SA115. Short-Term and Long-Term Efficacy of Brexpiprazole in Adults With Schizophrenia: Effect Across Marder Factors

Abstract

Abstract The efficacy of brexpiprazole across a spectrum of schizophrenia symptoms was evaluated in patients with acute schizophrenia in 2 short-term 6-week studies and in a long-term 52-week maintenance study using the 5 previously validated PANSS-derived Marder factors.[1–3] The analysis was performed on the pooled data from two 6-week, double-blind, placebo-controlled studies of patients with schizophrenia who were randomly assigned to fixed once-daily doses of brexpiprazole 2 mg (n = 359), 4 mg (n = 359), or placebo (n = 358; NCT01396421 and NCT01393613), and in one 52-week, double-blind, placebo-controlled study with patients randomized to bexpiprazole (1–4 mg; n = 97) and placebo, n = 105 [NCT01668797]). The maintenance study included a stabilization phase in which patients needed to be stable on brexpiprazole for at least 12 weeks before randomization to brexpiprazole or placebo. In the short-term studies, brexpiprazole 4 mg and 2 mg were each superior to placebo in change from baseline in PANSS Total score at Week 6 (least square mean difference [LSMD] versus placebo: −6.69, < .0001 and −5.46, = .0004, respectively). The LSMD versus placebo at Week 6 was also significant (<0.05) for brexpipazole 4 mg and 2 mg on all 5 Marder factor scores. In the maintenance study, brexpiprazole (1–4 mg) was superior to placebo in change from baseline in PANSS Total score at Week 52 (LSMD from placebo: −8.0). The PANSS Total score was relatively stable in the brexpiprazole group, whereas it worsened in the placebo group. There was also a decrease in mean score from baseline at the last visit (LOCF) in all 5 Marder factor scores in the stabilization phase and the LSMD versus placebo at Week 52 was significant ( < .05) for brexpiprazole on 3 of 5 Marder factor scores (positive symptoms, disorganized thoughts, and uncontrolled hostility excitement) and had numerical improvements on negative symptoms and anxiety/depression factors. In all studies, brexpiprazole was generally well tolerated. Results from short-term and long-term studies showed consistent efficacy of brexpiprazole across the spectrum of symptoms associated with schizophrenia. Treatment with brexpiprazole showed superiority over placebo on PANSS Total score and across all 5 PANSS Marder factors in short-term studies. In the 52-week maintenance phase, similar results were observed on the Marder factor scores. In addition, treatment with brexpiprazole was well tolerated.