Relapse in Adequately Versus Not Adequately Treated Female Patients With Schizophrenia Who Transitioned to Once-Every-3-Months Paliperidone Palmitate Injections: A Retrospective Claims Database Study

Abstract: Purpose: Paliperidone palmitate once-every-3-months (PP3M) is a long-acting injectable antipsychotic indicated for adults with schizophrenia adequately treated (AT) with once-monthly paliperidone palmitate (PP1M) for ≥4 months. This real-world study assessed outcomes among female patients AT versus not adequately treated (NAT) with PP1M prior to transitioning to PP3M. Methods: IBM® MarketScan® Multi-State Medicaid Database claims data (June 2015 to December 2020) for patients aged ≥18 years with ≥1 claim for schizophrenia diagnosis before and/or at index date (i.e., first PP3M prescription record) and continuous enrollment ≥12 months before and after index date were included. Two PP3M patient cohorts were created using propensity score matching: AT (treated with PP1M for ≥4 months [≥5 injections], of which the last 2 doses were the same) and NAT (received ≤2 PP1M injections). Time to first relapse was estimated using Kaplan-Meier survival curves and differences in time to first relapse between cohorts was compared using a log-rank test; hazard ratio was calculated using Cox proportional hazards models. Results: A total of 1314 patients were matched, 408 of whom were female (AT: 204; NAT: 204). First relapse rate was significantly lower in the AT (22.5%) versus NAT cohort (30.9%) (P = 0.04). Risk of first relapse decreased by 32% for AT compared with NAT (HR = 0.68; 95% CI, 0.46-0.99). Inpatient psychiatric hospitalization accounted for 79%-87% of relapses in each cohort. Conclusion: Adequate treatment with PP1M before transitioning to PP3M is associated with significantly lower first relapse rates and delayed time to first relapse among female patients.Short Description: Cohorts of female patients with schizophrenia who were adequately treated (AT) and not adequately treated (NAT) with once-monthly paliperidone palmitate (PP1M) before transitioning to once-every-3-months paliperidone palmitate (PP3M) injection were evaluated using the IBM® MarketScan® Multi-State Medicaid Database. Rate and risk of first relapse were significantly lower in the AT cohort compared with the NAT cohort. Adequate treatment with PP1M before transitioning to PP3M is critical to optimize outcomes among female patients.Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC