Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate

Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate

Amy O’Donnell,1 Sanjai Rao,2 Ibrahim Turkoz,3 Srihari Gopal,3 Edward Kim1 1Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA; 3Janssen Research and Development, LLC, Titusville, NJ, USACorrespondence: Ibr...

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Autores principales: O'Donnell A, Rao S, Turkoz I, Gopal S, Kim E
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2021
Materias:
treatment outcome
administration and dosage
neuropsychiatric symptoms
psychosocial functioning
stabilization
long-acting injectable antipsychotic
Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
Acceso en línea:https://doaj.org/article/f89da546a30f434ab68aa7b9d669cd90
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spelling oai:doaj.org-article:f89da546a30f434ab68aa7b9d669cd902021-12-02T11:55:28ZDefining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate1178-2021https://doaj.org/article/f89da546a30f434ab68aa7b9d669cd902021-01-01T00:00:00Zhttps://www.dovepress.com/defining-ldquoadequately-treatedrdquo-a-post-hoc-analysis-examining-ch-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Amy O’Donnell,1 Sanjai Rao,2 Ibrahim Turkoz,3 Srihari Gopal,3 Edward Kim1 1Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA; 3Janssen Research and Development, LLC, Titusville, NJ, USACorrespondence: Ibrahim TurkozJanssen Research and Development, LLC, Titusville, NJ, USATel +1 609-730-7719Fax +1 609-730-3232Email iturkoz@its.jnj.comPurpose: Paliperidone palmitate once every 3 months (PP3M) is indicated in adults with schizophrenia adequately treated with once-monthly paliperidone palmitate (PP1M) for at least 4 months, in whom the last two consecutive doses are the same. The decision of when to transition to PP3M is based on the patient’s symptom status while receiving PP1M.Patients and Methods: In a double-blind relapse–prevention study (NCT01529515), patients who met Positive and Negative Syndrome Scale (PANSS) score stabilization criteria after 4 months of PP1M were eligible for transition to PP3M; those who continued to meet stabilization criteria after 12 weeks following an open-label PP3M dose were randomized to receive PP3M or placebo. We compared (post hoc) PANSS, Clinical Global Impression–Severity (CGI-S), and Personal and Social Performance (PSP) scores during the pre-randomization, open-label phase in patients in randomized versus non-randomized groups using analysis of variance or chi-square tests.Results: Of 506 patients enrolled, 305 were randomized. After 4 months’ PP1M treatment, PANSS and CGI-S scores were significantly lower and PSP scores significantly higher in randomized patients versus non-randomized patients (least squares means [95% CI]: 57.1 [55.7, 58.6] vs 62.2 [60.0, 64.3], 2.9 [2.8, 3.1] vs 3.3 [3.1, 3.4], and 67.0 [65.7, 68.3] vs 64.5 [62.6, 66.4], respectively); changes from baseline between groups differed significantly (all P ≤ 0.009).Conclusion: Confirming adequate stabilization with PP1M prior to transitioning to PP3M is critical in maximizing treatment response; clinicians should consider transitioning patients to PP3M only if patients respond well to PP1M for at least 4 months and their last two consecutive doses are the same.Keywords: treatment outcome, administration and dosage, neuropsychiatric symptoms, psychosocial functioning, stabilization, long-acting injectable antipsychoticO'Donnell ARao STurkoz IGopal SKim EDove Medical Pressarticletreatment outcomeadministration and dosageneuropsychiatric symptomspsychosocial functioningstabilizationlong-acting injectable antipsychoticNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 17, Pp 1-9 (2021)
institution DOAJ
collection DOAJ
language EN
topic treatment outcome
administration and dosage
neuropsychiatric symptoms
psychosocial functioning
stabilization
long-acting injectable antipsychotic
Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
spellingShingle treatment outcome
administration and dosage
neuropsychiatric symptoms
psychosocial functioning
stabilization
long-acting injectable antipsychotic
Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
O'Donnell A
Rao S
Turkoz I
Gopal S
Kim E
Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate
description Amy O’Donnell,1 Sanjai Rao,2 Ibrahim Turkoz,3 Srihari Gopal,3 Edward Kim1 1Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA; 3Janssen Research and Development, LLC, Titusville, NJ, USACorrespondence: Ibrahim TurkozJanssen Research and Development, LLC, Titusville, NJ, USATel +1 609-730-7719Fax +1 609-730-3232Email iturkoz@its.jnj.comPurpose: Paliperidone palmitate once every 3 months (PP3M) is indicated in adults with schizophrenia adequately treated with once-monthly paliperidone palmitate (PP1M) for at least 4 months, in whom the last two consecutive doses are the same. The decision of when to transition to PP3M is based on the patient’s symptom status while receiving PP1M.Patients and Methods: In a double-blind relapse–prevention study (NCT01529515), patients who met Positive and Negative Syndrome Scale (PANSS) score stabilization criteria after 4 months of PP1M were eligible for transition to PP3M; those who continued to meet stabilization criteria after 12 weeks following an open-label PP3M dose were randomized to receive PP3M or placebo. We compared (post hoc) PANSS, Clinical Global Impression–Severity (CGI-S), and Personal and Social Performance (PSP) scores during the pre-randomization, open-label phase in patients in randomized versus non-randomized groups using analysis of variance or chi-square tests.Results: Of 506 patients enrolled, 305 were randomized. After 4 months’ PP1M treatment, PANSS and CGI-S scores were significantly lower and PSP scores significantly higher in randomized patients versus non-randomized patients (least squares means [95% CI]: 57.1 [55.7, 58.6] vs 62.2 [60.0, 64.3], 2.9 [2.8, 3.1] vs 3.3 [3.1, 3.4], and 67.0 [65.7, 68.3] vs 64.5 [62.6, 66.4], respectively); changes from baseline between groups differed significantly (all P ≤ 0.009).Conclusion: Confirming adequate stabilization with PP1M prior to transitioning to PP3M is critical in maximizing treatment response; clinicians should consider transitioning patients to PP3M only if patients respond well to PP1M for at least 4 months and their last two consecutive doses are the same.Keywords: treatment outcome, administration and dosage, neuropsychiatric symptoms, psychosocial functioning, stabilization, long-acting injectable antipsychotic
format article
author O'Donnell A
Rao S
Turkoz I
Gopal S
Kim E
author_facet O'Donnell A
Rao S
Turkoz I
Gopal S
Kim E
author_sort O'Donnell A
title Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate
title_short Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate
title_full Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate
title_fullStr Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate
title_full_unstemmed Defining “Adequately Treated”: A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate
title_sort defining “adequately treated”: a post hoc analysis examining characteristics of patients with schizophrenia successfully transitioned from once-monthly paliperidone palmitate to once-every-3-months paliperidone palmitate
publisher Dove Medical Press
publishDate 2021
url https://doaj.org/article/f89da546a30f434ab68aa7b9d669cd90
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