Abstract
BackgroundIn 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.MethodsThis 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.ResultsAt 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.ConclusionsOur 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.
Highlights
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
Adherence to pharmacological treatment may be improved when long-acting injectables (LAIs) are used, which has been mainly demonstrated under real life conditions [9,10,11,12,13,14]
One patient was excluded from the analysis because he did not receive any AOM injections
Summary
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. Schizophrenia is characterized by recurring episodes characterized by positive symptoms, such as hallucinations and thought disorders, as well as negative symptoms, like blunted affect and avolition. Treatment of these negative symptoms is challenging, as they may persist even after remission from an acute episode and as they can have a further negative impact on quality of life and general wellbeing. Patient functioning and quality of life were superior during AOM treatment compared with oral standard-of-care in a naturalistic study [18]
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