Real World Effectiveness 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/HD) study evaluating deutetrabenazine effectiveness when initiated using a 4-week patient titration kit, with further titration allowed based on efficacy and tolerability. Results from the first 50 patients enrolled in the TD cohort are presented in this interim analysis. Results: 50 patients were included (mean age, 58.7 years, 66% female, 74% White, mean baseline Abnormal Involuntary Movement Scale [AIMS] total motor score, 13.8). 49% (24/49) of patients achieved treatment success (“much”/“very much” improved) at week 12 per Clinical Global Impression of Change (GIC), 47% (23/49) per Patient GIC. Total motor AIMS scores were reduced by 4.8 points at week 12. Mean (SE) time to reach optimal dosage for the 38 (76%) patients who reached it was 46.3 (5.48) days. Mean (SE) 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. 39 (78%) patients successfully utilized the kit (completed kit at 24 or 30 mg/day). 22% of patients had an adverse event (AE); AEs led to dose reduction for 2%, drug interruption for 2%, and study discontinuation for 6%. Conclusions: 78% of patients with TD successfully utilized the kit and 49% achieved treatment success based on Clinical GIC.Short Description: START is an ongoing, routine-care, prospective, single-arm, 2-cohort (tardive dyskinesia [TD] and Huntington disease) study evaluating the effectiveness of deutetrabenazine initiated by a 4-week patient titration kit. As of this interim analysis, the kit enabled most (76%) patients with TD to reach an optimal dose with satisfactory effectiveness.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D, Inc.