Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies

Abstract

The successful treatment of schizophrenia entails improvement across a spectrum of symptoms. The aim of this post hoc analysis was to characterize the short- and long-term effects of brexpiprazole on Positive and Negative Syndrome Scale (PANSS) ‘Marder factors.’ Data were included from three 6-week, randomized, double-blind, placebo-controlled studies; a 52-week, randomized, double-blind, placebo-controlled maintenance treatment study; and two 52-week open-label extension (OLEx) studies—all in schizophrenia (DSM-IV-TR criteria). Patients receiving oral brexpiprazole were dosed at 2–4 mg/day (short-term studies) or 1–4 mg/day (long-term studies). At Week 6, least squares mean differences (LSMDs, with 95% confidence limits [CLs]) for brexpiprazole (n = 868) vs placebo (n = 517) were: Positive symptoms: −1.55 (−2.30, −0.80), P < .0001, Cohen’s d effect size (ES) = 0.27; Negative symptoms: −1.12 (−1.63, −0.61), P < .0001, ES = 0.29; Disorganized thought: −1.26 (−1.78, −0.74), P < .0001, ES = 0.32; Uncontrolled hostility/excitement: −0.76 (−1.15, −0.37), P = .0002, ES = 0.26; Anxiety/ depression: −0.56 (−0.91, −0.22), P = .0014, ES = 0.22. At last visit of the maintenance study, LSMDs (95% CLs) for brexpiprazole (n = 96) vs placebo (n = 104) were: Positive symptoms: −3.44 (−4.99, −1.89), P < .0001, ES = 0.62; Negative symptoms: −1.23 (−2.52, 0.07), P = .063, ES = 0.27; Disorganized thought: −1.69 (−2.81, −0.56), P = .0035, ES = 0.42; Uncontrolled hostility/excitement: −1.26 (−2.12, −0.39), P = .0046, ES = 0.41; Anxiety/depression: −0.72 (−1.47, 0.03), P = .061, ES = 0.27. In the OLEx studies, improvements were maintained over 58 (6 + 52) weeks of brexpiprazole treatment. In conclusion, these data suggest that brexpiprazole treats the continuum of schizophrenia symptoms, in the short- and long-term. Trial Registration: Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01668797, NCT01397786, NCT01810783.