Stable patients with schizophrenia switched to paliperidone palmitate 3-monthly formulation in a naturalistic setting: impact of patient age and disease duration on outcomes

Abstract

Background: Paliperidone palmitate 3-monthly (PP3M) is a second-generation, long-acting injectable antipsychotic formulation indicated for the maintenance treatment of adults with schizophrenia first stabilized with paliperidone palmitate 1-monthly (PP1M). This exploratory post hoc subgroup analysis of the 52-week, phase 3b REMISSIO study analysed outcomes according to patient age and disease duration in a naturalistic clinical setting. Methods: Outcomes of patients with schizophrenia were analysed according to age [3 years ( n = 233)]. The primary efficacy outcome was the proportion of patients achieving symptomatic remission according to the Andreasen criteria. Adverse events were monitored throughout the study. Results: At endpoint (last observation carried forward), 60.7% (95% CI: 51.4%, 69.4%) of younger patients and 54.1% of older patients (95% CI: 46.6%, 61.6%) achieved symptomatic remission. The proportions for patients with disease duration ⩽3 years and >3 years were similar: 57.8% (45.4%, 69.4%) versus 56.5% (49.8%, 62.9%). Functional remission was reached by 45.4% (36.2%, 54.8%) of patients aged <35 years and 36% (28.9%, 43.6%) of patients aged ⩾35 years with a similar pattern when analysed by disease duration. PP3M had a favourable safety profile and was generally well tolerated in both age groups. Conclusion: Patients with schizophrenia, previously stabilized on PP1M, may benefit from PP3M treatment with some additional potential improvements if started early in the disease course. Clinical trials.gov: NCT02713282