TREATMENT PERSISTENCE OF PALIPERIDONE PALMITATE 3-MONTH IN PATIENTS WITH SCHIZOPHRENIA -AN ANALYSIS OF JAPAN MEDICAL DATA CENTER CLAIMS DATABASE

Abstract Background Paliperidone palmitate three-month (PP3M) is a long-acting injectable antipsychotic approved in Japan since November 2020. It is indicated for patients with schizophrenia who have been stabilized through at least 4 months of PP1M monotherapy without concomitant use of oral antipsychotics. Furthermore, the approved label discourages the continuation of PP3M treatment after the initiation of concomitant antipsychotic use. The approved patient population of PP3M in Japan is more limited compared to other counties, and there is a paucity of real-world data on patients who have received PP3M as monotherapy. Aims & Objectives The study aims to describe the clinical characteristics of patients receiving PP3M treatment, and to examine the treatment persistence of PP3M monotherapy in the real-world setting in Japan. Methods We conducted a retrospective cohort study using the Japan Medical Data Center (JMDC) claims database. This database covers private sector employees and their dependents, and includes data only for individuals under 75 years old of age [1]. We extracted data from the database to identify patients with schizophrenia (ICD10 code F20) who initiated PP3M treatment between November 2020 and June 2022. The current analysis included patients who had transitioned from PP1M monotherapy to PP3M monotherapy in accordance with the approved label of PP3M in Japan. The treatment persistence of PP3M monotherapy was assessed using the Kaplan-Meier survival function. This analysis considered both the discontinuation of PP3M and the initiation of concomitant use of oral antipsychotics as events. The end of available data and study period were considered as censoring. Results As of June 2022, a total 62 patients in the database met the patient selection criteria. The mean age (SD) at the initiation of PP3M was 40.1 (9.1) years old, 29 patients (46.8%) were male. Approximately half of the patients (48.4%) were employed at the baseline. The treatment persistence of PP3M monotherapy was found to be 88.8% at 6 months and 75.7% at 12 months. Notably, employed patients had a higher 12-month treatment persistence rate (85.7%) in PP3M monotherapy compared with unemployed patients (66.2%). Additionally, the treatment persistence of PP3M was found to be 98.2% at 6 months and 90.1% at 12 months if the concomitant use of oral antipsychotic during PP3M treatment is not considered an event. This study will further incorporate updated results based on the March 2023 cut-off data. Discussion & Conclusion In this study, we will present evidence demonstrating the high treatment persistence of PP3M in Japan’ s clinical practice setting. Additionally, we will update the analysis to include the dataset as of March 2023 to ensure the presentation of the latest findings. Furthermore, we will provide additional data from patients who transitioned from PP1M to PP3M, irrespective of whether they were using concomitant use of antipsychotics at the time of transition. These results will contribute to a more comprehensive understanding of treatment persistence of PP3M in the real-world setting. References 1.Nagai, K. et al. (2020) 'Data resource profile: JMDC claims databases sourced from Medical Institutions,' Journal of General and Family Medicine, 21(6), pp. 211–218.