US biopharmaceutical company Neurocrine Biosciences Inc (Nasdaq:NBIX) announced on Wednesday the publication of new peer-reviewed research in The Journal of Clinical Psychiatry, demonstrating how the Tardive Dyskinesia Impact Scale helps characterise patient-reported burden in tardive dyskinesia and has been used in clinical studies to assess meaningful improvement over the course of treatment with INGREZZA (valbenazine) capsules.

The company says that the article builds on the original validation of the Tardive Dyskinesia Impact Scale (TDIS) by defining what meaningful improvement means and how TDIS results should be interpreted in clinical trials. Developed in partnership with thought leaders in neurology and psychiatry, TDIS is claimed to be the first and only psychometrically validated patient-reported outcome measure specifically designed to understand the impact of tardive dyskinesia (TD). It assesses physical and functional impairment, in addition to socio-emotional distress associated with involuntary movements, contributing to a more comprehensive, patient-centred view of the impacts of TD and the benefits of treatment.

The manuscript establishes a minimal clinically important difference of four points for the TDIS total score, helping define what constitutes clinically meaningful improvement from patient and clinician perspectives. Across the KINECT 3 and KINECT 4 studies of INGREZZA, TDIS captured reductions in the physical, social and emotional impact of TD that corresponded with improvements observed in clinician-rated movement severity and global assessments.

The findings also strengthen interpretation of previously reported results from KINECT-PRO, the first and only clinical study to specifically evaluate and demonstrate patient-reported improvement with INGREZZA on TD using multiple clinically validated scales, including TDIS. Similar to the KINECT-PRO results, these newly published findings showed that patients taking INGREZZA reported robust and clinically meaningful improvements in physical, social and emotional functioning as measured by TDIS.