Neurocrine Biosciences, Inc. has officially published top-line data from a Phase 4 study named KINECT-PRO™ data, which showcases clinically meaningful and sustained effects of INGREZZA® (valbenazine) capsules on the physical, social, and emotional impacts experienced by patients living with tardive dyskinesia (TD),
According to certain reports, KINECT-PRO is the first ever study to show patient-reported impact of a vesicular monoamine transporter 2 inhibitor on TD. This it did using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale, each one designed to evaluate physical, social and emotional impact held by TD-caused involuntary movements.
For better understanding, the idea behind figuring out these outcomes in rooted in their potential to provide a more complete perspective on the patient’s experience of living with TD, along with the broad range of improvements that occurred following treatment through INGREZZA.
More on Neurocrine’s study would reveal how it had enrolled 59 patients in total. These patients were given once-daily dose of INGREZZA (40 mg, 60 mg or 80 mg) for up to 24 weeks.
Markedly enough, there were comparable numbers of patients across TD severity (mild vs. moderate/severe) and underlying psychiatric condition subgroups (schizophrenia or schizoaffective disorder vs. bipolar disorder or major depression).
The four-week KINECT-PRO study included a four-week screening period saw participants receiving 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period.
The primary objective of Neurosciences’ study was to evaluate changes among patient-reported physical and socio-emotional impacts from TD. These changes include the ramifications across a person’s work, family, social life, and overall sense of well-being during INGREZZA treatment. The stated outcomes were measured at Weeks 4, 8, 16 and 24 by the Tardive Dyskinesia Impact Scale (TDIS), the Sheehan Disability Scale (SDS), and the EQ Visual Analogue Scale (EQ-VAS), respectively.
As for the study’s secondary objective, it was to evaluate clinician- and patient-reported changes in TD severity as measured by the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change–TD (PGI-C) and Clinical Global Impression of Severity–TD (CGI-TD-S).
Talk about the results, they went on to show significant and sustained improvements from baseline in all three patient-reported outcome measures, including patients with either mild or moderate/severe TD, with improvements observed as early as four weeks at the lowest dose (40 mg). Not just that, the observed scores also showed sustained reductions in involuntary movements, regardless of TD severity or underlying psychiatric condition.
If the discussion is on safety and tolerability of treatment, it was largely consistent with the known profile of INGREZZA, with no new concerns identified.
Tardive dyskinesia (TD), in case you weren’t aware, is understood to be a movement disorder, where the patient has to do deal with uncontrollable, abnormal, and repetitive movements of the face, torso and/or other body parts,
Entrusting the body of work we have so far, the stated condition stems, more often than not, from taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. These antipsychotics are prescribed to treat conditions like major depressive disorder, bipolar disorder, schizophrenia, and schizoaffective disorder. At present, TD affects more than 800,000 adults in the US alone.
Against that, INGREZZA brings forth a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia, as well as for the treatment of chorea associated with Huntington’s disease (HD).
“Tardive dyskinesia can significantly impact many aspects of patients’ lives, including daily activities, work or school attendance and social interactions,” said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. “The data from the KINECT-PRO trial, which was designed to follow typical clinical practice, show that patients and clinicians observed substantial reduction in the impact and severity of TD, as well as improvement in overall quality of life with use of INGREZZA. Importantly, patients reported significant improvements across measures regardless of their underlying psychiatric conditions or the baseline severity of their TD involuntary movement symptoms.”
