A post hoc analysis on hospitalization risk in Asian patients with schizophrenia switching to once-monthly paliperidone palmitate from oral antipsychotics

ABSTRACT

Background: In this post hoc analysis in patients recently diagnosed (≤5 years) with schizophrenia, the effect on hospitalization risk after switching from oral antipsychotic to once-monthly paliperidone palmitate (PP1M) was evaluated.

Research design and methods: Change in hospitalization risk following PP1M initiation among patients switching from oral antipsychotics was assessed using prescription sequence symmetry analysis. Hospitalization risk was expressed as an adjusted sequence ratio (ASR) of the number of patients hospitalized prior to PP1M initiation/post PP1M initiation. Cumulative distribution of the time to hospitalization was estimated by the Kaplan-Meier method and symmetry of distribution was assessed using log-rank test. Hazard ratio and 95% CI were calculated using the Cox proportional hazard model.

Results: The number of patients hospitalized after switching to PP1M: no change, 203/300 (67.7%); increase, 18/300 (6.0%); and decrease, 79/300 (26.3%). Following PP1M initiation, ASR (95% CI) was 3.56 (2.67, 5.33) suggesting asymmetry and a significant decline in hospitalization risk. Asymmetry in distribution of hospitalization events with significant (p ≤ 0.001) delay in time to hospitalization was also observed.

Conclusion: Switching to PP1M treatment from oral antipsychotics is likely to be associated with a significant reduction in hospitalization risk along with a delay in time to hospitalization and rehospitalization.

KEYWORDS:

• Asian
• hospitalization
• mirror analysis
• once-monthly paliperidone palmitate
• PP1M
• schizophrenia

Acknowledgments

This study was presented as a poster at the 30th European College of Neurpsychopharmacology (ECNP) Congress, 2–5 September 2017, Paris, France. The authors thank Shweta Pitre, M.Pharm, ISMPP CMPP™ (SIRO Clinpharm Pvt. Ltd. Thane, India) for providing writing assistance and Harry Ma, PhD (Janssen Research & Development, LLC, NJ, USA.) for providing additional editorial support for the development of this manuscript. Authors also thank the study participants and their legally-acceptable representatives, without whom this study would not have been accomplished.

Declaration of interest

Dr. N Li has been a consultant and/or advisor and received honoraria from Janssen Research and Development (Beijing), Lundbeck, Astellas, Sanofi, Merck Serono, Hisun-Pfizer. J Zhuo is an employee of Xian Janssen Pharmaceuticals, China. W Tan and Y Feng are employees of Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore. I Turkoz and M Mathews are employees of Janssen Research & Development, LLC, New Jersey. J Zho W Tan, Y Feng, I Turkoz and M Mathews all hold stocks in Johnson & Johnson. Writing assistance was utilized in this manuscript and funded by Janssen Asia Pacific, Pte.Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Nan Li, Yu Feng, Jian Min Zhuo were involved in the conception and design of this study. Ibrahim Turkoz was involved in the design of this study and data analyses. Nan Li and Jian Min Zhuo were involved in the data analyses. Nan Li, Yu Feng, Jian Min Zhuo, Ibrahim Turkoz, Wilson Tan and Maju Mathews were involved in data interpretation, manuscript development and critical evaluation of this manuscript. Nan Li, Yu Feng, Jian Min Zhuo, Ibrahim Turkoz, Wilson Tan and Maju Mathews approved the final manuscript for submission, had full access to all the data in this study and take final responsibility for the decision to submit it for publication.

Data sharing statement

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This study was funded by Janssen Asia Pacific, Pte.Ltd.