Earlier Use of Long-Acting Injectable Paliperidone Palmitate versus Oral Antipsychotics in Patients With Schizophrenia: An Integrated Patient-Level Post Hoc Analysis of the PRIDE and PROSIPAL studies

Abstract: Objective: A prior integrated patient-level analysis revealed a significant benefit of implementing paliperidone palmitate (PP) versus oral antipsychotics (OAPs) earlier in the course of schizophrenia. Notably, therapeutic interventions during the critical period, the first 3-5 years following disease presentation, can positively impact long-term schizophrenia outcomes. This analysis evaluated the risk of relapse overall and by varying durations of illness (0-3-years, >3-5-years, and >5-years) in adult patients with schizophrenia receiving PP or OAP. Methods: This post-hoc analysis included integrated patient-level data from the PRIDE and PROSIPAL studies which assessed relapse as the primary outcome. Results: The risk of relapse was reduced by 31% with PP versus OAP (HR 0.69; 95% CI 0.56-0.86, p < 0.001), independent of illness category. Fewer relapses were observed with PP versus OAP in the 0-3-year group (15.8% and 21.7%, respectively), >3-5-year group (19.6% and 29.9%, respectively), and >5-year group (41.7% and 51.6%, respectively). These differences represent a reduction in risk of relapse by 33% for patients receiving PP versus OAP in the 0-3-year group (HR 0.67; 95% CI 0.44-1.00, p=0.050), by 43% in the >3-5-year group (HR 0.57; 95% CI 0.35-0.93, p=0.02) and by 26% in the >5-year group (HR 0.74; 95% CI 0.55-1.00, p=0.049). Treatment-emergent adverse events rates were similar between treatment groups. Conclusions: This analysis showed that PP provides significant benefits in reducing relapse rates compared to OAPs, irrespective of the duration of illness. Furthermore, the findings reinforce the importance of implementing PP in the early stages of schizophrenia. Trial Registration: ClinicalTrials.gov identifiers NCT01157351 and NCT01081769Short Description: This post-hoc analysis utilized integrated patient-level data from the PRIDE & PROSIPAL studies to evaluate the risk of relapse in adult patients with schizophrenia and varying durations of illness (0-3-years, >3-5-years, and >5 years). The results showed that PP provides significant benefits in reducing relapse rates compared to OAPs, regardless of duration of illness. Furthermore, the findings reinforce the importance of implementing PP earlier in the course of schizophrenia.Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC