Once-monthly injection of paliperidone palmitate in patients with recently diagnosed and chronic schizophrenia: a post-hoc comparison of efficacy and safety

ABSTRACT

Background: The use of long-acting injectable antipsychotics in recently diagnosed schizophrenia remains less explored. We evaluated the efficacy and safety of paliperidone palmitate once-monthly (PP1M) treatment in adult patients with recently diagnosed vs. chronic schizophrenia.

Research design and methods: These post-hoc analyses included two multicenter studies. Study 1 (NCT01527305) enrolled recently diagnosed (≤5 years) and chronic (>5 years) patients; Study 2 (NCT01051531) enrolled recently diagnosed patients only. Recently diagnosed patients were further sub-grouped into ≤2 years or 2–5 years. The primary efficacy endpoint was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score.

Results: In Study 1, 41.5% patients had recent diagnosis (≤2 years: 56.8%; 2–5 years: 43.2%); 58.5% had chronic schizophrenia. In Study 2, 52.8% and 47.2% patients were grouped into ≤2 years and 2–5 years, respectively. PANSS total score showed significantly greater improvement in patients with recently diagnosed vs. chronic schizophrenia. Similar results were obtained for PANSS responder rate, improvements in PANSS, and CGI-S scores.

Conclusion: PP1M was efficacious in both recently diagnosed and chronic schizophrenia, with the benefits being more pronounced in patients with recently diagnosed schizophrenia. This adds to growing evidence recommending long-acting antipsychotic interventions at early stages of schizophrenia.

KEYWORDS:

• Chronic schizophrenia
• clinical global impressions – severity (CGI-S)
• long-acting injectable
• paliperidone palmitate
• positive and negative syndrome scale (PANSS)
• recently diagnosed schizophrenia

Acknowledgments

The authors thank Dr. Ellen Baum (Janssen Research and Development, LLC) for additional editorial assistance in the preparation of this manuscript.

Declaration of interest

T Si has been a consultant and/or advisor to or has received honoraria and grant from Xian, Janssen, Pfizer, Lundbeck and Otsuka. Y Feng is an employee of Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore. J Zhuo is an employee of Janssen Research & Development, Shanghai, People’s Republic of China. I Turkoz is an employee of Janssen Research & Development, Titusville, NJ, USA. M Mathews is an employee of Janssen Research & Development, Titusville, NJ, USA. W Tan is an employee of Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore. Writing assistance, provided by Ramandeep Singh, Tata Consultancy Services, was utilized in the production of this manuscript and funded by Janssen Asia Pacific. 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.

Additional information

Funding

This paper was funded by Janssen Asia Pacific.