Clinical effectiveness and resource utilization of paliperidone ER for schizophrenia: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry (PILAR)

Abstract

Objective:

To document prescribing patterns in clinical practice and assess long-term outcomes related to initiation of paliperidone ER and other oral antipsychotics among patients with schizophrenia in a naturalistic setting.

Research design and methods:

An international, non-interventional, naturalistic study of adult patients (≥18 years) with schizophrenia. Patients were assigned to the relevant treatment group (paliperidone ER or ‘all other oral antipsychotics’) after switching to, or initiating, oral antipsychotic treatment. Retrospective 12 month data collection was followed by 12 month prospective data collection, with 3-monthly assessments. The primary endpoint was time to all-cause discontinuation of new medication. Secondary endpoints included Clinical Global Impression–Severity (CGI-S) score, Clinical Global Impression–Schizophrenia (CGI-SCH) score, Personal and Social Performance (PSP) score, health-related quality of life (HR-QoL) and quality of sleep, evaluation of healthcare resource utilization and patient’s treatment satisfaction.

Results:

A total of 4051 patients were included in the intent-to-treat (ITT) analysis set. All-cause study discontinuation rates were comparable between the paliperidone ER group (16.8%) and the ‘all other oral antipsychotics’ group (15.5%). There was no difference in the time to discontinuation of newly initiated antipsychotic treatments between paliperidone ER and ‘all other oral antipsychotics’ groups. Paliperidone ER was associated with greater improvements from baseline to endpoint in both the PSP scale score (+14.2 vs +13.1, p = 0.041) and the physical component of quality of life (SF-12 Physical scores; +3.9 vs +2.9, p = 0.003) compared to ‘all other oral antipsychotics’. Improvements in mean CGI-S score, CGI-SCH score, HR-QoL, quality of sleep and daytime drowsiness, as well as patients’ treatment satisfaction were comparable between treatment groups. The incidence of adverse events was comparable between groups.

Conclusions:

This study provides valuable data on the prescribing habits and treatment outcomes associated with use of paliperidone ER in everyday clinical practice, and supports previous findings of the favorable functional improvement and treatment satisfaction associated with paliperidone ER.

Clinical trial registration:

NCT00696813; R076477SCH4015 (Register of German Association of Research-based Pharmaceutical Companies [VFA] http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb).

Keywords::

• Effectiveness
• Oral antipsychotics
• Paliperidone ER
• Schizophrenia

Transparency

Declaration of funding

This study was funded by Janssen Pharmaceutical Companies of Johnson & Johnson in Europe, Middle East & Africa (EMEA). All authors contributed to interpretation of the results, developed the draft of the manuscript, participated in subsequent revisions and read and approved the final manuscript.

Declaration of financial/other relationships

A.S. has disclosed that he is a full-time employee of Janssen-Cilag Medical & Scientific Affairs Europe, Middle East & Africa and a shareholder of Johnson & Johnson. K.H. and J.I.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. I.L. has disclosed that she has acted as a presenter on behalf of Janssen Cilag. A.H.S. has disclosed that he has received grants from and participated in research with Pfizer, Lundbeck, Janssen Cilag and Otsuka, acted as a presenter on behalf for: AstraZeneca, Eli Lilly, Lundbeck, Janssen Cilag, Sanofi Aventis and Servier as well as attended advisory board meetings for Pfizer and Otsuka. L.H. has disclosed that he is a full-time employee of Janssen-Cilag Medical & Scientific Affairs Europe, Middle East & Africa. J.D. has disclosed that he is a full-time employee of Janssen-Cilag Market Access Europe, Middle East & Africa.

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

Acknowledgments

Medical writing assistance with the preparation of this manuscript was provided by ApotheCom ScopeMedical and funded by Janssen EMEA.

The authors thank all the PILAR investigators and nurses, patients and their families for their participation in the registry. They also thank Angelika Mehnert for her contribution to the discussion and interpretation of the statistical analysis results.