Real-world effectiveness of aripiprazole once-monthly REACT study: Pooled analysis of two noninterventional studies

Abstract

Background: Non-interventional naturalistic studies are an important complement to randomized controlled trials. Aripiprazole once-monthly (AOM) is an atypical antipsychotic in a long-acting injectable formulation.Methods: A pooled analysis of 2 non-interventional studies was undertaken to validate previous results on AOM effectiveness and safety in a larger population and improve statistical power for pre-planned subgroup analyses. We analyzed data from 409 patients with schizophrenia who were treated with AOM and were enrolled in non-interventional studies in Germany (vfa non-interventional studies registry 15960N) and Canada (NCT02131415). Data collected at baseline, 3 months and 6 months were analyzed.Among the endpoints were psychopathology (Brief Psychiatric Rating Scale, BPRS) and disease severity (Clinical Global Impression, CGI).Results: Mean patient age was 38.9 (SD 14.8) years, and 59.9% were male. BPRS decreased from 48.1 (SD 15.6) at baseline to 36.5 (SD 13.7) at month 6 (p < 0.001). CGI decreased from 4.47 (SD 0.90) at baseline to 3.64 (SD 1.16) at month 6 (p < 0.001). 54.4% were responders (at least 20% reduction) on the BPRS, and 56.4% had a CGI-S-score that was at least 1 level better than baseline. 43.4% were considered responders on both the BPRS and CGI scales. 45.2% were considered in remission. Adverse events were rare and corresponded to the previously known safety profile of AOM.Conclusions: Treatment with AOM for patients with schizophrenia appeared effective and safe under real-life conditions.

BPRS domains, items and subgroups analyses, and CGI-I ratings in pooled data from non-interventional studies of aripiprazole once-monthly in schizophrenia (REACT study)

“…In the Canadian study, patients were treated with AOM as per local label. As reported previously, the mean duration of observation was 5.49 months (SD: 1.43) [15]. Three hundred and eighty-four patients (93.9%) completed the studies until month 6 [15].…”

“…Three hundred and eighty-four patients (93.9%) completed the studies until month 6 [15]. Reasons for discontinuation during the first 6 months or at month 6 included lack of effectiveness (2.7%), adverse drug reaction (1.7%) or other reasons (7.8%) [15].…”

“…In order to validate previous results on AOM effectiveness and safety in a larger population and to improve statistical power for preplanned subgroup analyses, data from both studies were pooled and re-analysed. Results on psychopathology (Brief Psychiatric Rating Scale, BPRS) and disease severity (Clinical Global Impression-Severity, CGI-S) have already been published [15]. Briefly, BPRS global score was 48.1 (SD 15.6) at baseline and reached 36.5 (SD 13.7) at month 6, while CGI-S decreased from 4.47 (SD 0.90) at baseline to 3.64 (SD 1.16) at month 6 [15].…”

“…Results on psychopathology (Brief Psychiatric Rating Scale, BPRS) and disease severity (Clinical Global Impression-Severity, CGI-S) have already been published [15]. Briefly, BPRS global score was 48.1 (SD 15.6) at baseline and reached 36.5 (SD 13.7) at month 6, while CGI-S decreased from 4.47 (SD 0.90) at baseline to 3.64 (SD 1.16) at month 6 [15]. Here, we report additional post-hoc analyses on BPRS domain and items scores, as well as subgroup analyses stratified by sex, disease duration and baseline severity.…”

Improvement of functioning in patients with schizophrenia: Real-world effectiveness of aripiprazole once-monthly (REACT study)

“…Analyses of effectiveness outcomes have already been reported: for the total population, the mean Brief Psychiatric Rating Scale total score decreased from 48.1 (standard deviation [SD] 15.6) at baseline to 36.5 (SD 13.7) at month 6 (p < 0.001). Clinical Global Impression -Severity decreased from 4.47 (SD 0.90) at baseline to 3.64 (SD 1.16) at month 6 (p < 0.001) [15]. The main objective of the current paper was to determine whether the GAF scores improved over this 6-month period.…”