.jagp.2021.08.003 8. Fernandez HH, Stamler D, Davis MD, et al. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. Published online July 10, 2019. doi:10.1136/jnnp-2018-319918 9. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13(suppl 1):773999. doi:10.3389/fneur.2022.773999 10. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010.