Clinical and functional response to paliperidone palmitate in early schizophrenia–A retrospective observational study in newly diagnosed patients treated over a 12-month period

Abstract

Introduction

Data on clinical outcomes with long-acting antipsychotic treatment in young, newly diagnosed patients with schizophrenia is sparse.

Objectives

To explore hospitalization, drug utilization and clinical outcomes from medical records of newly diagnosed schizophrenia patients during first 12 months of treatment with once-monthly paliperidone palmitate (PP).

Methods

International, multicenter, retrospective, observational study. Outcomes presented: baseline (BL) characteristics and demographics, clinically relevant improvements in disease severity (ie ≥ 20% decrease in PANSS or BPRS total score or CGI-S Change ≥ −2 or CGI-C ≥ 3, with no score showing worsening) and clinically relevant functional improvement (i.e. change in PSP total score ≥ +7 points or change in GAF total score ≥ +20 points, with no score showing worsening) from BL to last-observation-carried-forward endpoint (LOCF-EP) within 12-month documentation period, mean mode PP dose and adverse drug reactions.

Results

Eighty-four patients analyzed: 69% male, mean age at initiation of PP was 24.1 (SD2.7) years, mean BL weight was 78.7 (SD16.0) kg and 80.0 (SD14.7) kg at LOCF-EP, with a mean change of 1.2 (SD3.9) kg; mean time from first psychotic episode to initiation of PP was 5.5 (SD3.3) months. At LOCF-EP 86.6% achieved a clinically relevant improvement (71/84, Kaplan-Meier median time from initiation of PP: 52.4 days). 63.4% achieved a clinically relevant functional improvement (52/84, Kaplan-Meier median time from initiation of PP: 53.1 days). PP mean mode maintenance dose was 96.4 (SD19.8) mg. ADRs reported in ≥ 5% of patients were weight increase 9.1% and hyperprolactinemia 5.7%.

Conclusions

Treatment with once-monthly PP was well tolerated and associated with clinically relevant improvements in disease severity and functioning in young, newly diagnosed schizophrenia patients.

Disclosure of interest

The authors have not supplied their declaration of competing interest.