Data from a new study demonstrates valbenazine’s ability to effectively reduce TD symptoms over a long-term period.
Oskar Hansson, MD, PhD
Long-term results of a phase 3 study of valbenazine (Ingrezza; Neurocrine Biosciences) show that approximately 90% of patients with tardive dyskinesia (TD) reported a reduction of involuntary movements by 50% or more over a 48 week stretch.1
The open-label KINECT 4 trial (NCT02405091) included 163 patients who received a daily dose of valbenazine 40 mg, with escalation to 80 mg/d at week 4 based on efficacy and tolerability. A 4-week washout period was recorded following the 48-week trial. Patients who met inclusion criteria were between the ages of 18 and 86 with a diagnosis of schizophrenia, schizoaffective disorder, or neuroleptic-induced TD for >3 months before screening, and/or moderate or severe TD.
At week 4 follow-up, 107 (65.6%) patients were escalated to the 80 mg/d dose, while 45 (27.6%) remained on the 40 mg/d dose. Patients who remained on the 40 mg/d dose had an adequate treatment response or were held back from escalation due to tolerability issues. Notably, a subgroup of 11 patients who required a dose reduction from 80 to 40 mg/d did not report any efficacy changes.
At week 48, data showed that approximately 90% of patients who received the 40 mg/d (90%) or 80 mg/d (89.2%) dose of valbenazine showed a >50% improvement from baseline in total Abnormal Involuntary Movement Scale (AIMS) score, with a change in . AIMS total score from baseline to week 48 of -10.2 + 1.2 and -11.0 + .5, in the 40 mg/d and 80 mg/d groups, respectively.
Among the group of patients, 95.9% and 89.2% reported being much improved or very much improved on the Clinical Global Impression of Change-TD and Patient Global Impressive of Change rating scales, respectively.
Less than 15% of patients (13.7%) had a serious treatment emergent adverse event (TEAE) or a TEAE leading to discontinuation (11.8%). Urinary tract infection (8.5%) and headache (5.2%) were among the most common TEAEs reported in >5% of patients. No dose effects were apparent by week 36, but patients did experience some loss of treatment effect after washout at week 52.
"Data from this open-label study, which may be more reflective of actual clinical practice, provide clinicians with a better understanding of how Ingrezza can reduce the symptoms of tardive dyskinesia based on both the clinician's and patient's assessment of the patient's symptoms, tolerability and response," said Stephen Marder, MD, professor of psychiatry and biobehavioral sciences at the David Geffen School of Medicine at the University of California Los Angeles, in a statement.2
1. Marder SR, Singer C, Lindenmayer J, Tanner CM. A Phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6) 620-627. doi: 10.1097/JCP.0000000000001111.
2. Neurocrine Biosciences Publishes Long-Term INGREZZA (valbenazine) Data in the Journal of Clinical Psychopharmacology Demonstrating Once-Daily 40 mg and 80 mg Capsules Reduced Involuntary Movements in Adults with Tardive Dyskinesia [news release]. San Diego, CA: Neurocrine Biosciences. November 12, 2019. prnewswire.com/news-releases/neurocrine-biosciences-publishes-long-term-ingrezza-valbenazine-data-in-the-journal-of-clinical-psychopharmacology-demonstrating-once-daily-40-mg-and-80-mg-capsules-reduced-involuntary-movements-in-adults-with-tardive-dyskinesi-300956831.html. Accessed: November 13, 2019.