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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| Format: | Article |
| Language: | English |
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Dove Medical Press
2019-03-01
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| Series: | Neuropsychiatric Disease and Treatment |
| Subjects: | |
| Online Access: | https://www.dovepress.com/predictors-of-achieving-remission-in-schizophrenia-patients-treated-wi-peer-reviewed-article-NDT |
| _version_ | 1818346043378499584 |
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| 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 |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-12-13T17:11:59Z |
| format | Article |
| id | doaj.art-3025c88861b842c99e87d7d9337f7271 |
| institution | Directory Open Access Journal |
| issn | 1178-2021 |
| language | English |
| last_indexed | 2024-12-13T17:11:59Z |
| publishDate | 2019-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Neuropsychiatric Disease and Treatment |
| spelling | doaj.art-3025c88861b842c99e87d7d9337f72712022-12-21T23:37:31ZengDove Medical PressNeuropsychiatric Disease and Treatment1178-20212019-03-01Volume 1573173744722Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulationNash AITurkoz ISavitz AJMathews MKim EAbigail 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 treatmenthttps://www.dovepress.com/predictors-of-achieving-remission-in-schizophrenia-patients-treated-wi-peer-reviewed-article-NDTlong-acting injectablesymptomatic remissiondouble-blind treatment |
| spellingShingle | Nash AI Turkoz I Savitz AJ Mathews M Kim E Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation Neuropsychiatric Disease and Treatment long-acting injectable symptomatic remission double-blind treatment |
| title | 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_short | 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 |
| topic | long-acting injectable symptomatic remission double-blind treatment |
| url | https://www.dovepress.com/predictors-of-achieving-remission-in-schizophrenia-patients-treated-wi-peer-reviewed-article-NDT |
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