Reductions in TMC score from baseline observed through Week 8 in the Switch cohort2,3
TMC Score Following Overnight Switch to AUSTEDO3
Reductions from baseline in TMC score observed in the Switch cohort at Weeks 1, 4, and 82,3*
- The Switch cohort was one of two patient cohorts included in ARC-HD and was assessed independently through Week 8
- After Week 8, cohorts were merged
- Dose adjustments were permitted after Week 1
- At baseline, the median dose of tetrabenazine was 37.5 mg/day. The median doses of AUSTEDO were 18 mg/day (Week 1), 30 mg/day (Week 4), and 36 mg/day (Week 8)
Results were maintained through ~3 years2
Deuterium helps maintain more consistent drug levels.1,4,5
ARC-HD was an open-label, single-arm, 2-cohort study of long-term 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 Huntington’s disease 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. The 2 cohorts were analyzed separately from baseline to Week 8 and together from Week 8 to Week 132 (or last visit on AUSTEDO). 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 132 (or end of treatment).2
Switching patients from tetrabenazine to AUSTEDO4
Recommended Initial Dose, After Switch From Tetrabenazine4
AUSTEDO is contraindicated in patients taking tetrabenazine.
After switching from tetrabenazine, the dose may be adjusted at weekly
intervals by 6 mg/day, following the dosing and titration schedule for AUSTEDO.4
HD, Huntington’s disease; PK, pharmacokinetic; TMC, total maximal chorea; TMS, total motor score; UHDRS, Unified Huntington’s Disease Rating Scale.
REFERENCES: 1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 2. Frank S, Testa CM, Stamler D, et al; Huntington Study Group ARC-HD Investigators. Long-term efficacy and safety of deutetrabenazine for chorea in Huntington’s disease: results from the ARC-HD open-label study. Presented at: 27th Annual Meeting of the Huntington Study Group; October 29-31, 2020. 3. Frank S, Stamler D, Kayson E, et al; Huntington Study Group. Safety of converting from tetrabenazine to deutetrabenazine for the treatment of chorea. JAMA Neurol. 2017;74(8):977-982. 4. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 5. Tung R. The development of deuterium-containing drugs. Innov in Pharm Technol. 2010;32(32):24-28.