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Abstract
Background
Paliperidone palmitate once-monthly (PP1M) demonstrated symptomatic and functional remission in patients with schizophrenia. This post hoc analysis aimed to identify factors associated with improved clinical outcomes in patients switching to PP1M (75–150 mg eq.).
Methods
The improved patient outcomes were observed as Positive and Negative Symptom Scale (PANSS, symptoms) score <70:66.7% (407/610), Personal and Social Performance (PSP, function) score >70:34.3% (199/581), and Involvement Evaluation Questionnaire (IEQ, caregiver burden) reduction ≥6:50.2% (270/538). Independent variables including demographics, disease duration, employment status, and clinical scores were screened individually using a univariate analysis and subsequently, variables (cutoff p<0.15) were analyzed using a multivariate regression analysis for association with better clinical outcomes at week 13.
Results
The factors significantly associated with favorable clinical outcomes were reduction in PANSS at week 5 (odds ratio [OR]=1.14, 95% CI=1.11–1.17) with symptom reduction; baseline PSP total score (OR=1.07, 95% CI=1.05–1.10), PSP change at week 5 (OR=1.07, 95% CI=1.05–1.10), PANSS reduction at week 5 (OR=1.06, 95% CI=1.03–1.08) with functional improvement, reduction in PANSS at week 5 (OR=1.02, 95% CI=1.01–1.03), and total IEQ score at baseline (OR=1.09, 95% CI=1.07–1.11) with caregiver burden reduction.
Conclusion
Thus, symptom and functional improvements with caregiver burden reduction were observed in patients, and PANSS reduction at week 5 was commonly associated with favorable outcomes.
Supplementary materials
The following variables were included in the multivariate logistic regression analysis for PANSS<70
Disease duration (>3 years vs ≤3 years)
Dose of the third injection (75 mg eq.(1), 100 mg eq.(2), 150 mg eq.(3)) (Dummy variables in which “150 mg eq.” was considered as reference)
MARS total score at baseline
MSQ score of patients at baseline
CGI score at baseline
PSP total score at baseline
PSP change at week 5 LOCF
PANSS total score at baseline
PANSS reduction at week 5 LOCF
The following variables were included in the multivariate logistic regression analysis for PSP>70
Employed status (full employment(1), temporarily employed(2), unemployed/almost unemployed(3)) (Dummy variables in which full employment was considered as reference)
Disease duration (>3 years vs ≤3 years)
Dose of the third injection (75 mg eq.(1), 100 mg eq.(2), 150 mg eq.(3)) (Dummy variables in which “150 mg eq.” was considered as reference)
CGI score at baseline
IEQ total score at baseline
PSP total score at baseline
PSP change at week 5 LOCF
PANSS total score at baseline
PANSS reduction at week 5 LOCF
The following variables were included in the multivariate logistic regression analysis for IEQ reduction ≥6 (five classification data)
Disease duration (>3 years vs ≤3 years)
MARS total score at baseline
CGI score at baseline
IEQ total score at baseline
PSP total score at baseline
PANSS total score at baseline
PANSS reduction at week 5 LOCF
Abbreviations: CGI, Clinical Global Impression Scale; IEQ, Involvement Evaluation Questionnaire; LOCF, last observation carried forward; MARS, Medication Adherence Rating Scale; MSQ, Medication Satisfaction Questionnaire; PANSS, Positive and Negative Symptom Scale; PSP, Personal and Social Performance.
Table S1 Factors associated with better clinical outcome: PANSS score <70 (weeks 13, LOCF, univariate logistic regression analysis)
Table S2 Factors associated with better clinical outcome: PSP total score >70 (week 13, LOCF, univariate logistic regression analysis)
Table S3 Factors associated with better clinical outcome: IEQ reduction ≥6 (week 13, LOCF, univariate logistic regression analysis)
Acknowledgments
Dr Sonia Philipose (SIRO Clinpharm Pvt. Ltd.) provided writing assistance and Dr Ellen Baum (Janssen Research and Development, LLC) provided additional editorial support for this manuscript. The authors also thank the study participants, without whom this study would never have been accomplished, and the investigators for their participation in this study. This study was supported by funding from Janssen Research and Development, People’s Republic of China.
Author contributions
YF and TMS were involved in study design and NL, TMS, and YF were the lead scientists for the study, contributing to analysis of samples and data interpretation. YF, TMS, HFL, LLZ, and SLC were clinical leads for the study, and were also involved in data interpretation. JMZ and NL were the project statisticians. All authors had access to the study data, contributed to the data interpretation for the results, provided direction and comments on the manuscript, made the final decision about where to publish these data, and approved submission to the journal.
Disclosure
Nan Li has been a consultant and/or advisor to Janssen Research and Development (Beijing), Lundbeck, Astellas, Sanofi, Merck Serono, and Hisun Pfizer. He received honoraria and/or grant support from Janssen Research and Development (Beijing), Lundbeck, Astellas, Sanofi, Merck Serono, and Hisun Pfizer. Tianmei Si has been a consultant and/or advisor to Janssen Research and Development (Beijing); Pfizer, Lundbeck, and Otsuka. She received honoraria and/ or grant support from Janssen Research and Development (Beijing), Lundbeck, Pfizer, and Otsuka. Jianmin Zhuo is from Janssen Research and Development, Shanghai, People’s Republic of China. Feng Yu, Zhang Lili, and Huafei Lu are from Janssen Research and Development, Beijing, People’s Republic of China. Shang Li Cai was an employee of Janssen Research and Development, Beijing, People’s Republic of China at the time of this analysis. The authors report no other conflicts of interest in this work.