Health care resource use analysis of paliperidone palmitate 3 month injection from two phase 3 clinical trials

Abstract

Objective: The objective of this study was to compare occupational status and health care resource use between treatment groups in clinical trials 3012 (PP3M versus placebo) and 3011 (PP3M versus PP1M).

Methods: Occupational status was assessed at each study visit. Logistic regressions modeled the probability of hospitalization during the double-blind phase.

Results: At the start of each study, a low percentage of patients were full-time employed or gainfully self-employed (approximately 10% in trial 3012 and 11%–13% in trial 3011). Improvement from baseline in occupational status was slightly higher in the PP3M group than in placebo or PP1M groups. The odds of a hospitalization for psychiatric and social reasons during 1 year was 7.74 (95% CI, 2.39–25.05; p < .001) for a patient on placebo compared with the odds of hospitalization during 1 year for a patient on PP3M. No statistically significant difference was observed between PP3M and PP1M (odds ratio, 1.16; 95% CI, 0.70–1.93). Very similar results were observed for hospitalizations due to psychiatric reasons only, within each trial.

Conclusions: In both trials, most patients were unemployed and not seeking work or were retired at open-label baseline, and only a small number of patients changed their occupational status during the trials. In trial 3012, subjects who received placebo had significantly higher odds of hospitalization for either psychiatric and social reasons or for psychiatric reasons alone compared with subjects who received PP3M. In contrast, in trial 3011, the odds of hospitalizations were not significantly different between PP3M and PP1M.

Keywords:

• Health care resources
• Logistic regression
• paliperidone palmitate
• schizophrenia

Transparency

Declaration of funding

This research was performed under a research contract between RTI Health Solutions and Janssen, and was sponsored by Janssen.

Author contributions: C.C. wrote the statistical analysis plan, performed the analyses, and wrote the first draft of the manuscript. I.N. was the statistician for the two individual studies, reviewed the statistical analysis plan for this project, assisted in interpretation of the results, and provided feedback on the manuscript. K.W. reviewed the statistical analysis plan, assisted in interpretation of the results, and provided feedback on the manuscript.

Declaration of financial/other relationships

K.W. has disclosed that she is an employee of Janssen Scientific Affairs. I.N. has disclosed that he is an employee of Janssen Research and Development. They own stock in Johnson and Johnson (Janssen Scientific Affairs and Janssen Research and Development are Johnson and Johnson companies). C.C. has disclosed that he is an employee of RTI Health Solutions, which received research funding from Janssen Pharmaceuticals in support of this work.

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

Acknowledgments

The authors gratefully acknowledge the contributions of Ed Kim of Janssen Pharmaceuticals, who reviewed and provided input on the Introduction section; of Beth Sherrill of RTI Health Solutions, who reviewed and provided input on the manuscript as a whole; and of Kate Lothman of RTI Health Solutions, who provided editorial suggestions..