(#57) Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment

Abstract: Once-daily valbenazine is approved for tardive dyskinesia (TD) and chorea associated with Huntingtonís disease. In a 48-week open-label study (KINECTÆ 4 [NCT02405091]), treatment with valbenazine resulted in substantial mean improvements in Abnormal Involuntary Movement Scale (AIMS) total score. This post-hoc analysis aimed to assess a potential threshold for TD remission, defined as an AIMS item score of ?1 (ìnoneî or ìminimalî) in each of the 7 body regions (items 1-7). Among participants who reached the Week 48 visit (ìcompletersî), the percentage meeting the remission threshold was analyzed by dose (40 mg, 80 mg) and by psychiatric diagnosis (schizophrenia/schizoaffective disorder [SCHZ], mood disorder [MOOD]). AIMS total score (sum of items 1-7) was also analyzed by dose in participants meeting the remission threshold. In total, 103 participants made up the completer population: 80 mg (n=74), 40 mg (n=29), SCHZ (n=71), MOOD (n=32). Among 103 completers, 61 (59.2%) met the remission threshold at Week 48: 40 mg, 58.6% (17/29); 80 mg, 59.5% (44/74); SCHZ, 57.7% (41/71); MOOD, 62.5% (20/32). Mean values for AIMS total score at baseline (80 mg, 15.1 [range: 6-23]; 40 mg, 12.4 [6-22]) and Week 48 (80 mg, 2.5 [0-7]; 40 mg, 2.1 [0-6]) indicated substantial improvements with both valbenazine doses. In conclusion, the majority of participants who received 48 weeks of once-daily valbenazine reached this defined threshold for TD remission during treatment, regardless of dose or psychiatric diagnosis. This remission threshold could be applied to clinical settings and/or used in future research as a potential treatment goal for TD.Short Description: Valbenazine, a uniquely selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of adults with tardive dyskinesia (TD) and Huntingtonís disease chorea. The KINECTÆ 4 trial demonstrated substantial and sustained TD improvements with long-term valbenazine treatment (Marder et al, J Clin Psychopharmacol 2019). This post-hoc analysis of the study data defines a TD remission threshold that could be applied in clinical settings and/or future research as a potential treatment goal for TD.Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.