Back to Journals » Neuropsychiatric Disease and Treatment » Volume 15

Long-term efficacy and safety of paliperidone palmitate once-monthly in Chinese patients with recent-onset schizophrenia

Authors Si T, Zhuo J, Feng Y, Lu H, Hong D, Zhang LL

Received 23 October 2018

Accepted for publication 2 April 2019

Published 27 June 2019 Volume 2019:15 Pages 1685—1694

DOI https://doi.org/10.2147/NDT.S191803

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Andrew Yee

Peer reviewer comments 2

Editor who approved publication: Professor Jun Chen


Tianmei Si,1,2 Jianmin Zhuo,3 Yu Feng,4 Huafei Lu,5 Di Hong,5 Lili Zhang5

1National Clinical Research Center for Mental Disorders & The Key Laboratory of Mental Health, Ministry of Health (Peking University), Beijing, People’s Republic of China; 2Peking University Institute of Mental Health/The Sixth Hospital, Beijing, People’s Republic of China; 3Janssen (China) Research & Development Center, Johnson & Johnson (China) Investment Ltd., Shanghai, People’s Republic of China; 4Department of Neuroscience, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore; 5Medical Affairs, Xi’an Janssen Pharmaceuticals, Beijing, People’s Republic of China

Background: The subgroup analysis of a primary study (NCT01051531) evaluated the effect of long-term paliperidone palmitate once-monthly (PP1M) therapy in Chinese patients with recent-onset schizophrenia responding unsatisfactorily to previous oral antipsychotics.
Patients and methods: This 18-month, open-label study consisted of 3 phases – screening (7 days), treatment (18 months) and end-of-study/withdrawal visit. All enrolled patients (18–50 years) received PP1M: 150 mg eq. (day 1), 100 mg eq. (day 8) followed by a once-monthly flexible dose (50, 75, 100 or 150 mg eq.). Efficacy and safety were assessed.
Results: Among the 118 enrolled Chinese patients, 68 completed the treatment (mean age: 25.6 years; male: 54.7%). A clinically meaningful change from baseline to day 548 was observed in Positive and Negative Syndrome scale (primary endpoint, mean [SD]: −15.3 [20.76]), Personal and Social Performance scale (15.9 [19.65]), Clinician Global Impression-schizophrenia score (−1.2 [1.54]) and Medication Satisfaction Questionnaire score (0.9 [1.73]). Commonly reported treatment-emergent adverse events (TEAEs) included insomnia (13.9%), injection-site pain (13.9%), upper respiratory tract infection (13.0%), restlessness (13.0%) and akathisia (13.0%). Serious TEAEs were reported in 9.3% patients with schizophrenia being most common (6.5%) and one death (suicide) was observed.
Conclusion: Efficacy of PP1M corroborate findings from earlier studies and no new safety concerns emerged in this Chinese subgroup of patients with schizophrenia.

Keywords: Chinese patients, long-acting injectable, maintenance therapy, paliperidone palmitate once-monthly, schizophrenia

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]