Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

Introduction The use of the blonanserin patch (BLO-P) for schizophrenia treatment was approved in Japan in 2019. This systematic review of trials in Japan assessed the efficacy and safety profile of BLO-P compared with other antipsychotics. Methods The systematic review included 6-week, double-blind, randomized, placebo-controlled, phase 3 trials in Japan that included patients with acute schizophrenia. Pooled data for patients receiving BLO-P 40 and 80 mg/day (BLO-P40+80) were compared with pooled data for patients receiving asenapine 10 and 20 mg/day (ASE10+20) and data for those receiving brexpiprazole 2 mg/day (BRE2) and paliperidone extended-release 6 mg/day (PAL-ER6). Results All the investigated treatments were superior to placebo in reducing the Positive and Negative Syndrome Scale (PANSS) total score; the Hedges’ g values (95% confidence interval) for BLO-P40+80, ASE10+20, BRE2, and PAL-ER6 were−0.40 (−0.58,−0.22),−0.61 (−0.79,−0.42),−0.33 (−0.60,−0.07), and−0.69 (−0.93,−0.45), respectively. There were differences among the antipsychotics in the incidence of various individual adverse events. Discussion BLO-P40+80 may have a good efficacy/safety/tolerability profile for the treatment of patients with acute schizophrenia.

44 Real World Effectiveness: A 6-month Naturalistic Follow-up Study of Schizophrenia Patients After Switching to Aripiprazole Monohydrate (AOM) Treatment

RationaleLong-acting injectable antipsychotic therapies may offer benefits over oral antipsychotics in patients with schizophrenia. However, there is still a lack of real-world studies assessing the effectiveness of these therapies.ObjectiveThis study aimed to explore the safety, tolerability, and treatment response of aripiprazole monohydrate (AOM) once monthly in non-acute but symptomatic adult patients switched from previous therapy with frequently used oral or injectable atypical antipsychotics.MethodsThis was a post hoc analysis of a prospective, interventional, single-arm, open-label, 6-month study.ResultsThe patients (N=54) were switched to aripiprazole monohydrate once-monthly (AOM) from daily oral treatment or monthly injectable treatment with either aripiprazole (n=25), olanzapine (n=7), paliperidone extended-release (PP1M) (n=10), quetiapine (n=4), or risperidone (n=8). In all groups, mean Positive and Negative Syndrome Scale total (p=0.0001) and Clinical Global Impression-Severity scores improved significantly (p=0.0001). A reduction of ≥50% reduction of BPRS total-score and a CGI severity-score ≤4 in the Positive and Negative Syndrome Scale total score were observed in 16.7% (aripiprazole), 21.2% (olanzapine), 35.1% (PP1M), 27.3% (quetiapine), and 37.2% (risperidone) of patients. The patients showed significant improvements involving safety features as they experienced significant overall weight loss (p=0.0001) and prolactine decrease (risperidone p=0.0001, paliperidone extended-release p=0.0001). AOM once-monthly was well tolerated, presenting no new safety signals. Patient also reported an overall significant improvement on their quality of life measured with the Quality of Life Rating Scale (QLS) (p=0.0004) as well as in sexual functioning PRSexDQ-SALSEX (p=0.0001). In addition, the all cause treatment discontinuation rate after6-month follow-up was small (n=3; 5,55%)ConclusionsThese data illustrate that stable, non-acute but symptomatic patients either on oral antipsychotic therapy or under monthly antipsychotic treatment may show clinically meaningful improvement of psychotic symptoms, tolerability involving relevant side effects and quality of life perception. The findings are limited by the naturalistic study design; thus, further studies are required to confirm the current findings.Keywords: Long-acting injectable antipsychotic therapy. Oral antipsychotic. Effectiveness- Tolerability-Quality oflife.