Objective: To evaluate the efficacy of deutetrabenazine (DTBZ) in reducing TD in the most severely impacted patients using data from an ongoing open-label extension (OLE)
trial.

Background: There are no established treatment guidelines for TD based on symptom severity. In the 12-wk ARM-TD and AIM-TD studies of patients with moderate or severe TD
and baseline (BL) Abnormal Involuntary Movement Scale (AIMS) score (items 1-7) of ≥6, DTBZ showed clinically significant improvements in AIMS score vs
placebo. Patients who completed ARM-TD or AIM-TD were eligible for the OLE.

Method: This post hoc analysis included all patients who entered OLE (data cutoff: July 2019). Two subgroups were defined by the upper quartile of BL AIMS score (local
rating). Endpoints were change and % change from BL in AIMS score, and percent of patients achieving ≥50% AIMS reduction from BL.

Results: 343 patients entered the OLE. The upper quartile of the BL AIMS score was 14. Subgroups were defined as >14 and ≤14. Numbers of patients, respectively, were:
BL: 69, 274; Wk 54: 49, 202; Wk 106: 46, 148; Wk 145: 41, 121. Mean duration of treatment was 835.6 and 756.2 days. Mean daily doses ±SE (mg) were: Wk 54:
39.8±1.3, 38.3±0.8; Wk 106: 40.3±1.4, 38.8±0.9; Wk 145: 41.0±1.5, 38.7±1.0.
At all time points from Wk 2 to Wk 145, change from BL in AIMS score was greater in those with BL AIMS score >14 vs ≤14 (mean ±SE at Wk 145: -10.9±0.8,
-5.1±0.3). Percent change from BL was greater in patients with BL AIMS score >14 vs ≤14 and reached -59.4%±3.6% vs -55.2%±3.1% at Wk 145. The percent of
patients with ≥50% AIMS reduction at each visit was higher in patients with BL AIMS score >14 vs ≤14 (71% vs 64% at Wk 145). Reasons for discontinuation for
patients with BL AIMS score >14 vs ≤14, respectively, included withdrawal by subject: 9 (13%), 67 (24%); adverse event: 2 (3%), 30 (11%); and lost to follow-up: 8
(12%), 20 (7%). Withdrawal due to lack of efficacy was uncommon: 3 (4%), 6 (2%).

Conclusion: Patients who were most severely impacted by TD at BL had robust and clinically meaningful reductions in AIMS score, had longer treatment duration, and were less
likely to withdraw from treatment than patients with less severe TD. Results suggest that DTBZ has long-term benefit in patients with TD who are most severely
impacted by abnormal movements.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/deutetrabenazine-reduces-involuntary-movements-in-patients-most-severely-impacted-by-tardive-dyskinesia-in-a-3-year-open-label-extension-trial/