Impact of time of initiation of once-monthly paliperidone palmitate in hospitalized Asian patients with acute exacerbation of schizophrenia: a post hoc analysis from the PREVAIL study

Abstract

Purpose

To evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups (≤1 week and >1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate.

Patients and methods

PREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18–65 years) diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis.

Results

Significant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates (P≤0.01), PANSS subscales (positive and general psychopathology; all P≤0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all P≤0.01), Personal and Social Performance scale scores (P≤0.05) and Clinical Global Impression-Severity categorical summary (P≤0.05) were significantly greater in the ≤1 week subgroup versus >1 week subgroup (P≤0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups.

Conclusion

Early initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization.

Keywords:

• early treatment initiation
• hospital setting
• long acting injectable
• Asian
• hospital discharge
• efficacy
• safety
• positive and negative syndrome scale total score

Supplementary material

Table S1 Institutional Review Board/Committees

Acknowledgments

The authors thank Rohit Bhandari (SIRO Clinpharm Pvt. Ltd.) for writing assistance and Harry Ma (Janssen Research & Development, LLC) for additional editorial assistance for the development of this manuscript. The authors also thank the participants of the study, without whom the study would never have been accomplished. The study was supported by Janssen Research and Development, LLC. The sponsor provided a formal review of the manuscript.

Author contributions

All authors have provided substantial contribution for the study conception, design, acquisition of data, and analysis and interpretation of data as per the journal guidelines. All authors were involved in drafting/revising this manuscript for important intellectual content and have given final approval of the version to be published.

Disclosure

YF and WT are employees of Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore. JZ is an employee of Janssen China Research and Development, Shanghai, China. IT and MM are employees of Janssen Research & Development LLC, Titusville, New Jersey, USA. The other authors report no conflicts of interest in this work.