Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies

Maju Mathews,1 Srihari Gopal,2 Arun Singh,3 Isaac Nuamah,4 Katalin Pungor,5 Wilson Tan,6 Bernardo Soares,7 Edward Kim,8 Adam J Savitz2 1Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2Department of Neuroscience, Janssen Research & Development, LLC,...

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Autores principales:	Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	long-acting injectables relapse prevention schizophrenia oral paliperidone extended release paliperidone palmitate once monthly paliperidone palmitate three monthly Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/f4725d040b5f44bab2cab8cb43f06574
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spelling	oai:doaj.org-article:f4725d040b5f44bab2cab8cb43f065742021-12-02T08:59:47ZComparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies1178-2021https://doaj.org/article/f4725d040b5f44bab2cab8cb43f065742020-06-01T00:00:00Zhttps://www.dovepress.com/comparison-of-relapse-prevention-with-3-different-paliperidone-formula-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Maju Mathews,1 Srihari Gopal,2 Arun Singh,3 Isaac Nuamah,4 Katalin Pungor,5 Wilson Tan,6 Bernardo Soares,7 Edward Kim,8 Adam J Savitz2 1Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA; 3Department of Neuroscience, Janssen Research & Development, LLC, Pennington, PA, USA; 4Clinical Biostatistics, Janssen Research & Development, LLC, Titusville, NJ, USA; 5Medical Affairs, Janssen-Cilag GmbH, Neuss, North Rhine-Westphalia, Germany; 6Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore; 7Medical Affairs, Jan-Cil, High Wycombe, Buckinghamshire, UK; 8Janssen Scientific Affairs, Janssen Scientific Affairs, LLC, Titusville, NJ, USACorrespondence: Maju MathewsGlobal Medical Affairs, Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, USATel +1 609 433-9257Email mmathe20@its.jnj.comBackground: Sudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents.Objective: To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables).Methods: Data from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed.Results: In total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M PP1M (172 days [134– 222 days])> paliperidone ER (58 days [42– 114 days]) and was “not-estimable” in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P< 0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P< 0.001]).Conclusion: The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence.Clinical trial registration: paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515).Keywords: relapse prevention, schizophrenia, oral paliperidone extended release, paliperidone palmitate once monthly, paliperidone palmitate three monthlyMathews MGopal SSingh ANuamah IPungor KTan WSoares BKim ESavitz AJDove Medical Pressarticlelong-acting injectablesrelapse preventionschizophreniaoral paliperidone extended releasepaliperidone palmitate once monthlypaliperidone palmitate three monthlyNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 16, Pp 1533-1542 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	long-acting injectables relapse prevention schizophrenia oral paliperidone extended release paliperidone palmitate once monthly paliperidone palmitate three monthly Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	long-acting injectables relapse prevention schizophrenia oral paliperidone extended release paliperidone palmitate once monthly paliperidone palmitate three monthly Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Mathews M Gopal S Singh A Nuamah I Pungor K Tan W Soares B Kim E Savitz AJ Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies
description	Maju Mathews,1 Srihari Gopal,2 Arun Singh,3 Isaac Nuamah,4 Katalin Pungor,5 Wilson Tan,6 Bernardo Soares,7 Edward Kim,8 Adam J Savitz2 1Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA; 3Department of Neuroscience, Janssen Research & Development, LLC, Pennington, PA, USA; 4Clinical Biostatistics, Janssen Research & Development, LLC, Titusville, NJ, USA; 5Medical Affairs, Janssen-Cilag GmbH, Neuss, North Rhine-Westphalia, Germany; 6Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore; 7Medical Affairs, Jan-Cil, High Wycombe, Buckinghamshire, UK; 8Janssen Scientific Affairs, Janssen Scientific Affairs, LLC, Titusville, NJ, USACorrespondence: Maju MathewsGlobal Medical Affairs, Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, USATel +1 609 433-9257Email mmathe20@its.jnj.comBackground: Sudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents.Objective: To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables).Methods: Data from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed.Results: In total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M PP1M (172 days [134– 222 days])> paliperidone ER (58 days [42– 114 days]) and was “not-estimable” in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P< 0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P< 0.001]).Conclusion: The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence.Clinical trial registration: paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515).Keywords: relapse prevention, schizophrenia, oral paliperidone extended release, paliperidone palmitate once monthly, paliperidone palmitate three monthly
format	article
author	Mathews M Gopal S Singh A Nuamah I Pungor K Tan W Soares B Kim E Savitz AJ
author_facet	Mathews M Gopal S Singh A Nuamah I Pungor K Tan W Soares B Kim E Savitz AJ
author_sort	Mathews M
title	Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies
title_short	Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies
title_full	Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies
title_fullStr	Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies
title_full_unstemmed	Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies
title_sort	comparison of relapse prevention with 3 different paliperidone formulations in patients with schizophrenia continuing versus discontinuing active antipsychotic treatment: a post-hoc analysis of 3 similarly designed randomized studies
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/f4725d040b5f44bab2cab8cb43f06574
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Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies

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