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

TY - JOUR

T1 - Real-world effectiveness of aripiprazole once-monthly REACT study: Pooled analysis of two noninterventional studies

AU - Schöttle, Daniel

AU - Clerzius, Guerline

AU - Janetzky, Wolfgang

AU - Oluboka, Oloruntoba

AU - Roy, Marc-André

AU - Therrien, François

AU - Wiedemann, Klaus

PY - 2022/7/20

Y1 - 2022/7/20

N2 - BACKGROUND: Noninterventional 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 two noninterventional studies was undertaken to validate previous results on AOM effectiveness and safety in a larger population and improve statistical power for preplanned subgroup analyses. We analyzed data from 409 patients with schizophrenia who were treated with AOM and were enrolled in noninterventional studies in Germany (via noninterventional studies registry 15,960 N) and Canada (NCT02131415). Data collected at baseline, 3 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). A total of 54.4% were responders (at least 20% reduction) on the BPRS, and 56.5% had a CGI-S-score that was at least 1 level better than baseline. A total of 43.4% were considered responders on both the BPRS and CGI scales. A total of 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.

AB - BACKGROUND: Noninterventional 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 two noninterventional studies was undertaken to validate previous results on AOM effectiveness and safety in a larger population and improve statistical power for preplanned subgroup analyses. We analyzed data from 409 patients with schizophrenia who were treated with AOM and were enrolled in noninterventional studies in Germany (via noninterventional studies registry 15,960 N) and Canada (NCT02131415). Data collected at baseline, 3 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). A total of 54.4% were responders (at least 20% reduction) on the BPRS, and 56.5% had a CGI-S-score that was at least 1 level better than baseline. A total of 43.4% were considered responders on both the BPRS and CGI scales. A total of 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.

U2 - 10.1192/j.eurpsy.2022.27

DO - 10.1192/j.eurpsy.2022.27

M3 - SCORING: Journal article

C2 - 35855645

VL - 65

SP - e42

JO - EUR PSYCHIAT

JF - EUR PSYCHIAT

SN - 0924-9338

IS - 1

M1 - e42

ER -