Most of the patients in the study were taking concomitant antidepressants and/or antipsychotics, and mood disorders remained stable during treatment with valbenazine.
Eiry W. Roberts, MD
Tardive dyskinesia patients with a mood disorder can see clinically meaningful tardive dyskinesia improvements after long-term treatment with valbenazine (Ingrezza), according to a new data presented at the 2018 Annual Psych Congress.
Neurocrine Biosciences researchers collected patients from 2 long-term phase 3 studies of valbenazine and divided them into groups in order to determine the safety and efficacy of valbenazine in tardive dyskinesia patients with mood disorders such as bipolar disorder and major depressive disorder. Two groups of patients were included in the new analysis: patients who received valbenazine 40 mg once-daily without dose escalation to 80 mg, and patients who were escalated from 40 mg to 80 at Week 4.
“Maintaining stability of psychiatric symptoms is an important concern for patients with bipolar disorder and severe depression who are also suffering from tardive dyskinesia, as it typically takes time to find a treatment regimen that adequately manages their psychiatric illness,” Eiry W. Roberts, MD, Chief Medical Officer, Neurocrine Biosciences, told MD Magazine®. "That’s why this study is different from previous investigations into valbenazine."
Most of the patients received antidepressants (84%) and/or antipsychotics (76%) in addition to the valbenazine treatment. Other concomitant drugs included antiepileptics, anxiolytics, and anticholinergics.
The investigators reported meaningful and sustained tardive dyskinesia improvements based on the Abnormal Involuntary Movement Scale (AIMS) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) measures after 48 weeks. About 70% of all mood disorder patients reached an AIMS response of greater than 50% improvement and three-quarters achieved CGI-TD response. There was some return toward baseline levels after 52 weeks, which followed a four-week washout, the investigators said.
The patients’ mood symptoms remained generally stable during the investigation, the researchers observed. There were minimal changes from baseline in mean total Montgomery-Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). After 48 and 52 weeks there were no worsening specific mood symptoms.
The researchers also examined suicidal ideation in the mood disorder patients at baseline. Just one patient experienced suicidal ideation, and that patient didn’t have any worsening of suicidal ideation throughout the course of the study.
“Patients with bipolar disorder and severe depression may be on multiple medications to manage their mental illness,” Roberts added. “It is therefore important that we understand the effects of Ingrezza on their tardive dyskinesia symptoms as well as any impact that the addition of Ingrezza might have on the management of their underlying mood disorder. For tardive dyskinesia patients who are managing an underlying mood disorder, such as bipolar or severe depression, this analysis showed that Ingrezza is an effective, long-term treatment option that does not interfere with other psychiatric medications or the stability of underlying psychiatric symptoms.”
Previous studies have demonstrated that valbenazine has a low potential for affecting the metabolism or pharmacokinetics of concomitant medications, which this latest study also supports, the researchers wrote.
The poster, “Effects of Long-Term Valbenazine on Psychiatric Status in Patients with Tardive Dyskinesia and a Primary Mood Disorder” was presented at the 2018 Annual Psych Congress in Orlando, Florida.