Patients with schizophrenia who were treated with brexpiprazole (Rexulti®) showed greater improvement in Personal and Social Performance (PSP) at week 6 than patients who received a placebo. The results of a post hoc analysis of multiple randomized, double-blind, placebo-controlled studies were published in the Journal of Clinical Psychiatry.

Because schizophrenia symptoms accumulate, treatment guidelines state that improving functioning in the acute phase, and maintaining functioning, are the major goals. However, the researchers note that some patients may experience residual symptoms when treated with antipsychotics, due in part to their side effects. The analysis aims to examine both short-term improvement and residual symptoms.

The current studies examine the impact of brexpiprazole, an atypical antipsychotic, on both acute PSP and long-term functioning per the Global Assessment of Functioning (GAF) scales. The short-term analysis included 3 brexpiprazole clinical trials — ClinicalTrials.gov identifier: NCT01396421, BEACON (NCT01393613), and LIGHTHOUSE (NCT01810380). The post hoc study also looked at 1 long-term 52-week maintenance study — EQUATOR (NCT01668797), as well as data from 2 long-term schizophrenia studies conducted between 2011 and 2016.


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Of the 1,414 patients included in the short-term analysis, the median baseline PSP score was 44. The 202 patients in the maintenance study met the criteria for stabilization.

In the short-term studies, brexpiprazole was associated with greater improvement than placebo from baseline to week 6 in overall PSP score with a mean change of 12.5 points compared with 9.3 for the placebo. At week 6, 11% of the brexpiprazole-treated patients achieved functional remission compared with 6.7% treated with the placebo.

In the maintenance study, GAF scores improved by a mean 16.2 points and maintained, while the placebo group worsened. In the long-term 2016 studies, the mean change from baseline to week 52 include: PSP: 23.6 (12.9), within-group effect size [ES] = 1.82; Activities: −1.5 (1.0), ES = 1.53; Relationships: -1.4 (1.0), ES = 1.46; Self-care: −1.1 (0.9), ES = 1.20; Behaviors: −0.6 (1.0), ES = 0.64. Baseline values were PSP: 44.3 [11.5]; Activities: 3.4 [0.8]; Relationships: 3.0 [0.8]; Self-care: 1.7 [1.1]; Behaviors: 1.0 [1.0].

While the analysis used a large dataset and long-term follow-up, its post hoc nature, patient selection criteria, and lack of active comparator may have influenced the results. However, the researchers concluded “treatment with brexpiprazole was associated with clinically relevant improvement in functioning among adults with acute schizophrenia, and maintenance of this improvement over the long term, with high rates of functional response and remission.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. This research was supported by Otsuka Pharmaceutical Development & Commercialization Inc. and H. Lundbeck A/S. Please see the original reference for a full list of disclosures.

Reference

Correll CU, He Y, Therrien F, et al. Effects of brexpiprazole on functioning in patients with schizophrenia: post hoc analysis of short- and long-term studies. J Clin Psychiatry. 2022;83(2):20m13793. doi.org/10.4088/JCP.20m13793