Effectiveness of Deutetrabenazine for Tardive Dyskinesia When Initiated Using a 4-Week Patient Titration Kit: Final Results of the START Study

Abstract: Background: Deutetrabenazine is a vesicular monoamine transporter type 2 inhibitor for the treatment of adults with tardive dyskinesia (TD) and Huntington disease (HD)–related chorea. A 4-week titration kit was launched in July 2021 to assist patients in titrating to optimal deutetrabenazine dosages. Methods: START was a noninterventional, 2-cohort (TD/HD) study evaluating deutetrabenazine effectiveness, dosing patterns, and treatment satisfaction using a 4 week drug-titration kit, with further titration allowed based on effectiveness and tolerability. Results: Of the 53 TD patients (mean age, 58.1 years; mean baseline Abnormal Involuntary Movement Scale total motor score, 13.6), 72% successfully completed the kit within 5 weeks or reached minimal therapeutic dose of ≥24 mg/d within 4 weeks. At weeks 4, 12 (primary end point), and 24, 15/52 (29%), 25/52 (48%), and 25/51 (49%) patients, respectively, achieved treatment success per Clinical Global Impression of Change score and 17/52 (33%), 23/52 (44%), and 26/51 (51%) per Patient Global Impression of Change score. 28/41 (68%) patients found it easy to understand when to take which dose, and 32/41 (78%) to use the kit overall; 31/41 (76%) found it easy to change doses weekly and found the kit helpful to remember taking medication. There were 11/53 (21%) patients who had an adverse event, leading to dose reduction for 1, drug interruption for 1, and study discontinuation for 2 patients. Conclusions: The titration kit enabled patients to titrate to minimal therapeutic deutetrabenazine dosages, with effectiveness similar to that of the pivotal clinical trials and high adherence and patient satisfaction rates.Short Description: START was a noninterventional, prospective, single-arm study evaluating the effectiveness of deutetrabenazine initiation using a 4-week titration kit for patients. By week 12, 48% and 44% of patients with tardive dyskinesia achieved treatment success using the Clinical Global Impression of Change and Patient Global Impression of Change scores, respectively. The titration kit enabled patients with tardive dyskinesia to achieve minimal therapeutic deutetrabenazine doses with effectiveness observed in clinical trials.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products, R&D, Inc.