Caregiver burden in schizophrenia following paliperidone palmitate long acting injectables treatment: pooled analysis of two double-blind randomized phase three studies

Srihari Gopal,Haiyan Xu,Kimberly Woodruff,Adam Savitz,Isaac Nuamah,Maju Mathews,Kelly Mcquarrie

doi:10.1038/s41537-017-0025-5

Srihari Gopal, Haiyan Xu + Show 5 more

Open Access

https://doi.org/10.1038/s41537-017-0025-5

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Journal: npj Schizophrenia	Publication Date: Jul 27, 2017
Citations: 27	License type: open-access

Affiliation: Janssen (United States)

Abstract

The pooled analysis of two double-blind, randomized, multicenter, phase-3 studies evaluated predictors of improvement or worsening of schizophrenia-related caregiver burden following paliperidone palmitate long-acting injectables (1-monthly [PP1M] and 3-monthly [PP3M]) treatment. Caregivers were offered to complete the involvement evaluation questionnaire (involvement evaluation questionnaire; 31-item scale). Total, 1498 caregivers (intent-to-treat open-label analysis set, n = 1497; mean [SD] age: 51.5 [13.02] years, 27 countries) were included: 49% were parents and >50% caregivers spent >32 hours/week in caregiving. Majority of caregivers with considerable burden (n = 1405; mean [SD] baseline involvement evaluation questionnaire scores: 28.4 [15.07]) improved significantly from baseline to end-of-study (n = 756; mean [SD] change from open-label baseline to double-blind endpoint in long-acting injectable scores:−8.9 [14.73]); most improvements were seen in urging followed by worrying, tension, and supervision domains (mean [SD] change from open-label baseline to double-blind endpoint in involvement evaluation questionnaire scores, urging: −3.7 [6.45]; worrying:−2.6 [5.11]; tension:−2.3 [4.84]; supervision: −1.3 [3.69]). Improvements significantly correlated with relapse status, patient age, and age of diagnosis (p < 0.001) while long-acting injectable use at baseline, number, and duration of prior psychiatric hospitalizations (<24 months) had no significant correlation. Caregiver burden was significantly improved for patients on prior oral antipsychotics post-switching to long-acting injectable, with less impact on leisure days and hours spent in caregiving (p < 0.001). Family members of patients with schizophrenia experience considerable caregiver burden. Switching from oral antipsychotic to long-acting injectable can provide meaningful and significant improvement in caregiver burden.

Highlights

Caregiver burden in schizophrenia is significant, though often underestimated.[1]
A systematic review for the global population with schizophrenia stated that the annual cost per country ranges from US$94 million to US$102 billion; of which indirect cost is 50–85%
In this study we analyzed data from two large DB, randomized, multicenter, phase 3 studies to assess the role of 2 long-acting injectable (LAI) formulations of paliperidone, PP1M and paliperidone palmitate 3-monthly (PP3M), in alleviating caregiver burden in schizophrenia

Summary

Introduction

Caregiver burden in schizophrenia is significant, though often underestimated.[1] Studies demonstrated that in western countries, about 25–50% patients with schizophrenia live with their caregivers and depend on their assistance. In Asian countries, patient dependency on caregivers is as high as 70%.2. This burden causes increased work load, sleep disturbance, financial problems, and decreased leisure hours for caregivers.[1] A systematic review for the global population with schizophrenia stated that the annual cost per country ranges from US$94 million to US$102 billion; of which indirect cost (monetary loss due to missed working hours, decreased productivity at work, unemployment, disability and early retirement for patients, family members, and caregivers) is 50–85%.

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