<p>Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation</p>

Abstract

PurposeLong-acting injectable (LAI) antipsychotic paliperidone palmitate 3-month formulation (PP3M) is indicated in the United States for the treatment of schizophrenia only after adequate treatment with paliperidone palmitate 1-month formulation (PP1M) for ≥4 months. This analysis aimed to identify patient and disease characteristics during PP1M treatment associated with greater likelihood of achieving remission after transition to PP3M.MethodsA post hoc analysis of a randomized, Phase III, double-blind, noninferiority trial of PP3M vs PP1M (ClinicalTrials.gov identifier: NCT01515423) was conducted in adult patients with schizophrenia. Patients achieving clinical stability after 17 weeks of open-label PP1M were randomized to 48 weeks of double-blind treatment with PP3M or PP1M. The primary objective of this exploratory post hoc analysis was to identify demographic and/or clinical variables associated with persistent remission after treatment with PP3M. Multiple logistic regression analysis identified the following significant predictors of remission: Positive and Negative Syndrome Scale (PANSS) Marder negative symptom factor score, Clinical Global Impression-Severity (CGI-S) total score, and Personal and Social Performance (PSP) total score.ResultsAt double-blind baseline, a 1-point reduction in Marder negative symptom factor score was associated with a 20% increase in the odds of achieving remission after PP3M treatment; 1-point reduction in CGI-S was associated with a doubling in remission odds; and 7- and 10-point improvements in PSP scores, respectively, were associated with 42% and 65% increases in remission odds.ConclusionPatients with early clinically meaningful improvements in disease symptoms and severity while establishing stable PP1M dosage are more likely to achieve remission after transition to PP3M.

Paliperidone Palmitate Every Three Months (PP3M) 2-Year Treatment Compliance, Effectiveness and Satisfaction Compared with Paliperidone Palmitate-Monthly (PP1M) in People with Severe Schizophrenia

“…Another research [ 25 ] identified patient and disease characteristics during PP1M treatment associated with greater likelihood of achieving remission after transition to PP3M. Patients with early clinically meaningful improvements in disease symptoms and severity while establishing stable PP1M dosage were more likely to achieve remission after transition to PP3M.…”

Factors predicting relapse and treatment discontinuation with paliperidone 3-monthly long-acting injection: A 2-year naturalistic follow-up study

“…Given that they were switched to the same drug, we can assume that the reason for the switch was not related to paliperidone itself, but rather the formulation and the frequency of its use. In conventional trials, PP1M and PP3M have near identical efficacy and tolerability [18].…”

Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting

“…The Clinical Anti-psychotic Trials of Intervention Effectiveness (CATIE) study reported that over 70% of patients discontinued oral medications within 1.5 years as a result of medication-related factors such as adverse events and lack of perceived efficacy [ 32 ]. Importantly, non-adherence contributes to disease relapse [ 1 , 7 , 32 ], higher rates of psychiatric rehospitalization [ 2 , 10 , 33 , 34 ], and increased need for ER visits [ 33 , 34 ]. The high treatment completion rate in our study suggests good adherence, which may have translated to the high symptomatic remission rate (71%) and low hospitalization (1%) and ER visit rates (3%) after 12 months of PP3M treatment.…”

“…Symptomatic remission is an important milestone in the management of schizophrenia [ 1 ]. Without adequate symptom control, patients continue to suffer from disruptions in lifestyle, productivity and an increased risk of hospitalization [ 1 ].…”

“…Symptomatic remission is an important milestone in the management of schizophrenia [ 1 ]. Without adequate symptom control, patients continue to suffer from disruptions in lifestyle, productivity and an increased risk of hospitalization [ 1 ]. While antipsychotic medications are effective for managing schizophrenia [ 2 ], prevalent non-adherence amongst patients with schizophrenia renders symptomatic remission difficult to achieve [ 3 ].…”