Background: Paliperidone palmitate 3-monthly (PP3M) formulation is a long-acting, injectable antipsychotic treatment approved in many countries worldwide for the maintenance treatment of adult patients with schizophrenia. This single-arm, open-label, phase IIIb study evaluated the efficacy and safety of converting patients with schizophrenia stabilized with paliperidone palmitate 1-month (PP1M) to PP3M in a naturalistic clinical setting. Methods: After screening (days –7 to 1), patients were converted from PP1M (50–150 mg eq.) to PP3M (175–525 mg eq.), and entered a 52-week, flexible-dose PP3M treatment period. The primary efficacy endpoint was symptomatic remission (SR) (Andreasen criteria) at last observation carried forward (LOCF) endpoint. Results: Patients ( n = 305) received PP3M, of whom 291 (95.4%) completed the study. Doses of PP3M remained stable during the 12-month treatment period, and changes in dose were uncommon. Overall, 56.8% of patients [95% confidence interval (CI): 51.0, 62.4] achieved SR, and 31.8% achieved both symptomatic and functional remission (Personal and Social Performance scale total score > 70) at LOCF endpoint. Secondary endpoint results were generally consistent with primary endpoint results. There were improvements in Positive and Negative Syndrome Scale total, subscale and Marder factor scores, and also Clinical Global Impression-Severity and -Change scores from baseline to LOCF endpoint. Carer burden was reduced, and the proportion of patients requiring hospitalization for psychiatric reasons decreased from 13.5% in the 12 months prior to baseline to 4.6% during the treatment period. No new safety signals were identified. Conclusion: Results from this naturalistic study were similar to those observed in previous randomized clinical trials of PP3M and underline the importance of continuous maintenance treatment in patients with schizophrenia.

Background To understand the implications of switching from paliperidone palmitate 1-monthly (PP1M) to paliperidone palmitate 3-monthly (PP3M) treatment of schizophrenia from the perspective of four key stakeholders: patients, physicians, nurses and carers. Methods This was a cross-sectional, retrospective, non-interventional study comprising a one-time questionnaire (PINC-Q) for adult patients (aged ≥18 years) with schizophrenia (International Classification of Diseases; ICD-10) and their physician, nurse and carer. Questionnaires were developed in association with patient and carer advocacy groups (GAMIAN and EUFAMI) and following an advisory board formed of psychiatrists and nurses. The degree of alignment between stakeholders was also examined. Results Responses were received from a total of 224 evaluable patients. For most patients (88.4%), responses were received from at least two other stakeholders. Patients were moderately ill with mild-to-moderate lack of insight and had received PP1M for a mean (standard deviation [SD]) of 23.9 (21.28) months before switching to PP3M (duration mean [SD] 12.8 [3.72] months). The most frequently reported reasons to switch from PP1M to PP3M were ‘to live life as normally as possible’ and ‘patient convenience’. Over 79% of responses within each stakeholder group stated that PP3M helped the patients, with increased patient activity and social involvement, improved frequency and quality of physician–patient and nurse–patient communication and decreased perceived stigma. Conclusions The results of this study add to the increasing body of evidence supporting the benefits of PP3M in a population of patients with schizophrenia representative of real-world clinical practice.

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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.