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

Abigail I Nash,1 Ibrahim Turkoz,2 Adam J Savitz,2 Maju Mathews,2 Edward Kim1 1Janssen Scientific Affairs, LLC, Titusville, NJ 08560, USA; 2Janssen Research and Development, LLC, Titusville, NJ 08560, USA Purpose: Long-acting injectable (LAI) antipsychotic paliperidone palmitate 3-month formulation...

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Autores principales:	Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	long-acting injectable symptomatic remission double-blind treatment Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/3025c88861b842c99e87d7d9337f7271
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spelling	oai:doaj.org-article:3025c88861b842c99e87d7d9337f72712021-12-02T06:01:56ZPredictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation1178-2021https://doaj.org/article/3025c88861b842c99e87d7d9337f72712019-03-01T00:00:00Zhttps://www.dovepress.com/predictors-of-achieving-remission-in-schizophrenia-patients-treated-wi-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Abigail I Nash,1 Ibrahim Turkoz,2 Adam J Savitz,2 Maju Mathews,2 Edward Kim1 1Janssen Scientific Affairs, LLC, Titusville, NJ 08560, USA; 2Janssen Research and Development, LLC, Titusville, NJ 08560, USA 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: long-acting injectable, symptomatic remission, double-blind treatmentNash AITurkoz ISavitz AJMathews MKim EDove Medical Pressarticlelong-acting injectablesymptomatic remissiondouble-blind treatmentNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 15, Pp 731-737 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	long-acting injectable symptomatic remission double-blind treatment Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	long-acting injectable symptomatic remission double-blind treatment Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Nash AI Turkoz I Savitz AJ Mathews M Kim E Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
description	Abigail I Nash,1 Ibrahim Turkoz,2 Adam J Savitz,2 Maju Mathews,2 Edward Kim1 1Janssen Scientific Affairs, LLC, Titusville, NJ 08560, USA; 2Janssen Research and Development, LLC, Titusville, NJ 08560, USA 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: long-acting injectable, symptomatic remission, double-blind treatment
format	article
author	Nash AI Turkoz I Savitz AJ Mathews M Kim E
author_facet	Nash AI Turkoz I Savitz AJ Mathews M Kim E
author_sort	Nash AI
title	Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
title_short	Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
title_full	Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
title_fullStr	Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
title_full_unstemmed	Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
title_sort	predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/3025c88861b842c99e87d7d9337f7271
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Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation

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