The use of long-acting Aripiprazole in a multi-center, prospective, uncontrolled, open-label, cohort study in Germany: a report on global assessment of functioning and the WHO wellbeing index

Abstract

Background: In this non-interventional study, the functionality and well-being of patients with schizophrenia with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic population. Methods: This non-interventional, prospective, multicenter 6-month study included 242 predominantly symptomatically stable patients (mean age 43.1 ± 15.1 years, 55% male) who switched their treatment to AOM after 9.7 (± 22.3) months of oral treatment. Outcome parameters included functionality (Global Assessment of Functioning, GAF), patient's wellbeing (WHO-5 Well-Being Index, WHO-5), and both patient's and clinician's assessment of efficacy and tolerability of AOM. Treatment emergent adverse events (TRAE) were also recorded. Results: At baseline, the mean GAF score was 47.0 (±13.9), indicating that patients experienced serious impairment in functioning. A continuous increase to 60.2 (±17.0) during treatment was found, with a robust and significant increase already after 4 weeks. At study start, patients reported diminished wellbeing, with a mean score of 10.6 (±5.6) on the WHO-5 scale. During treatment, patient wellbeing increased continuously with strong and significant improvements even after 4 weeks and an overall improvement of 4.8 (±6.9) over the course of 6 months with an endpoint of 15.4 (± 5.5). Stratification of these results showed that more pronounced effects were achieved in younger patients ≤35 years (p<0.05 for GAF). The effectiveness and tolerability of AOM was rated good/very good by most patients (89.2 and 93.7%) and physicians (91.4 and 96.8%). Only few TRAEs occurred. Conclusions: Our results show a significant positive effect after initiation of AOM treatment in predominantly stable patients with schizophrenia on their functioning and wellbeing, which was even more pronounced in patients aged ≤35 years, thereby supporting previous randomized controlled findings under routine conditions in clinical practice.

Effectiveness of More Personalized, Case-Managed, and Multicomponent Treatment for Patients with Severe Schizophrenia Compared to the Standard Treatment: A Ten-Year Follow-Up

“…LAI APs are a safe, tolerable [ 35 , 52 ] and effective treatment option; they prevent relapses and hospital admissions and are a strategy for improving adherence [ 24 , 31 , 32 , 36 , 37 , 53 ]). However, most recent studies comparing SGA OAPs with LAIs in severely ill patients are relatively scarce, and they have the disadvantage of a brief follow-up and relatively small samples [ 3 , 4 , 8 , 9 , 11 , 12 ].…”

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

“…We conducted post-hoc analyses of pooled data from two prospective non-interventional studies in which patients with schizophrenia from Canada (Trial registration 06/05/2014 (NCT02131415)) [14] and Germany (Trial registration 02/07/2014 (15960N)) [12,13] were treated with AOM. In the current analysis, we included all patients who had received AOM treatment and for whom a GAF assessment at baseline and at least one time point post-baseline was available.…”

“…Here, we present pooled data from two non-interventional studies conducted in Germany [12,13] and Canada [14] that assessed the functioning of outpatients with schizophrenia treated with AOM using the Global Assessment of Functioning (GAF) scale. 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).…”

„Rückkehr an den Arbeitsplatz“ für an Schizophrenie erkrankte Menschen

“…Psychisch stabil eingeschätzte Patienten mit Schizophrenie wurden von einer Behandlung mit oralem Aripiprazol umgestellt auf die Depotformulierung des Antipsychotikums. Dadurch konnten weitere Verbesserungen der Psychopathologie, des Funktionsniveaus und der Lebensqualität erreicht werden [25,26]. Überdies hat sich gezeigt, dass die symptomatischen und funktionellen Erfolge der Behandlung mit einer Verbesserung der Arbeitsfähigkeit einhergingen [27,28].…”