Treatment Success and Psychiatric Stability in Adults with Tardive Dyskinesia: Post Hoc Analyses of Two Long-Term Valbenazine Studies

Abstract: Background: In clinical trials of valbenazine, which is approved for once-daily treatment of tardive dyskinesia (TD), psychiatric stability was assessed along with global changes in TD. Post hoc analyses of two studies (KINECT 3, KINECT 4) were conducted to evaluate changes in psychiatric status and clinician-/patient-reported treatment success in participants who received valbenazine (40 or 80 mg) for 48 weeks. Methods: Data were pooled and analyzed by psychiatric diagnosis: schizophrenia/schizoaffective disorder (“SCHZ”) or mood disorder (“MD”). Treatment success was defined as a rating of “much improved” or “very much improved” at Week 48 using the Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC). Psychiatric stability was monitored using: Positive and Negative Syndrome Scale (PANSS) and Calgary Depression Scale for Schizophrenia (CDSS) [SCHZ subgroup]; Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) [MD subgroup]; Columbia-Suicide Severity Rating Scale [all participants]. Results: More than 75% of the SCHZ subgroup achieved treatment success with valbenazine per clinician assessment (CGI-TD=79.7%) and patient self-report (PGIC=78.0%). Mean changes from baseline to Week 48 for PANSS (positive symptoms [-0.7], negative symptoms [-0.6], general psychopathology [-¬1.9], total [-3.2]) and CDSS (-0.5) indicated that psychiatric stability was maintained. The MD subgroup experienced similar rates of treatment success (CGI-TD=77.6%, PGIC=84.5%) with minimal changes in YMRS (-1.0) and MADRS (+0.3) total scores. No emergence of suicidal ideation/behavior was observed. Conclusions: Long-term treatment with valbenazine resulted in substantial clinician- and patient-reported global improvements in TD symptoms, while psychiatric stability was maintained.Short Description: In two long-term clinical trials (KINECT 3, KINECT 4), patients with tardive dyskinesia (TD) received once-daily valbenazine for 48 weeks. Data from these studies were pooled and analyzed by psychiatric diagnosis (schizophrenia/schizoaffective disorder, mood disorder). Results of this analysis showed that >75% of study participants in each subgroup achieved treatment success with long-term valbenazine, defined as clinician- and patient-reported ratings of “much improved” or “very much improved”. Psychiatric stability was also maintained in both subgroups.Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.