Poster
87
(#87) Comparative analysis of relapse rates with paliperidone palmitate 6-month in patients with schizophrenia: randomized controlled trial vs matched real-world data
Psych Congress 2025
Abstract: Background: Paliperidone palmitate (PP) 6-month (PP6M) is the longest-acting injectable antipsychotic approved for the treatment of adult schizophrenia patients adequately stabilized with PP monthly (PP1M) or quarterly (PP3M) formulations. This study compared 12-month relapse rates from a phase-3 clinical trial (n=702) with data from a real-world cohort (RWD) to assess generalizability of clinical data for PP6M to broader real-world settings.
Methods: RWD were identified from the Merative™ MarketScan® Multi-State Medicaid database (MDCD). Eligible patients had ≥3 months of continuous enrollment before and after first (index) PP6M injection and were adequately treated before PP6M initiation with either ≥4 PP1M or ≥1 injection cycle of PP3M. Time-to-relapse was analyzed using Kaplan-Meier estimates.
Results: Overall, 129 adult patients from MDCD were included following 1:1 propensity score matching to patients from the clinical study with same index PP dose and gender. Overall, 83/129 (64.3%) patients received a high index PP6M dose (1000 mg eq. of paliperidone), and 89/129 (69%) were men in both cohorts. Mean (SD) ages for the clinical study and RWD were 37.5 (11.2) and 37.6 (11.3) years, respectively (standardized mean difference: 0.10). The 12-month relapse rates were 7.0% (clinical study) and 9.3% (RWD) (risk difference [95% CI]: −2.3% [-9.0%; 4.3%]). No significant difference in time-to-relapse was observed (Log-rank, p=0.31). Sensitivity analyses using 1:2 matching and inverse probability of treatment weighting yielded consistent results.
Conclusion: Findings support the generalizability of PP6M effectiveness from a controlled clinical study setting to real-world practice among adequately treated adult patients with schizophrenia.
Short Description: This analysis presents a comparative evaluation of relapse rates among adult patients with schizophrenia, treated with PP6M in a phase 3 clinical study and a propensity score-matched real-world cohort. The findings showed that relapse rates were comparable between the clinical study and the real-world data, suggesting equal effectiveness of PP6M in RWD compared to RCT in preventing relapses in adequately treated patients with schizophrenia.
Name of Sponsoring Organization(s): Funded by Johnson & Johnson, NJ, USA
Methods: RWD were identified from the Merative™ MarketScan® Multi-State Medicaid database (MDCD). Eligible patients had ≥3 months of continuous enrollment before and after first (index) PP6M injection and were adequately treated before PP6M initiation with either ≥4 PP1M or ≥1 injection cycle of PP3M. Time-to-relapse was analyzed using Kaplan-Meier estimates.
Results: Overall, 129 adult patients from MDCD were included following 1:1 propensity score matching to patients from the clinical study with same index PP dose and gender. Overall, 83/129 (64.3%) patients received a high index PP6M dose (1000 mg eq. of paliperidone), and 89/129 (69%) were men in both cohorts. Mean (SD) ages for the clinical study and RWD were 37.5 (11.2) and 37.6 (11.3) years, respectively (standardized mean difference: 0.10). The 12-month relapse rates were 7.0% (clinical study) and 9.3% (RWD) (risk difference [95% CI]: −2.3% [-9.0%; 4.3%]). No significant difference in time-to-relapse was observed (Log-rank, p=0.31). Sensitivity analyses using 1:2 matching and inverse probability of treatment weighting yielded consistent results.
Conclusion: Findings support the generalizability of PP6M effectiveness from a controlled clinical study setting to real-world practice among adequately treated adult patients with schizophrenia.
Short Description: This analysis presents a comparative evaluation of relapse rates among adult patients with schizophrenia, treated with PP6M in a phase 3 clinical study and a propensity score-matched real-world cohort. The findings showed that relapse rates were comparable between the clinical study and the real-world data, suggesting equal effectiveness of PP6M in RWD compared to RCT in preventing relapses in adequately treated patients with schizophrenia.
Name of Sponsoring Organization(s): Funded by Johnson & Johnson, NJ, USA
