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Poster
1593579
Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-world Data for the 1-Month and 3-Month Formulations
Psych Congress 2023
This work was sponsored by Janssen Research & Development, LLC
Background: Paliperidone palmitate (PP), available as 1-month (PP1M), 3-month (PP3M), and 6-month (PP6M) long-acting injectable formulations, has shown to reduce the occurrence of relapses in adult patients with schizophrenia. In this study, relapse prevention with PP6M from an open-label extension (OLE) study was compared to PP3M and PP1M derived from real-world external comparator arms (ECA).
Methods: PP6M data were derived from a single-arm, 24-month OLE study (NCT04072575) which included adult patients with schizophrenia who completed a 12-month randomized, active control, double-blind, noninferiority phase-3 study, without relapse. PP3M and PP1M ECAs were constructed using data from the IBM® MarketScan® Multistate Medicaid US Database based on similar eligibility criteria as the PP6M cohort. Propensity score matching (PSM) was used to align the three cohorts based on relevant baseline characteristics. Primary endpoint was time-to-first relapse. Supporting sensitivity analyses were conducted.
Results: PSM yielded three cohorts of 178 patients each. Most patients were men (>70%); mean age: 39-41 years. Time-to-relapse was significantly delayed in the PP6M cohort (P
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