Patient Satisfaction With the Deutetrabenazine 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 patient satisfaction with the deutetrabenazine 4-week patient titration kit, with further titration allowed based on efficacy and tolerability. Treatment success (“much”/“very much” improved) was assessed via Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC). Patient satisfaction with the kit was assessed via questionnaire at week 8. Results from the first 50 patients enrolled in the TD cohort are presented in this interim analysis. Results: Mean (SE) time to reach optimal dosage (≥24 mg/day) for the 38 (76%) patients who reached it was 46.3 (5.48 ) days. 49% (24/49) and 47% (23/49) of patients achieved treatment success at week 12, based on the CGIC and PGIC, respectively. Among the 39 (78%) patients who responded to the questionnaire, 72% found it easy to understand when/which dosage to take, 77% easy to remember to take their medication, 74% easy to change the dose weekly, 69% easy to follow kit instructions, and 77% easy to use the kit overall. Conclusions: Patients reported that the titration kit helped with daily deutetrabenazine usage and following the recommended dosing schedule, and reported high levels of satisfaction with the kit. Nearly half of patients achieved treatment success.Short Description: START is an ongoing, routine-care, prospective, single-arm, 2-cohort (tardive dyskinesia [TD] and Huntington disease) study evaluating patient satisfaction with deutetrabenazine, initiated using a 4-week patient titration kit. As of this interim analysis, patients with TD reported high levels of satisfaction with the titration kit, and nearly half of the patients achieved treatment success at week 12.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.