Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia

Abstract

AimsPaliperidone palmitate 3-month (PP3M) represents a new long-acting injectable antipsychotic therapeutic option. This review aims: 1) to summarize available data relating to efficacy, safety, tolerability and costs of PP3M; 2) to describe hospitalization rate, occupational status, treatment preference, satisfaction, adherence and caregiver burden of patients with schizophrenia who participate in PP3M clinical trials; 3) to examine ethical implications, pros and cons of PP3M use and 4) to propose study designs to further assess PP3M.MethodsOn August 21, 2017, a search on PubMed about PPM3, without any filter restriction, was conducted and all available records were analyzed. Records written in a language other than English were excluded.ResultsTwenty-two records were included in this review: 6 reviews, 1 report, 4 pharmacokinetic studies, 2 cost-effectiveness analyses, 1 open-label clinical trial, 2 randomized controlled trials (RCTs), 5 studies based on these 2 RCTs and 1 observational study.DiscussionAccording to these last 9 studies, when compared with placebo, PP3M showed a longer time to relapse and good safety and tolerability profiles. Furthermore, when compared with paliperidone palmitate 1 month (PP1M), PP3M treatment showed: 1) non-inferiority in terms of efficacy, safety, tolerability, rate of hospitalization, symptomatic and functional remission, treatment preference and variations of the occupational status; 2) a longer time to relapse after treatment discontinuation and 3) a similar reduction of the caregiver burden.ConclusionPP3M is the only 3-monthly long-acting injectable antipsychotic available on the market. This makes it a unique option of treatment, which could be chosen both in early and advanced phases of illness. Nonetheless, longer naturalistic follow-up studies, two-arm head-to-head superiority trials and mirror studies, based on real-world samples of patients, are needed to further assess long-term safety and advantages of this new option of treatment and to define patients’ sub-populations that would most beneficiate from it.

Health Care Resource Utilization and Costs Associated with Transitioning to 3-month Paliperidone Palmitate Among US Veterans

“…23,34 In the same vein, tolerability outcomes were not reported in this study; however, tolerability has previously been reported in the literature via a multicenter, randomized clinical trial as well as various reviews. 23,40,41 Last, as is a limitation with all retrospective studies, other unobserved factors may have been unavailable from the data, potentially biasing our results. Despite these limitations, this is one of the first studies from the United States to show that transitioning from PP1M to PP3M was associated with reduced HRU and health care costs among veterans.…”

Patients’ perspectives on three-monthly administration of antipsychotic treatment with paliperidone palmitate – a qualitative interview study

“…Administration of paliperidone palmitate every third month (PP3M) is the longest injection interval available. It prolongs time to relapse compared to other paliperidone formulations [12], improves adherence and co-morbidity relapse [14], and is beneficial for the caregivers [15]. A three-monthly dosage was demonstrated to be non-inferior to administration once per month (PP1M), with a similar safety profile [12,15,16].…”

“…It prolongs time to relapse compared to other paliperidone formulations [12], improves adherence and co-morbidity relapse [14], and is beneficial for the caregivers [15]. A three-monthly dosage was demonstrated to be non-inferior to administration once per month (PP1M), with a similar safety profile [12,15,16]. Hence, PP3M seems to be an effective maintenance treatment for this patient group [17].…”

Transitioning from oral risperidone or paliperidone to once-monthly paliperidone palmitate: a real-world analysis among Veterans Health Administration patients with schizophrenia who have had at least one prior hospitalization

“…LAIs, such as PP1M, give patients and providers a better way to track medication administration since it must be administered by a medical provider. Patients will have to make an outpatient visit for administration, but may still have improved adherence (due to a sense of responsibility not to miss outpatient appointments for PP1M and the lack of the burden of remembering daily oral medications), which leads to better management of schizophrenia 30,31 . However, adherence is a multifaceted aspect of schizophrenia and there could be other factors that influence adherence (e.g.…”