Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation

Abstract

Purpose: Long-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.

Methods: A 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.

Results: At 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.

Conclusion: Patients 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.

Keywords: double-blind treatment; long-acting injectable; symptomatic remission.

Conflict of interest statement

Disclosure Nash, Turkoz, Savitz, Mathews, and Kim are employees of Janssen (a Johnson & Johnson company) and hold stock in Johnson & Johnson. The authors report no other conflicts of interest in this work.

Figures

Figure 1

Predicted probabilities of remission using the univariate model for each significant predictor of remission: (A) PANSS Marder negative symptom factor, (B) CGI-S, and (C) PSP total score.a Notes:aSolid lines with 95% CI bands show predicted probability of remission. Markers at Y=0 (no remission) and Y=1 (remission) list actual observations. Abbreviations: CGI-S, Clinical Global Impression-Severity; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance.

Figure 2

Variables predicting achievement of remission with PP3M during the double-blind treatment phase (multivariate analyses). Notes:aScoring direction is reversed for the variable. OR indicates that 1-point decrease in the scale score increases odds of achieving remission by corresponding unit in x-axis. Abbreviations: CGI-S, Clinical Global Impression-Severity; PANSS, Positive and Negative Syndrome Scale; PP3M, paliperidone palmitate 3-month formulation; PSP, Personal and Social Performance.