This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.
Introduction: TD is an involuntary movement disorder with a high unmet need; there are no FDA-approved treatments to date. In ARM-TD, deutetrabenazine, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, reduced overall Abnormal Involuntary Movement Scale (AIMS) score compared with placebo (-3.0 vs -1.6, P=0.0188; primary endpoint) in patients with moderate to severe TD, and was well tolerated.
Objective: To examine response rates between deutetrabenazine-treated patients and placebo; responders achieved pre-specified response levels from 10-90% improvement on AIMS from baseline in 10% increments.
Methods: Patients were randomized (1:1) to 12 weeks' treatment with deutetrabenazine or placebo. AlMS score was assessed by blinded central video rating. Cumulative proportion (10-90% improvement) of AIMS responders from baseline to Week 12 was a secondary endpoint. Results reported include TD patients with baseline AIMS score ≥6, the intended study population.
Results: For all assessable response levels, deutetrabenazine-treated patients (n=48) had higher odds of being a responder compared with placebo (n=49) (odds ratio [OR] >1). More patients treated with deutetrabenazine were responders versus placebo at ≥10% (77.1% vs 44.9%; OR:4.1), ≥20% (54.2% vs 30.6%; OR:2.7), ≥30% (50.0% vs 26.5%; OR:2.8), ≥40% (33.3% vs 24.5%; OR:1.5), ≥50% (25.0% vs 18.4%; OR:1.5), ≥60% (20.8% vs 8.2%; OR: 3.0), ≥70% (10.4% vs 0%; OR: NA), ≥80% (8.3% vs 0%; OR: NA), and ≥90% (2.1% vs 0%; OR: NA) response levels.
Conclusions: In ARM-TD, a higher proportion of deutetrabenazine patients were responders compared with placebo, defined by percent improvement on AIMS from baseline to Week 12.