Clinically significant chorea control across multiple endpoints1,2
AUSTEDO reduced total maximal chorea (TMC) score by 4.4 points from baseline (P<0.0001)1
FIRST-HD Primary Endpoint: Change in TMC Score From Baseline to Maintenance Therapy (N=90, ITT)1,2
in TMC score seen with AUSTEDO vs placebo
- 33% of patients treated with AUSTEDO achieved a ≥6-point improvement in TMC score compared to 2% of patients treated with placebo2
AUSTEDO reduced total motor score (TMS), improving control of motor function2
FIRST-HD: LS Mean Change in TMS From Baseline to Maintenance Therapy (N=90, ITT)2
in total motor function impairment with
AUSTEDO vs placebo (P=0.002)
LS, least squares.
TMS confirms the clinical relevance of the change in TMC. TMS assesses all domains of motor dysfunction in HD, including chorea, dystonia, initiation of voluntary movement (dysarthria, tongue protrusion, finger tapping, hand pronation, and supination of hands), gait, and balance.2
AUSTEDO reduced disability and improved physical function2
FIRST-HD: SF-36 Physical Functioning Score (N=90, ITT)
- Patients taking AUSTEDO achieved greater improvement in the SF-36 Physical Functioning Score at 12 weeks vs placebo (0.74 vs -3.61)2
Treatment success recognized by both physicians and patients1
The first and only therapy to have more physicians and patients who rated overall HD chorea symptoms as “much improved” or “very much improved” as measured by CGIC and PGIC
CGIC and PGIC are single-item questionnaires that ask the patient and physician to assess overall HD symptoms on a 7-point scale—from “very much worse”(-3) to “very much improved”(+3). Treatment success was defined as “much improved” or “very much improved” at Week 12.2
- “Minimally improved,” defined as slightly better functioning from baseline, answers were also observed but not included in this measure
- Patients whose status at Week 12 was not known were not included in this measure
The PGIC is a patient-centered endpoint that is determined by how patients answered the question: “With respect to your overall Huntington disease symptoms, how would you describe yourself now compared to immediately before starting study medication?” Only those patients who stated they were “much improved” or “very much improved” were considered to have treatment success. The CGIC assessed the change in HD chorea symptoms the same way, but used the HCP’s perspective.3
FIRST-HD was a randomized, 12-week, placebo-controlled study in patients with chorea associated with HD. Patients were randomized to receive AUSTEDO (n=45) or placebo (n=45). The mean age of patients taking AUSTEDO was 55.4 years (vs 52.1 years with placebo). 62% of patients on AUSTEDO were concomitantly taking antidepressants (vs 53% with placebo). The mean dose of AUSTEDO taken by patients at the end of the titration period was 40 mg/day. The primary efficacy endpoint was the treatment effect of AUSTEDO vs placebo, as measured by the TMC score, an item of the Unified Huntington’s Disease Rating Scale, from baseline to maintenance. On this scale, chorea is rated from 0 to 4 (with 0 representing no chorea) for 7 different parts of the body. The total score ranges from 0 to 28. The combined group mean TMC score at baseline was 12.7.1-3
SF-36, Short Form (36) Health Survey.
REFERENCES: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ, Teva Neuroscience, Inc. 2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. Frank S, Testa CM, Stamler D, et al.; Huntington Study Group. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. JAMA. 2016;316(1):40-50.