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

Abstract

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. OBJECTIVE: This 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. METHODS: This was a post hoc analysis of a prospective, interventional, single-arm, open-label, 6-month study. RESULTS: The 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%) CONCLUSIONS: These 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.