TOPLINE:

The use of brexpiprazole 2-4 mg daily was linked to reduced symptoms, improved overall functioning, and greater response rates at 6 weeks compared with placebo in patients with early-episode schizophrenia, with no new safety signals, new research showed.

METHODOLOGY:

• The post hoc analysis pooled 2011-2023 data from four 6-week, randomized, double-blind, placebo-controlled phase 3 trials of brexpiprazole in schizophrenia, including three trials with adults and one with adolescents.
• Nearly 500 patients aged 13-35 years with early-episode schizophrenia (illness duration, ≤ 5 years) were randomly assigned to receive either brexpiprazole 2-4 mg daily or placebo.
• The primary endpoint was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 6.
• Secondary outcomes included functioning, as assessed with the Personal and Social Performance (PSP) scale in adults and the Children’s Global Assessment Scale (CGAS) in adolescents. Safety outcomes included treatment-emergent adverse events (AEs), metabolic changes, and extrapyramidal symptoms.

TAKEAWAY:

• Brexpiprazole was linked to greater improvements in PANSS total score at week 6 (mean difference, -3.6; P = .04) than placebo, with improvements starting from week 3 onward (P < .05). At week 6, there were also greater improvements for brexpiprazole in PANSS-derived prosocial factor scores (P = .01), positive symptoms (P = .03), uncontrolled hostility/excitement (P < .01), and anxiety/depression (P = .03).
• Brexpiprazole was linked to better combined functioning PSP/CGAS (P = .04) and Clinical Global Impression (CGI)-Improvement scores (P = .02) at week 6 than placebo. However, CGI-Severity score changes were similar between the two groups.
• Response rates at week 6 were higher for brexpiprazole than for placebo (47% vs 34%; relative risk, 1.4; P = .01), with consistent benefits observed across most subgroups.
• Treatment-emergent AEs were comparable between brexpiprazole and placebo groups (51% vs 46%), with the most common being insomnia (9.2% vs 9.5%) and akathisia (6.5% vs 2.1%). Weight gain ≥ 7% was more frequent with brexpiprazole (relative risk, 2.1), whereas metabolic and extrapyramidal symptom changes were minimal. 

IN PRACTICE:

“This pooled analysis of four randomized, placebo-controlled trials expands the evidence base for brexpiprazole in schizophrenia by demonstrating efficacy specifically in patients who are early in the disease course,” the investigators wrote.

SOURCE:

This study was led by Christoph U. Correll, MD, Zucker Hillside Hospital, New York City. It was published online on March 12 in Psychiatry Research.

LIMITATIONS:

This study included only short-term data and lacked an active comparator. Adult participants were hospitalized for acute exacerbation, whereas adolescents were treated in an outpatient setting, introducing heterogeneity. Additionally, the combined PSP and CGAS scores were not adjusted or validated, and evidence supporting their relationship was limited to a small prior study.

DISCLOSURES:

This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. and H. Lundbeck A/S. Disclosure information for study authors is available in the original study publication.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.