Ingrezza treatment eases chorea regardless of sex, age: Trial data
Approved Huntington's therapy may also help with patient anger issues
Ingrezza (valbenazine), an approved treatment for chorea, or uncontrolled movements, related to Huntington’s disease, shows similar effectiveness among patients irrespective of factors like sex, age, or disease severity, according to a new analysis of data from a Phase 3 clinical trial.
Moreover, a separate data analysis from the trial — dubbed KINECT-HD (NCT04102579) and completed in 2021 — suggests that treatment with Ingrezza can help ease emotional issues like anger, frustration, and feelings of being overwhelmed.
Neurocrine Biosciences, the company that markets Ingrezza, presented the new analyses at the 2024 Annual Meeting of the Huntington Study Group, held last week in Ohio.
“These data not only support the consistent efficacy of Ingrezza in reducing chorea across various subgroups but also its potential positive impact on emotional health in patients because of the reduced movements,” Eiry W. Roberts, MD, chief medical officer of Neurocrine, said in a company press release.
Similar efficacy seen with Ingrezza treatment irrespective of disease severity
Involuntary, jerky movements known as chorea are a common symptom of Huntington’s, affecting most patients. Ingrezza is thought to ease chorea by modulating the activity of certain signaling molecules in the brain. It’s available as an oral capsule that can be swallowed, or in a different capsule formulation, called Ingrezza Sprinkle, that can be sprinkled over soft food for people with swallowing issues.
The Phase 3 KINECT-HD study enrolled 128 people with Huntington’s-related chorea who were randomly assigned to take either Ingrezza or a placebo for about three months. Top-line trial data, which supported Ingrezza’s approval in the U.S., showed that the therapy was better than the placebo at easing chorea, as assessed with the Unified Huntington’s Disease Rating Scale-Total Maximal Chorea (TMC) score.
Now, a team of researchers conducted further analyses to see if these effects on TMC scores were consistent across different subgroups of patients. The researchers looked at demographic factors like age, sex, and body mass index (BMI, a ratio of weight to height), as well as clinical factors, such as different scores in disease and symptom severity measures at the trial’s start.
Across all 19 subgroups analyzed, the results showed that TMC score changes consistently favored Ingrezza over the placebo.
The team then focused on other effects of the neurodegenerative disease.
“In addition to physical symptoms, Huntington’s disease significantly affects emotional and psychological health, often leading to increased anxiety and irritability or anger,” Roberts said.
A separate analysis was thus conducted to evaluate how Ingrezza affected participants’ emotional health and psychiatric stability. This was assessed through the emotional health subscale of the Huntington’s Disease Health Index.
Data from patients affected by emotional problems showed that, relative to the placebo, Ingrezza led to greater decreases in the severity of a range of emotional problems. Among them were anger, feelings of being overwhelmed, fluctuating mood, reduced enjoyment of activities, emotional outbursts, frustration, and anxiety.
Importantly, Ingrezza’s label carries a boxed warning noting that the therapy may increase the risk of depression and suicidal thoughts or behaviors in people with Huntington’s, who are already at risk.
Among the 127 KINECT-HD participants with available safety data, adverse events related to depression or suicidal thoughts or behaviors were reported in three patients on Ingrezza and two on the placebo.
However, treatment with Ingrezza was not associated with worsening of anxiety symptoms, depression symptoms, or suicidal ideation, as based on scores of the Hospital Anxiety and Depression Scale and the Columbia-Suicide Severity Rating Scale.
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