Efficacy

Pivotal Study

Statistically significant improvement over placebo across multiple endpoints in patients with Huntington’s disease chorea1,2

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)1-3

FIRST-HD: Total Maximal Chorea (TMC) score from baseline to maintenance therapy (N=90, ITT), >2x improvement in TMC score seen with AUSTEDO vs placebo.

>2x IMPROVEMENT

in TMC score seen with AUSTEDO vs placebo

Long-term results through 3 years

Patients in the pivotal and long-term studies received the AUSTEDO BID formulation.1,3

ITT, intent-to-treat.

  • 33% of patients achieved a ≥6-point improvement compared to 2% of patients treated with placebo2

The TMC score quantifies choreic movements of the face, mouth, trunk, both arms, and both legs, resulting in an overall score for the 7 regions that is based on independent visual review.2

FDA approved: Once-daily AUSTEDO XR formulation1

Sustained concentration over 24 hours1,2

  • Bioequivalence of once-daily AUSTEDO XR has been established in pharmacokinetic profile studies2†
  • Peak plasma concentrations (Cmax) of AUSTEDO® XR (deutetrabenazine) extended-release tablets are reached within approximately 3 hours1

Plasma Concentration at Steady State Over 24 Hours: AUSTEDO XR vs BID2‡

Bioequivalence Data: Plasma Concentration at Steady State Over 24 Hours in AUSTEDO XR vs BID, data support bioequivalence of XR and BID across the full dosing range of AUSTEDO.

†Data supports bioequivalence of XR and BID across the full dosing range of AUSTEDO.1,3

‡Based on active alpha and beta metabolites.2

*Versus maintenance therapy (average of Weeks 9 and 12).1

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

FIRST-HD: Change in Total Motor Score (TMS) from baseline to maintenance therapy (N=90, ITT), >2x reduction in total motor function impairment with AUSTEDO vs placebo (P=0.0002).

>2x REDUCTION

in total motor function impairment with

AUSTEDO vs placebo (P=0.002)

LS, least squares.

Patients in the pivotal study received the AUSTEDO BID formulation.1

TMS confirms the clinical relevance of the change in TMC. The 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

Significantly reduced disability and improved physical functioning2

FIRST-HD: SF-36 Physical Functioning Score (N=90, ITT)2

SF-36 physical functioning scale score in FIRST-HD (N=90, ITT), significant 4.3-point mean difference vs placebo (P=0.03).

Patients in the FIRST-HD study received the AUSTEDO BID formulation.1

  • Patients taking AUSTEDO® (deutetrabenazine) tablets achieved greater improvement in the SF-36 Physical Functioning Score at 12 weeks vs placebo (0.74 vs -3.61)2

Patients on AUSTEDO reported being better able to perform daily activities2,4

The physical functioning portion of the SF-36 assesses patients’ reported ability to perform routine physical activities, such as:
  • Dressing Icon
    dressing
  • Bathing Icon
    bathing
  • Lifting/Carrying Groceries Icon
    lifting/carrying
    groceries
  • Walking Icon
    walking
  • Moderate to Vigorous Activities Icon
    moderate to
    vigorous activities
  • Climbing Stairs Icon
    climbing stairs
  • Bending, Kneeling, or Stooping Icon
    bending, kneeling,
    or stooping

Treatment success recognized by both physicians and patients1§

FIRST-HD: Global Impression of Change at the End of Treatment for AUSTEDO Compared to Placebo (N=90, ITT)2,5

PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)

Very much improved/
much improved
​

20%

51%

Of Patients Observed
Treatment Success§
(P=0.002)

CLINICAL GLOBAL IMPRESSION OF CHANGE (CGIC)

Very much improved/
much improved
​

13%

42%

Of Physicians Observed
Treatment Success§
(P=0.002)

Placebo (n=45) AUSTEDO (n=45)

Patients in the FIRST-HD study received the AUSTEDO BID formulation.1

§Treatment success was defined as “much improved” or “very much improved” at Week 12.2

PGIC and CGIC measurements
  • The Patient Global Impression of Change (PGIC) and the Clinical Global Impression of Change (CGIC) are patient- and HCP-centered endpoints2,5
  • Patients and HCPs are asked to describe HD symptoms now compared to immediately before the start of treatment2,5
FIRST-HD study design

FIRST-HD was a randomized, 12-week, placebo-controlled study of the use of AUSTEDO 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 (UHDRS), 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 12.7.1,2,5

ARC-HD 3-year, open-label extension study design

ARC-HD was an open-label, single-arm, 2-cohort, 3-year extension study of the use of AUSTEDO in patients with HD chorea. The Rollover cohort had successfully completed FIRST-HD and underwent a 1-week washout prior to initiating 6 mg of AUSTEDO daily. The Switch cohort comprised patients with HD chorea who had been on a stable dose of tetrabenazine and were converted overnight to a dose of AUSTEDO predicted to provide comparable systemic exposure. A total of 119 patients with HD chorea were enrolled (Rollover cohort, n=82; Switch cohort, n=37). In both cohorts, dosage was titrated by 6 mg/day per week. Endpoints were changes in the UHDRS TMS and TMC scores from baseline to Week 8, as well as those from Week 8 to Week 145 (or end of treatment).3

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Watch: Dr. Rajeev Kumar discuss SF-36 results and impact on activities of daily living

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VIEW THE 3-YEAR STUDY Add person icon Request a rep

HD, Huntington's disease; SF-36, Short Form (36) Health Survey.

REFERENCES: 1. AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. Frank S, Testa CM, Edmondson MC, et al. The safety of deutetrabenazine for chorea in Huntington Disease: an open-label extension study. CNS Drugs. 2022;36(11):1207-1216. doi:10.1007/s40263-022-00956-8 4. RAND Corporation. 36-Item Short Form Survey Instrument (SF-36). RAND Corporation. Accessed June 10, 2022. https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/survey-instrument.html 5. 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.