Relapse and Treatment Adherence in Patients with Schizophrenia Switching from Paliperidone Palmitate Once-Monthly to Three-Monthly Formulation: A Retrospective Health Claims Database Analysis

Abstract

Purpose: Relapse and treatment adherence to paliperidone palmitate once-monthly (PP1M) and three-monthly (PP3M) formulations in patients with schizophrenia were evaluated and compared using health claims data. Patients and Methods: Data (June 2015─June 2018) obtained from the MarketScan ® Multi-State Medicaid Database were retrospectively analyzed. Patients aged ≥18 years with ≥1 claim for schizophrenia diagnosis prior to and/or at index date (i.e., date of first PP3M prescription record for PP3M patients and same month/year as the matched PP3M patients for PP1M patients) and continuous enrollment in the insurance plan for ≥12 months prior to index date (baseline) were included. PP1M cohort included patients who received ≥4 PP1M doses. PP3M patients were matched with PP1M patients (1:3) using propensity score matching and prevalent new user design. Outcome measures were relapse rate, time to relapse, proportion of days covered (PDC), and level of treatment adherence defined by PDC in five levels. Time to relapse was compared by Kaplan-Meier survival curves and log-rank test with the hazard ratio calculated using Cox proportion hazards model; PDC by t-test, and relapse rate and PDC categories by chi-square test. Results: A total of 1564 patients (428 PP3M and 1136 PP1M) were included. Relapse rate was lower in PP3M cohort (10.5%) compared with PP1M cohort (15.7%). Incidence rate of relapse was 8.98/100 person-years (PY) in PP3M cohort and 13.81/100 PY in PP1M cohort. After a mean (SD) follow-up of 456.1 (240.28) days in PP3M cohort and 465.4 (237.95) days in PP1M cohort, PP3M patients had a significantly lower relapse risk (hazard ratio: 0.65, 95% CI: 0.47, 0.90) than PP1M patients. Treatment adherence was significantly (p<0.0001) higher in PP3M versus PP1M cohort. Conclusion: Risk of relapse was significantly lower, and treatment adherence was significantly higher in PP3M cohort compared with PP1M cohort. Higher treatment adherence was associated with lower relapse rate.

Real-life effectiveness of transitioning from paliperidone palmitate 1-monthly to paliperidone palmitate 3-monthly long-acting injectable formulation

“…Other naturalistic studies have been conducted, but as previously discussed, there are many issues that hinder their comparability with the present findings. [9][10][11] The study with the most comparable methodological design to the present one is that reported by Wallman et al 13 and Clark et al 14 in which relapse rates of 7.2% and 10.8% were found during the 2 years following PP3M initiation, which is much lower than the relapse rate herein reported. A first explanation for these lower rates than that obtained here are the different definitions of relapse used.…”

“…Consent was again required for study participation and patients with psychiatric comorbidities, including substance use disorder, were excluded, thereby limiting the representativeness of their sample. Third, Li et al 11 retrospectively compared 428 patients with non-affective disorders on PP3M with 1136 matched patients on PP1M using the Multi-State Medicaid Database in the United States. After an average follow-up period of around 15 months, they observed a significantly lower relapse rate (10.5% versus 15.7%) and better treatment adherence for patients on PP3M compared with PP1M.…”

Radiolabeled Risperidone microSPECT/CT Imaging for Intranasal Implant Studies Development

“…This is especially important for schizophrenia treatment, as it has been reported that up to 75% of patients discontinue the treatment within the first year and a half [ 44 ]. Non-adherence to treatment has an enormous impact for this patient as it increases the risk of relapse, hospitalization, and even suicide rates [ 45 , 46 , 47 , 48 , 49 ]. Moreover, there is an obvious economic impact for healthcare systems.…”

Comparing Relapse Rates in Real-World Patients with Schizophrenia Who Were Adequately versus Not Adequately Treated with Paliperidone Palmitate Once-Monthly Injections Before Transitioning to Once-Every-3-Months Injections

“…Patient-level claims files include linked inpatient, outpatient, long-term care, and pharmacy records. Medicaid claims are commonly analyzed in real-world studies of patients with schizophrenia; 23 the selection is appropriate because Medicaid is the second largest payer in the United States for mental health services related to schizophrenia. 8 The IBM MDCD collects administrative data from 10 states with varying sociodemographic compositions; therefore, the data analyzed in this study are likely representative of the broader US population.…”