Observational Study of Long-Acting Injectables in Schizophrenia (OASIS): Baseline Patient Demographics and Clinical Characteristics of Early Enrollees

Abstract: Background/Objective: Atypical long-acting injectable (aLAI) antipsychotics are efficacious treatments for schizophrenia; however, a deeper understanding of the real-world outcomes resulting from their use is needed. OASIS is an ongoing, prospective, observational study assessing real-world treatment patterns and clinical, socioeconomic, and patient-reported outcomes in patients with schizophrenia who initiate an aLAI antipsychotic. We present the study design of OASIS and baseline demographics and clinical characteristics of patients enrolled through March 2021. Methods: Adults ≥18 years old with schizophrenia who initiate 1 of 3 aLAI antipsychotics (aripiprazole lauroxil, paliperidone palmitate, or aripiprazole monohydrate) are enrolled. Patients are assessed over 12 months during routine follow-up; aLAI treatment patterns, clinical symptoms, patient-reported outcomes, and healthcare resource utilization are documented . Results: Data from 173 patients (aripiprazole lauroxil, n=70; paliperidone palmitate, n=66; aripiprazole monohydrate, n=37) were included in this analysis. The mean (SD) age at baseline was 37.39 (14.64) years; 65% of patients were male, and 56% were unemployed. The mean (SD) time since diagnosis was 12.79 (12.60) years . Baseline illness severity was moderate, with a mean (SD) Clinical Global Impressions Severity of Illness Scale score of 4.21 (1.03) . Overall, 26% and 40% of patients reported ≥1 schizophrenia-related emergency department and inpatient visit, respectively, in the previous 12 months . Conclusions: Overall, patient characteristics of early enrollees in OASIS are representative of patients with schizophrenia. The results of OASIS will provide data to clinicians, patients, and health care professionals on real-world patterns of use and patient-reported outcomes of aLAI antipsychotic treatment of schizophrenia.Short Description: OASIS is an ongoing prospective, observational study assessing real-world treatment patterns and clinical, socioeconomic, and patient-reported outcomes in patients with schizophrenia who initiate treatment with an atypical long-acting injectable (aLAI) antipsychotic. Here, we present the study design of OASIS and baseline demographics and clinical characteristics of early enrollees in the study.Name of Sponsoring Organization(s): This study was funded by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.