Dosing and Treatment Patterns of Deutetrabenazine When Initiated Using a 4-Week Patient Titration Kit: Interim Results of the START Study

Abstract: Background: Deutetrabenazine is a vesicular monoamine transporter type 2 inhibitor (VMAT2i) for treatment of adults with tardive dyskinesia (TD) and Huntington disease (HD)-related chorea. A 4-week patient titration kit was launched (July 2021) to assist patients in titrating to optimal deutetrabenazine dosages. Methods: START is an ongoing, routine-care, 2-cohort (TD and HD) study evaluating deutetrabenazine dosing and treatment patterns when initiated using a 4-week patient titration kit, with further titration allowed based on effectiveness and tolerability. Results from the first 50 patients enrolled in the TD cohort are presented in this interim analysis. Results: 39/50 (78%) patients in the TD cohort successfully completed the titration kit (completed within 5 weeks or reached optimal dose [≥24 mg/day] within 4 weeks; mean [SE] days, 27.5 [0.32]). Mean (SE) deutetrabenazine dosages were 27.7 (0.92) mg/day at week 4, 32.5 (1.00) mg/day at week 8, and 32.8 (1.18) mg/day at week 12. At week 12, 24/49 (49%) patients were “much”/“very much” improved per Clinical Global Impression of Change (CGIC). After completion of the kit, mean (SE) dosage was 31.8 (1.24) mg/day, and 95% of patients reaching week 12 had a maintenance dosage ≥24 mg/day. Mean (SE) adherence with the kit was 97.2% (1.39%). Serious and treatment-related adverse events were reported for 2% and 6% of patients. Conclusions: Patients with TD successfully completed the 4-week titration kit in a mean of 27.5 days, with adherence rates of 97.2%. 95% of patients reaching week 12 had a maintenance dosage ≥24 mg/day.Short Description: START is an ongoing, routine-care, prospective, single-arm, 2-cohort (tardive dyskinesia [TD] and Huntington disease) study evaluating dosing and treatment patterns with deutetrabenazine, initiated using a 4-week patient titration kit. As of this interim analysis, patients with TD successfully completed the kit in a mean of 27.5 days. The mean prescribed dosage was 31.8 mg/day after titration kit completion, and adherence with the 4-week patient titration kit was 97.2%.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.